Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-30 @ 4:20 AM
Study NCT ID:
NCT07458659
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-09
First Post:
2026-02-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Study of BCMA-Targeted CAR T-Cell Injection in the Treatment of Patients With Relapsed/Refractory Multiple Myeloma
Sponsor:
Chulalongkorn University
Organization:
Study Overview
Official Title:
Phase Ib Clinical Study of BCMA-Targeted Chimeric Antigen Receptor T-Cell Injection (CART-BCMA) in the Treatment of Patients With Relapsed/Refractory Multiple Myeloma
Status:
NOT_YET_RECRUITING
Status Verified Date:
2026-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CART-BCMA
Brief Summary:
A Phase 1b clinical trial to evaluate the safety and efficacy of BCMA-targeted CAR T-cell therapy in Thai patients with relapsed or refractory multiple myeloma.
Detailed Description:
The investigational product used in this study is a chimeric antigen receptor T-cell, also known as "CAR T-cell," engineered to specifically target B-cell maturation antigen (BCMA) protein. The patient's own T-lymphocytes are genetically modified ex vivo to express receptors capable of binding to BCMA protein expressed on the surface of malignant cells. These CAR T-cells are then expanded and infused back into each patient for the treatment of relapsed or refractory multiple myeloma.
Previous clinical research has demonstrated promising outcomes in the treatment of multiple myeloma with CAR T-cell therapy. For example, a clinical trial conducted by Bluebird Bio in 128 patients reported an overall response rate of 73% and a complete response rate of 33%, leading to approval by the United States Food and Drug Administration (FDA) in March 2021. Additionally, a clinical trial by Nanjing Legend Biotech in China, evaluating the investigational CAR T-cell product LCAR-B38M in 97 patients, demonstrated an overall response rate of 97.9% and a complete response rate of 80.4%.
The investigational product used in the current study has previously undergone a Phase 1 clinical trial in 15 patients with relapsed or refractory multiple myeloma, evaluating three dose levels: low (0.25 × 10⁷ cells/kg body weight), intermediate (0.5 × 10⁷ cells/kg body weight), and high (0.75 × 10⁷ cells/kg body weight). The study demonstrated an overall response rate of 100% and a complete response rate of 66.7%. Furthermore, patients who had previously received anti-CD38 monoclonal antibody immunotherapy and/or those with extramedullary disease also achieved an overall response rate of 100%.
Regarding safety, the most notable adverse event associated with BCMA-directed CAR T-cell gene therapy was cytokine release syndrome (CRS), which was observed in all patients and tended to be more severe in the high-dose cohort. However, all adverse events were manageable and clinically controllable. No treatment-related study discontinuations or deaths were reported.
Based on the efficacy and safety data, the high dose level (0.75 × 10⁷ cells/kg) was found to be associated with dose-limiting toxicity. Therefore, the intermediate dose (0.5 × 10⁷ cells/kg) - which demonstrated favorable therapeutic efficacy with an acceptable safety profile - was selected for the Phase 1b clinical trial in Thailand, in order to maximize benefit while minimizing risk to participants.
For the aforementioned reasons, this research project aims to further evaluate the safety and efficacy of BCMA-targeted CAR T-cell therapy in Thai patients with relapsed or refractory multiple myeloma. This Phase 1b study represents the first-in-Thai-patient clinical investigation of this approach. The research team anticipates that this therapy will demonstrate a high safety profile and effective disease control in patients with relapsed or refractory multiple myeloma.
Previous clinical research has demonstrated promising outcomes in the treatment of multiple myeloma with CAR T-cell therapy. For example, a clinical trial conducted by Bluebird Bio in 128 patients reported an overall response rate of 73% and a complete response rate of 33%, leading to approval by the United States Food and Drug Administration (FDA) in March 2021. Additionally, a clinical trial by Nanjing Legend Biotech in China, evaluating the investigational CAR T-cell product LCAR-B38M in 97 patients, demonstrated an overall response rate of 97.9% and a complete response rate of 80.4%.
The investigational product used in the current study has previously undergone a Phase 1 clinical trial in 15 patients with relapsed or refractory multiple myeloma, evaluating three dose levels: low (0.25 × 10⁷ cells/kg body weight), intermediate (0.5 × 10⁷ cells/kg body weight), and high (0.75 × 10⁷ cells/kg body weight). The study demonstrated an overall response rate of 100% and a complete response rate of 66.7%. Furthermore, patients who had previously received anti-CD38 monoclonal antibody immunotherapy and/or those with extramedullary disease also achieved an overall response rate of 100%.
Regarding safety, the most notable adverse event associated with BCMA-directed CAR T-cell gene therapy was cytokine release syndrome (CRS), which was observed in all patients and tended to be more severe in the high-dose cohort. However, all adverse events were manageable and clinically controllable. No treatment-related study discontinuations or deaths were reported.
Based on the efficacy and safety data, the high dose level (0.75 × 10⁷ cells/kg) was found to be associated with dose-limiting toxicity. Therefore, the intermediate dose (0.5 × 10⁷ cells/kg) - which demonstrated favorable therapeutic efficacy with an acceptable safety profile - was selected for the Phase 1b clinical trial in Thailand, in order to maximize benefit while minimizing risk to participants.
For the aforementioned reasons, this research project aims to further evaluate the safety and efficacy of BCMA-targeted CAR T-cell therapy in Thai patients with relapsed or refractory multiple myeloma. This Phase 1b study represents the first-in-Thai-patient clinical investigation of this approach. The research team anticipates that this therapy will demonstrate a high safety profile and effective disease control in patients with relapsed or refractory multiple myeloma.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: