CAR-T Cells for Non-Hodgkin's Lymphoma

Recruiting in Palo Alto (17 mi)

Overseen ByC. Babis Andreadis, MD

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

Sponsor: C. Babis Andreadis

No Placebo Group

Trial Summary

What is the purpose of this trial?This study will assess safety and feasibility of infusing genetically modified autologous T cells transduced to express a chimeric antigen receptor targeting the B cell surface antigen Cluster of Differentiation 19 (CD19)

Eligibility Criteria

Adults with certain types of B-cell Non-Hodgkin Lymphoma that have relapsed or didn't respond to previous treatments can join. They should not be eligible for stem cell transplant, must have tried at least two systemic therapies, and still show CD19 positive cells. Key organ functions need to be within normal ranges, they shouldn't have other active cancers or severe illnesses, and women who can get pregnant must agree to use contraception for a year after treatment.

Inclusion Criteria

My lymphoma shows up on PET scans.

I have a type of B-cell NHL that has come back or didn't respond to treatment.

Exclusion Criteria

I am HIV positive.

I had a stem cell transplant using my own cells less than 6 weeks ago.

I have an autoimmune disease and need medication to suppress my immune system.

My body weight is less than 40 kilograms.

I have no active cancer except for non-dangerous skin cancer or very early stage cancers.

I have a significant brain or spinal cord condition.

I do not have an active hepatitis B or C infection.

I do not have any unmanaged ongoing illnesses.

I have previously received CAR-T cell therapy targeting CD19.

Participant Groups

The trial is testing genetically modified T cells that target CD19 on the surface of B cells. Patients will receive Cyclophosphamide and Fludarabine as part of the preparation before getting these anti-CD19 CAR-T cells infused into their bloodstream.

1Treatment groups

Experimental Treatment

Group I: Treatment RegimenExperimental Treatment3 Interventions

Apheresis (1 day): Autologous lymphocytes/ mononuclear cell collection will be collected through standard apheresis procedures as per University of California, San Francisco (UCSF) institutional practices CAR-T cell manufacturing (estimated \~13-14 days) Lymphodepleting chemotherapy: 3 days of immunosuppressive chemotherapy. Cyclophosphamide given at a dose of 300 mg/m2/IV and fludarabine given at 30 mg/m2 /IV on days -5, -4, and -3. CAR-T cell infusion (1 day): The infusion of CAR-T cells targeting CD19 will occur over 5-30 minutes.