An Open-label, Single-arm, Prospective, Multicenter, Phase I/II Clinical Study on the Safety and … (NCT07324889) | Clinical Trial Compass
Not Yet RecruitingPhase 1/2
An Open-label, Single-arm, Prospective, Multicenter, Phase I/II Clinical Study on the Safety and Efficacy of CD19/BCMA CAR-T Cell Therapy for Relapsed/Refractory Warm Antibody Autoimmune Hemolytic Anemia
24 participantsStarted 2026-01-31
Plain-language summary
This study is an open-label, single-arm, prospective, multicenter, phase I/II clinical trial. It adopts the two-stage optimal design proposed by Bryant and Day to investigate the efficacy, safety, and in vivo pharmacokinetic characteristics of CD19/BCMA CAR-T cell therapy in the treatment of relapsed/refractory warm antibody 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
. Aged ≥ 18 years and ≤ 75 years.
. Meeting the criteria for relapsed/refractory warm antibody autoimmune hemolytic anemia (wAIHA), and the patient must have received treatment with at least one of rituximab or cyclophosphamide.
. Criteria for diagnosing relapsed/refractory warm antibody AIHA: It refers to warm antibody AIHA in which the patient has poor response to first-line and second-line or above standard treatments (e.g., glucocorticoids), or the disease recurs after effective treatment, or the patient requires continuous or repeated treatment to control the disease.
. Disease duration of more than 6 months, with persistent disease activity or progression despite receiving conventional treatment for ≥ 2 months, or recurrence of disease activity after disease remission. Definition of conventional treatment: Use of glucocorticoids plus at least one of the following immunomodulators: cyclophosphamide, cyclosporine, and biological agents (including rituximab, etc.).
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.
. Concomitant diagnosis of any type of tumor, which is deemed unsuitable for participation in this study by the investigator.
. A history of clinically significant central nervous system (CNS) diseases or pathological changes caused by non-autoimmune diseases prior to screening, including but not limited to: cerebrovascular accident, aneurysm, epilepsy, convulsions/seizures, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis.
. A history of major organ transplantation (e.g., heart, lung, kidney, liver) or hematopoietic stem cell/bone marrow transplantation.
. Presence of IgA deficiency at screening (serum IgA level \< 10 mg/dL).
. Presence of any of the following conditions at screening:
. Active hepatitis (hepatitis B virus deoxyribonucleic acid \[HBV-DNA\] or hepatitis C virus ribonucleic acid \[HCV-RNA\] test results above the lower limit of detection);
. Human immunodeficiency virus (HIV) infection, known acquired immunodeficiency syndrome (AIDS), or syphilis infection.
. A history of any of the following cardiovascular diseases within 6 months prior to screening: New York Heart Association (NYHA) Class III or IV heart failure, myocardial infarction, unstable angina pectoris, uncontrolled or symptomatic atrial arrhythmia, any ventricular arrhythmia, or other heart diseases with significant clinical significance.