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Recruiting Phase 1

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

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About this study

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.

Condition
Relapsed Pediatric ALL, Hematopoietic Cell Transplantation, Hematologic Malignancy
Tested
Anti-Thymocyte Globulin (Rabbit), Cyclophosphamide, Fludarabine, Thiotepa, Mesna, Melphalan, Filgrastim, CliniMACS Syste...
Sponsor
St. Jude Children's Research Hospital

Who can join

Age
Up to 21 years
Sex
All sexes
Healthy volunteers
Not accepted

Inclusion 21

  • Maximum age: 21 years
  • Study condition: Relapsed Pediatric ALL, Hematopoietic Cell Transplantation, Hematologic Malignancy
  • 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
  • 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 10

  • 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
  • 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

1 site, 1 recruiting

St. Jude Children's Research Hospital

Memphis, Tennessee, United States

Recruiting

Contact

Potential match only. Final eligibility is determined by the study team.