RegulationOrphan Drug (United States), Orphan Drug (European Union), Priority Review (United States), Orphan Drug (United Kingdom), PRIME (European Union), Breakthrough Therapy (United States), Orphan Drug (Japan)

Structure/Sequence

Sequence Code 315628595

Source: *****

Clinical Trials associated with Idecabtagene Vicleucel

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

[+11]

NCT06698887

/ RecruitingNot Applicable

Long-Term Safety Follow-Up Surveillance for Phase 3 Trial (KarMMA-9/CA089-1043) to Compare the Efficacy and Safety of Idecabtagene Vicleucel With Lenalidomide Maintenance Therapy Versus Lenalidomide Maintenance Therapy Alone in Adult Participants With Newly Diagnosed Multiple Myeloma Who Have Suboptimal Response After Autologous Stem Cell Transplantation

The purpose of this study is to monitor the long-term safety of participants who received idecabtagene vicleucel treatment as part of the KarMMa-9 (CA089-1043) Phase 3 clinical trial.

Start Date11 Sep 2024

Sponsor / Collaborator

Bristol Myers Squibb Co.

NCT06045806

/ Active, not recruitingPhase 3

A Randomized, Open-Label, Phase 3 Trial to Compare the Efficacy and Safety of Idecabtagene Vicleucel With Lenalidomide Maintenance Versus Lenalidomide Maintenance Therapy Alone in Adult Participants With Newly Diagnosed Multiple Myeloma Who Have Suboptimal Response After Autologous Stem Cell Transplantation (KarMMa-9)

The purpose of this study is to compare the efficacy, safety, and tolerability of ide-cel with lenalidomide (LEN) maintenance to that of LEN maintenance alone in adult participants with Newly Diagnosed Multiple Myeloma (NDMM) who have achieved a suboptimal response post autologous stem cell transplantation (ASCT).

Start Date16 Oct 2023

Sponsor / Collaborator

Celgene Corp.

[+1]

100 Clinical Results associated with Idecabtagene Vicleucel

100 Translational Medicine associated with Idecabtagene Vicleucel

100 Patents (Medical) associated with Idecabtagene Vicleucel

157

Literatures (Medical) associated with Idecabtagene Vicleucel

01 Apr 2025·CYTOTHERAPY

Severe hypophosphatemia following idecabtagene vicleucel regardless of the severity of cytokine release syndrome

Article

Author: Kobayashi, Hiroki ; Asada, Noboru ; Fujiwara, Hideaki ; Hayashino, Kenta ; Fujii, Nobuharu ; Maeda, Yoshinobu ; Kitamura, Wataru ; Kamoi, Chihiro ; Fujii, Keiko ; Kondo, Takumi ; Ennishi, Daisuke ; Seike, Keisuke ; Terao, Toshiki

BACKGROUND AIMS:

Hypophosphatemia has been recently recognized adverse event in chimeric antigen receptor (CAR)-T cell therapy, complicating 70-75% of patients. Severe hypophosphatemia can cause cytokine release syndrome (CRS)-like symptoms, such as respiratory and cardiovascular dysfunction. Some reports have described the association between inorganic phosphate (iP) and CRS in patients treated with tisagenlecleucel (tisa-cel), lisocabtagene maraleucel (liso-cel), axicabtagene ciloleucel (axi-cel). However, the association between iP and idecabtagene vicleucel (ide-cel) has not been reported and the kinetics of serum iP for each CAR-T cell product have not been compared. We aimed to analyze the kinetics of iP with CAR-T cell products, including ide-cel, and the association between hypophosphatemia and severe CRS.

METHODS:

We retrospectively analyzed patients aged ≥ 18 years with B-cell malignancies who received CAR-T cell therapy in our institution. All available laboratory data were collected for 21 days after CAR-T cell infusion; clinical and laboratory data were extracted from electronic medical records.

RESULTS:

A total of 108 patients were treated with CAR-T cell therapy (tisa-cel, n = 56; liso-cel, n = 11; axi-cel, n = 28; ide-cel, n = 13). The cumulative incidence of hypophosphatemia and severe hypophosphatemia were significantly higher in the ide-cel group than the other CAR-T products group (92.3% versus 67.5%, P = 0.0045, and 15.4% versus 2.1%, P = 0.017), Patients treated with ide-cel had significantly lower serum iP levels from day -4 to 8 compared to other CAR-T products. As previous reports, the cumulative incidence of hypophosphatemia in the other CAR-T products group was significantly higher in the severe CRS group than in the mild CRS group (84.0% versus 60.0%, P = 0.0002). In contrast, there was no significant difference between the two groups in the ide-cel group (65% versus 100%, P = 0.13).

CONCLUSION:

Our results suggest that and that it is important to monitor iP kinetics more carefully because patients treated with ide-cel complicate severe hypophosphatemia, regardless of CRS severity.

11 Mar 2025·Blood Advances

BCMA-directed CAR T-cell therapy in patients with multiple myeloma and CNS involvement

Article

Author: Hansen, Doris K. ; Cohen, Adam ; Gaballa, Mahmoud R. ; Ferreri, Christopher J. ; Chung, Alfred ; Puglianini, Omar Castaneda ; Patel, Krina K. ; Voorhees, Peter ; Vogl, Dan

Abstract:

We investigated B-cell maturation antigen-directed chimeric antigen receptor T-cell (CAR-T) therapy in patients with relapsed or refractory multiple myeloma (MM) and central nervous system (CNS) involvement. Ten patients received either idecabtagene vicleucel (n = 6) or ciltacabtagene autoleucel (n = 4), where brain/cranial nerve and/or spinal cord involvement/leptomeningeal disease were evident on either magnetic resonance imaging (100%) and/or cerebrospinal fluid (40%). Eight patients had their CNS diagnosis before CAR-T therapy, and two were diagnosed within 14 days post-infusion. Seven received CNS-directed therapy during bridging before CAR-T therapy. There were no excess toxicities: no cytokine release syndrome grade ≥3; 10% immune effector cell-associated neurotoxicity syndrome (ICANS) grade 3; and no ICANS grade 4. Two patients experienced delayed but treatable neurotoxicity, with no reported parkinsonian side effects. The best overall response rate was 80% (≥70% very good partial response) and a 100% CNS response. With a median follow-up of 381 days, patients with CNS myeloma diagnosed before CAR-T therapy (n = 8) had a median overall survival and progression-free survival (PFS) of 13.3 and 6.3 months, respectively. Best outcomes were observed in 4 patients who had a response to bridging therapy, suggesting that optimizing pre-CAR-T therapy may be key for improved outcomes. Our study suggests that CAR-T therapy in patients with CNS MM is safe and feasible, and screening for CNS involvement before CAR-T therapy could be warranted in high-risk patients. The excellent initial response but relatively short PFS suggests consideration for post-CAR-T maintenance. Larger studies are needed to confirm these findings.

01 Mar 2025·CLINICAL MICROBIOLOGY AND INFECTION

Timeline and outcomes of viral and fungal infections after chimeric antigen receptor T-cell therapy: a large database analysis

Article

Author: Siegrist, Emily A. ; Henao-Martínez, Andrés F ; Bastias, Alfonso G ; Agudelo Higuita, Nelson Iván ; Henao-Cordero, José ; Connelly, Patrick ; Dib, Rita Wilson ; Corbisiero, Michaele Francesco ; Chiu, Chia-Yu ; Henao- Martínez, Andrés F. ; Saeedi, Arman ; Siegrist, Emily A ; Bastias, Alfonso G. ; Chastain, Daniel B. ; Sassine, Joseph ; Chastain, Daniel B

OBJECTIVES:

This large database analysis aims to describe the incidence, timeline, and risk factors for viral and fungal infections after chimeric antigen receptor (CAR) T-cell therapy.

METHODS:

We queried a global research network database, TriNetX, for patients who received CAR T-cell therapy, who were identified and followed for the development of viral and fungal infections. Baseline demographic, oncologic history, laboratory data and medication histories were collected. We evaluated risk factors for respiratory viral infections (RVIs), herpesvirus, fungal infections and mortality using Cox regression.

RESULTS:

A total of 2256 patients who received CAR T-cell therapy were included, 1867 (82.7%) were CD19-targeted and 400 (17.7%) were B-cell maturation antigen-targeted. After CAR T-cell infusion, RVIs were the most prevalent (23.3%) with a median onset of 160 days (interquartile range [IQR]: 52-348 days), whereas herpesvirus and fungal infections were less frequent, occurring in 13.6% and 11.4% of cases with median onsets of 71 (IQR, 18-252) and 73 days (IQR, 14-236 days), respectively. On multivariable Cox regression, independent predictors of RVI included acute lymphoblastic leukaemia (hazard ratio [HR], 1.61), prior haematopoietic cell transplant (HCT; HR, 1.29), cytokine release syndrome (HR, 1.41), hemophagocytic lymphohistiocytosis (HR, 1.96) and glucocorticoids (HR, 3.37). Prior HCT (HR, 2.00), hypogammaglobulinemia (HR, 1.51), immune effector cell-associated neurotoxicity syndrome (HR, 1.52) and hemophagocytic lymphohistiocytosis (HR, 1.99) were associated with a higher risk of herpesviruses. Independent predictors of fungal infections included prior HCT (HR, 1.59), cytokine release syndrome (HR, 1.58) and hypogammaglobulinemia (HR, 1.40). Idecabtagene vicleucel was associated with a lower risk of herpesvirus and fungal infections (HR, 0.39 and 0.44, respectively).

DISCUSSION:

In a large cohort of CAR T-cell therapy recipients, RVIs were the most common but occurred later, whereas herpesvirus and fungal infections were less frequent but occurred earlier. Prospective studies investigating prophylaxis and pre-emptive monitoring strategies are needed in this population.

335

News (Medical) associated with Idecabtagene Vicleucel

11 Mar 2025

·pipelinereview.com

2seventy bio Enters into Definitive Agreement to be Acquired by Bristol Myers Squibb

$5.00 per share, all-cash transaction Expected to close in the second quarter of 2025, subject to customary closing conditions CAMBRIDGE, MA, USA I March 10, 2025 I 2seventy bio, Inc. (Nasdaq: TSVT), today announced a definitive merger agreement under which Bristol Myers Squibb (NYSE: BMY) (“BMS”) will acquire all of the outstanding shares of 2seventy bio at a price of $5.00 per share in an all-cash transaction for a total equity value of approximately $286 million, or $102 million net of estimated cash. The deal represents an 88% premium to the closing price of $2.66 on March 7, 2025. “A year ago, 2seventy decided to exclusively focus on unlocking the value of Abecma , with the goal of delivering more time for people living with multiple myeloma and maximizing value for all stakeholders,” said Chip Baird, chief executive officer, 2seventy bio. “The strategic rationale for this acquisition is clear and today’s announcement represents the culmination of the journey for 2seventy bio. We believe that Abecma will continue to benefit from BMS’ experience and resources to ensure this important therapy is delivered to patients who need it. I would like to express my deep gratitude for current and past 2seventy team members and more broadly the dedicated community of patients, scientists, providers and partners that helped take cell and gene therapy from a complicated idea to reality for patients.” Transaction Details and Path to Completion Under the terms of the agreement, BMS will promptly commence a tender offer to acquire all outstanding shares of 2seventy bio at a price of $5.00 per share in an all-cash transaction. 2seventy bio’s Board of Directors unanimously recommends that 2seventy bio stockholders tender their shares in the tender offer. The closing of the transaction is expected to occur in the second quarter of 2025 and is subject to customary closing conditions, including the tender of a majority of the outstanding shares of 2seventy bio’s common stock and the expiration or termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976. Following the successful closing of the tender offer, BMS will acquire all remaining shares of 2seventy bio common stock that are not tendered in the tender offer through a second-step merger at the same price in the tender offer of $5.00 per share. Following the completion of this transaction, 2seventy bio’s common stock will no longer be listed for trading on Nasdaq. In connection with the execution of the merger agreement, certain stockholders of 2seventy bio owning approximately 5.3% of the outstanding shares of 2seventy bio’s common stock have entered into tender and support agreements pursuant to which they have agreed to tender all of their owned shares in the offer. Advisors Goldman Sachs & Co. LLC is serving as exclusive financial advisor to 2seventy bio, and Goodwin Procter LLP is serving as legal counsel. ABECMA U.S. INDICATION ABECMA is a B-cell maturation antigen (BCMA)-directed genetically modified autologous T cell immunotherapy indicated for the treatment of adult patients with relapsed or refractory multiple myeloma after two or more prior lines of therapy including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody. Please see full Prescribing Information , including Boxed WARNINGS and Medication Guide . About Bristol Myers Squibb and 2seventy bio Abecma is being jointly developed and commercialized in the U.S. as part of a Co-Development, Co-Promotion, and Profit Share Agreement between Bristol Myers Squibb and 2seventy bio. Bristol Myers Squibb assumes sole responsibility for Abecma drug product manufacturing and commercialization outside of the U.S. The companies’ clinical development program for Abecma includes ongoing clinical studies (KarMMa-2, KarMMa-3) in earlier lines of treatment for patients with multiple myeloma. For more information visit clinicaltrials.gov . About 2seventy bio Our name, 2seventy bio, reflects why we do what we do – TIME. Cancer rips time away, and our goal is to work at the maximum speed of translating human thought into action – 270 miles per hour – to give the people we serve more time. With a deep understanding of the human body’s immune response to tumor cells and how to translate cell therapies into practice, we’re applying this knowledge to deliver the first FDA-approved CAR T cell therapy for multiple myeloma to as many patients as possible. Importantly, we remain focused on accomplishing our mission by staying genuine and authentic to our “why” and keeping our people and culture top of mind every day. For more information, visit www.2seventybio.com . Follow 2seventy bio on social media: X (Twitter) and LinkedIn . SOURCE: 2seventy

ImmunotherapyAcquisitionCell Therapy

11 Mar 2025

·firstwordpharma.com

BMS snaps up Abecma partner 2seventy bio in $286M all-cash deal

Bristol Myers Squibb is set to acquire 2seventy bio — its US partner on the BCMA-directed CAR-T therapy Abecma (idecabtagene vicleucel) for multiple myeloma — in an all-cash deal valued at approximately $286 million, or about $102 million after factoring in the cell therapy firm's estimated cash reserves.Under terms announced Monday, BMS will acquire all outstanding shares of 2seventy at $5.00 apiece, representing an 88% premium over the latter’s closing price on March 7. Subject to regulatory and shareholder approvals, the transaction is expected to close in the second quarter.The takeover comes at a crucial time for 2seventy, as it had started implementing strategic adjustments, including the recent discontinuation of enrolment in the Phase III KarMMa-9 study evaluating Abecma for newly diagnosed multiple myeloma (NDMM), owing to the evolving treatment landscape and financial considerations. Chip Baird, chief executive of 2seventy at the time, explained that the trial termination aimed to conserve over $80 million in near-term expenditures and accelerate the biotech’s path to breakeven in 2025. The move was also preceded by a series of restructuring initiatives, including a 40% workforce reduction in September and divestment of pipeline assets to Novo Nordisk and Regeneron."A year ago, 2seventy decided to exclusively focus on unlocking the value of Abecma, with the goal of delivering more time for people living with multiple myeloma and maximising value for all stakeholders," remarked Baird on Monday.Abecma was first approved by the FDA in 2021 for relapsed/refractory MM in patients who had undergone at least four prior therapies, with its label later expanded for earlier use. The product generated US revenue of $242 million last year, with Jefferies analysts estimating peak sales of $1.6 billion in a best-case scenario.

AcquisitionDrug ApprovalCell TherapyPhase 3Immunotherapy

11 Mar 2025

·www.pharmaceutical-technology.com

BMS to acquire longtime cell therapy partner 2seventy bio for $286m

BMS and 2seventy bio first teamed up in 2021. Credit: Moyo Studio via Getty Images. Bristol Myers Squibb (BMS) has agreed to acquire its longtime cell therapy partner 2seventy bio in a deal valued at $286m. Announced after markets closed on 10 March, the $5-per-share offer represents an 88% premium on 2seventy bio’s closing share price on Friday, 7 March. The market reacted favourably with 2seventy bio’s share price increasing by 76% since the news announcement. . Adjusted for 2seventy bio’s cash reserves, the net acquisition cost for BMS is approximately $102m. The transaction is expected to close in Q2 2025. The two companies first teamed up in 2021 when 2seventy bio was spun out of bluebird bio. They co-developed Abecma (idecabtagene vicleucel), a BCMA-targeted chimeric antigen receptor (CAR)-T cell therapy for multiple myeloma, which secured US Food and Drug Administration (FDA) approval in April 2024. However, Abecma has faced increasing competition in the multiple myeloma space, particularly from Johnson & Johnson and Legend Biotech’s BCMA CAR-T Carvykti (ciltacabtagene autoleucel). In 2024, Abecma generated $406m in sales, down from $472m in 2023, notably due to Carvykti’s rapid adoption. Carvykti holds an approval as a second-line treatment , while Abecma remains limited to third or later=line use . According to GlobalData’s Pharma Intelligence Center, Carvykti is projected to generate $7.2bn in sales in 2030, compared to Abecma’s forecast of $775m in the same year. GlobalData is the parent company of Pharmaceutical Technology. In September 2024, the two companies announced plans to discontinue enrolment of subjects in the Phase III KarMMa-9 clinical trial (NCT06045806) of Abecma for newly diagnosed multiple myeloma patients. The reason for the suspension was said to be influenced by the “evolving treatment landscape for NDMM [newly diagnosed multiple myeloma]”, with the introduction of more intensive and prolonged induction therapies like Carvykti. The acquisition follows a challenging few years for 2seventy bio. In 2023, the company divested its R&D pipeline – including cell therapy candidates for non-Hodgkin lymphoma (NHL), acute myeloid leukaemia (AML), and ovarian cancer – to Regeneron for just $5m upfront , refocusing its business solely on Abecma’s commercialisation with BMS. Since then, 2seventy bio has undergone workforce reductions and offloaded additional assets, including a haemophilia A programme and in vivo gene editing technology to Novo Nordisk in June 2024. In the announcement accompanying the acquisition, 2seventy bio’s CEO Chip Baird said: “The strategic rationale for this acquisition is clear and today’s announcement represents the culmination of the journey for 2seventy bio.” It’s not been an easy ride for cell and gene companies recently. The move comes just a few weeks after bluebird bio had to be rescued by investment firms Carlyle and SK Capital Partners. Bluebird has faced years of financial struggles, declining stock performance, and mounting cash flow concerns, with the investment firms stepping in to provide the necessary capital to keep the company’s gene therapy programmes afloat.

Cell TherapyAcquisitionDrug ApprovalImmunotherapyPhase 3

100 Deals associated with Idecabtagene Vicleucel

External Link

KEGG	Wiki	ATC	Drug Bank
D11556	-	L01XX	-

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Multiple Myeloma	United States	Celgene Corp.	03 Mar 2021

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Relapse multiple myeloma	Phase 3	United States	2seventy Bio, Inc.	30 Jan 2022
Relapse multiple myeloma	Phase 3	United States	Sino-American Shanghai Squibb Pharmaceuticals Ltd.	30 Jan 2022
BCMA Positive Multiple Myeloma	Phase 1	United States	bluebird bio, Inc.	22 Dec 2015
BCMA Positive Multiple Myeloma	Phase 1	United States	Celgene Corp.	22 Dec 2015

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


3791CAR-T (ASH2024) Manual	Not Applicable	Multiple Myeloma	-	Ide-cel	ifbtfzuxyw(auhslhpmkz) = oeptsfkbgp kdpekibsnx (gskdzzgsfj ) View more	Similar	08 Dec 2024
				Cilta-cel	ifbtfzuxyw(auhslhpmkz) = azoxmtfzwm kdpekibsnx (gskdzzgsfj ) View more
ASCO2024	Not Applicable	Relapse multiple myeloma	-	ide-cel	xehwnkonnr(gncadsrnwm) = yewcbeghaw erhoaeluea (meevuqzpnp ) View more	-	24 May 2024
ASCO2024	Not Applicable	Multiple Myeloma	351	idecabtagene vicleucel (Extramedullary disease (EMD))	cvudrivnhn(ahxjqhsgqw) = mqhxqksdky vvwupgfjze (biwaynyqol ) View more	Negative	24 May 2024
				idecabtagene vicleucel (Non-EMD)	cvudrivnhn(ahxjqhsgqw) = ovlffdurfs vvwupgfjze (biwaynyqol ) View more
NCT03601078 (KarMMa-2, EHA 12024 \| EHA 22024) Manual	Phase 2	Recurrent Chronic Lymphoid Leukemia \| Chronic lymphocytic leukaemia refractory Second line	35	Idecabtagene vicleucel	vifviukrci(htpzjlshmv) = fsldzaovig fpawsocsth (fkpdughpom, 52 - 86) View more	Positive	14 May 2024
DESCAR-T \| IFM STUDY (EHA2024)	Not Applicable	Relapse multiple myeloma HRCAs \| EMD	435	idecabtagene vicleucel (ide-cel)	tzvzlalfla(ibyxdaofsc) = qtzhluhuri hhbazvsffb (vndgabqyry, 5.3 - NR)	Positive	14 May 2024
				BsAb (bispecific antibody)	ysxdbxbapn(tpysnsqekb) = ucjrlwgorb corcpposyv (haojstttin ) View more
CIBMTR Registry (EHA2024)	Not Applicable	Multiple Myeloma	817	IDECABTAGENE VICLEUCEL (IDE-CEL) (Very Good Partial Response (VGPR) or better)	zqairmmuiv(iihcmfcohp) = observed in SD and PD groups hwibmyjkyu (dcgohosync ) View more	Positive	14 May 2024
				IDECABTAGENE VICLEUCEL (IDE-CEL) (Stable Disease (SD) or Progressive Disease (PD))
EHA2024	Not Applicable	Multiple Myeloma sBCMA \| circulating EVs	19	PHE885	gonykcgqie(rabcofdgwd) = The presence of BCMA was observed and quantified in circulating EVs (these EVs were characterized by canonical EV-associated proteins). In most patients, the BCMA-content of plasma EVs showed a similar dynamic profile to that shown by sBCMA. ptgjruyifc (wotksjglte ) View more	-	14 May 2024
				ARI0002h
NCT03651128 (KarMMa-3, Pubmed) Manual	Phase 3	Multiple Myeloma	-	ide-cel	ktcdhnumkg(wfnezlpevo) = ihodgzwjim rziouuregc (melsrsyvkt )	Positive	23 Apr 2024
				Standard of care regimens	ktcdhnumkg(wfnezlpevo) = xfqfhfcgjc rziouuregc (melsrsyvkt )
Tandem Meetings ASTCT and CIBMTR2024 Manual	Not Applicable	Plasma Cell Leukemia	11	Idecabtagene Vicleucel (ide-cel) (Secondary Plasma Cell Leukemia (sPCL))	eaqhpzwnnn(klxffrdkdx) = bivzbyxlen tnxtqecdvj (vgtluyzvqy, 4.6 - NR) View more	Negative	01 Feb 2024
NCT03651128 (KarMMa-3, Tandem Meetings ASTCT and CIBMTR2024) Manual	Phase 3	Multiple Myeloma soluble BCMA (sBCMA) concentration	226	Idecabtagene Vicleucel (ide-cel)	fvqqidrzmr(irpemadqvh) = tagaufvdha ecghcmkvhe (sjuucaxyex, 8.9 - not reached) View more	Positive	01 Feb 2024
				Standard Regimens (SRs)	fvqqidrzmr(irpemadqvh) = fvwffawemm ecghcmkvhe (sjuucaxyex, 3.7 - 22.5) View more

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