Orelabrutinib for relapsed or refractory AIHA

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 2, interventional study enrolling adults with AIHA, including warm AIHA and cold agglutinin AIHA, to receive one of three fixed daily doses of orelabrutinib (50 mg, 100 mg, or 150 mg) for at least 12 weeks, with the option to continue up to 52 weeks if they respond. Dosing may be adjusted in the 50 mg group based on hemoglobin response, and transfusion support is permitted under defined thresholds. Stable glucocorticoid therapy is allowed with documentation of tapering. Primary goals include demonstrating safety and observing signs of efficacy, long-term safety, and durability of response, with transfusion and hemoglobin parameters guiding treatment decisions.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age ≥ 18 years.
* Patients with a definitive diagnosis of AIHA. wAIHA or Evans syndrome, primary or secondary to connective tissue disease (CTD) or lymphoproliferative disorder (LPD). If secondary, CTD should have no indication for treatment for other system involvement, and LPD should be in an asymptomatic, observation phase without treatment indication.

cAIHA, primary or secondary to LPD. If secondary, LPD should be in an asymptomatic, observation phase without treatment indication.

* For wAIHA: No response (no partial response after 3 weeks) to full-dose glucocorticoid therapy (1-2 mg/kg/day), intolerance, or relapse (after initial response, hemoglobin drop ≥20 g/L or requiring re-initiation of immunosuppressive therapy). And hemoglobin ≤ 100 g/L.
* For cAIHA: No response or relapse after anti-CD20 monoclonal antibody therapy (after initial response, hemoglobin drop ≥20 g/L or recurrence of vascular symptoms, or requiring re-initiation of immunosuppressive therapy), or unsuitable for anti-CD20 therapy. And hemoglobin ≤ 100 g/L or presence of vascular symptoms.
* Baseline liver and kidney function (ALT, Cr) within 2 times the upper limit of normal (elevated AST, LDH, Bil due to hemolysis are not used as indicators for liver function assessment).
* Agreement to sign the informed consent form.

Exclusion Criteria:

* Active involvement of other major organs due to connective tissue disease.
* Uncontrolled infection or bleeding per standard treatment.
* Uncontrolled active HIV, HCV, or HBV infection per standard treatment.
* Concurrent advanced uncontrolled malignancy, lymphoma.
* Presence of other uncorrected types of anemia at screening, such as nutritional anemia, thalassemia, etc.
* Currently receiving glucocorticoid therapy at screening and unable to discontinue or taper to ≤ 15 mg/day (prednisone equivalent) within 1 week before enrollment.
* Currently receiving treatment with medications such as cyclosporine, tacrolimus, sirolimus, cyclophosphamide, azathioprine, stanozolol, testosterone undecanoate, danazol, etc., at screening, and the treatment duration at a stable dose is \< 12 weeks, or unable to discontinue directly.
* Last dose of rituximab \< 3 months prior to enrollment.
* Prior treatment with any BTK inhibitor.
* Liver cirrhosis or portal hypertension.
* Pregnant or breastfeeding women.
* Participation in another clinical trial within the past 3 months.

Where it's running

• Peking Union Medical College Hospital
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Principal investigator: Miao Chen — Peking Union Medical College
• Study coordinator: Miao Chen
• Email: chenm@pumch.cn
• Phone: +86 18618230229

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.