NCT06622694

CD7 CAR T Cells (RD13-02) in the Treatment of Relapsed/Refractory Severe Aplastic Anemia

A Clinical Study of Safety, Efficacy, and Pharmacokinetics of Universal CD7 CAR T Cells (RD13-02) in the Treatment of Relapsed/Refractory Severe Aplastic Anemia

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: Institute of Hematology & Blood Diseases Hospital, China · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This trial is exploratory research aimed at evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of RD13-02, a universal CD7 CAR T therapy, in subjects with relapsed/refractory severe aplastic anemia (SAA)

Detailed description

This trial used a single-arm, open-label, and "3+3" dose-escalation design. It is divided into two phases, the dose escalation phase and the expansion phase. The dose escalation and expansion phases each consisted of a screening period of up to 2 weeks, a 7-day conditioning period, a 28-day treatment period, and a follow-up period (to 6 months after the first infusion).

Conditions

• Severe Aplastic Anemia
• Relapse
• Refractory
• CAR T-cell Therapy

Interventions

Type	Name	Description
BIOLOGICAL	RD13-02	Before cell infusion (Day 0), subjects will undergo a lymphodepleting chemotherapy based on the "Fludarabine + Cyclophosphamide" (FC regimen). Prior to the lymphodepleting chemotherapy, subjects must undergo an assessment, and only those meeting the criteria will be eligible for the lymphodepleting chemotherapy. The CAR T infusion should be performed at least 48 hours after the completion of the lymphodepleting chemotherapy. The infusion will be administered intravenously as a single dose. It should be completed within 30 minutes, with continuous cardiac monitoring during the infusion to observe heart rate (HR), blood pressure (BP), respiratory rate (R), and peripheral oxygen saturation (SpO2) for up to 2 hours post-infusion.

Timeline

• Start date: 2025-06-19
• Primary completion: 2026-10-07
• Completion: 2026-12-31
• First posted: 2024-10-02
• Last updated: 2025-07-24

Locations

1 site across 1 country: China