Modified T-Cell Therapy for Acute Lymphoblastic Leukemia
Recruiting at 1 trial location
Age: < 65
Sex: Any
Trial Phase: Phase 1
Sponsor: Memorial Sloan Kettering Cancer Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
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.
Research Team
Kevin Curran
Principal Investigator
Memorial Sloan Kettering Cancer Center
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.
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Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Conditioning Chemotherapy
Participants receive conditioning chemotherapy prior to T cell infusion
1-2 weeks
T Cell Infusion
Participants receive 19-28z+ T cells infusion over 1 to 2 days
1-2 days
Follow-up
Participants are monitored for safety and effectiveness after T cell infusion
1 year
Treatment Details
Interventions
- Cyclophosphamide
- Modified T cells
Trial Overview 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.
Participant Groups
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Memorial Sloan Kettering Cancer Center
Lead Sponsor
Trials
1,998
Recruited
602,000+
Dana-Farber Cancer Institute
Collaborator
Trials
1,128
Recruited
382,000+
Dana-Farber Cancer Institute:Dana- Farber/Children's Hospital
Collaborator
Trials
1
Recruited
20+
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