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CAR-T Cell Therapy for Kidney Transplant Desensitization

This study is for people aged 18-65 with kidney failure who need a kidney transplant and have a very high chance of rejecting a donated kidney (cPRA of 99.5% or higher). This means your immune system would likely reject most available kidneys. Researchers are testing if special cells called Chimeric Antigen Receptor T Cells (CAR T Cells), specifically CART-BCMA and huCART19, given with chemotherapy drugs like Cyclophosphamide and Fludarabine, can safely reduce this risk. The main goal is to see how safe these treatments are by tracking any side effects for 12 months after you receive the CAR T Cells.

Study design
This is an interventional study with up to 20 participants. It involves a safety run-in and three different treatment groups to evaluate the safety and effects of the CAR T cell therapies.
What's involved
You would have up to 30 clinic or hospital visits over one year. If you receive a transplant, there will be 9 more visits after that.
Compensation
Not stated in the trial record.
Follow-up
You will be followed for 15 years after receiving the CAR T cells, as required by the FDA.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06056102

CAR-T Cell Therapy for Desensitization in Kidney Transplantation

Recruiting
PHASE1Ages 18–65InterventionalTreatment
National Institute of Allergy and Infectious Diseases (NIAID)
~20 participants
Updated 2026-05-22 on ClinicalTrials.gov
What's tested:CyclophosphamideCART-BCMAhuCART19Fludarabine

At a glance

Recruiting sites
3 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
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)
Measured over 12 months after infusion of CART-BCMA with huCART-19
+3 more outcomes measured

Conditions

Kidney Transplant
Kidney Failure
End Stage Renal Failure on Dialysis

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Where it's being run

3 sites across 3 states
Massachusetts1
New York1
Pennsylvania1

Study leadership

  • Vijay Bhoj, M.D., Ph.D. · STUDY_CHAIR · University of Pennsylvania Medical Center: Transplantation
  • Ali Naji, MD, Ph.D. · PRINCIPAL_INVESTIGATOR · University of Pennsylvania Medical Center: Transplantation
  • Alfred Garfall, MD · STUDY_CHAIR · University of Pennsylvania Medical Center: Transplantation

Who to contact

Mary Kaminski, PA
[email protected]
215-349-8334
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Protocol-specific cPRA ≥99.5%
No suitable living donor OR has been active in a kidney paired donation program but not received a match within 12 months
Have blood group Type O or B, and predictive of a positive virtual crossmatch to an available deceased donor.
United Network for Organ Sharing (UNOS) listed for kidney transplant for at least 1 year 2. Protocol-specific cPRA ≥99.9% Protocol-specific cPRA must be rounded from three significant figures measured ≤90 days from the time of enrollment (i.e., cPRA of 0.994500 or 0.998500 would be eligible) using the web-based OPTN cPRA calculator (https://optn.transplant.hrsa.gov/resources/allocation-calculators/cpra-calculator/); accounting for HLA-A, -B, -C, -DRB1, -DRB3/4/5, and -DQB1 Luminex Single Antigen Beads (SAB) with MFI ≥3000; 1 archived sample within 6 months of screening required. 3. Based on center-specific listing policies, a cPRA in UNet Waitlist that is ≥99.5% (the candidate must be eligible for additional priority of kidneys equivalent to individuals with a 100% cPRA) 4. Able to understand and give written informed consent to participate in all aspects of the study. 5. Willing to stay within 2 hours of the home study site for at least 28 days after the last T cell infusion 6. Subjects of reproductive potential must agree to use contraception for at least one year after CAR T Cell infusion 7. In the absence of contraindication, vaccinations must be up to date per the DAIT Guidance for Patients in Transplant Trials and include TdAP 8. Positive for EBV capsid IgG 9. Negative testing for latent TB infection within 3 months prior to enrollment. Testing should be conducted using either a PPD or interferon-gamma release assay (i.e. QuantiFERON-TB, T-SPOT.TB). Patients with a positive test for latent TB infection must complete appropriate therapy for Latent Tuberculosis Infection (LTBI). A subject is considered eligible only if they have a negative test for LTBI within 3 months prior to enrollment OR they have appropriately completed LTBI therapy prior to transplant. Latent TB infection treatment regimens should be among those endorsed by the CDC 10. Hemoglobin ≥9g/dL 11. ANC ≥ 1,800/μL, \> 1,200/ μL for patients with Duffy-null associated neutrophil count (DANC) 12. Absolute Lymphocyte Counts ≥500/μL or CD3 T cell Count ≥150/μL 13. Platelet count ≥120,000/μL

What this trial measures

  • 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)12 months after infusion of CART-BCMA with huCART-19

    Adverse events will be categorized and described according to CTCAE v5.0. Specific safety outcomes will include but are not limited to: 1. Cytokine release syndrome, as defined by American Society for Transplantation and Cellular Therapy (ASTCT) consensus grading 2. Neurotoxicity (ICANS), as defined by ASTCT consensus grading 3. Delayed hematopoetic recovery: proportion of subjects achieving ANC \>1,000/microL (≥600/microL for those with Duffy null associated phenotype) and Platelets \>75,000/microL at 60 days after first CART cell infusion 4. Dose limiting toxicity

  • 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)12 months after infusion of CART-BCMA with huCART-19

    Adverse events will be categorized and described according to CTCAE v5.0. Specific safety outcomes will include but are not limited to: 1. Cytokine release syndrome, as defined by ASTCT consensus grading 2. Neurotoxicity (ICANS), as defined by ASTCT consensus grading 3. Delayed hematopoetic recovery: proportion of subjects achieving ANC \>1,000/microL (≥600/microL for those with Duffy null associated phenotype) and Platelets \>75,000/microL at 60 days after first CART cell infusion 4. Dose limiting toxicity

  • 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)12 months after infusion of CART-BCMA with huCART-19

    Adverse events will be categorized and described according to CTCAE v5.0. Specific safety outcomes will include but are not limited to: 1. Cytokine release syndrome, as defined by ASTCT consensus grading 2. Neurotoxicity (ICANS), as defined by ASTCT consensus grading 3. Delayed hematopoetic recovery: proportion of subjects achieving ANC \>1,000/microL (≥600/microL for those with Duffy null associated phenotype) and Platelets \>75,000/microL at 60 days after first CART cell infusion 4. Dose limiting toxicity

  • The proportion of apheresed subjects who receive the intended/planned Chimeric antigen receptor T (CAR T) cell dose in the respective cohortFrom time of lymphodepletion to 12 months