New combo aims to tame autoimmune anemia without Long-Term steroids
NCT ID NCT07518277
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether adding sirolimus to standard steroid treatment helps people with newly diagnosed mild autoimmune hemolytic anemia (AIHA) achieve lasting remission. About 216 adults will be randomly assigned to get either steroids alone or steroids plus sirolimus for 6 months, then followed for 2 years. The main goal is to see if more people in the combo group can stop steroids and stay in remission at 12 months.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- sirolimus combined with glucocorticoids (steroids)
- What this could lead to
- If it works, this could offer a way to treat AIHA with fewer steroids and a higher chance of staying in remission without ongoing medication.
- What could go wrong
- This is an early-stage trial with no phase assigned, so results are uncertain. Sirolimus can cause side effects like infections or metabolic issues, and the benefit over steroids alone may be small.
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
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 216 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Apr 2026
An estimate. Start dates often move.
- Expected to finish
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Apr 2028
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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, gender not limited; 2. Diagnosed as newly diagnosed wAIHA and requiring systemic immunosuppressive therapy (those with short-term hormone exposure of ≤2 weeks before enrollment can be included) 3. After a comprehensive rheumatology and immunology assessment, there is no evidence of clinical organ involvement in SLE or other connective tissue diseases (only serological abnormalities can be included). 4. Positive Coombs test (IgG type, IgG+C3d type, or only C3d type with a condensed agglutinin titer of 1:64); 5. Active hemolytic anemia, hemoglobin (HGB) ≤ 100 g/L; 6. Liver and kidney function: Alanine aminotransferase (ALT) \< 3 times the upper limit of the normal value (ULN), isolated elevation of aspartate aminotransferase (AST) (normal ALT) is acceptable; Serum creatinine ≤2×ULN; 7. Eastern Cooperative Oncology Group (ECOG) Performance status score ≤2 points; 8. Those with a history of malignant tumors must meet the following conditions: Radical treatment has been achieved; The disease-free survival period complies with the protocol provisions (such as ≥1 year for basal cell carcinoma, ≥5 years for early solid tumors, ≥5 years for curable lymphoma, etc.); There is currently no evidence of recurrence. Those who do not meet the above conditions (such as CLL, advanced solid tumors, and active tumors) are not included. 9. Voluntarily sign a written informed consent form. Exclusion Criteria: 1. Pregnant or lactating patients; 2. Clinically confirmed SLE or other definite connective tissue diseases; 3. Secondary AIHA secondary to lymphoproliferative diseases, other hematological malignancies, solid tumors, infections, and drugs; 4. Cold-resistant type or hybrid type AIHA; 5. Received before group enrollment: Other immunosuppressants (such as rituximab, cyclosporine, etc., regardless of the duration); Glucocorticoid treatment for more than 2 weeks; 6. Severe cardiac insufficiency (NYHA grade III/IV, or LVEF \< 40%); 7. Currently active malignant tumors, or previous tumors that do not meet the requirements of Article 8 of the inclusion criteria; 8. Chronic active infections (active tuberculosis, active hepatitis B/C, etc.); 9. Severe immunodeficiency diseases, HIV infection (CD4⁺ \< 200/μL), currently using other potent immunosuppressants, and using targeted biological agents within the last 3 months; 10. Have a history of severe allergy to sirolimus, glucocorticoids or related excipients; 11. Other circumstances where the researcher deems it inappropriate to participate.
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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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.
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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.
Contacts and locations
Locations
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Peking union medical college hospital
Beijing, Shuangfuyuan, NO I., 100730, China
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