Anti-CD19 Chimeric Antigen Receptor T-Cell Immunotherapy for Leukemias

Part of paid clinical trials in Bethesda, Maryland.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT06364423
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Acute Lymphoblastic Leukemia
  • B-Cell Chronic Lymphocytic Leukemia
  • B-Lymphocytic Leukemia, Chronic
  • Leukemia, Acute Lymphoblastic
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Lymphoblastic Lymphoma
  • Small Lymphocytic Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 120 Years
Healthy Volunteers
Not accepted

Interventions

  • Autologous HuCD19 ( Anti-CD19)CAR T cells — BIOLOGICAL
    1.0x10\^6 CAR+T-cells - 12x10\^6 CAR+ T cells/kg (weight based dosing per cohort) infused on day 0
  • Cyclophosphamide — DRUG
    500 mg/m\^2 IV infusion over 30 minutes on days -5, -4 and -3
  • Fludarabine — DRUG
    30 mg/m\^2 IV infusion over 30 minutes administered immediately following the cyclophosphamide on days -5, -4,and -3
  • Rituximab — DRUG
    500 mg/m\^2 IV infusion over 30 minutes on day -5; 375 mg/m\^2 IV infusion over 30 minutes on days 2-9 prior to apheresis

Study Details

Background: Chronic lymphocytic leukemia (CLL),small lymphocytic lymphoma (SLL) and B-cell acute lymphoblastic leukemia or lymphoma (ALL) are blood cancers that affect certain white blood cells. Advanced forms of these diseases are difficult to treat. CD19 is a protein often found on the surfaces of these cancer cells. Researchers can modify a person's own immune cells (T cells) to target CD19. When these modified T cells are returned to the body-a treatment called anti-CD19 chimeric antigen receptor (CAR) T cell therapy-they may help kill cancer cells. Objective: To test anti-CD19 CAR T cell therapy in people with CLL or SLL and ALL. Eligibility: People aged 18 years and older with CLL or SLL and ALL that has not been controlled with standard drugs. Design: Participants will be screened. They will have imaging scans and tests of their heart function. If a sample of tissue from their tumor is not available, a new one may be taken; the sample will be tested for CD19. Participants will receive a drug to reduce the leukemia cells in their blood. Then they will undergo apheresis: Blood will be taken from the body through a needle. The blood will pass through a machine that separates out the T cells. The remaining blood will be returned to the body through a different needle. The collected T cells will be gene edited to make them attack cells with CD19. Participants will take drugs to prepare them for treatment for 3 days. These drugs will start 5 days before the treatment. Then their own modified CAR T cells will be returned to their bloodstream. Participants will stay in the hospital for at least 9 days after the treatment. Follow-up visits will continue for 5 years.

Key Dates

First listed
Apr 15, 2024
Start date
Sep 3, 2024
Status verified
Jul 2026
Primary completion
Jul 1, 2029
Completion
Jul 1, 2030

Study Design

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

Arms

  • Experimental: 1/Rituximab, conditioning chemotherapy plus CAR T-cells- Dose escalation in participants with CLL/SL
    Escalating dose of anti-CD19 CAR T- cells/kg + rituximab and conditioning chemotherapy in participants with CLL/SLL
  • Experimental: 2/Rituximab, conditioning chemotherapy plus CAR T-cells- Dose expansion in participants with CLL/SLL
    MTD dose or Optimal dose of Anti-CD19 CAR T- cells/kg + rituximab and conditioning chemotherapy in participants with CLL/SLL
  • Experimental: 3/Rituximab, conditioning chemotherapy plus CAR T-cells- Dose escalation in participants with ALL
    Escalating dose of anti-CD19 CAR T- cells/kg + rituximab and conditioning chemotherapy in participants with ALL
  • Experimental: 4/Rituximab, conditioning chemotherapy plus CAR T-cells- Dose expansion in participants with ALL
    MTD dose or Optimal dose of Anti-CD19 CAR T- cells/kg + rituximab and conditioning chemotherapy in participants with ALL

Primary Outcome Measure

Phase II: Determine the overall response rate (ORR) of T cells expressing an anti-CD19 CAR with a fully-human single chain variable fragment (scFv) to participants with advanced CLL/SLL or ALL. [ Time Frame: From time of the pre-leukapheresis rituximab through 5 years after CAR T infusion. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
National Institutes of Health Clinical CenterBethesdaMaryland20892
NCI Medical Oncology Referral Office
[email protected]
240-760-6050
Micaela Ganaden, M.D.
[email protected]
(240) 858-3654

Find similar trials in Bethesda, MD

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
National Institutes of Health Clinical Center· Bethesda, MD

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