CD19-Directed CAR-T Cell Therapy for the Treatment of Relapsed/Refractory B Cell Malignancies

Part of paid clinical trials in Rochester, Minnesota.

Sponsor
Mayo Clinic
Study ID
NCT04892277
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Recurrent B-Cell Non-Hodgkin Lymphoma
  • Recurrent Chronic Lymphocytic Leukemia
  • Recurrent Small Lymphocytic Lymphoma
  • Recurrent Transformed Chronic Lymphocytic Leukemia
  • Refractory B-Cell Non-Hodgkin Lymphoma
  • Refractory Chronic Lymphocytic Leukemia
  • Refractory Small Lymphocytic Lymphoma
  • Refractory Transformed Chronic Lymphocytic Leukemia

Eligibility Criteria

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

Interventions

  • Autologous Anti-CD19 CAR-expressing T-lymphocytes IC19/1563 — BIOLOGICAL
    Given IV
  • Bendamustine — DRUG
    Given IV
  • Biospecimen Collection — PROCEDURE
    Undergo collection of blood and tissue samples
  • Bone Marrow Aspiration — PROCEDURE
    Undergo bone marrow aspiration
  • Bone Marrow Biopsy — PROCEDURE
    Undergo bone marrow biopsy
  • Computed Tomography — PROCEDURE
    Undergo CT
  • Cyclophosphamide — DRUG
    Given IV
  • Fludarabine — DRUG
    Given IV
  • Magnetic Resonance Imaging — PROCEDURE
    Undergo MRI
  • Positron Emission Tomography — PROCEDURE
    Undergo CT/PET

Study Details

This phase I trial studies the effects of CD-19 directed chimeric antigen receptor (CAR)-T cell therapy for the treatment of patients with B cell malignancies that have come back (recurrent) or have not responded to treatment (refractory). CD-19 CAR-T cells use some of a patient's own immune cells, called T cells, to kill cancer. T cells fight infections and, in some cases, can also kill cancer cells. Some T cells are removed from the blood, and then laboratory, researchers will put a new gene into the T cells. This gene allows the T cells to recognize and possibly treat cancer. The new modified T cells are called the IC19/1563 treatment. IC19/1563 may help treat patients with relapsed/refractory B cell malignancies.

Key Dates

Start date
Oct 3, 2022
Status verified
Jun 2026
Primary completion
Mar 27, 2028
Completion
Mar 27, 2040

Study Design

Enrollment
25 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (cyclophosphamide, fludarabine, IC19/1563)
    Patients receive cyclophosphamide IV over 60 minutes and fludarabine IV over 30 minutes on days -5, -4, -3, or bendamustine IV over 10 minutes on days -4 and -3, and IC19/1563 IV on day 0. Patients also undergo bone marrow biopsy and aspiration, CT-PET or CT scans, MRI, and collection of blood and tissue samples throughout the trial.

Primary Outcome Measure

Maximum tolerated dose (MTD) [ Time Frame: 90 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Mayo Clinic in RochesterRochesterMinnesota55905
Clinical Trials Referral Office
[email protected]
855-776-0015
Saad J. Kenderian, M.D. (PRINCIPAL_INVESTIGATOR)

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Mayo Clinic in Rochester· Rochester, MN

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