Fludarabine and Cyclophosphamide With or Without Rituximab Before CD19 Chimeric Antigen Receptor T Cells for the Treatment of Relapsed or Refractory Diffuse Large B-Cell Lymphoma

Part of paid clinical trials in Sacramento, California.

Sponsor
Mehrdad Abedi, MD
Study ID
NCT05052528
Phase
PHASE1
Status
Unknown

Conditions

  • Recurrent Diffuse Large B-Cell Lymphoma
  • Refractory Diffuse Large B-Cell Lymphoma

Eligibility Criteria

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

Interventions

  • Chimeric Antigen Receptor T-Cell Therapy — BIOLOGICAL
    Given CD19 CAR T cells IV
  • Cyclophosphamide — DRUG
    Given IV
  • Fludarabine Phosphate — DRUG
    Given IV
  • Rituximab — BIOLOGICAL
    Given IV

Study Details

This phase I trial evaluates the best dose, possible benefits and/or side effects of fludarabine and cyclophosphamide with or without rituximab before CD19 chimeric antigen receptor T cells in treating patients with diffuse large B-cell lymphoma that has come back (relapsed) or has not responded to previous treatment (refractory). T-cells are a normal part of the immune system. To make the T-cell medication, T-cells are taken from the blood and altered in a laboratory. They are then returned to the body. The altered T-cells will latch on to a specific part of the cancer cells and hopefully kill them. Once the T-cells have been altered in the laboratory, they are called "CAR T-cells." CAR is short for "chimeric antigen receptors." These are structures on the surface of cells that allow the altered T-Cells to find and destroy the cancer cells. Another part of the T-Cell medication is called "CD19." This part is called a "biomarker." Biomarkers help doctors determine whether a cancer is getting worse and whether medications are working to stop it. The chemotherapy drugs that are given before the T-Cell therapy are cyclophosphamide, fludarabine and rituximab. Rituximab is an immunotherapy drug. These chemotherapy drugs will reduce the number of normal (unaltered) T-Cells in the body to make room for the altered T-cells to kill the cancer cells. Giving fludarabine and cyclophosphamide with or without rituximab before CD19 CAR T cell therapy may help improve response to CD19 CAR T cell therapy in patients with diffuse large B-cell lymphoma.

Key Dates

Start date
Sep 17, 2021
Status verified
May 2024
Primary completion
May 15, 2025
Completion
Dec 15, 2025

Study Design

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

Arms

  • Experimental: Dose level 1 (fludarabine, cyclophosphamide, CD19 CAR T)
    Patients receive fludarabine phosphate IV over 30 minutes daily and cyclophosphamide IV over 60 minutes daily on days -5 to -3. Patients also receive CD19 CAR T cells IV on day 0.
  • Experimental: Dose level 2 (rituximab, fludarabine, cyclophosphamide, CAR T)
    Patients receive rituximab IV on day -5, fludarabine phosphate IV over 30 minutes daily on days -5 to -3, and cyclophosphamide IV over 60 minutes on days -5 to -3. Patients also receive CD19 CAR T cells IV on day 0.
  • Experimental: Dose level 3 (fludarabine, cyclophosphamide, CD19 CAR T)
    Patients receive fludarabine phosphate IV over 30 minutes daily on days -3 to -5 and cyclophosphamide IV over 60 minutes daily on day -5. Patients also receive CD19 CAR T cells IV on day 0.
  • Experimental: Dose level 4 (rituximab, fludarabine, cyclophosphamide, CAR T)
    Patients receive rituximab IV on day -5, fludarabine phosphate IV over 30 minutes daily on days -5 to -3, and cyclophosphamide IV over 60 minutes on day -5. Patients also receive CD19 CAR T cells IV on day 0.
  • Experimental: Dose level 5 (fludarabine, cyclophosphamide, CD19 CAR T)
    Patients receive fludarabine phosphate IV over 30 minutes daily on days -5 to -1 and cyclophosphamide IV over 60 minutes daily on days -5 and -4. Patients also receive CD19 CAR T cells IV on day 0.
  • Experimental: Dose level 6 (rituximab, fludarabine, cyclophosphamide, CAR T)
    Patients receive rituximab IV on day -5, fludarabine phosphate IV over 30 minutes daily on days -5 to -1, and cyclophosphamide IV over 60 minutes on days -5 and -4. Patients also receive CD19 CAR T cells IV on day 0.

Primary Outcome Measure

Proportion of products successfully manufactured meeting the established release criteria with a goal of at least 1.0 x 10^6 cells/kilogram [ Time Frame: Up to 15 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of California Davis Comprehensive Cancer CenterSacramentoCalifornia95817
Mehrdad Abedi
[email protected]
916-734-3771
Mehrdad Abedi (PRINCIPAL_INVESTIGATOR)

Find similar trials in Sacramento, CA

By research site
University of California Davis Comprehensive Cancer Center· Sacramento, CA

Related Studies