Fully Human Bispecific Anti-CD20, Anti-CD19 CAR T Cells for Patients With Relapsed and/or Refractory B Cell Malignancies

Part of paid clinical trials in Milwaukee, Wisconsin.

Sponsor
Medical College of Wisconsin
Study ID
NCT07335328
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

  • B-cell Non Hodgkin Lymphoma

Eligibility Criteria

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

Interventions

  • 1 X 10^6 cells/kg — BIOLOGICAL
    Dose escalation: CAR-T cells will be administered at one of two dose levels either fresh or thawed after cryopreservation by IV injection.
  • 2.5 X 10^6 cells/kg — BIOLOGICAL
    Dose escalation: CAR-T cells will be administered at one of two dose levels either fresh or thawed after cryopreservation by IV injection.
  • Dose expansion: The maximum tolerated dose of CAR-T cells — BIOLOGICAL
    Dose expansion: The maximum tolerated dose intervention will be updated when it is determined. It will be one of two doses: 1 X 10\^6 cells/kg or 2.5 X 10\^6 cells/kg.

Study Details

This is a Phase 1 interventional, single-arm, open- label, treatment study designed to evaluate the safety of h20.19 CAR T cells in patients with B-cell malignancies that have failed prior therapies.

Key Dates

Start date
Sep 1, 2026
Status verified
Jun 2026
Primary completion
May 1, 2027
Completion
May 1, 2031

Study Design

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

Arms

  • Experimental: Dose Level 0: 1 X 10^6 cells/kg
    The investigators will start at a dose of 1 X 10\^6 cells/kg and escalate based on the presence of toxicities.
  • Experimental: Dose Level 1: 2.5 X 10^6 cells/kg
    The investigators will start at a dose of 1 X 10\^6 cells/kg and escalate based on the presence of toxicities.
  • Experimental: Dose Expansion: Maximum Tolerated Dose
    The maximum tolerated dose intervention will be updated when it is determined. It will be one of two doses: 1 X 10\^6 cells/kg or 2.5 X 10\^6 cells/kg. After completing the dose escalation cohort, the investigators will open a 12-patient dose-expansion evaluation of h20.19 CAR T cells.

Primary Outcome Measure

Maximum tolerated dose [ Time Frame: 28 days post CAR-T cell infusion ]

Central Contacts

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

Locations (1)

FacilityCityStateZIPSite coordinators
Froedtert & the Medical College of WisconsinMilwaukeeWisconsin53226
Nirav Shah, MD
[email protected]
414-805-4600
Nirav Shah, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Froedtert & the Medical College of Wisconsin· Milwaukee, WI

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