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CAR T-cell Therapy
CAR-T Cell Therapy for Kidney Transplant Desensitization
Phase 1
Waitlist Available
Led By Ali Naji, MD, Ph.D.
Research Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Male or female patients aged 18-65 years with kidney failure requiring hemodialysis
UNOS listed for kidney transplant for at least 1 year
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years after transplantation
Awards & highlights
Study Summary
This trial tests a new product, CART BCMA + huCART-19, to reduce cPRA in people who have been waiting for a kidney transplant for at least a year and have an immune system that would reject 99.5% of available kidneys. It will test safety & feasibility over a two-year period & followed up to 15 years.
Who is the study for?
This trial is for adults aged 18-65 with kidney failure who have been on the transplant waitlist for over a year and are highly likely to reject a transplanted kidney. They must be able to consent, live near the study site, use contraception post-treatment, and meet specific health criteria like certain blood counts.Check my eligibility
What is being tested?
The study tests if CAR T Cells (CART-BCMA + huCART19) combined with chemotherapy can safely lower immune rejection rates in patients awaiting kidney transplants. It involves multiple clinic visits over two years, plus long-term follow-up as required by the FDA.See study design
What are the potential side effects?
Potential side effects may include reactions from the infusion of CAR T cells or chemotherapy drugs such as Cyclophosphamide and Fludarabine. These could range from mild symptoms like fatigue to more serious ones affecting different organs.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 65 years old and need hemodialysis for kidney failure.
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I have been on the kidney transplant list for at least a year.
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My vaccinations, including TdAP, are up to date as required for transplant trials.
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I have antibodies against the Epstein-Barr virus.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from time of infusion to 12 months or 3 years after transplantation
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from time of infusion to 12 months or 3 years after transplantation
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
The frequency of adverse events after infusion of Chimeric antigen receptor T - B cell maturation antigen (CART-BCMA) with CD19 Targeted Humanized CAR T Cell (huCART-19)
The proportion of apheresed subjects who receive the planned Chimeric antigen receptor T (CAR T) cell dose in the respective cohort
The severity of adverse events after infusion of Chimeric antigen receptor T - B cell maturation antigen (CART-BCMA) with CD19 Targeted Humanized CAR T Cell (huCART-19)
+1 moreSecondary outcome measures
Duration of Calculated Panel Reactive Antibody (cPRA) response
For subjects who are transplanted, the proportion of subjects experiencing acute cellular rejection or antibody mediated rejection, delayed graft function (as well as AKI), graft loss OR De Novo donor specific antibody
The proportion of subjects meeting the predefined Calculated Panel Reactive Antibody (cPRA) reduction criteria after the infusion of CART-BCMA + huCART-19
+1 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Participant CohortsExperimental Treatment4 Interventions
Safety Run-in phase (2 subjects at UPenn)
Cohort 1 (3-6 subjects)
Cohort 2 (3-6 subjects)
Cohort 3 (3-6 subjects)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
huCART19
2014
Completed Phase 1
~90
CART-BCMA
2015
Completed Phase 1
~30
Cyclophosphamide
1995
Completed Phase 3
~3770
Fludarabine
2012
Completed Phase 3
~1100
Find a Location
Who is running the clinical trial?
National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor
3,269 Previous Clinical Trials
5,481,449 Total Patients Enrolled
3 Trials studying Kidney Failure
5,586 Patients Enrolled for Kidney Failure
University of Pennsylvania Clinical Cell and Vaccine Production Facility (CVPF)UNKNOWN
Vijay Bhoj, M.D., Ph.D.Study ChairUniversity of Pennsylvania Medical Center: Transplantation
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any risks associated with being part of a Participant Cohort?
"Given the early-stage nature of this trial, our team at Power has assessed Participant Cohorts' safety as a 1 due to limited data on efficacy and security."
Answered by AI
Who qualifies for inclusion in this medical research?
"To be eligible for this trial, applicants must have a kidney transplant and should fall between the ages of 18-65. As such, 20 participants are being sought out to complete the study."
Answered by AI
Are any participants in this experiment aged 55 or above?
"Patients of mature age (over 18, but below 65) are being selected to partake in this clinical trial."
Answered by AI
Could I apply to participate in this experiment at present?
"As documented on clinicaltrials.gov, this medical trial is not presently enrolling participants. The study was first uploaded to the site on May 1st 2024 and last amended on September 20th 2023. Although no longer accepting patients for this particular research endeavour, 258 other studies are actively recruiting subjects at present time."
Answered by AI
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