Recruiting
Phase 1

CD19-CAR T Cells

Sponsor:

St. Jude Children's Research Hospital

Code:

NCT07257419

Conditions

Relapsed Pediatric ALL

Hematopoietic Cell Transplantation

Hematologic Malignancy

Eligibility Criteria

Sex: All

Age: 0 - 21

Healthy Volunteers: Not accepted

Interventions

Anti-Thymocyte Globulin (Rabbit)

Cyclophosphamide

Fludarabine

Thiotepa

Mesna

Study Details

Brief summary:

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.

Conditions

Relapsed Pediatric ALL

Hematopoietic Cell Transplantation

Hematologic Malignancy

Study ID

NCT07257419

Start date

Oct 3, 2026

Status verified date

Aug, 2026

Completion date

Dec, 2035

Anticipated

Primary completion date

Dec, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 21

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Design

Enrollment

70 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: HAPALL Treatment

Patients receive a conditioning regimen that will comprise of ATG, Fludarabine, Cyclophosphamide. Melphalan and Thiotepa. Following the conditioning regimen, patients receive infusion of TCRαβ+/CD19 B cell depleted progenitor cell infusion on day 0. Then as early as day + 14 patients will receive the previously manufactured CD19-CAR(Mem) T cell product. Patients will then be monitored for safety and efficacy of the infused CAR T-cell product,

Cells for infusion are prepared using the CliniMACS system.

Interventions

Anti-Thymocyte Globulin (Rabbit)

Days -10, -11, -12.

Cyclophosphamide

60 mg/kg intravenous once daily on day -9.

Fludarabine

30 mg/m2 intravenous once daily for >10 kg, 1 mg/kg intravenous once daily for ≤10 kg on days -4, -5, -6, -7, -8.

Thiotepa

5 mg/kg intravenous twice daily on day -3.

Mesna

Mesna is planned to be administered at 15 mg/kg/dose prior to cyclophosphamide and at approximately 3, 6, and 9 hours after the cyclophosphamide infusion, to give a 1:1 ratio of mesna:cyclophosphamide.

Melphalan

70 mg/m2 intravenous once daily for >10 kg, 2.3 mg/kg intravenous once daily for ≤10 kg on days -1, and -2.

Filgrastim

G-CSF\* 10 mcg/kg/day SC days 0, -1, -2, -3, -4, -5.

CliniMACS System

The mechanism of action of the CliniMACS Cell Selection System is based on magnetic-activated cell sorting (MACS). The CliniMACS device is a powerful tool for the isolation of many cell types from heterogeneous cell mixtures, (e.g. apheresis products). These can then be separated in a magnetic field using an immunomagnetic label specific for the cell type of interest.

Primary outcome measure

  • To assess the safety of combining CD19-CAR(Mem) T cells after TCRαβ+/CD19 depleted haploidentical donor transplantation for pediatric patients with relapsed/refractory CD19+ B-cell malignancies. [ Time Frame: This will be assessed 100 days post-HCT ]
  • To assess the 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. [ Time Frame: This will be assessed in the first 60 days post-HCT ]

Central Contacts and Locations

Central contacts

Swati Naik, MBBS

888-226-4343referralinfo@stjude.org

Locations

St. Jude Children's Research Hospital

Recruiting

Memphis, Tennessee, United States, 38105

Contacts

Swati Naik, MBBS

888-226-4343referralinfo@stjude.org

Principal Investigator:

Swati Naik, MBBS

More Information

Sponsor

St. Jude Children's Research Hospital

Last update posted

Aug 28, 2026

Last verified

Aug, 2026

Keywords

  • Relapsed/Refractory ALL

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by St. Jude Children's Research Hospital on 2026-08-28.