Armored CAR T Cells for Blood Cancer

Recruiting in Palo Alto (17 mi)

Overseen by Jae Park, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Memorial Sloan Kettering Cancer Center

No Placebo Group

Trial Summary

What is the purpose of this trial?

The purpose of this phase I study is to test the safety of different dose levels of specially prepared cells collected from the patient called "modified T cells". The investigators want to find a safe dose of modified T cells for patients with this type of cancer that has progressed after standard therapy. The investigators also want to find out what effects these modified T cells have on the patient and the cancer. For patients who were treated, had progression of disease and were removed from study, duplicate enrollment is permitted if it is determined the patients could receive a benefit. If the patients meet all eligibility criteria, they can be enrolled onto study a second time as a new accrual, and receive treatment in a higher dose level cohort.

Eligibility Criteria

Adults with certain blood cancers like CLL, ALL, and others that have not responded to standard treatments can join. They must have a specific marker called CD19 on their cancer cells and meet health criteria such as proper kidney function, liver function, heart performance (LVEF ≥40%), and no severe active infections or autoimmune diseases.

Inclusion Criteria

My cancer affects B cells, has returned or didn't respond to treatment, and tests positive for CD19.

My lymphoma has returned after treatment, confirmed by a biopsy.

My iNHL cancer did not respond or has returned after 2 treatments.

Exclusion Criteria

My heart's pumping ability is severely reduced (EF 20% or less).

My heart's pumping ability is reduced (below 40%).

I have severe heart failure.

Participant Groups

This trial is testing different doses of 'armored' CAR T cells designed to target CD19+ cancer cells in patients whose disease has returned after treatment. The study aims to find the safest dose level for these modified T cells and see how they affect the patient's body and cancer.

Group I: EGFRt/19-28z/4-1BBL CAR T cells Experimental Treatment 1 Intervention

Following enrollment, patients will undergo leukapheresis of peripheral blood for further T cell enrichment, activation and genetic modification using a retroviral vector encoding a CD19targeted CAR, the co-stimulatory ligand 4-1BBL and the EGFRt safety system (EGFRt/19-28z/4-1BBL). These T cells will be expanded and after the appropriate number of cells is generated, the modified T cells may be infused fresh or frozen for later use according to standard operation procedures. Modified T cell infusions will be administered 2-7 days following completion of the treating investigator's choice of conditioning chemotherapy. Serial sampling of blood and bone marrow will be performed following treatment to assess toxicity, therapeutic effects, and survival of the genetically modified T cells.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Memorial Sloan Kettering Cancer Center New York, NY

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center Lead Sponsor

Juno Therapeutics, Inc., a Bristol-Myers Squibb Company Industry Sponsor

Juno Therapeutics, Inc. Industry Sponsor

References