Anti-CD19 Chimeric Antigen Receptor T Cells for Treatment of Relapsed or Refractory Non-Hodgkin Lymphoma

Part of paid clinical trials in San Francisco, California.

Sponsor
C. Babis Andreadis
Study ID
NCT04545762
Phase
PHASE1
Status
Recruiting
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Conditions

  • Burkitt Lymphoma
  • Diffuse Large B Cell Lymphoma
  • Follicular Lymphoma
  • Lymphoplasmacytic Lymphoma
  • Mantle Cell Lymphoma
  • Non-Hodgkin Lymphoma
  • Primary Mediastinal Large B Cell Lymphoma
  • Refractory Non-Hodgkin Lymphoma
  • Small Lymphocytic Lymphoma
  • Transformed Lymphoma

Eligibility Criteria

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

Interventions

  • Fludarabine — DRUG
    Given intravenously (IV)
  • Cyclophosphamide — DRUG
    Given intravenously (IV)
  • anti-CD19 CAR-T cells — BIOLOGICAL
    Single infusion

Study Details

This study will assess safety and feasibility of infusing genetically modified autologous T cells transduced to express a chimeric antigen receptor targeting the B cell surface antigen Cluster of Differentiation 19 (CD19).

Key Dates

Start date
Sep 11, 2020
Status verified
Aug 2025
Primary completion
Oct 31, 2026
Completion
Oct 31, 2026

Study Design

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

Arms

  • Experimental: CLOSED TO ENROLLMENT: Dose escalation (CART-T Therapy)
    Participants will undergo Apheresis (1 day) to collect autologous lymphocytes/ mononuclear cells as per University of California, San Francisco (UCSF) institutional practices. CAR-T cell manufacturing (estimated \~13-14 days), during which participants will receive a lymphodepleting regimen of immunosuppressive chemotherapy (Cyclophosphamide 300 mg/m2/IV and fludarabine 30 mg/m2 /IV) followed by the infusion of CAR-T cells at an initial dose of 5 x 10\^5 cells/kg, targeting CD19 over 5-30 minutes. Participants will be followed up 30 days after infusion, for up to 12 months, if the participant in continued remission, and for survival up to 15 years.
  • Experimental: Dose Expansion: Burkitt, Marginal Zone, or Waldenström Macroglobulinemia ONLY (CAR-T Therapy)
    Participants with Burkitt lymphoma, or Marginal Zone Lymphoma (MZL) and Waldenström Macroglobulinemia (WM) will undergo Apheresis (1 day) to collect autologous lymphocytes/ mononuclear cells as per University of California, San Francisco (UCSF) institutional practices. CAR-T cell manufacturing (estimated \~13-14 days), during which participants will receive a lymphodepleting regimen of immunosuppressive chemotherapy (Cyclophosphamide 300 mg/m2/IV and fludarabine 30 mg/m2 /IV) followed by the infusion of the maximum tolerated dose of CAR-T cells established in the dose escalation phase, targeting CD19 over 5-30 minutes. Participants will be followed up 30 days after infusion, for up to 12 months, if the participant in continued remission, and for survival up to 15 years.

Primary Outcome Measure

Proportion of participants with treatment-emergent adverse events (AEs) [ Time Frame: From initiation of study treatment to 12 months following CAR-T infusion, approximately 15 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of California, San FranciscoSan FranciscoCalifornia94143
UCSF HDFCCC Cancer Immunotherapy Program
[email protected]
877-827-3222
[email protected]
C. Babis Andreadis, MD (SUB_INVESTIGATOR)
Carrie Ho, MD (PRINCIPAL_INVESTIGATOR)

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