A Single-arm Phase 2 Prospective Clinical Study of Linprixel in the Treatment of Relapsed/Refractory Autoimmune Hemolytic Anemia

NCT07149818 | Not Yet Recruiting DMC

• 1 other identifier: Linperlisib-AIHA
• Study Type: observational
• Target: 22
• Locations: 0 countries
• Sites: N/A

Brief Summary

wAIHA or EVANS syndrome: Linpriril 40mg, oral, once daily. The therapeutic effect will be evaluated after 4 weeks. If the therapeutic effect does not reach the PR, the dose will be increased to 60mg once a day. After continuing to take it for 4 weeks, the therapeutic effect will be evaluated again. If the PR is not reached, it can be increased to 80mg. If the PR is still not reached after continuing to take it for 4 weeks, it will be discontinued (for a total of 12 weeks). The initial dose is 40mg, taken orally once a day. If the therapeutic effect reaches PR or above after 4 weeks, continue taking this dose. The evaluation is the same as before every 4 weeks. The research period was 12 weeks. The duration of continuous treatment for effective patients is determined by the researchers, and the dosage of the drug can be reduced or increased. cAIHA: Linpriril 80mg, oral administration, once daily. The therapeutic effect was evaluated every 4 weeks. The research period was 12 weeks. The treatment was discontinued if the therapeutic effect did not reach the PR within 12 weeks. The duration of continuous treatment for effective patients is determined by the researchers, and the dosage of the drug can be reduced or increased.

Conditions

Autoimmune Hemolytic Anemia

Keywords

Autoimmune Hemolytic Anemia

Outcome Measures

Primary Outcomes (2)

• The overall response rate (ORR) at 12 weeks

  The overall response rate (ORR)

  12 weeks

• The complete response rate (CRR) at 12 weeks

  The complete response rate (CRR) at 12 weeks

  12 weeks

Secondary Outcomes (1)

• The incidence of adverse events

  12 weeks

Study Arms (1)

parsaclisib 40mg qd

Drug: Parsaclisib

Interventions

Parsaclisib DRUG

parsaclisib 40mg qd

parsaclisib 40mg qd

Eligibility Criteria

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

Study Population

1. Record complete demographic data, improve the patient's medical history and physical examination. 2. Routine examinations include blood routine (including reticulocytes), biochemistry (liver and kidney function, lactate dehydrogenase, ferritin, folic acid, vitamin B12), coagulation function, direct anti-human globulin test (DAT) and typing, colagglutinin test, autoantibody, antiphospholipid antibody, immunoglobulin, serum protein electrophoresis, and TB cell subset analysis. Cytokines (flow cytometry), chest and abdominal CT or abdominal ultrasound. 3. Bone Marrow smear, biopsy, flow immunotyping, chromosome (optional)

You may qualify if:

• （1）Age ≥18 years old (2) Clearly diagnosed wAIHA or EVANS syndrome, cAIHA, primary or secondary connective tissue diseases. If it is secondary, there are no indications for the treatment of connective tissue diseases involving other systems.
• (3) Patients who relapse or are refractory after at least two lines of treatment (previous treatments include glucocorticoids, CD20 monoclonal antibodies or at least two other immunosuppressants). Refractory is defined as the failure to achieve partial remission after 3 months of stable dose treatment with immunosuppressants.
• (4) hb≤100 g / L (5) Those with complete clinical data, high treatment compliance, and those who have signed the informed consent form; (6) If glucocorticoids are being taken, they should be discontinued or the minimum maintenance dose has been taken for at least two weeks, and the minimum maintenance dose (≤15mg/day) should be continued subsequently (7) The infusion of CD20 monoclonal antibody should be at least 3 months or more. If the stable dose of immunosuppressants such as cyclosporine and sirolimus has been taken for at least 3 months, they should be discontinued upon enrollment.

You may not qualify if:

• Those with incomplete functions of organs such as the heart, liver and lungs; Patients with acute renal insufficiency
• Combined with connective tissue diseases, other vital organs are involved.
• Uncontrolled infection or bleeding after standard treatment. Standard treatment for uncontrolled active infections of HIV, HCV or HBV.
• Combined with advanced uncontrolled malignant tumors and lymphomas.
• At the time of screening, the subjects had other types of uncorrected anemia, such as nutritional anemia, etc
• Pregnant or lactating women.
• Those who have used PI3Kδ inhibitors within the past 6 months;
• Those who have participated in other clinical trials within three months.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

MeSH Terms

Conditions

Anemia, Hemolytic, Autoimmune

Interventions

parsaclisib

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Peking Union Medical College Hospital

Study Record Dates

• First Submitted: June 11, 2025
• First Posted: September 2, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: September 2, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share