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Experimental drug tested for stubborn blood disorder – but trial cut short

NCT ID NCT05676697

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
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 Results may not be published yet.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 This study
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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This early-phase study tested the drug Linperlisib in just 4 adults with autoimmune hemolytic anemia (AIHA) whose disease did not improve after at least two prior treatments. The goal was to see if the drug could help control the disease by targeting a key immune pathway. However, the trial was terminated early, so we have very limited information on how well it worked or its safety.

What this could mean

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

Active substance
Linperlisib (a PI3K delta inhibitor)
What this could lead to
If it works, this could point toward a new treatment option for people with hard-to-treat autoimmune hemolytic anemia.
What could go wrong
This was a very small, early-phase trial (only 4 participants) that was terminated early, so results are limited and may not be reliable. The drug may not prove effective or safe in larger studies.

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.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

4 people

The number who actually took part.

Started

Jan 2023

Finished

Feb 2024

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.

Ages

18 years and older

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: * Male or female age ≥ 18 years * Diagnosis of primary warm antibody hemolytic anemia (AIHA). * Hemoglobin \< 100g/L * Refractory to or relapsed after at least 2 prior treatment line. * ECOG performance status ≤ 2 * Willing and able to comply with the requirements for this study and written informed consent. Exclusion Criteria: * Neutrophils counts \< 0.5×10\^9/L or platelet counts \< 50 x 10\^9/L * Diagnosis of any of the following diseases: Cold agglutinin disease, cold agglutinin syndrome, mixed AIHA, paroxysmal cold hemoglobinuria (PCH). * Diagnosis of the active stage of the connective tissue or systemic autoimmune rheumatic diseases (SARDs) * History of lymphoproliferative neoplasms * Had other inherited or acquired hemolytic diseases. * Secondary AIHA caused by drugs or infection * Previously received organ or stem cell transplantation. * Had malignant tumor within 5 years before enrollment, exclusive of cured basal or squamous cell skin cancer, superficial bladder cancer, prostate intraepithelial tumor, cervical carcinoma in situ or other indolent tumors * Patients with HBV, HCV, HIV or other infections that require treatment. * Abnormal liver function: two consecutive examinations with an interval of ≥1 week suggest that ALT and AST are 2.5 times higher than the upper limit of normal values * Renal impairment: creatinine clearance \<60ml/min * Any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study, including clinically significant cardiac diseases, refractory hypertension, metabolic disorders and other diseases that seriously affect the function of the gastrointestinal tract. * Had a history of any psychiatric diseases, cerebrovascular disease or cognitive sequelae of head injury. * Received rituximab in 6 weeks before enrollment. * Received attenuated vaccine 4 in weeks before enrollment * Participation in another clinical trial within 4 weeks before the start of this trial * Have an allergy to Linperlisib or any other part of this medicine. * Previously treated with other PI3Kδ inhibitor. * Pregnant or breast-feeding patients * Patients considered to be ineligible for the study by the investigator for reasons other than the above

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Regenerative Medicine Center

    Tianjin, Tianjin Municipality, China

  • Zhoukou Central Hospital

    Zhoukou, Henan, China

More trials for these conditions

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