RecruitingPhase 1Phase 2NCT06364423

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

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


Sponsor

National Cancer Institute (NCI)

Enrollment

132 participants

Start Date

Sep 3, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 120 Years

Plain Language Summary

Simplified for easier understanding

This NIH study tests a type of immune cell therapy called CAR-T cells engineered to target a protein called CD19, which is found on certain blood cancer cells. It is designed for people with certain types of leukemia or lymphoma that have not responded to or have returned after other treatments. **You may be eligible if...** - You have confirmed chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), or B-cell acute lymphoblastic leukemia (ALL) - Your cancer cells express the CD19 protein - You have relapsed or your cancer did not respond to prior treatments - Richter's transformation (a more aggressive form) is also eligible if CLL/SLL is confirmed **You may NOT be eligible if...** - Your cancer does not express CD19 - You have certain serious medical conditions that make this experimental therapy unsafe - You do not meet other health criteria assessed by NIH Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALAutologous 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

DRUGCyclophosphamide

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

DRUGFludarabine

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

DRUGRituximab

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

View Full Details on ClinicalTrials.gov

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NCT06364423


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