CD19.20.22 CAR T-cells for Patients With Relapsed/Refractory B-Cell Lymphomas

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
University of Maryland, Baltimore
Study ID
NCT07168486
Phase
PHASE1
Status
Enrolling By Invitation

Conditions

  • B-Cell Lymphoma
  • Chronic Lymphocytic Leukemia
  • Diffuse Large B Cell Lymphoma (DLBCL)
  • Follicular Lymphoma
  • Mantle Cell Lymphoma
  • Marginal Zone Lymphoma
  • Primary Mediastinal Large B-cell Lymphoma (PMBCL)
  • Richter Transformation
  • Small Lymphocytic Lymphoma
  • Transformed Follicular Lymphoma (tFL)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • CD19.20.22 CAR T cells — BIOLOGICAL
    CAR19.20.22 is a type of immunotherapy known as a chimeric antigen receptor T-cells (CAR T-cells).
  • Fludarabine and Cyclophosphamide — DRUG
    Lymphodepletion with Flu-Cy prior to CAR T cell therapy

Study Details

The goal of this study is to treat patients diagnosed with relapsed or refractory positive B cell lymphoma - positive for 2 or more target antigens - with CAR19.20.22 CAR T-cells. Based on the preclinical characteristics of the LTG2950, CAR19.20.22 tri-specific CAR T-cells the Investigators have developed the following hypotheses to be tested in our phase Ia clinical trial. The Investigators hypothesize that these novel CAR T-cells will show: * good safety and tolerability * a high degree of efficacy * very good persistence * an acceptable level of exhaustion

Key Dates

Start date
Oct 28, 2024
Status verified
Sep 2025
Primary completion
Jul 1, 2027
Completion
Jul 1, 2028

Study Design

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

Arms

  • Experimental: Dose Level -1
    Autologous CAR19.20.22 T-cells, 0.75 × 10\^6 cells/kg (±20%), IV infusion following fludarabine/cyclophosphamide lymphodepletion.
  • Experimental: Dose Level 0
    Autologous CAR19.20.22 T-cells, 1.0 × 10\^6 cells/kg (±20%), IV infusion following fludarabine/cyclophosphamide lymphodepletion.
  • Experimental: Dose Level 1
    Autologous CAR19.20.22 T-cells, 2.5 × 10\^6 cells/kg (±20%), IV infusion following fludarabine/cyclophosphamide lymphodepletion.

Primary Outcome Measure

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [Safety and Tolerability] [ Time Frame: From date of enrollment assessed up to 24 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Maryland, BaltimoreBaltimoreMaryland21201-

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