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New hope for rare blood disorder: linprixel trial launches

NCT ID NCT07149818

Disease control Sponsor: Peking Union Medical College Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This phase 2 trial tests linprixel, a daily pill, in 22 adults with relapsed or refractory autoimmune hemolytic anemia (AIHA). The study aims to see if the drug can improve red blood cell counts after 12 weeks. Participants start at 40mg daily, with possible dose increases if needed. The trial is not yet recruiting.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
linprixel (parsaclisib)
What this could lead to
If successful, this could offer a new treatment option for people with hard-to-treat autoimmune hemolytic anemia, potentially reducing the need for long-term steroids.
What could go wrong
This is a small, early-phase trial with only 22 participants and no comparison group. The drug may not work for everyone, and side effects are possible. Results may not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 22 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2025

An estimate. Start dates often move.

Expected to finish

Jan 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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)

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: （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. Exclusion Criteria: 1. Those with incomplete functions of organs such as the heart, liver and lungs; Patients with acute renal insufficiency 2. Combined with connective tissue diseases, other vital organs are involved. 3. Uncontrolled infection or bleeding after standard treatment. Standard treatment for uncontrolled active infections of HIV, HCV or HBV. 4. Combined with advanced uncontrolled malignant tumors and lymphomas. 5. At the time of screening, the subjects had other types of uncorrected anemia, such as nutritional anemia, etc 6. Pregnant or lactating women. 7. Those who have used PI3Kδ inhibitors within the past 6 months; 8. Those who have participated in other clinical trials within three months.

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Conditions

The condition(s) this trial relates to.

autoimmune hemolytic anemia autoimmune hemolytic anemia, warm type cold agglutinin disease Evans syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Autoimmune hemolytic anemia

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  2. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

More trials for these conditions

Other studies related to the condition(s) this trial covers.