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

Start date
Sep 3, 2024
Status verified
Apr 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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