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

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
AgeUp to 21
SponsorSt. Jude Children's Research Hospital

About this trial

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.

Eligibility criteria

Qualifiers

Age less than or equal to 21 years

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Anti-Thymocyte Globulin (Rabbit)
  • Cyclophosphamide
  • Fludarabine
  • Thiotepa
  • Mesna
  • Melphalan
  • Filgrastim
  • CliniMACS System

Treatment groups

70 Participants
are divided into 1 treatment group