Your session is about to expire
← Back to Search
T Cell Depletion
1. CliniMACS CD3+/CD19+ depletion for Immunodeficiency (CliniMACs Trial)
Phase 2
Waitlist Available
Led By Nancy J Bunin, MD
Research Sponsored by Children's Hospital of Philadelphia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 100 days post transplant
Awards & highlights
CliniMACs Trial Summary
This trial is testing a new way to transplant stem cells from donors who are either unrelated or only partially matched to the patient. The goal is to reduce the risk of a severe side effect called graft vs. host disease.
Eligible Conditions
- Immunodeficiency
CliniMACs Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 100 days post transplant
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~100 days post transplant
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Participants With Successful Engraftment
Side effects data
From 2017 Phase 2 trial • 93 Patients • NCT0057912433%
Non-relapsed mortality
100%
80%
60%
40%
20%
0%
Study treatment Arm
AEs for Total Number of Participants: Stratum 2
AEs for Total Number of Participants: Stratum 1
CliniMACs Trial Design
2Treatment groups
Experimental Treatment
Group I: 2. CliniMACS CD3+/CD19+ depletionExperimental Treatment1 Intervention
Stratum 2. CliniMACS CD3+/CD19+ depletion:
Haploidentical match
2 antigen and/or allele mismatched where one of the mismatches includes DRB1
For patients in Stratum 2 we will perform CD3+ (T cell) and CD19+ (B cell) depletion. There will be no T cell add back in this stratum.
Group II: 1. CliniMACS CD3+/CD19+ depletionExperimental Treatment1 Intervention
6/6 or 8/8 matched (fully matched)
1 antigen or allele mismatched (mismatch at A or B or DRB1)
2 antigen or allele mismatched (mismatch ONLY at A and B but NOT at DRB1 plus either A or B).
Patients will receive grafts that have undergone CD3+ and CD19+ depletion. The CD3(-) fraction will be infused.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CliniMACs
2005
Completed Phase 2
~100
Find a Location
Who is running the clinical trial?
Children's Hospital of PhiladelphiaLead Sponsor
708 Previous Clinical Trials
8,580,966 Total Patients Enrolled
Nancy J Bunin, MDPrincipal InvestigatorChildren's Hospital of Philadelphia
3 Previous Clinical Trials
260 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has this therapy been federally approved in the United States?
"There is limited data supporting the safety of this treatment, as it is only in Phase 2 trials. No efficacy data exists currently."
Answered by AI
Are there still opportunities for people to participate in this clinical trial?
"The trial in question is not currently looking for participants, as evidenced by the lack of recent updates on clinicaltrials.gov. Although this particular study is not ongoing, there are 92 other trials that patients might be interested in."
Answered by AI
Share this study with friends
Copy Link
Messenger