This is a single arm study to evaluate the efficacy and safety of BCMA-targeted prime CAR-T cells therapy for patients with relapsed/refractory Multiple Myeloma.

Start Date07 Mar 2021

Sponsor / Collaborator

Chongqing Precision Biotechnology Co., Ltd.

NCT04272151

/ RecruitingPhase 1/2

Safety and Efficacy of BCMA-Targeted CAR-T Therapy for Relapsed/Refractory Multiple Myeloma

This is a single arm study to evaluate the efficacy and safety of BCMA-targeted CAR-T cells therapy for patients with relapsed/refractory Multiple Myeloma.

Start Date01 Dec 2019

Sponsor / Collaborator

Chongqing Precision Biotechnology Co., Ltd.

NCT04271644

/ RecruitingPhase 1/2

BCMA-Targeted CAR-T Cell Therapy for Relapsed/Refractory Multiple Myeloma

This is a single arm study to evaluate the efficacy and safety of BCMA-targeted CAR-T cells therapy for patients with relapsed/refractory Multiple Myeloma.

Start Date01 Apr 2019

Sponsor / Collaborator

Chongqing Precision Biotechnology Co., Ltd.

100 Clinical Results associated with BCMA CAR-T cell therapy(Chongqing Precision Biotechnology Co., Ltd.)

100 Translational Medicine associated with BCMA CAR-T cell therapy(Chongqing Precision Biotechnology Co., Ltd.)

100 Patents (Medical) associated with BCMA CAR-T cell therapy(Chongqing Precision Biotechnology Co., Ltd.)

Literatures (Medical) associated with BCMA CAR-T cell therapy(Chongqing Precision Biotechnology Co., Ltd.)

09 Jan 2025·Cancer Immunology Research

CD27-Armored BCMA CAR T-cell Therapy (CBG-002) for Relapsed and Refractory Multiple Myeloma: A Phase I Clinical Trial

Article

Author: Xiao, Xibin ; Zhang, Jiawei ; Qiu, Xi ; Yu, Jiandong ; Wang, Luyao ; Xin, Dijia ; Xu, Yang ; Zhang, Xuzhao ; Chen, Boxiao ; Yang, Xin ; Yang, Wenjun ; Lei, Wen ; Qian, Wenbin ; Huang, Liansheng ; Jiang, Huawei ; Zhu, Jiangao ; Fan, Yili

AbstractB-cell maturation antigen (BCMA) chimeric antigen receptor (CAR) T-cell therapy has been approved for the treatment of relapsed and refractory multiple myeloma (RRMM); however, whether patients have long-term responses has yet to be established. We investigated the feasibility of CBG-002, a CD27-armored BCMA CAR T-cell therapy, to improve clinical efficacy in patients with RRMM. We present preclinical data showing the activity of CBG-002 against myeloma and results from a phase I clinical trial (NCT04706936) evaluating its safety and efficacy in patients with RRMM. The primary endpoint was safety, as assessed by grade 3 or 4 adverse events (AE). Key secondary endpoints were overall response rate (ORR), duration of response (DOR), progression-free survival (PFS), and overall survival (OS). A total of 11 patients were enrolled and received CBG-002 therapy. Nine patients developed grade 1 or 2 cytokine release syndrome (CRS), whereas no patients experienced grade 3 or higher CRS or immune effector cell–associated neurotoxicity syndrome. Other grade 3 or higher AEs included neutropenia (72.7%), thrombocytopenia (45.5%), and anemia (36.4%). At a median follow-up of 16.7 months, the ORR was 81.8%, including a stringent complete response/complete response rate of 45.5%, very good partial response rate of 18.2%, and partial response rate of 18.2%, with a median DOR of 8.9 (range 1.8–21.9) months. The median OS was not reached, and the median PFS was 8.5 (2.7–22.9) months. In this phase I study, CBG-002, a CD27-armored BCMA CAR T-cell therapy, demonstrated safety and clinical efficacy in patients with RRMM.

09 Jul 2024·Blood Advances

CD4+ CAR T-cell exhaustion associated with early relapse of multiple myeloma after BCMA CAR T-cell therapy

Article

Author: Roybal, Kole T ; Fan, Zenghua ; Shah, Nina ; Chang, Hewitt ; Bylsma, Sophia ; Ledergor, Guy ; Wu, Kai ; Hansen, Erik ; Hyrenius-Wittsten, Axel ; Ye, Chun J ; Wolf, Jeffrey ; Kwek, Serena ; McCarthy, Elizabeth ; Cheung, Alexander ; Fong, Lawrence ; Starzinski, Alec ; Martin, Thomas ; Bridge, Mark ; Wong, Sandy

AbstractMultiple myeloma is characterized by frequent clinical relapses after conventional therapy. Recently, chimeric antigen receptor (CAR) T cells targeting B-cell maturation antigen (BCMA) has been established as a treatment option for patients with relapsed or refractory disease. However, although >70% of patients initially respond to this treatment, clinical relapse and disease progression occur in most cases. Recent studies showed persistent expression of BCMA at the time of relapse, indicating that immune-intrinsic mechanisms may contribute to this resistance. Although there were no preexisting T-cell features associated with clinical outcomes, we found that patients with a durable response to CAR T-cell treatment had greater persistence of their CAR T cells than patients with transient clinical responses. They also possessed a significantly higher proportion of CD8+ T-effector memory cells. In contrast, patients with short-lived responses to treatment have increased frequencies of cytotoxic CD4+ CAR T cells. These cells expand in vivo early after infusion but express exhaustion markers (hepatitis A virus cellular receptor 2 [HAVCR2] and T-cell immunoglobulin and mucin domain-containing-3 [TIGIT]) and remain polyclonal. Finally, we demonstrate that nonclassical monocytes are enriched in the myeloma niche and may induce CAR T-cell dysfunction through mechanisms that include transforming growth factor β. These findings shed new light on the role of cytotoxic CD4+ T cells in disease progression after CAR T-cell therapy.

01 May 2024·Internal Medicine Journal

Real‐world outcomes in relapsed refractory multiple myeloma patients exposed to three or more prior treatments: an analysis from the ANZ myeloma and related diseases registry

Article

Author: Rajagopal, Rajeev ; Hang, Quach ; Harrison, Simon J ; Spencer, Andrew ; Wellard, Cameron ; Lim, Sueh-Li ; Moore, Elizabeth ; Ho, Joy

AbstractBackgroundThere is no currently available standard of care for triple‐class exposed, relapsed refractory myeloma (RRMM) patients in Australia. CARTITUDE‐1 (CART‐1) was a single‐arm, phase 1b/2 study of 97 triple‐class exposed RRMM patients, who received BCMA‐CAR‐T cell therapy with ciltacabtagene autocel. Overall response rate (ORR) was 98%. Median progression free survival (PFS) and overall survival (OS) had not been reached at a median follow‐up of 28 months.MethodsWe performed a retrospective analysis on a cohort of CART‐1 comparable RRMM patients participating in the Australian and New Zealand Myeloma and Related Diseases Registry (MRDR), to compare outcomes in triple‐class exposed MM patients treated with currently available therapies, in a real‐world context. The CE‐MRDR cohort (n = 28) fulfilled CARTITUDE‐1 eligibility (CE) criteria: ≥3 lines of therapy (LOT) including an immunomodulatory agent, proteasome inhibitor and CD38‐directed monoclonal antibody (CD38mAb) and Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0–2 at diagnosis. The modified‐CE‐MRDR (n = 132) received ≥3 LOT but may not have received a CD38mAb with an ECOG PS score of 3 (0–3).ResultsResponses to the first subsequent therapy after eligibility were poor – ORR was 23% and 0% with progressive disease (PD) reported in 61% and 36%, CE‐MRDR and m‐CE‐MRDR respectively. Responses to the second subsequent therapy after eligibility were worse, ORR 0% and 31%, CE‐MRDR and m‐CE‐MRDR respectively, with high rates of PD, particularly in CE‐MRDR. Median OS was 5.4 versus 9.5 months, CE‐MRDR versus m‐CE‐MRDR.ConclusionsThis retrospective analysis confirms uniformly poor outcomes for Australian RRMM patients. There remains a critical need for greater accessibility to novel treatments, such as CAR‐T, outside clinical trials.

100 Deals associated with BCMA CAR-T cell therapy(Chongqing Precision Biotechnology Co., Ltd.)

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Indication	Highest Phase	Country/Location	Organization	Date
Refractory Multiple Myeloma	Phase 2	CN	Chongqing Precision Biotechnology Co., Ltd.	01 Apr 2019
Relapse multiple myeloma	Phase 2	CN	Chongqing Precision Biotechnology Co., Ltd.	01 Apr 2019

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