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CAR T-cell Therapy

CAR-T Cell Therapy for Kidney Transplant Desensitization

Phase 1

Recruiting

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

Must not have

Previous solid organ (except kidney) or bone marrow transplant

Active or history of certain infections

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from time of lymphodepletion to 12 months

Awards & highlights

No Placebo-Only Group

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.

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.

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 below

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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.

Exclusion Criteria

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

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I have had an organ transplant, but it wasn't a kidney transplant.

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I have or had serious infections.

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I haven't had B cell or antibody therapy in the last 6 months.

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I am on continuous medication for blood thinning.

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My heart has been cleared for transplant over 6 months ago, or I have specific heart conditions.

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I have moderate to severe breathing problems.

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I produce more than 100 cc of urine daily and have had many UTIs.

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My BMI is over 30.

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I have a history of severe liver disease or cirrhosis.

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I am currently on medication to suppress my immune system.

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I have a history of sickle cell disease or systemic amyloidosis.

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I have a history of HIV, chronic hepatitis B, or chronic hepatitis C.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from time of lymphodepletion to 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from time of lymphodepletion to 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and from time of lymphodepletion to 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

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 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)

The timing 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)