Haploidentical Hematopoietic Stem Cell Transplantation With Ex Vivo TCR Alpha/Beta and CD19 Depletion in Pediatric Hematologic Malignancies

Conditions

• Pediatric Hematologic Malignancies

Eligibility Criteria

Sex

ALL

Age

N/A - 30 Years

Healthy Volunteers

Not accepted

Interventions

• Ex Vivo T-cell receptor alpha-beta and CD19+ Depletion using CliniMACs Plus — DEVICE
  Once pheresed, the product will be washed to remove platelets and the cell concentration will be adjusted per laboratory and ClinicMACS technology recommendations. It is then labeled using the CliniMACS αβ-TCR Biotin Kit and CD19+ immunomagnetic microbeads. After labeling, the cells are washed to remove unbound microbeads. The partially processed product is loaded on the CliniMACS device where labeled cells are depleted and the negative fraction is eluted off the device. The negative fraction is centrifuged and volume reconstituted to obtain the final product

Study Details

This single arm pilot phase I study with safety run-in is designed to estimate the safety and efficacy of a familial mismatched or haploidentical hematopoietic stem cell transplantation (haplo-HSCT) using a novel graft modification technique (selective αβ-TCR and CD19 depletion).

Key Dates

Start date

Nov 3, 2022

Status verified

Mar 2026

Primary completion

May 31, 2029

Completion

May 31, 2029

Study Design

Enrollment

50 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Recipients: ex vivo αβ-TCR/CD19 depleted haplo-hematopoietic stem cell infusion (HSCT)
  * Patients will undergo standard of care conditioning regiment prior to HSCT * On Day 0, patients will undergo infusion of the ex vivo αβ-TCR/CD19 depleted haplo-HSCT from a stimulated peripheral stem cell source per institutional standard of care. Patients whose graft has a residual CD20+ count \> 1.0 x 10\^5 may receive a single infusion of rituximab on Day +1 at a dose of 375 mg/m\^2 at provider's discretion.
• No Intervention: Donors:
  Donors who meet the eligibility criteria will be mobilized as per institutional standard practice using G-CSF 10 mcg/kg/day with leukapheresis to take place on Day 5. The target volume for collection is 20 L. Up to 4 days of pheresis are permitted to ensure target collection.

Primary Outcome Measure

Safety as measured by the number of events occurring within the first 100 days post-transplant [ Time Frame: Through 100 days post-transplant ]

Central Contacts

• Thomas Pfeiffer, M.D.
  314-273-2070
  [email protected]

Locations (1)

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