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ACTIVE NOT RECRUITING
NCT05797233
PHASE1

Trial of Anti-CD19 and Anti-CD20 Bicistronic Chimeric Antigen Receptor T Cells for Treating B-Cell Malignancies

Sponsor: National Cancer Institute (NCI)

View on ClinicalTrials.gov

Summary

Background: About 23,000 people die from B-cell cancers in the US each year. These cancers, often called leukemia or lymphoma, affect a type of white blood cell called B cells. These cancers are difficult to treat, and the therapies used can have bad side effects. Researchers want to try a new type of treatment. This new treatment uses a patient s own immune cells (T cells) that are modified to carry genes (chimeric antigen receptor, or CAR T cells) to kill cancer cells. Objective: To test a treatment using CAR T cells in people with B-cell cancers. Eligibility: People aged 18 to 75 years with a B-cell cancer that has not been controlled with standard therapies. Design: Participants will be screened. They will have: Blood and urine tests. A needle will be inserted to draw a sample of tissue from inside the hip bone. For some patients, a needle will be inserted into their lower back to get a sample of the fluid around their spinal cord. A tumor biopsy might be needed. Imaging scans. Tests of their heart function. Participants will undergo apheresis: Blood will be drawn from a needle in an arm. The blood will pass through a machine that separates out the T cells. The remaining blood will be returned to the body through a second needle. Participants will receive 2 chemotherapy drugs once a day for 3 days. Participants will be admitted to the hospital for at least 9 days. Their T cells, now modified, will be infused back into their bloodstream through a tube placed in a large vein. Follow-up visits will continue for 5 years, but patients will need to stay in touch with the CAR treatment team for 15 year.

Official title: A Phase I Trial of Anti-CD19 and Anti-CD20 Bicistronic Chimeric Antigen Receptor T- Cells for Treating B-cell Malignancies

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

58

Start Date

2023-08-28

Completion Date

2029-12-30

Last Updated

2026-01-13

Healthy Volunteers

No

Interventions

BIOLOGICAL

Anti-CD19 and anti-CD20 bicistronic CAR T- cells

0.66x10\^6 CAR+ T - 10x10\^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

Locations (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, United States