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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 (Jun 2026). This Phase 1 trial studies multiple treatments for relapsed pediatric all.

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

Treatments studied

Chemotherapy

CyclophosphamideFludarabineThiotepaMelphalan

Other

Anti-Thymocyte Globulin (Rabbit)MesnaFilgrastimCliniMACS System

Cancer type

Acute Lymphoblastic Leukemia

Acute Myeloid Leukemia

Non-Hodgkin Lymphoma

Multiple Myeloma

Myelodysplastic Syndrome

Chronic Lymphocytic Leukemia

Biomarker criteria

Required: CD19 positive

Demographics

Ages ≤ 21

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

Showing up to 5 US sites.

See all sites on ClinicalTrials.gov →

Frequently asked questions

Is NCT07257419 currently recruiting?

Yes, this trial is currently recruiting patients.

Are there prior therapy exclusions?

Yes. Prior allogeneic hematopoietic cell transplant disqualifies patients from enrollment.

Does this trial require CD19?

Yes, CD19 positive is a required biomarker for enrollment.

Is there an age limit?

Yes. Patients must be 21 years or younger.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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