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

Sponsor
Medical College of Wisconsin
Study ID
NCT05976555
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

First listed
Aug 4, 2023
Start date
Jul 1, 2026
Status verified
May 2026
Primary completion
May 31, 2028
Completion
May 31, 2029

Study Design

Enrollment
30 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: BCMA-TGFβ CAR-T cells (0.50 x 10^6 cells/kg)
    BCMA-TGFβ CAR-T cells will be administered either fresh or thawed after cryopreservation by IV injection. Subjects will receive one of four dose levels of BCMA-TGFβ CAR-T cells based on the dose escalation design.
  • Experimental: BCMA-TGFβ CAR-T cells (0.75 x10^6 cells/kg)
    BCMA-TGFβ CAR-T cells will be administered either fresh or thawed after cryopreservation by IV injection. Subjects will receive one of four dose levels of BCMA-TGFβ CAR-T cells based on the dose escalation design.
  • Experimental: BCMA-TGFβ CAR-T cells (1 x 10^6 cells/kg)
    BCMA-TGFβ CAR-T cells will be administered either fresh or thawed after cryopreservation by IV injection. Subjects will receive one of four dose levels of BCMA-TGFβ CAR-T cells based on the dose escalation design.
  • Experimental: BCMA-TGFβ CAR-T cells (2.5 x 10^6 cells/kg)
    BCMA-TGFβ CAR-T cells will be administered either fresh or thawed after cryopreservation by IV injection. Subjects will receive one of four dose levels of BCMA-TGFβ CAR-T cells based on the dose escalation design.
  • Experimental: BCMA-TGFβ CAR-T cells (Maximum tolerated dose)
    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.

Primary Outcome Measure

Number of Adverse Events After BCMA-TGFβ CAR-T Cell Infusion [ Time Frame: from infusion until Day +28 post CAR T infusion ]

Central Contacts

  • Medical College of Wisconsin Cancer Center Clinical Trials Office
    866-680-0505
    [email protected]

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