Clinical Study of BCMA-Targeted CAR T-Cell Injection in the Treatment of Patients With Relapsed/Refractory Multiple Myeloma

NCT07458659 | Not Yet Recruiting Early Phase 1 DMC

• 1 other identifier: TTCI-BCMA-MM-P1b-2026
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Relapsed/Refractory Multiple Myeloma (MM)

Keywords

Relapsed/Refractory Multiple Myeloma; CART-BCMA; BCMA; CAR T-cell

Outcome Measures

Primary Outcomes (2)

• The safety of CART-BCMA in patients with relapsed or refractory multiple myeloma.

  Number and percentage of participants experiencing treatment-emergent adverse events (AEs) and serious adverse events (SAEs) after CART-BCMA cell infusion. AEs will be graded according to CTCAE version 5.0

  Day 1 to Day 8, Day 14, Day 21, Day 28, Day 60, Day 90, Day 120, Day 180, Day 270, Day 360, and every 90 days from Day 450 to Day 720 after CART-BCMA cell infusion

• Incidence of Dose-Limiting Toxicities (DLTs)

  Number and percentage of participants experiencing dose-limiting toxicities (DLTs) during the DLT evaluation period following CART-BCMA cell infusion. DLTs will be defined according to protocol-specified criteria and graded using Common Terminology Criteria for Adverse Events (CTCAE), version 5.0

  From Day 1 to Day 28 after CART-BCMA cell infusion (DLT evaluation period)

Secondary Outcomes (7)

• The overall response rate (ORR, at least PR or better) per IMWG 2016 Criteria

  Day 28, Day 60, Day 90, Day 120, Day 180, Day 270, Day 360, and every 90 days from Day 450 to Day 720 after CART-BCMA cell infusion

• Complete Response (CR) or Stringent Complete Response (sCR) Rate per IMWG 2016 Criteria

  Day 28, Day 60, Day 90, Day 120, Day 180, Day 270, Day 360, and every 90 days from Day 450 to Day 720 after CART-BCMA cell infusion

• Very Good Partial Response (VGPR) or Better Rate per IMWG 2016 Criteria

  Day 28, Day 60, Day 90, Day 120, Day 180, Day 270, Day 360, and every 90 days from Day 450 to Day 720 after CART-BCMA cell infusion

• Time to First Documented Response (≥PR) per IMWG 2016 Criteria

  From infusion date up to Day 720 (approximately 24 months)

• Duration of Response per IMWG 2016 Criteria

  From first documented response up to Day 720 (approximately 24 months)

Other Outcomes (4)

• Maximum Observed CAR-T Cell Expansion (Cmax)

  Day 0, Day 8, Day 14, Day 21, Day 28, Day 60, Day 90, Day 120, Day 180, Day 270, Day 360, and every 90 days from Day 450 to Day 720 after CART-BCMA cell infusion

• Time to Maximum Observed CAR-T Cell Expansion (Tmax)

  From Day 0 up to Day 90 after infusion

• Area Under the Concentration-Time Curve of CAR-T Cells from Day 0 to Day 28 (AUC0-28d)

  Day 0 to Day 28 after CART-BCMA cell infusion

Study Arms (1)

CART-BCMA in multiple myeloma

EXPERIMENTAL

Chimeric antigen receptor T-cell injection targeting BCMA (CART-BCMA) Dose level: 0.5×10e7 cells/Kg

Biological: Chimeric Antigen Receptor T Cells (CAR-T)

Interventions

Chimeric Antigen Receptor T Cells (CAR-T) BIOLOGICAL

This product is a CAR T-cell therapy utilizing the participant's own autologous T-lymphocytes, which are collected via apheresis, processed in a laboratory setting, and subsequently reinfused intravenously through a peripheral vein at a rate of 2-5 mL/min. Participants will undergo cell collection via apheresis for product preparation, followed by lymphodepleting chemotherapy. This process includes pre-chemotherapy and pre-infusion assessments prior to the administration of CART-BCMA cells.

CART-BCMA in multiple myeloma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age above 18 years old (inclusive), regardless of gender.
• Patients with multiple myeloma who have received at least three lines of treatment for multiple myeloma and have failed at least after treatment with proteasome inhibitors and immunomodulators; At least one complete cycle of each line of therapy, unless the best response to that therapy was documented as progressive disease (PD) (according to the 2016 published IMWG criteria for efficacy evaluation, Appendix 4); Patients must have PD records during or within 12 months after the last treatment or no response (no MR or better response) within 60 days after the last treatment.
• The presence of measurable lesions at screening was defined as any of the following:
• Serum M protein ≥ 1 g/dL (≥ 10 g/L)
• Urinary M-protein level ≥ 200 mg/24 hours
• Serum free light chains (FLC): abnormal serum FLC ratio (\< 0.26 or \> 1.65) with involved FLC ≥ 10 mg/dL (100 mg/L)
• ECOG Performance Status (Appendix 1) of 0-1.
• Expected survival time ≥ 3 months.
• Meets the following criteria prior to mononuclear cell apheresis:
• Hematology
• Absolute count of lymphoid cells ≥ 0.5×109/L \[Granulocyte colony-stimulating factor (G-CSF) is allowed, but this supportive treatment shall not be received by the test subjects within 7 days before laboratory tests during the screening period\];
• Absolute neutrophil count ≥ 1.0 ×109/L \[Granulocyte colony-stimulating factor (G-CSF) is allowed, but the subjects shall not receive this supportive treatment within 7 days before laboratory tests during the screening period\];
• Platelet count ≥ 50×109/L (subjects must not receive blood transfusion support within 7 days before the screening laboratory test);
• Hemoglobin ≥ 8.0 g/dL (recombinant human erythropoietin is allowed) \[subjects have not received red blood cells (RBCS) within 7 days prior to screening laboratory testing\]; Heart
• Ejection function: Left ventricular ejection fraction (LVEF) ≥ 50% Lungs

You may not qualify if:

• Subjects with a known history of allergy, hypersensitivity, intolerance, or contraindication to any component of CART-BCMA or drugs that may be used in the study (including fludarabine, cyclophosphamide, tocilizumab); or subjects allergic to beta-lactam antibiotics; or subjects with a history of severe allergic reactions.
• Subjects who have previously received any CAR-T therapy or BCMA-targeted therapy.
• Subjects who have received the following anti-multiple myeloma (anti-MM) treatments within the specified time frame before apheresis:
• Small-molecule targeted therapy within 4 weeks or five half-lives, whichever was longer
• Macromolecular drug therapy within 4 weeks or 2 half-lives (whichever is longer)
• Cytotoxic therapy or proteasome inhibitor within 2 weeks
• Immunomodulatory drug therapy within 1 week
• Radiotherapy within 1 week
• Subjects who have received any investigational drug within 4 weeks prior to apheresis or are concurrently participating in another clinical study (except for the following: subjects participating in observational, non-interventional clinical studies, or those in the follow-up period of an interventional clinical study).
• Patients who have received autologous hematopoietic stem cell transplantation (ASCT) within 12 weeks prior to apheresis or have previously received allogeneic stem cell transplantation (with no time limit).
• Subjects who have received live vaccines or attenuated vaccines within 4 weeks prior to CART-BCMA apheresis.
• Note: Administration of inactivated viral vaccines for seasonal influenza via injection is permitted; however, intranasal attenuated live influenza vaccines are not permitted.
• Subjects who have received any of the following treatments within 7 days prior to apheresis, or are judged by the investigator to require long-term receipt of such treatments during the study:
• Cumulative corticosteroids use equivalent to ≥ 70 mg prednisone within 7 days prior to apheresis, or long-term receipt of therapeutic-dose corticosteroids during the study as judged by the investigator
• Immunosuppressive therapy

Sponsors & Collaborators

• Chulalongkorn University: lead
• King Chulalongkorn Memorial Hospital: collaborator
• Chula Clinical Research Center (Chula CRC), Faculty of Medicine, Chulalongkorn University: collaborator

Study Sites (1)

King Chulalongkorn Memorial Hospital

Bangkok, Pathumwan, 10330, Thailand

Location

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Immunotherapy, Adoptive

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Adoptive Transfer; Immunization, Passive; Immunization; Immunotherapy; Immunomodulation; Biological Therapy; Therapeutics; Immunologic Techniques; Investigative Techniques

Study Officials

• Kritsada Wuttigorn, Associate Professor, MD

  Chulalongkorn University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kritsada Wuttigorn, Associate Professor, MD

CONTACT

+66805623592; kitsada.w@chula.ac.th

Koramit Suppipat, MD

CONTACT

+66816282068; koramit.s@chula.ac.th

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The optimal dose of investigational drug CART BCMA in the phase I trial, 0.5×107 CAR-Positive T cells/kg (body weight), was selected as the fixed dose for this trial.

Study Record Dates

• First Submitted: February 26, 2026
• First Posted: March 9, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2029
• Last Updated: March 9, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)