MedTrace Logo

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

NCT07091370 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2025-09-22

No results posted yet for this study

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.

Conditions

  • AIHA - Cold Autoimmune Hemolytic Anemia

Interventions

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

Sponsors & Collaborators

  • Juventas Cell Therapy Ltd.

    lead INDUSTRY

Principal Investigators

  • Jun Shi, Dr. · Institute of Hematology & Blood Diseases Hospital, China

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-27
Primary Completion
2026-09-30
Completion
2028-03-30

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07091370 on ClinicalTrials.gov