META 10-19 in Patients With Relapsed/Refractory Autoimmune Hemolytic Anemia (NCT07689604) | Clinical Trial Compass
Not Yet RecruitingEarly Phase 1
META 10-19 in Patients With Relapsed/Refractory Autoimmune Hemolytic Anemia
China18 participantsStarted 2026-07-08
Plain-language summary
A Study of Metabolically Armed Autologous CD19 CAR T-Cell Therapy (META 10-19) in Patients with Relapsed/Refractory Autoimmune Hemolytic Anemia
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Hemoglobin \< 10 g/dL with clinical manifestations of hemolytic anemia;
. After treatment with at least two immunosuppressive agents (which must include an anti-CD20 monoclonal antibody, with a cumulative dose of the anti-CD20 antibody reaching at least 375 mg/m² × 4, or a total dose of 2.0 g, or at least 6 cumulative administrations with an interval of ≥1 week between each);
. Glucocorticoid therapy for no less than 3 months (except for those with comorbidities that contraindicate corticosteroid use, severe infection, severe osteoporosis, previous fractures, or intolerance to glucocorticoids).
Exclusion criteria
. Hepatitis B: HBsAg or HBeAg positive; or hepatitis B e antibody (HBe-Ab) and/or hepatitis B core antibody (HBc-Ab) positive with HBV-DNA copy number above the lower limit of detection.
. Hepatitis C: Anti-HCV positive and HCV RNA ≥ lower limit of quantification (LLoQ).
. Human immunodeficiency virus (HIV) antibody positive.
. Active syphilis infection (excluding those with only positive syphilis-specific antibodies).
. Cardiovascular disease with New York Heart Association (NYHA) class \> 2 within 6 months prior to the first study drug administration.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence and severity of adverse events
Timeframe: Up to 28 days after META 10-19 infusion.
Trial details
NCT IDNCT07689604
SponsorInstitute of Hematology & Blood Diseases Hospital, China
. Unstable angina or severe arrhythmia requiring medication, including QTcF \> 480 ms (calculated by Fridericia's formula).
. Other significant electrocardiogram (ECG) abnormalities, including second-degree type II atrioventricular block, third-degree atrioventricular block, bradycardia (ventricular rate \< 50 bpm with clinical symptoms), etc.