ClinicalTrials.gov record NCT07816341
Phase 1 Study of F182112 in Relapsed/Refractory Autoimmune Hemolytic Anemia
A Phase 1 Study to Evaluate the Safety, Tolerability, Preliminary Efficacy, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of F182112 in Patients With Relapsed/Refractory Autoimmune Hemolytic Anemia
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AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
This open-label Phase 1 study tests the investigational drug F182112 in people with relapsed or refractory autoimmune hemolytic anemia (AIHA). Participants receive F182112 given intravenously at escalating dose levels using a priming dose followed by a target dose. The main goal is to evaluate safety and tolerability and to identify an appropriate dose for further study.
What it is studying. The study is testing whether F182112 can be given safely to people with relapsed or refractory AIHA, and it will collect early information on dosing, how the drug behaves in the body (pharmacokinetics and pharmacodynamics), immune response to the drug (immunogenicity), and any preliminary signs of effect on disease.
What the researchers hope to learn. To evaluate the safety and tolerability of F182112; to identify a dose suitable for further clinical development; to collect pharmacokinetic, pharmacodynamic, immunogenicity, and preliminary efficacy data.
What this study is about
The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.
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.
Interventions being studied
Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.
- Drug
- F182112 single-agent
Eligibility
The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.
Inclusion criteria
- 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.
Exclusion criteria
- 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.
- Pregnant or breastfeeding women.
- Psychiatric disorders, impaired consciousness, or central nervous system disorders, including a history of epilepsy or Parkinson's disease.
- Known hypersensitivity to any component of F182112.
- Any other condition that, in the investigator's judgment, makes the participant unsuitable for the study.
Study description and what participation involves
The registry record has no detailed description beyond the summary above.
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AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
After giving written informed consent and completing screening, participants receive intravenous F182112 in a dose-escalation plan: a priming dose followed by a target dose at one of three dose levels (30, 90, or 180 μg/kg) using a standard 3+3 design. Dosing requires clinic visits for the infusions and related monitoring. Study staff will record and assess adverse events, with safety monitored through at least 28 days after the last dose. Participants and their partners must agree to use effective contraception from consent through 1 year after study treatment.
How the study is structured. This is an open-label, single-group Phase 1 trial using a standard 3+3 dose-escalation design. Participants receive one of three sequential target intravenous dose levels (30 μg/kg, 90 μg/kg, 180 μg/kg) with a priming dose followed by the target dose. There is no masking and no comparison group. The main safety measure is incidence of adverse events assessed with Common Terminology Criteria for Adverse Events (CTCAE) Version 6 up to 28 days after the last dose.
Questions you could ask
These questions are suggestions for a conversation with the study team or your own clinician, not advice.
- This is an early-phase study, mainly about safety and dose. What is already known about this treatment?
- The registry says recruitment has not started. When is it expected to open, and can I register interest now?
- The listed sites are in China. Is any of them reachable for me, and does the study help with travel?
- Which of the eligibility criteria would need to be checked with tests before I could join?
More on autoimmune hemolytic anemia
Important dates
- Study start
- Oct 10, 2026 (estimated)
- Primary completion
- Dec 31, 2027 (estimated)
- Study completion
- Dec 31, 2028 (estimated)
- Target enrollment
- 12 participants (estimated)
- Last updated on registry
- Sep 11, 2026
- Data verified
- Oct 10, 2026
Sponsor and research team
The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, China
- Principal investigator
- Jun Shi, Director of the Red Blood Cell Diseases Center and Regenerative Medicine Center
Institute of Hematology & Blood Diseases Hospital, China
Central study contact
If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.
- Lele Zhang 📞 8602223908328 ✉ zhanglele@ihcams.ac.cn
Participating sites (1)
- Red Blood Cell Diseases Center and Regenerative Medicine Center
Tianjin, Tianjin Municipality, 301617 · China
- Lele Zhang · 02223608328 · zhanglele@ihcams.ac.cn
Terms used on this page · explanations by MedicalUpdates.ai
- open-label
- No masking is used, so the assigned intervention is not deliberately hidden from participants or study staff.
- relapsed or refractory
- A condition that has not responded to a treatment. 'Relapsed' means it responded and then came back; 'refractory' means it did not respond in the first place.
- lines of therapy
- Treatment a person has already had for the condition. A 'line of therapy' is one course of treatment; studies often require, or limit, the number of prior lines.
- immunosuppressive
- A medicine that reduces the activity of the immune system. Studies of autoimmune conditions often require a stable dose, a prior failure, or a washout of such medicines.
- Glucocorticoid
- Steroid medicines, such as prednisone, that reduce inflammation. Studies often require a stable dose at entry or measure whether the study treatment allows the dose to be reduced.
- contraindicated
- A reason a particular test or treatment should not be used for a person, for example a metal implant that rules out an MRI scan.
- ECOG performance status
- A scale from 0 to 5 that describes how a person's condition affects daily activity. 0 means fully active; 1 means restricted in strenuous activity; 2 means able to self-care but unable to work; higher numbers mean more limitation.
- informed consent
- The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
- enrollment
- The number of participants a study plans to include, or has included. 'Estimated' means the planned number; 'actual' means the number who joined.
- washout
- A period during which a participant stops a previous treatment before starting the study treatment, so the earlier treatment does not affect the results.
- 5 half-lives
- The time it takes for the amount of a drug in the body to fall by half. 'Five half-lives' is often used as the point at which a previous drug has essentially left the body.
- QTc
- A recording of the heart's electrical activity. QTc is one measurement from it; some drugs are avoided if it is prolonged.
- before screening
- The checks done before enrolment to see whether a person qualifies, such as tests, scans or a review of medical history.
- investigational
- A treatment that is being tested and has not been approved for this use. It may be approved for a different condition. Being studied does not mean it works or is available outside the study.
- Inclusion Criteria
- The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
- Exclusion Criteria
- The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.
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