CAR T-Cell Therapy for Non-Hodgkin's Lymphoma

Recruiting in Palo Alto (17 mi)

Shadman | Division of Hematology & Oncology

Overseen ByMazyar Shadman

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Fred Hutchinson Cancer Research Center

No Placebo Group

Trial Summary

What is the purpose of this trial?The purpose of this research is to find the best dose of genetically modified T-cells, to study the safety of this treatment, and to see how well it works in treating patients with B cell non-Hodgkin lymphoma that has come back (relapsed) or did not respond to previous treatment (refractory).

Eligibility Criteria

Adults with certain types of B cell non-Hodgkin lymphoma or chronic lymphocytic leukemia that have relapsed or are refractory. They must understand the study, be willing to use contraception, and meet health criteria including organ function and performance status. Excluded are those with recent significant heart disease, active autoimmune diseases needing steroids, HIV positive individuals, pregnant or breastfeeding women, and those with other progressing cancers.

Inclusion Criteria

I meet the requirements for a specific type of chemotherapy to reduce my white blood cells.

I can understand and sign the consent form.

I have B-cell non-Hodgkin lymphoma or chronic lymphocytic leukemia.

My DLBCL has not responded to treatment or has come back.

I can care for myself but may need occasional help.

My lymphoma affects my brain or spinal cord.

Exclusion Criteria

I have another cancer that is getting worse or needs treatment.

I am on medication to suppress my immune system due to an autoimmune disease.

I am taking 15 mg or more of prednisone daily.

I am not pregnant or breastfeeding.

I have a history of significant brain disorders not related to lymphoma.

I have had serious heart problems in the last 6 months.

I have received treatments targeting CD19 or CD20, or been part of a clinical trial.

I have low B cell counts due to previous treatments.

I do not have CNS issues, GVHD, or any uncontrolled infections.

Participant Groups

The trial is testing genetically modified T-cells targeting CD20 in patients with specific B cell malignancies. It aims to determine the optimal dose for safety and effectiveness. The process includes leukapheresis (to collect white blood cells), followed by laboratory biomarker analysis, chemotherapy conditioning (with Cyclophosphamide and Fludarabine Phosphate), then infusion of engineered T-cells.

1Treatment groups

Experimental Treatment

Group I: Treatment (CD20-specific CAR T cell, chemotherapy)Experimental Treatment5 Interventions

Patients undergo leukapheresis and may receive treatment after if needed for disease control. Patients then receive cyclophosphamide IV. Patients may also receive fludarabine IV. After 36-96 hours, patients receive CD20-specific CAR T cell infusion IV over 20-30 minutes.