Recruiting

CliniMACS® αβT/CD19 Depletion

Sponsor:

Nationwide Children's Hospital

Code:

NCT06082947

Conditions

Hematopoietic Stem Cell Transplantation

Hematologic Malignancy

Eligibility Criteria

Sex: All

Age: 0 - 30

Healthy Volunteers: Not accepted

Interventions

CliniMACS®

Study Details

Brief summary:

This is a study utilizing the Magnetic-activated cell sorting (CliniMACS®) Alpha-Beta T-cell (αβT)/Cluster of Differentiation 19 (CD19), also called B lymphocyte antigen CD19 depletion device for Children and Young Adults with Hematologic Malignancies undergoing alternative Donor Allogeneic Hematopoietic Cell Transplantation (HSCT). Patients will receive an allogenic HSCT from a matched unrelated donor (MUD), mismatch unrelated donor (MMUD) or a mismatched related (haploidentical) donor. Patients will receive a granulocyte-colony stimulating factor (G-CSF) ± Plerixafor donor mobilized peripheral stem cell donor transplant following CliniMACS® αβT cell/CD19+B cell depletion. Cluster of Differentiation 34 (CD34) and αβT cell content of the graft is determined based on the transplant indication.

Conditions

Hematopoietic Stem Cell Transplantation

Hematologic Malignancy

Study ID

NCT06082947

Start date

Dec 18, 2023

Status verified date

Mar, 2025

Completion date

Dec 1, 2030

Anticipated

Primary completion date

Dec 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 30

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Age ≤ 30 years
  • Patients who will benefit from an allogenic stem cell transplant to treat underlying primary hematological malignancy and lacks a suitably available matched sibling donor.
  • Karnofsky Index or Lansky Performance Scale ≥ 60 % on pre-transplant evaluation.
  • Karnofsky scores must be used for patients > 16 years of age and Lansky scores for patients ≤ 16 years of age.
  • Patient or legal guardian must give informed consent if patient is ≥ 18 years. Legal guardian must give informed consent (and patient must give assent if appropriate) if patient is < 18 years.
  • Adequate organ function (within 4 weeks of initiation of preparative regimen). For patients receiving Myeloablative conditioning (MAC) on this platform, they should meet organ function to tolerate MAC. Similar if patients are receiving Reduced intensity conditioning (RIC).
  • High resolution human leukocyte antigen (HLA) available

Exclusion Criteria:

  • Patient does not have a suitable donor who is willing and able (meets donor criteria).
  • Patient reports a history of allergic reactions to murine protein
  • Pregnant or lactating females are ineligible as many of the medications used in this protocol could be harmful to unborn children and infants. Female patients of childbearing potential females ≥11 years of age or post- menarche and should have a negative pregnancy test
  • Patients with HIV or uncontrolled fungal, bacterial or viral infections are excluded. Patients with history of fungal disease during induction therapy may proceed if they have a significant response to antifungal therapy with no or minimal evidence of disease remaining by CT evaluation. Viremia by Pluripotency Check (PCR) analysis is not considered an active infection but may require immediate viral prophylaxis. Patients with possible fungal infections must have had at least 2 weeks of appropriate anti-fungal therapy and be asymptomatic -
  • Patients receiving umbilical cord blood and matched sibling donor transplants

Study Design

Enrollment

50 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: HSCT using TCR αβ/CD19+ depleted grafts

Allogeneic HSCT using the TCR αβ/CD19+ depleted platform and grafts from alternative donors (MUD, MMUD and haploidentical)

Interventions

CliniMACS®

CliniMACS® αβT cell/CD19+B cell depletion device for Children and Young Adults with Hematologic Malignancies undergoing alternative Donor Allogeneic Hematopoietic Cell Transplantation (HSCT)

Primary outcome measure

  • One-year overall survival of patients undergoing allogeneic HSCT using the T-Cell Receptor (TCR) αβ/CD19+ depleted platform and grafts from alternative donors (MUD, MMUD and haploidentical) [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Clelie Peck

614-722-5634clelie.peck@nationwidechildrens.org

Lauren Rayman

614-722-3729lauren.rayman@nationwidechildrens.org

Locations

Nationwide Children's Hospital

Recruiting

Columbus, Ohio, United States, 43205

Contacts

Rolla Abu-Arja, MD

614-722-3250rolla.abu-arja@nationwidechildrens.org

Hemalatha Rangarajan, MD

hemalatha.rangarajan@nationwidechildrens.org

Principal Investigator:

Rolla Abu-Arja, MD

More Information

Sponsor

Nationwide Children's Hospital

Last update posted

Apr 2, 2025

Last verified

Mar, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Nationwide Children's Hospital on 2025-04-02.