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T-Cell Depletion

CliniMACS® T-Cell Depletion for Stem Cell Transplant Patients

N/A

Recruiting

Led By Christopher C Dvorak, MD

Research Sponsored by Christopher Dvorak

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Documentation of a disease requiring HCT

Male or female 0-30 years of age at time of transplant admission

Must not have

Presence of a healthy and willing HLA-identical related donor (except when the patient has Fanconi Anemia).

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether or not the CliniMACS® Device can be used to deplete T cells from donor cells for patients who need an allogeneic HCT.

Who is the study for?

This trial is for males and females aged 0-30 needing a stem cell transplant due to certain diseases, with donors available who can give bone marrow or blood stem cells. It's not for those with identical related donors (unless they have Fanconi Anemia), life expectancy under one month, mouse protein or iron dextran allergies, pregnant/breastfeeding individuals, or if birth control isn't used.

What is being tested?

The study tests the CliniMACS® Device's ability to remove specific T-cells from donor cells before transplant to prevent graft-versus-host disease. This process is being evaluated as it's currently only FDA-approved for limited use and needs further investigation in other settings.

What are the potential side effects?

Potential side effects are not explicitly listed but may include reactions related to immune system suppression such as increased infection risk and complications associated with the transplantation procedure itself.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My condition requires a stem cell transplant.

Select...

I am 30 years old or younger and am going for a transplant.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have a healthy, willing, and HLA-matched relative to donate (unless I have Fanconi Anemia).

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

100-day incidence of Grade III-IV acute GVHD

Secondary study objectives

1-year incidence of autoimmunity requiring intervention with immunosuppressive agents as treatment.

1-year incidence of systemic steroid-requiring chronic GVHD

1-year incidence of transplant-related mortality

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Patients receiving allogeneic hematopoietic cell transplantExperimental Treatment1 Intervention

The test product is a stem cell product which has been alpha-beta T- cell depleted using the CliniMACS system. Alpha-beta T-cell depleted cells are given intravenously over a period of time as dictated by the final volume of the infused product (5 ml/kg/hour). The target dose of CD34+ cells is ≥20x10\^6/kg, but a minimum of ≥2.5x10\^6/kg is required. The target dose of T-cell receptor (TCR) alpha-beta CD3+ cells is ≤1x10\^5/kg.

0 / 3Eligibility criteria met