Not Yet RecruitingPhase 1

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

12 participantsStarted 2025-12-27

Plain-language 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.

Who can participate

Age range18 Years – 75 Years

SexALL

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Inclusion criteria

✓. Age range: 18-75 years (including 18 and 75 years), regardless of gender.
✓. Clinically diagnosed with AIHA or Evans, with hemoglobin lower than 100g/L and symptoms related to anemia according to the diagnostic criteria of the "Diagnosis and Treatment Guidelines for Autoimmune Hemolytic Anemia in Chinese Adults (2023 Edition)" and the "Chinese Expert Consensus on the Diagnosis and Treatment of Evans Syndrome (2024 Edition)". And meet the diagnostic criteria of failure in at least three lines of treatment as follows:
✓. Women of childbearing potential must have a negative blood pregnancy test during the screening period. Any male and female patients of childbearing potential must agree to use an effective method of contraception throughout the study and for at least 2 year following infusion of CAR-T cells. Childbearing potential is biologically capable of bearing a living baby and sexually active. Female patients who were not of childbearing potential (ie, met at least 1 of the following criteria):
✓. Adequate organ function according to the following criteria:
✓. The Eastern Cancer Consortium (ECOG) performance status score is 0-2.

Exclusion criteria

✕. Previously diagnosed proliferative tumors of the lymphatic system;
✕. Secondary AIHA caused by drugs or infections;
✕. Pregnancy or breastfeeding;
✕. Previously undergone organ or hematopoietic stem cell transplantation;
✕. A history of new thrombosis or organ infarction within 6 months prior to screening;
✕. The active stage diagnosed as a connective tissue disease;
✕. Suffering from hereditary hemolytic diseases or other acquired hemolytic diseases;
✕. Combined with active infections (such as sepsis, bacteremia, mycosis, uncontrolled pulmonary infection and active tuberculosis, etc.);

What they're measuring

Incidence of Treatment-related Adverse Events

Timeframe: Up to 28 days post-infusion

The safe dosage for a single infusion of Inaticabtagene Autoleucel Injection

Timeframe: Up to 28 days post-infusion

Trial details

NCT IDNCT07091370

SponsorJuventas Cell Therapy Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-09-30

Contact for this trial

Junyin Yu

13920424844 Yujunyin@juventas.cn

View on ClinicalTrials.gov More AIHA - Cold Autoimmune Hemolytic Anemia trials