NCT05976555

Phase I Trial of BCMA-TGF-BETA CAR-T Cells in Relapsed, Refractory Myeloma

Phase I Study of BCMA-TGF-BETA Insensitive Armored CAR T Cells in Patients With Relapsed and/or Refractory Multiple Myeloma

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Medical College of Wisconsin · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This is a phase I, interventional, single-arm, open-label, dose-finding treatment study designed to evaluate the safety and efficacy of interleukin-7(IL-7) / interleukin-15 (IL-15) manufactured CAR T cells in adult patients with relapsed and/or refractory myeloma that have failed prior therapies.

Detailed description

BCMA-Transforming growth factor-beta (TGFβ) CAR-T cells will be administered either fresh or thawed after cryopreservation by IV injection. Patients will receive one of three dose levels of BCMA-TGFβ CAR-T cells based on our dose escalation design. After the maximal tolerated dose (MTD) is determined, an additional dose-expansion cohort of up to 9 patients (3 BCMA-naïve and 6 BCMA exposed) may be enrolled at that dose to further describe the safety and preliminary efficacy of that dose.

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
BIOLOGICAL	BCMA-TGFβ CAR-T cells (0.50 x 10^6 cells/kg)	This is dose level 0 (de-escalation).
BIOLOGICAL	BCMA-TGFβ CAR-T cells (0.75 x10^6 cells/kg)	This is dose level 1, the starting dose.
BIOLOGICAL	BCMA-TGFβ CAR-T cells (1 x 10^6 cells/kg)	This is dose level 2.
BIOLOGICAL	BCMA-TGFβ CAR-T cells (2.5 x 10^6 cells/kg)	This is dose level 3.
BIOLOGICAL	Maximum tolerated dose	The maximum tolerated dose is yet to be determined.

Timeline

• Start date: 2026-03-01
• Primary completion: 2028-05-01
• Completion: 2029-05-01
• First posted: 2023-08-04
• Last updated: 2025-06-11

Regulatory

• FDA-regulated drug study