NCT07350837 CAR-T Therapy Targeting CD19 and BCMA in Highly Sensitized Kidney Transplant Participants
| NCT ID | NCT07350837 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | Tongji Hospital |
| Condition | Highly Sensitized Patients Awaiting Kidney Transplant |
| Study Type | INTERVENTIONAL |
| Enrollment | 12 participants |
| Start Date | 2026-01-28 |
| Primary Completion | 2026-12-31 |
Trial Parameters
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
Brief Summary
The purpose of this study is to assess the safety, tolerability, and efficacy of AZD0120 in highly sensitized adult participants with ESKD awaiting kidney transplant-who, as assessed by investigators, are improbable desensitization through conventional treatments (e.g., plasmapheresis and immunoadsorption)- with or without living donors.
Eligibility Criteria
Inclusion Criteria: * 1\. Adult men or women aged 18 to 65 years with end-stage kidney disease who are waiting for kidney transplant and require desensitization to enable safe kidney transplant. 2\. Cohort 1: * A living donor who meets criteria for kidney donation based on national and local center-specific guidelines has been identified * Highly sensitized participants with a requirement of positive flow cytometry crossmatch, resulting from at least one DSA detected using Luminex SAB during or before Screening * A positive virtual crossmatch, using Luminex SAB (MFI ≥ 2000), obtained within 30 days of Screening and during Screening Cohort 2: * PRA greater than or equal to 80% which is consistent with highly sensitized based on national criteria * At least one anti-HLA antibody that is unacceptable for kidney transplantation 3. High-resolution HLA typing for both the recipient and the donor within 2 years of Screening. 4\. The participant is currently eligible for transplantation accord
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.