CAR-T Therapy for Leukemia

Recruiting in Palo Alto (17 mi)

Overseen byBachanova Veronika, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Masonic Cancer Center, University of Minnesota

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial is testing a new treatment using modified donor immune cells in adults with a type of leukemia that hasn't responded to other treatments. These special cells are trained to find and control cancer cells. This approach has changed the treatment paradigm for relapsed or refractory lymphoma by enabling immune cells to detect and eliminate cancer cells.

Research Team

Bachanova Veronika, MD

Principal Investigator

Masonic Cancer Center, Univeristy of Minnesota

Eligibility Criteria

Adults with relapsed/refractory CD19+ B-ALL who've failed standard treatments can join this trial. They must have a certain level of organ function, not be on recent immunosuppressives or investigational drugs, and cannot be pregnant or breastfeeding. Those with active infections, severe heart conditions, allergies to specific manufacturing components, or available FDA-approved CAR T cell therapy are excluded.

Inclusion Criteria

I had a stem cell transplant over 3 months ago and have been off immune suppressive therapy for 4 weeks without GVHD.

I had CAR-T therapy over 2 months ago and my cancer still shows CD19 at the latest relapse.

Adequate organ function: Renal: Calculated estimated glomerular filtration rate ≥50 mL/min/1.73 m2, Hepatic: ALT and AST < 3x upper limit of normal, bilirubin < 2x upper limit of normal, Cardiac: Left ventricular ejection fraction (LVEF) > 45%, Pulmonary: SpO2 > 92% on room air

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Exclusion Criteria

I have been diagnosed with Burkitt lymphoma.

I have heart problems that could make treatment risky.

An FDA-approved CAR T cell therapy for CD19+ B-ALL is available to me.

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Treatment Details

Interventions

CAR19 regulatory T cells (CAR19-tTreg) (CAR T-cell Therapy)

Trial OverviewThe trial is testing the safety and effectiveness of allogeneic CAR19 regulatory T cells (CAR19-tTreg) in adults with stubborn leukemia that hasn't responded to other treatments. It's a two-part study: first finding the right dose and then seeing how well it works more broadly.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Phase I/IIExperimental Treatment3 Interventions

Determine the maximum tolerated dose (MTD) of CAR19-tTreg. It will be administered in a single dose after high dose lymphodepleting chemotherapy to promote adoptive transfer. First dose of 1.0 x 10 6 CAR19-tTreg/kg recipient body weight (dose level 1).The subsequent doses are 3.0, 10.0 and 30.0 x 10 6 CAR19- tTreg/kg. PHASE II Expand trial on maximum tolerated dose (MTD) of CAR19-tTreg from Phase I. It will be administered in a single dose after high dose lymphodepleting chemotherapy to promote adoptive transfer.The CAR19-tTreg/kg dose is to be determined.