NCT05577000

Anti-BCMA Chimeric Antigen Receptor T Cells for Relapsed or Refractory Multiple Myeloma

A Phase 1b Clinical Trial of Anti-BCMA Chimeric Antigen Receptor T Cells for Treatment of Relapsed or Refractory Multiple Myeloma

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Thomas Martin, MD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label study to determine the safety of anti-B-cell maturation antigen (BCMA) Chimeric antigen receptor T-cell (CAR T) therapy in participants with Relapsed or Refractory Multiple Myeloma (RRMM).

Detailed description

PRIMARY OBJECTIVE: 1. To evaluate the safety of administering chimeric antigen receptor (CAR)-T cells targeting BCMA to participants with RRMM (Dose Escalation). 2. To determine the maximum tolerated dose (MTD) for anti-BCMA CAR-T cells (Dose Escalation). 3. Determine whether administering chimeric antigen receptor T cells targeting BCMA to participants with RRMM increases the overall response rate (ORR) in RRMM compared with historical data for non-CAR agents per International Myeloma Working Group (IMWG) response criteria (Dose Expansion). SECONDARY OBJECTIVES: Dose Expansion Only: 1. To describe the efficacy of CAR-T cells targeting BCMA in participants with RRMM defined by ORR using IMWG criteria. 2. To evaluate the feasibility of manufacturing anti-BCMA CAR-T cells locally and ability to produce adequate quantities of vector positive T-cells. 3. To evaluate the safety and toxicity of CAR-T cells targeting BCMA to participants with RRMM. OUTLINE: Participants will be enrolled sequentially to each dose level dependent on analysis of dose-limiting toxicities at the previous dose level. A dose expansion will occur at the maximum tolerated dose (MTD). Participants will undergo apheresis with collection of autologous peripheral blood mononuclear cells that will be used to generate CAR-T cells. After successful generation of the anti-BCMA CAR-T cells drug product (DP), participants will undergo lymphodepleting chemotherapy with fludarabine (and cyclophosphamide). Participants will undergo an additional evaluation of eligibility on Day -1 or 1 prior to infusion of anti-BCMA CAR-T cell product. A single infusion of anti-BCMA CAR-T cells at the starting dose will be given on Day 1. Following treatment with DP, participants will be followed up at 12 months and annually for up to 15 years.

Conditions

• Refractory Multiple Myeloma
• Relapsed Multiple Myeloma

Interventions

Type	Name	Description
BIOLOGICAL	Manufactured Anti-BCMA CAR-T cells	Given IV
DRUG	Fludarabine	Given IV
DRUG	Cyclophosphamide	Given IV

Timeline

• Start date: 2021-10-18
• Primary completion: 2025-11-30
• Completion: 2038-08-31
• First posted: 2022-10-13
• Last updated: 2026-02-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study