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

NCT05976555 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-05-20

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Medical College of Wisconsin

    lead OTHER

Principal Investigators

  • Binod Dhakal, MD · Medical College of Wisconsin

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-01
Primary Completion
2028-05-31
Completion
2029-05-31
FDA Drug
Yes

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05976555 on ClinicalTrials.gov