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OncoMatch/Clinical Trials/NCT07257419

CD45RA-depleted CD19-CAR T Cell Consolidation After TCRαβ+/CD19 B Cell-depleted Haploidentical Hematopoietic Cell Transplantation for Relapsed/Refractory CD19+ ALL and Lymphoma

Is NCT07257419 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments for relapsed pediatric all.

Phase 1RecruitingSt. Jude Children's Research HospitalNCT07257419Data as of May 2026

Treatment: Anti-Thymocyte Globulin (Rabbit) · Cyclophosphamide · Fludarabine · Thiotepa · Mesna · Melphalan · Filgrastim · CliniMACS SystemThe purpose of this study is to learn more about newer methods of transplanting blood cells donated by a partially matched family member to children with high-risk CD19 positive leukemia ALL. Primary Objective: \- To assess the safety and feasibility of combining CD19-CAR(Mem) T cells after TCRαβ+/CD19 depleted haploidentical donor transplantation for pediatric patients with relapsed/refractory CD19+ B-cell malignancies. Secondary Objectives: * To estimate 1-year post-transplant overall survival, event-free survival, and GVHD-free relapse-free survival (GRFS). * To estimate cumulative incidence of engraftment, acute and chronic GVHD, and immune-related adverse events, including CRS and ICANS.

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Extracted eligibility criteria

Cancer type

Acute Lymphoblastic Leukemia

Acute Myeloid Leukemia

Non-Hodgkin Lymphoma

Multiple Myeloma

Myelodysplastic Syndrome

Chronic Lymphocytic Leukemia

Biomarker criteria

Required: CD19 positive

Prior therapy

Cannot have received: allogeneic hematopoietic cell transplant

Received a prior allogeneic HCT at any time

Lab requirements

Kidney function

creatinine clearance (crcl) or glomerular filtration rate (gfr) ≥ 50 ml/min/1.73m2

Liver function

bilirubin ≤ 3 times the upper limit of normal for age; alt or ast ≤ 5 times the upper limit of normal for age

Cardiac function

left ventricular ejection fraction > 40%, or shortening fraction ≥ 25%

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • St. Jude Children's Research Hospital · Memphis, Tennessee

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