CAR-T Cell Therapy for Desensitization in Kidney Transplantation (NCT06056102) | Clinical Trial Compass
RecruitingPhase 1
CAR-T Cell Therapy for Desensitization in Kidney Transplantation
United States20 participantsStarted 2024-05-09
Plain-language summary
This research study is for people who have been waiting for a kidney transplant for at least one year, and who have a cPRA of 99.5% or higher. Having a cPRA of 99.5% or higher means that your immune system would reject 99.5% of kidneys available for transplant. The study will test whether new products called Chimeric Antigen Receptor T Cells (CAR T Cells), when given with chemotherapy, is safe and will reduce cPRA.
The main study will last up to 2 years: Participants will have up to 30 clinic or hospital visits over a one-year period. If a transplant takes place, there will be 9 more visits after transplant. Long term follow up is required by the Food and Drug Administration (FDA) for 15 years after receiving CAR T cell.
The primary objective is to evaluate the safety and feasibility of administering CART BCMA + huCART-19 following lymphodepletion, including determination of optimal tolerated regimen (OTR) and/or recommended phase 2 regimen, according to the incidence of dose limiting toxicity (DLT) in highly sensitized patients awaiting kidney transplant.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion criteria
✓. Male or female patients aged 18-65 years with kidney failure requiring hemodialysis.
✓. United Network for Organ Sharing (UNOS) listed for kidney transplant for at least 1 year.
✓. Patients must meet one of the following two criteria:
✓. Protocol-specific cPRA ≥99.5-99.895% AND no matched living donor, ineligible for kidney paired donation programs, have blood group Type O or B, have documentation of virtual crossmatch (current or past) and predictive of a positive physical crossmatch to a deceased donor
✓. 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.
✓. 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)
✓. Able to understand and give written informed consent to participate in all aspects of the study.
What they're measuring
1
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)
Timeframe: From time of lymphodepletion to 12 months
2
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)
Timeframe: From time of lymphodepletion to 12 months
3
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)
Timeframe: From time of lymphodepletion to 12 months
4
The proportion of apheresed subjects who receive the intended/planned Chimeric antigen receptor T (CAR T) cell dose in the respective cohort
Timeframe: From time of lymphodepletion to 12 months
Trial details
NCT IDNCT06056102
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
. Willing to stay within 2 hours of the home study site for at least 28 days after the last T cell infusion
Exclusion criteria
✕. Subjects with indwelling catheters as primary access for hemodialysis
✕. Previous solid organ (except kidney) or bone marrow transplant
✕. BMI ≥35 kg/m\^2
✕. Subjects who have preserved or oliguric urine output \> 100 cc/day with history of recurrent UTI (2 in 6 months or 3 in 1 year, see study definitions)
✕. Subjects described in exclusion #4 with structural disease such as polycystic kidney disease, obstructive uropathy with nephrolithiasis or those otherwise at higher risk of urinary tract infections. Anuric subjects with structural kidney disease are not excluded
✕. Known active current or history of invasive fungal infection; any non-tuberculous mycobacterial infection that has been active or has required therapy within the last year. Any infection requiring hospitalization and IV antibiotics within 4 weeks of screening or PO antibiotics within 2 weeks
✕. History of HIV, chronic HBV, or chronic HCV, regardless of treatment