CD19‑CAR T‑cell consolidation after TCRαβ/CD19‑depleted haploidentical family donor transplant for relapsed/refractory CD19+ B‑cell leukemia and lymphoma
Official title: CD45RA-depleted CD19-CAR T Cell Consolidation After TCRαβ+/CD19 B Cell-depleted Haploidentical Hematopoietic Cell Transplantation for Relapsed/Refractory CD19+ ALL and Lymphoma
Run by St. Jude Children's Research Hospital · NCT07257419 · Data updated 2026-11-12
This will try giving CD19‑targeted CAR T cells shortly after a partially matched family‑donor transplant to children and young adults (≤21) with relapsed or refractory CD19+ B‑cell leukemia or lymphoma to see if the approach is safe and feasible.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | Any age to 21 Years |
| Sex | All |
| Enrollment | 70 (estimated) |
| Sponsor | St. Jude Children's Research Hospital Academic / other |
| Drugs / interventions | CAR T, chemotherapy |
| Locations | 1 site (Memphis, Tennessee) |
| Status | Recruiting |
| Started | October 3, 2026 |
| Main results expected | December 2031 |
| Study ends | December 2035 |
| Registry record updated | August 28, 2026 |
| Trial ID | NCT07257419 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Children and young adults (≤21 years) with high‑risk or relapsed/refractory CD19+ B‑cell ALL or lymphoma who require allogeneic transplantation and have an eligible haploidentical family donor (≥18 years) are the intended candidates.
✕Probably not a fit
Patients with CD19‑negative disease, severe organ dysfunction or inadequate pulmonary/renal/cardiac function, uncontrolled infection, or no suitable haploidentical family donor are unlikely to benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This Phase I protocol gives a CD19‑directed CAR T‑cell product after a TCRαβ and CD19‑depleted haploidentical (partially matched family) stem cell transplant in pediatric patients with relapsed/refractory CD19+ B‑cell malignancies. Donors undergo two apheresis collections — a G‑CSF–mobilized collection for the stem cell graft and a non‑mobilized PBMC collection for CAR T‑cell manufacturing and possible DLI. Patients receive conditioning chemotherapy followed by the depleted progenitor graft on day 0 and the manufactured CD19‑CAR(Mem) T cells as early as day +14, with close monitoring for safety and efficacy. Key outcomes include safety/feasibility, 1‑year survival metrics, engraftment, GVHD incidence, and immune‑related toxicities such as CRS and ICANS, with all procedures performed at a single pediatric cancer center.
Why it matters
Potential benefit: If successful, this approach could reduce post‑transplant relapse and improve survival for children with high‑risk CD19+ B‑cell malignancies.
How similar studies have gone: CD19 CAR T‑cell therapy has achieved high remission rates in relapsed pediatric ALL and TCRαβ/CD19‑depleted haploidentical transplants are used clinically, but planned post‑transplant CD19‑CAR addback is a relatively new strategy with limited early evidence.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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St. Jude Children's Research Hospital
Memphis, Tennessee, United States Recruiting
Study contacts
- Principal investigator: Swati Naik, MBBS — St. Jude Children's Research Hospital
- Study coordinator: Swati Naik, MBBS
- Email: referralinfo@stjude.org
- Phone: 888-226-4343
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.