TCRαβ+/CD19+ Depleted Allogeneic Hematopoietic Stem Cell Transplantation for Malignant and Non-malignant Disorders

NCT04088760 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: 2018-8568
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to investigate the safety and efficacy of TCRαβ+/CD19+ depleted allogeneic hematopoietic stem cell transplant (HSCT) for malignant and non-malignant disorders in children and adolescent/young adult patients using the CliniMACS® immunomagnetic selection device (Miltenyi Biotec).

Conditions

Allogeneic Hematopoietic Cell Transplantation

Outcome Measures

Primary Outcomes (1)

• Incidence of Infusion-related Reactions

  Number of patients who experienced infusion reactions including rash, fever, difficulty breathing, and blood pressure abnormalities at the time of infusion of stem cells.

  100 days

Secondary Outcomes (4)

• Engraftment and Sustained Donor Chimerism

  28 days and 1 year

• Number of Participants With Acute GVHD

  100 days

• Number of Participants With Chronic GVHD

  1 year

• GVHD-free Survival

  1 year

Study Arms (1)

TCRαβ+/CD19+ depleted HSCT

EXPERIMENTAL

Drug: TCRαβ+/CD19+ depleted allogeneic hematopoietic stem cell transplant (HSCT)

Interventions

TCRαβ+/CD19+ depleted allogeneic hematopoietic stem cell transplant (HSCT) DRUG

The majority of TCRαβ+ T cells and CD19+ B cells will be removed from the allogeneic graft utilizing the CliniMACS® immunomagnetic selection device (Miltenyi Biotec). The depletion process involves two phases; cell labeling (phase 1) and the automated immunomagnetic depletion process (phase 2). The CD34+ dose may be adjusted by the need to not exceed the TCRαβ+CD3+ dose threshold.

TCRαβ+/CD19+ depleted HSCT

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Any patient being treated at Cincinnati Children's Hospital requiring an allogeneic HSCT who lacks an HLA-genotypically matched related donor. Genotypically matched related donors are allowed when there is a clinical desire to avoid the use of GVHD prophylaxis medications.

You may not qualify if:

• Prior allogeneic transplant with active acute or chronic GVHD, or life-threatening infection. Patients with a prior history of allogenic transplant without active GVHD or life-threatening infection can be considered.

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Results Point of Contact

• Title: Rebecca Marsh, MD
• Organization: Cincinnati Children's Hospital Medical Center

Rebecca.Marsh@cchmc.org

(513) 803-1139

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2019
• First Posted: September 13, 2019
• Study Start: September 16, 2019
• Primary Completion: May 14, 2021
• Study Completion: September 3, 2021
• Last Updated: September 8, 2023
• Results First Posted: September 8, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)