NCT07091370

Inaticabtagene Autoleucel Injection in the Treatment of Autoimmune Hemolytic Anemia After Three or More Lines of Therapy

A Multicenter, Open-label, Single-arm Phase I Clinical Trial on the Safety and Tolerability of Inaticabtagene Autoleucel Injection in the Treatment of Autoimmune Hemolytic Anemia That Has Failed at Least Three Lines of Treatment

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Juventas Cell Therapy Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, open-label, single-arm Phase I clinical trial to evaluate the safety and tolerability of Inaticabtagene Autoleucel Injection treatment in autoimmune hemolytic anemia that has failed at least three lines of treatment.

Detailed description

This study will be conducted in Chinese hospitals and to include 6 to 12 subjects with autoimmune hemolytic anemia . The main purpose of the study is to evaluate the safety and tolerability of Inaticabtagene Autoleucel Injection in the treatment of autoimmune hemolytic anemia that has failed at least three lines of treatment, and determine the recommended phase II dose (RP2D) of Inaticabtagene Autoleucel Injection in subjects with autoimmune hemolytic anemia who have failed at least three lines of treatment. The Secondary purpose of the study is to evaluate the efficacy of Inaticabtagene Autoleucel Injection in the treatment of autoimmune hemolytic anemia that has failed at least three lines of treatment and to evaluate the pharmacokinetic (PK) characteristics, pharmacodynamic (PD) characteristics and immunogenicity in the treated patients.

Conditions

• AIHA - Cold Autoimmune Hemolytic Anemia

Interventions

Type	Name	Description
DRUG	Inaticabtagene Autoleucel Injection	The dose was incremented according to the "3+3" principle, and the three dose levels A, B and C were given in sequence at one time, which were respectively: A-1 dose group: 0.25×10\^6 CAR-T live cells /kg body weight Group A (initial dose) : 0.5×10\^6 CAR-T live cells /kg body weight Group B: 1.0×10\^6 CAR-T live cells /kg body weight Group C: 1.5×10\^6 CAR-T live cells /kg body weight

Timeline

• Start date: 2025-12-27
• Primary completion: 2026-09-30
• Completion: 2028-03-30
• First posted: 2025-07-29
• Last updated: 2025-09-22