Delving into the Latest Updates on Ciltacabtagene autoleucel with Synapse

RegulationPriority Review (United States), Breakthrough Therapy (United States), Orphan Drug (United States), Orphan Drug (European Union), PRIME (European Union), Breakthrough Therapy (China), Conditional marketing approval (China), Orphan Drug (South Korea), Conditional marketing approval (European Union), Orphan Drug (United Kingdom), Special Review Project (China), Priority Review (China)

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Structure/Sequence

Sequence Code 13031374

Source: *****

This phase II trial tests how well giving dasatinib and quercetin with cyclophosphamide, fludarabine and chimeric antigen receptor (CAR)-T cell therapy works in treating patients with multiple myeloma that has come back after a period of improvement (relapsed) or that has not responded to previous treatment (refractory). Dasatinib is in a class of medications called tyrosine kinase inhibitors. It works by blocking the action of an abnormal protein that signals cancer cells to multiply, which may help keep cancer cells from growing. Quercetin is a compound found in plants that may prevent multiple myeloma from forming. Chemotherapy such as cyclophosphamide and fludarabine are given to help kill any remaining cancer cells in the body and to prepare the bone marrow for CAR-T therapy. Chimeric antigen receptor T-cell Therapy is a type of treatment in which a patient's T cells (a type of immune system cell) are changed in the laboratory so they will attack cancer cells. T cells are taken from a patient's blood. Then the gene for a special receptor that binds to a certain protein on the patient's cancer cells is added to the T cells in the laboratory. The special receptor is called a chimeric antigen receptor. Large numbers of the CAR T cells are grown in the laboratory and given to the patient by infusion for treatment of certain cancers. Giving dasatinib and quercetin with cyclophosphamide, fludarabine and CAR-T cell therapy may kill more cancer cells in patients with relapsed or refractory multiple myeloma.

Start Date23 Jun 2025

Sponsor / Collaborator

Mayo Clinic

[+1]

NCT06855121

/ RecruitingNot ApplicableIIT

The Norwegian Immunotherapy in Multiple Myeloma Study - A Population-based Longitudinal Observational Multicenter Study on Effectiveness and Complications of Immunotherapy in Multiple Myeloma in the Norwegian Myeloma Cohort

The goal of this observational study is to study the effectiveness and complications of novel immunotherapies used in the treatment of multiple myeloma in routine care in Norway. The aim is to close knowledge gaps, generate evidence for future clinical trials and contribute to future consensus on how to monitor for adverse events, and what mitigation strategies should be implemented, so that we can increase patient survival and quality-of-life.

Start Date15 Jan 2025

Sponsor / Collaborator

St. Olavs Hospital HF

[+9]

NCT06623630

/ RecruitingPhase 1IIT

A Pilot Safety and Feasibility Study of Lymphodepleting Total Body Irradiation (TBI) Plus Cyclophosphamide Prior to Ciltacabtagene Autoleucel (Carvykti; Cilta-cel) for Multiple Myeloma (MM) Patients With Impaired Renal Function

Treatment for relapsed/refractory multiple myeloma continues to evolve with the approval of highly effective anti-BCMA CAR T therapies in recent years. However, despite the high prevalence of renal insufficiency in this population, pivotal clinical trials have excluded patients with impaired renal function, leading to an urgent, unmet clinical need to develop safe and effective lymphodepleting regimens prior to CAR T administration for this population. In addition, renal insufficiency is linked to poor disease-related outcomes and is highly associated with several underserved populations.
This study is testing the hypotheses that:
1. low-dose total body irradiation (TBI) in combination with cyclophosphamide (Cy) as lymphodepletion prior to administration of cilta-cel will be safe and tolerable in patients with multiple myeloma who have impaired renal function
2. low-dose TBI-Cy as lymphodepletion prior to cilta-cel will result in comparable CAR T expansion/persistence and disease response rates as those seen with standard lymphodepleting chemotherapy (fludarabine / cyclophosphamide).

Start Date04 Dec 2024

Sponsor / Collaborator

Washington University School of Medicine

[+2]

100 Clinical Results associated with Ciltacabtagene autoleucel

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100 Translational Medicine associated with Ciltacabtagene autoleucel

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100 Patents (Medical) associated with Ciltacabtagene autoleucel

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337

Literatures (Medical) associated with Ciltacabtagene autoleucel

31 Dec 2025·Hematology

BCMA CAR-T therapy as salvage therapy in patients with plasmablastic myeloma

Article

Author: Jin, Chengwei ; Zhu, Jun ; Li, Su ; Deng, Jing ; Kang, Liqing ; Jiang, Ying

OBJECTIVES:

Plasmablastic myeloma (PBM) is a variant of multiple myeloma associated with a poor prognosis. We investigated the efficacy and safety of B-cell maturation antigen (BCMA) chimeric antigen receptor T cell (CAR-T) therapy in patients with PBM.

METHODS:

The study comprised six patients diagnosed with PBM between January 1, 2023 and December 31, 2023. The patients received BCMA single-target CAR-T therapy or BMCA/CD19 dual-target CAR-T therapy, with some patients undergoing hematopoietic stem cell transplantation before treatment. The median patient age was 55.5 years (range, 41-63). Four patients exhibited high-risk cytogenetic abnormalities.

RESULTS:

The objective response rate (ORR) was 83.3%, with four of six patients achieving a complete response or better and three of six achieving a strigent complete response. Two patients exhibited progression-free survival (PFS) of at least 6 months, one of whom succumbed to a pulmonary infection, whereas four patients died of disease progression. Cytokine release syndrome (CRS) was observed in all patients, three of whom experienced grade 3-4 CRS. Two patients experienced grade 1-2 immune effector cell-associated neurotoxicity syndrome. There were no CRS-related deaths.

CONCLUSION:

BCMA CAR-T therapy was safe and effective as a salvage treatment for PBM, and its toxicity was controllable. Future research will examine the use of CAR-T therapy as part of combination regimens.

01 Dec 2025·Human Vaccines & Immunotherapeutics

The hotspots and publication trends in glioblastoma and CAR-T immunotherapy: A bibliometric analysis.

Article

Author: Xie, Yun ; Gu, Jingyu ; Song, Zhaoming ; Nong, Xun ; Chen, Zhouqing ; Guo, Yanao ; Yang, Chen ; Wang, Zhong ; Qu, Ruisi

In recent years, chimeric antigen receptor T cell (CAR-T) immunotherapy has made considerable progress in the treatment of glioblastoma. The aim of this study was to comprehensively explore the prospects and future trends of CAR-T immunotherapy for glioblastoma through systematic bibliometric analysis. Publications pertaining to glioblastoma and CAR-T immunotherapy from 2008 to 2024 were extracted from the Web of Science Core Collection. Utilizing VOSviewer (version 1.6.20), CiteSpace (version 6.3.R1), and R 4.3.3, this study concentrated on evaluating contributions from countries, institutions, authors, and journals, while also identifying research hotspots and emerging trends. A total of 570 publications were identified, demonstrating an annual growth rate of 31.71%. The USA led the field with 269 publications, followed by China (113). The University of Pennsylvania, Harvard University, and the University of California System emerged as the most prolific institutions. Frontiers in Immunology published the most articles (42), while Clinical Cancer Research garnered the highest number of citations (2,867). Recent keyword bursts (2022-2024) underscored an increasing focus on combination therapy approaches and outcomes, particularly emphasizing "radiotherapy" (strength 3.49), "solid tumor" (strength 3.49), and "efficacy" (strength 2.79). In recent years, research on CAR-T immunotherapy for glioblastoma has gradually shifted from the exploration of basic mechanisms to the application of clinical combination therapy, and this shift in research direction indicates that CAR-T immunotherapy has a relatively mature technology and great clinical translation potential. In the coming years, CAR-T immunotherapy is expected to usher in a golden era and benefit more patients suffering from glioblastoma.

14 Jul 2025·CURRENT OPINION IN ONCOLOGY

Chimeric antigen receptor T-cell therapy for multiple myeloma.

Article

Author: Liu, Lawrence ; Htut, Myo

PURPOSE OF REVIEW:

Chimeric antigen receptor T-cell therapy (CAR T) in relapsed, refractory multiple myeloma (RRMM) has rapidly expanded with two FDA-approved agents and many more in the clinical trial pipeline. As such, we aim to review the standard of care and investigational products.

RECENT FINDINGS:

Idecabtagene vicleucel (ide-cel) and ciltacabtagene autoleucel (cilta-cel) were initially approved in the fourth-line setting and quickly moved to the second-line and third-line settings due to efficacy. Delayed neurotoxicities remain a challenging entity to consider when deciding on CAR T versus other options. Given the high efficacy of cilta-cel, many trials are evaluating its role as frontline consolidation or even in smoldering myeloma. Many novel CAR T products are being studied and will improve the impressive armamentarium of RRMM therapeutics.

SUMMARY:

This is an exciting area with countless studies investigating novel CAR T constructs and sequencing in hopes of further extending and improving our patients' lives.

436

News (Medical) associated with Ciltacabtagene autoleucel

16 Jul 2025

·www.fiercepharma.com

J&J flexes $15B quarter for innovative drugs as biosimilars chip away at Stelara

Johnson & Johnson now expects to reel in between $92.7 billion to $93.1 billion in total sales for the year, a $2 billion increase compared with the guidance it provided in April. Leading up to the entry of the first Stelara biosimilars in the U.S. at the start of 2025, executives at Johnson & Johnson remained steadfast in their belief that the company could maintain revenue growth despite the blockbuster drug’s toppling over the patent cliff.Now, after setting an innovative medicines sales record in the year’s second quarter against the backdrop of that biosimilar erosion, it appears J&J’s confidence was well placed.For the first time, J&J’s global innovative medicines sales have reached more than $15 billion in a single quarter, the company noted (PDF) in a July 16 earnings presentation.That performance, buoyed by a slate of promising launches in oncology, immunology and neurology, contributed to a total companywide sales haul of $23.7 billion for the second quarter, nearly a 6% increase from the sum J&J recorded for the same period in 2024.J&J logged those gains despite sales of Stelara—which peaked at around $11 billion in 2023—plunging more than $1.2 billion year over year. For the second quarter, the inflammatory med posted worldwide sales of around $1.7 billion, down roughly 43% compared to its performance in 2024’s second quarter. “We had 13 brands that were growing double digits [in Q2], and as we take a look at those, the vast majority of those are not only our growth drivers for today and tomorrow but are also key growth drivers out through the end of the decade,” Jennifer Taubert, J&J’s executive vice president of innovative medicine, said on a conference call Wednesday.Taubert spotlighted the performance of cancer drugs like Darzalex, which grew sales 23% to $3.5 billion; Carvykti, which recorded sales of $439 million; and Erleada, which rose 23% to $908 million. She also noted that the company is “really pleased with the launch and uptake thus far” of Rybrevant plus Lazcluze, which won the FDA’s blessing last August to treat certain patients with newly diagnosed non-small cell lung cancer.Together, that performance bodes well for J&J’s overall ambitions in cancer, with CEO Joaquin Duato reiterating on the company’s earnings call that “[w]e expect to become the number one oncology company by 2030 with sales of more than $50 billion.”Beyond cancer, Taubert touted Tremfya’s “great start” in ulcerative colitis and Crohn’s disease, where the burgeoning immunology drug picked up FDA nods in September and March, respectively. Altogether, Tremfya—which is scooping up indications previously dominated by Stelara—grew sales 31% to $1.2 billion in the second quarter. Given the strong showing in the quarter, J&J now expects to reel in between $92.7 billion and $93.1 billion in total sales for the year, a $2 billion increase over the guidance it provided in April.Elsewhere, executives at the company praised the passing of President Donald Trump’s "big, beautiful bill," with Chief Financial Officer Joe Wolk noting that the law “provides certainty for a previously announced $55 billion commitment to invest here in the United States.”From J&J's perspective, Wolk spotlighted several favorable provisions in the bill, including “permanent expensing for domestic R&D spend, permanent bonus depreciation and 100% expensing of qualified production property, including our newly planned facility in North Carolina.”

Drug ApprovalBiosimilar

16 Jul 2025

·www.biospace.com

J&J Targets $50B Oncology Sales By 2030: Updated

iStock, yuelan Johnson & Johnson’s $23.7 billion in second-quarter earnings, driven by cancer and neuroscience drugs, exceeded analyst expectations, while CEO Joaquin Duato set a target of $50 billion in oncology sales by 2030. Johnson & Johnson’s oncology and neuroscience units more than offset pressures on other parts of the business to drive medicine sales up 4.9%, the company reported Wednesday morning, with CEO Joaquin Duato setting an ambitious five-year target for the oncology division. The New Jersey–based pharma posted global sales of $23.7 billion and diluted earnings per share of $2.29. J&J’s medicine unit accounted for $15.2 billion of the sales, with medtech products contributing the other $8.5 billion. Both units beat the consensus estimate of analysts, Leerink Partners analysts said in a note to investors Wednesday morning, with medicine sales coming in 4% above expectations. Medicines and devices both contributed to the beat-and-raise quarter. Jennifer Taubert, worldwide chairman, innovative medicine at J&J, said on an investor call Wednesday morning that a broad set of products drove the pharma unit’s growth. “If you take a look at the 90% of our business that is not Stelara, we actually had extraordinarily robust growth of 15.5%, really demonstrating the strength across our portfolio,” Taubert said. “We had 13 brands that were growing double digits.” Oncology and neuroscience were the standout performers. In oncology, J&J reported 24% growth, fueled by market share gains for multiple myeloma blockbuster Darzalex, prostate cancer drug Erleada and CAR T cell therapy Carvykti. J&J named the launches of the bispecific antibodies Tecvayli, Talvey and Rybrevant as additional growth drivers. The company aims to grow oncology sales to $50 billion by 2030, Duato said on the call. J&J’s forecast is at least three times above the 2028 consensus, Taubert said, naming bladder cancer candidate TAR-200 as the asset with “the biggest disconnect between our internal forecasts and what the Street expects.” In neuroscience, rising demand for the depression drug Spravato helped J&J grow sales by 15.1% on a reported basis. The company grew neuroscience sales despite the Medicare Part D redesign and an unfavorable patient mix depressing sales of drugs including the atypical antipsychotic Invega Sustenna. In its Q2 presentation, J&J cited the Part D redesign as a headwind to multiple products, including its inflammatory disease drug Stelara. With Stelara also facing biosimilar competition, J&J said the product had an approximately 1,170 basis points (11.7%) impact on growth. Falling Stelara sales more than offset the growth of Tremfya and Simponi, causing immunology sales to fall 15.4%. The company expects Stelara biosimilar competition to accelerate in the second half of the year. Despite mounting pressure on the inflammatory disease drug, J&J raised its estimated reported sales growth for the full year. Previously, J&J forecast growth of 2.6% to 3.6%. Now, the company is targeting reported growth of 5.1% to 5.6% based on its strong performance in the quarter, CEO Joaquin Duato said on an investor call Wednesday morning. The change added $2 billion to the midpoint of J&J’s full-year sales estimate. Editor’s note: This story was updated with additional commentary from J&J’s earnings call.

16 Jul 2025

·www.biopharmadive.com

J&J absorbs Stelara, tariff hits to deliver beat-and-raise quarter

Johnson & Johnson on Wednesday reported quarterly prescription drug sales that for the first time surpassed $15 billion, highlighting the strength of the pharmaceutical companys portfolio during a year in which its formerly top-selling drug lost market exclusivity.Second quarter sales for J&Js pharmaceuticals business reached $15.2 billion between April and June, nearly 4% higher than the same period last year on an operational basis. Overall second quarter sales were up 4.6% on the same basis to total $23.7 billion, beating Wall Street forecasts.J&J now expects higher operational growth for 2025, increasing the midpoint of its guidance range for both adjusted sales and earnings per share.The company also halved its estimates for how much U.S. tariffs would weigh on its business this year. It now anticipates a roughly $200 million hit, exclusively within its medical device unit. President Donald Trump has said further levies on pharmaceuticals are coming soon, but indicated the duties would be phased in, potentially giving drugmakers time to adjust their operations and stockpile inventory.J&J shares jumped by more than 6% Wednesday morning following its earnings release.No other healthcare company has grown through the loss of exclusivity of a multibillion-dollar product in the first year, in our case Stelara, J&J CEO Joaquin Duato said on a conference call with analysts, referring to the companys 16-year-old psoriasis and inflammatory bowel disease medicine.Stelara sales during the quarter fell by 43% year over year, to $1.7 billion.J&J has a newer drug, Tremfya, that it has positioned as a successor to Stelara in many of the same diseases and hopes will eventually grow into a $10 billion-a-year product. Sales in the second quarter rose 30% year over year to $1.2 billion as more doctors prescribed it for Crohns disease and ulcerative colitis.But its J&Js oncology business thats providing the most significant counterweight to Stelaras loss of exclusivity. Overall cancer drug sales were $6.3 billion between April and June, more than $1 billion higher than in the same period last year.Over half of that total came from J&Js multiple myeloma medicine Darzalex, which is one of several drugs the company sells for the blood cancer. Duato claimed about 80% of all multiple myeloma patients receive a J&J therapy as some point in their treatment.By the end of the decade, J&J predicts its oncology business will bring in $50 billion in annual sales, notably higher than what analysts on Wall Street currently estimate.Jennifer Taubert, head of the companys pharmaceuticals business, pointed to Darzalex and its multiple myeloma cell therapy Carvykti as key contributors to that goal. Two other J&J medicines, Tecvayli and Talvey, are also approved for the blood cancer, but are early in their respective launches.Taubert also highlighted a drug-device combination called TAR-200 that J&J is targeting for use in non-muscle invasive bladder cancer. That is probably the asset that has the biggest disconnect between our internal forecasts and what the Street expects, she said. If you take a look at 2028 consensus, we actually see our numbers at least three times higher.J&J previously detailed several other drugs for which analysts forecasts diverge from its own. One other is a combination of the medicines Rybrevant and Lazcluze, which are approved for a certain type of metastatic lung cancer. The company aims to win U.S. clearance for a subcutaneous version of Rybrevant, but had its application rejected by the Food and Drug Administration in December.On Wednesdays call, Taubert said the agencys complete response letter related to a manufacturing question or two and J&J has since responded. '

Drug ApprovalCell Therapy

100 Deals associated with Ciltacabtagene autoleucel

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R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Multiple Myeloma	United States	Nanjing Legend Biotech Co., Ltd.	28 Feb 2022
Multiple Myeloma	United States	Janssen Biotech, Inc.	28 Feb 2022

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Relapse multiple myeloma	Phase 3	United States	Janssen Research & Development LLC	12 Jun 2020
Relapse multiple myeloma	Phase 3	Japan	Janssen Research & Development LLC	12 Jun 2020
Relapse multiple myeloma	Phase 3	Australia	Janssen Research & Development LLC	12 Jun 2020
Relapse multiple myeloma	Phase 3	Belgium	Janssen Research & Development LLC	12 Jun 2020
Relapse multiple myeloma	Phase 3	Denmark	Janssen Research & Development LLC	12 Jun 2020
Relapse multiple myeloma	Phase 3	France	Janssen Research & Development LLC	12 Jun 2020
Relapse multiple myeloma	Phase 3	Germany	Janssen Research & Development LLC	12 Jun 2020
Relapse multiple myeloma	Phase 3	Greece	Janssen Research & Development LLC	12 Jun 2020
Relapse multiple myeloma	Phase 3	Israel	Janssen Research & Development LLC	12 Jun 2020
Relapse multiple myeloma	Phase 3	Italy	Janssen Research & Development LLC	12 Jun 2020

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04181827 (CARTITUDE-4, ASCO2025) Manual	Phase 3	Multiple Myeloma	419	Ciltacabtagene autoleucel (cilta-cel) (pts with extramedullary disease (EMD)	gepfplqonk(jojuiwxzwq) = yurttvagdc ouskldhvcp (croyvtiutu ) View more	Positive	30 May 2025
				Standard of Care (SOC) (pts with extramedullary disease (EMD)	gepfplqonk(jojuiwxzwq) = wrxynlibxm ouskldhvcp (croyvtiutu ) View more
NCT03548207 (CARTITUDE-1, ASCO2025)	Phase 1/2	Relapse multiple myeloma hemoglobin \| platelets \| effector-to-target ratio	97	Ciltacabtagene autoleucel (cilta-cel)	fnfaicnknu(jchpcmpdee) = styhfulsfs brmsfdtshr (guhuorubrd, 41.9 - NE) View more	Positive	30 May 2025
Cartitude 1 and 4 (ASCO2025)	Not Applicable	Refractory Multiple Myeloma	140	ciltacabtagene-autoleucel (Patients with CNP)	ywtlwricfi(jxzmkiwrpm) = ujdyvnjlvj rzaeejwxfp (wcplbycvvb ) View more	Positive	30 May 2025
NCT05201781 (CARTITUDE-1, EHA2025)	Phase 4	Relapse multiple myeloma hemoglobin \| platelets \| effector-to-target ratio	97	Ciltacabtagene autoleucel	bfubqksxvu(hbchuzdnab) = spfnhjaxds ygtgtpyoly (vcjhanudbk ) View more	Positive	22 May 2025
CARTITUDE-4 (EHA2025)	Not Applicable	Relapse multiple myeloma lenalidomide-refractory	-	Ciltacabtagene autoleucel (cilta-cel)	gsgffhwzwg(qkgjwqmeug) = ivfhsvjylr bptioalytv (zryzoaaflu ) View more	Positive	22 May 2025
				Standard of care (PVd or DPd)	gsgffhwzwg(qkgjwqmeug) = ldaallvhfw bptioalytv (zryzoaaflu ) View more
NCT04181827 (CARTITUDE-4, CTgov)	Phase 3	Relapse multiple myeloma \| Multiple Myeloma	419	daratumumab+pomalidomide+bortezomib+dexamethasone (DPd) (Arm A: Standard Therapy: PVd or DPd)	koavfvzdkl(sffqpgfmxj) = zrvizenkqw eslsxefszs (vrytcjnoqz, ksjvcamydu - lnojtaniph) View more	-	20 May 2025
				Autoleucel [Cilta-cel]+JNJ-68284528 (Arm B: JNJ-68284528 (Ciltacabtagene Autoleucel [Cilta-cel]))	koavfvzdkl(sffqpgfmxj) = nojlbjoveu eslsxefszs (vrytcjnoqz, cawbollypo - idghhstedp) View more
PB3088 (EHA2025)	Not Applicable	Relapse multiple myeloma	-	BCMA CAR-T (EMD-negative patients)	lmygarzmwd(izgnjzfwog) = rsluydieuz glnscmcfqf (brkiuukmrg, 0.42 - 0.59) View more	-	14 May 2025
				BCMA CAR-T (EMD-positive patients)	lmygarzmwd(izgnjzfwog) = oifsepefzq glnscmcfqf (brkiuukmrg, 0.32 - 0.51) View more
PS2152 (EHA2025)	Not Applicable	Multiple Myeloma	235	Cilta-cel	mhbltepiec(qzgbsuedzb) = kypmcqvcki hnjzbppczl (jfpdbtqhll ) View more	-	14 May 2025
				Cilta-Cel (Control group)	mhbltepiec(qzgbsuedzb) = nbgceuclwb hnjzbppczl (jfpdbtqhll ) View more
CARTITUDE-1 (EHA2025)	Not Applicable	Refractory Multiple Myeloma	105	Ciltacabtagene autoleucel	afiydtmfbi(pnvrwxiypd) = Infections occurred in 49% of patients and were severe in 32%. Earlier infections in the first 30 days were equally bacterial (42%) and viral (42%). Later infections between days 31-100, and after day 100 were mostly viral (59% and 60%), with only 32% and 12% being grade ≥3 at each time period. On univariate analysis, worse ECOG performance status at lymphodepletion (p=0.012), higher maximum grade of CRS (p=0.036), steroid and anakinra use (p=0.042 and p=0.024), and lower IgA levels at day 90 (p=0.014) were associated with severe infections. At the end of follow-up, 16 patients had expired. Of them, 38% died due to myeloma progression, and the rest due to non-relapse mortality causes. The most common cause of non-relapse mortality was infection (31% of all deaths) kawabtlcum (cogyeezxrm )	-	14 May 2025
PB2891 (EHA2025)	Phase 3	BCMA	-	Belantamab mafodotin plus bortezomib/dexamethasone	lkzuisbpvb(qzqjcyvqkm): HR = 0.67 (95% CI, 0.26 - 1.75)	Positive	14 May 2025
				Ciltacabtagene autoleucel