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RECRUITING
NCT06364423
PHASE1/PHASE2

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

Sponsor: National Cancer Institute (NCI)

View on ClinicalTrials.gov

Summary

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.

Official title: Phase I/II Trial of Anti-CD19 Chimeric Antigen Receptor T-Cell Immunotherapy for B-cell Leukemias

Key Details

Gender

All

Age Range

18 Years - 120 Years

Study Type

INTERVENTIONAL

Enrollment

132

Start Date

2024-09-03

Completion Date

2030-07-01

Last Updated

2026-03-02

Healthy Volunteers

No

Interventions

BIOLOGICAL

Autologous HuCD19 ( Anti-CD19)CAR T cells

1.0x10\^6 CAR+T-cells - 12x10\^6 CAR+ T cells/kg (weight based dosing per cohort) infused on day 0

DRUG

Cyclophosphamide

500 mg/m\^2 IV infusion over 30 minutes on days -5, -4 and -3

DRUG

Fludarabine

30 mg/m\^2 IV infusion over 30 minutes administered immediately following the cyclophosphamide on days -5, -4,and -3

DRUG

Rituximab

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

Locations (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, United States