NCT07350837

CAR-T Therapy Targeting CD19 and BCMA in Highly Sensitized Kidney Transplant Participants

An Early-Phase Study of AZD0120 (Also Known as GC012F), a Chimeric Antigen Receptor-T Cell (CAR-T) Therapy Targeting CD19 and B Cell Maturation Antigen (BCMA), for Desensitization in Highly Sensitized Participants With End Stage Kidney Disease Awaiting Kidney Transplant

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Tongji Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a single-arm, open-label, early-phase clinical study of AZD0120, a dual-directed CD19/BCMA CAR-T therapy in highly sensitized adult participants with ESKD awaiting kidney transplant. This study aims to evaluate the safety, tolerability, and efficacy of AZD0120 in highly sensitized adult participants with end-stage kidney disease (ESKD) awaiting kidney transplantation-who, as assessed by investigators, are improbable desensitization through conventional treatments (e.g., plasmapheresis and immunoadsorption)-with the participants divided into Cohort 1 (with living donors) and Cohort 2 (without living donors).

Conditions

• Highly Sensitized Patients Awaiting Kidney Transplant

Interventions

Type	Name	Description
DRUG	AZD0120	Treatment duration: A single dose of AZD0120 via IV infusion

Timeline

• Start date: 2026-01-28
• Primary completion: 2026-12-31
• Completion: 2029-12-31
• First posted: 2026-01-20
• Last updated: 2026-04-16

Locations

1 site across 1 country: China