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

Recruiting now · Phase 1

Conditions studied: Relapsed Pediatric ALL, Hematopoietic Cell Transplantation, Hematologic Malignancy

In brief

The 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.

Key facts

Study ID

NCT07257419

Run by

St. Jude Children's Research Hospital

People needed

70

Starts

2026-08-03

Expected to finish

2035-12-01

Last updated by the study team

2026-07-17

Who can join

Age: any, up to 21. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Recipient
• Age less than or equal to 21 years
• High risk hematologic malignancy where allogeneic transplantation is the current standard of care. This includes (but is not limited to):
• High risk CD19+ B cell ALL in CR1 or CR2
• Any CD19+ B-cell ALL in CR3 or subsequent
• If prior CNS leukemia, it must be treated and in CNS CR
• Left ventricular ejection fraction > 40%, or shortening fraction ≥ 25%
• Creatinine clearance (CrCl) or glomerular filtration rate (GFR) ≥ 50 ml/min/1.73m2
• Forced vital capacity (FVC) ≥ 50% of predicted value; or pulse oximetry ≥ 92% on room air if patient is unable to perform pulmonary function testing
• Karnofsky or Lansky (age dependent) performance score ≥ 50 (See APPENDIX A)
• Bilirubin ≤ 3 times the upper limit of normal for age
• Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST) ≤ 5 times the upper limit of normal for age
• Donor
• At least single haplotype matched (≥ 4 of 8) family member
• At least 18 years of age
• HIV negative
• If sexually active, agreement to use birth control until 2 weeks after completion of the mobilization and apheresis procedure
• Regarding donation eligibility, is identified as either:
• Completed the process of donor eligibility determination as outlined in 21 CFR 1271 and agency guidance; OR
• Does not meet 21 CFR 1271 eligibility requirements, but has a declaration of urgent medical need completed by the principal investigator or physician sub-investigator per 21 CFR 1271

You may not qualify if…

• Recipient
• Has a suitable HLA-identical sibling or suitable 12/12 (HLA-A, B, C, DRB1, DQB1, and DPB1) HLA-matched unrelated donor available in an appropriate time frame
• Any other active malignancy other than the one for which this HCT is indicated
• Received a prior allogeneic HCT at any time
• Pregnant, if female is of childbearing potential, negative test must be confirmed by serum or urine pregnancy test within 14 days prior to enrollment
• If sexually active, agreement to use birth control until 6 months after T cell infusion
• Breast feeding
• Any severe current uncontrolled bacterial, fungal or viral infection
• Donor
• Pregnant, negative test must be confirmed by serum or urine pregnancy test within 14 days prior to enrollment if female
• If female, breast feeding

Where it is running

• St. Jude Children's Research Hospital — Memphis, Tennessee, United States (enrolling)

Full record on ClinicalTrials.gov

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