Modified T-Cell Therapy for Acute Lymphoblastic Leukemia

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen byKevin Curran

Age: < 65

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 study is to test the safety of giving the patient special cells made from their own blood called "Modified T-cells". The goal is to find a safe dose of modified T-cells for patients whose leukemia has returned to the bone marrow.

Eligibility Criteria

This trial is for pediatric and young adult patients with a relapse of B-cell acute lymphoblastic leukemia. Eligible participants include those diagnosed at age ≥13 years, with specific genetic markers or high-risk features, and who are in their first or subsequent bone marrow relapse.

Inclusion Criteria

My leukemia was CNS-3 at diagnosis.

There is still evidence of cancer cells in your bone marrow after the initial treatment.

My leukemia is either t(17;19) ALL or Ph-Like ALL.

+6 more

Participant Groups

The study tests the safety of modified T-cells made from the patient's own blood to treat leukemia that has returned. It aims to determine a safe dose for these special cells after standard chemotherapy regimens.

2Treatment groups

Experimental Treatment

Group I: Cohort 2 (Morphologic Disease)Experimental Treatment3 Interventions

Pts with morphologic evidence of disease at the time of T cell infusion, (≥5% blasts in the bone marrow) as assessed by morphology or flow cytometry. Participating site PI to determine cohort stratification in the event of morphology/flow cytometry blast count discrepancy. Pts with increased blasts (5-10% blasts) that are immunophenotypically consistent with recovering marrow from prior re-induction chemo may be treated under Cohort 1 with approval of the participating site PI. Cohort 2 pts will get conditioning chemo followed by 1x10\^6 19-28z+ T cells/kg over 1 to 2 days. During formulation of EOP T cells, under or over estimation of CAR modified T-cells may occur. Pts may get up to 35% over total cell dose with approval by the participating site PI. Both cohorts, pts will be allowed to receive a 2nd treatment of 19-28z+ T cells if they benefited from the first infusion \& did not experience any non-hematologic grade 4 toxicities.

Group II: Cohort 1 (MRD)Experimental Treatment3 Interventions

Patients with no morphologic evidence of disease at the time of T cell infusion, (\<5% blasts in the bone marrow) as assessed by morphology or flow cytometry. Participating site PI to determine cohort stratification in the event of morphology/flow cytometry blast count discrepancy. Cohort 1 patients will receive conditioning chemotherapy followed by 1x10\^6 19-28z+ T cells/kg over 1 to 2 days. During formulation of End of Production (EOP) T cells, under or over estimation of CAR modified T-cells may occur. Patients may receive an altered fractionation of the total doses (e.g. ½ on Day 0 and ½ on Day +1) or up to 35% over total cell dose with approval by the participating site PI. In both cohorts, patients will be allowed to receive a 2nd treatment of 19-28z+ T cells if they benefited from the first infusion and did not experience any non-hematologic grade 4 toxicities.