Phase 1 Study of F182112 in Relapsed/Refractory Autoimmune Hemolytic Anemia

NCT07816341 | Not Yet Recruiting Phase 1 DMC

• 1 other identifier: F182112-IIT-005
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

This is an open-label, phase I clinical study of F182112 in patients with relapsed or refractory autoimmune hemolytic anemia (AIHA). Participants will receive F182112 at different dose levels. The main purpose of the study is to evaluate the safety and tolerability of F182112 and to identify an appropriate dose for further clinical development.

Conditions

Autoimmune Hemolytic Anemia

Keywords

Autoimmune Hemolytic Anemia, F182112

Outcome Measures

Primary Outcomes (1)

• Incidence of adverse events

  Use Common Terminology Criteria for Adverse Events (CTCAE) Version 6 to assess the adverse event

  28 days post the last dose treatment

Study Arms (1)

F182112 in Relapsed/Refractory Autoimmune Hemolytic Anemia

EXPERIMENTAL

F182112 is a recombinant humanized anti-BCMA/CD3 bispecific antibody for injection. By binding to CD3 receptors on T cells, F182112 can effectively deplete BCMA-expressing B cells and plasma cells in vivo, thereby alleviating the clinical manifestations of autoimmune diseases.

Drug: F182112 single-agent

Interventions

F182112 single-agent DRUG

The dose-escalation phase will evaluate three sequential target dose levels of F182112: 30 μg/kg, 90 μg/kg, and 180 μg/kg, using a standard 3+3 design. F182112 will be administered intravenously using a priming dose followed by a target dose.

F182112 in Relapsed/Refractory Autoimmune Hemolytic Anemia

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-75 years.
• Diagnosis of AIHA according to established Chinese or international criteria, including warm AIHA, mixed AIHA, cold agglutinin disease, or Evans syndrome.
• Refractory to multiple lines of therapy, meeting all of the following: HGB \<100 g/L with evidence of hemolytic anemia; Prior treatment with ≥2 immunosuppressive therapies, including a CD20 monoclonal antibody; Glucocorticoid treatment for ≥3 months, unless contraindicated or intolerable; Adequate prior CD20 monoclonal antibody treatment (≥4 doses of 100 mg or 375 mg/m², or 2 doses of 1,000 mg).
• ECOG performance status ≤2.
• Participants and their partners agree to use effective contraception from informed consent through 1 year after study treatment.
• Written informed consent must be obtained before any study-specific screening procedures.

You may not qualify if:

• Diagnosed lymphoproliferative malignancy.
• Secondary AIHA caused by drugs or infection.
• Congenital immunodeficiency or other inherited or acquired hemolytic disorders.
• Prior organ or hematopoietic stem cell transplantation.
• New thrombotic events or organ infarction within 6 months before enrollment.
• Prior BCMA-targeted therapy within 6 months before enrollment.
• Any of the following prior treatments within the specified washout periods: Anti-CD20 monoclonal antibody within 12 weeks; Sutimlimab or other approved biologic therapy within 5 half-lives; Plasma exchange within 4 weeks; Splenectomy within 12 weeks.
• Any of the following cardiovascular conditions: LVEF ≤45%; Active cardiac disease or NYHA class III/IV heart failure; Clinically significant arrhythmia requiring treatment, except atrial fibrillation or paroxysmal supraventricular tachycardia; QTc ≥450 ms in males or ≥470 ms in females; Myocardial infarction, coronary artery bypass grafting, or coronary stent placement within 6 months; Other clinically significant cardiac disease considered unsuitable by the investigator.
• Unstable systemic disease, including severe hepatic or renal disease requiring treatment.
• History of another primary malignancy within 5 years before screening, except adequately treated non-melanoma skin cancer, carcinoma in situ, or other malignancies without recurrence for ≥5 years.
• Major surgery within 4 weeks before screening if considered unsuitable for enrollment by the investigator.
• Uncontrolled active fungal, viral, bacterial, tuberculosis, or other infection, or infection requiring intravenous antimicrobial therapy.
• Active or clinically significant HBV, HCV, HIV, or syphilis infection
• Live-virus vaccination within 4 weeks before enrollment.
• Participation in another interventional clinical study within 5 half-lives of the investigational treatment before screening, or planned use of another investigational treatment during this study.

Sponsors & Collaborators

• Institute of Hematology & Blood Diseases Hospital, China: lead

Study Sites (1)

Red Blood Cell Diseases Center and Regenerative Medicine Center

Tianjin, Tianjin Municipality, 301617, China

Location

MeSH Terms

Conditions

Anemia, Hemolytic, Autoimmune

Condition Hierarchy (Ancestors)

Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Jun Shi

  Institute of Hematology & Blood Diseases Hosptial, Chinese Academy of Medical Science and Peking Union Medical College Principal Investigator

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lele Zhang

CONTACT

8602223908328; zhanglele@ihcams.ac.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Red Blood Cell Diseases Center and Regenerative Medicine Center

Study Record Dates

• First Submitted: September 7, 2026
• First Posted: September 11, 2026
• Study Start (Estimated): October 10, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: September 11, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)