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

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