Engineered immune cells take on tough blood disorder
NCT ID NCT07530380
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage study tests a new treatment for people with a severe type of autoimmune hemolytic anemia (AIHA) that hasn't improved after at least three prior therapies. The treatment uses specially engineered immune cells (CAR-T cells) from a healthy donor to target and destroy the faulty B cells causing the disease. The main goals are to check safety and see if the therapy can control the anemia.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
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About 15 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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Dec 2030
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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10 years and older
- 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 ≥ 10 years, regardless of sex; * 2\. Flow cytometry-confirmed CD19 or BCMA positivity on B cells in peripheral blood or bone marrow; * 3\. Patients diagnosed with AIHA, including warm antibody type, cold agglutinin disease, mixed type, and other types of AIHA, with diagnostic criteria referring to the "Chinese Adult Autoimmune Hemolytic Anemia Diagnosis and Treatment Guidelines (2023 Edition)"; * 4\. The definition of recurrent/refractory AIHA that has received at least 3 failed lines of treatment is symptomatic anemia (hemoglobin\<100g/ L) that persists after a routine treatment cycle of at least 6 months and is still ineffective or reappears after disease remission. The definition of conventional treatment: treatment with glucocorticoids and/or rituximab, as well as any 1-2 or more of the following immunomodulatory drugs: cyclophosphamide, azathioprine, mycophenolate mofetil, cyclosporine A, azathioprine, danazol, bendamustine, fludarabine, bortezomib, and biologics including daratumumab, BTK inhibitors, Syk inhibitors, and complement inhibitors; * 5\. Functional requirements for major organs are as follows: 1. The bone marrow function needs to meet: a Neutrophil count ≥ 1.0 × 10 \^ 9/L; b. Platelets ≥ 30 × 10 \^ 9/L. 2. Liver function: ALT ≤ 3 × UL; AST ≤ 3×ULN# Total bilirubin ≤ 2.0 × ULN (excluding Gilbert syndrome, total bilirubin ≤ 3.0 × ULN). 3. Renal function: creatinine clearance rate (CrCl) ≥ 30 ml/min (Cockcroft/Gault formula, excluding acute CrCl decline caused by the disease itself). * 6\. ECOG ≤ 2; * 7\. Female subjects of childbearing potential and male subjects with partners of childbearing potential must use medically approved contraception or abstinence during the study treatment period and for at least 6 months after the end of the study treatment; Female subjects of childbearing potential must have a negative Human chorionic gonadotropin (HCG) test within 7 days before study enrollment and not be lactating; * 8\. Willing to participate in this clinical study, sign an informed consent form, have good compliance, and cooperate with follow-up. Exclusion Criteria: * 1\. Subjects with a history of severe drug allergies or allergic tendencies; * 2\. Presence or suspicion of uncontrolled or treatment-required fungal, bacterial, viral, or other infections; * 3\. History of recurrent infections (e.g., ≥3 episodes of active infection requiring medical intervention within 6 months prior to enrollment); * 4\. History of cytomegalovirus (CMV), Epstein-Barr virus (EBV), or fungal infections within 3 months prior to screening, or history of recurrent CMV, EBV, or fungal infections; * 5\. Receipt of any vaccination within 12 weeks prior to enrollment, or participation in a vaccine clinical trial within 12 weeks prior to enrollment; * 6\. Subjects with insufficient cardiac function; * 7\. Moderate to severe congestive heart failure (New York Heart Association \[NYHA\] Class III-IV); * 8\. Subjects with congenital immunoglobulin deficiencies; * 9\. History of malignancy within the past 5 years (except for non-melanoma skin cancer, completely resected Stage I tumor with low risk of recurrence, treated clinically localized prostate cancer, biopsy-proven cervical carcinoma in situ or squamous intraepithelial lesion on smear, and stable papillary or follicular thyroid cancer); * 10\. Subjects who are positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) with peripheral blood HBV DNA \>ULN; subjects positive for hepatitis C virus (HCV) antibody and peripheral blood HCV RNA; individuals positive for human immunodeficiency virus (HIV) antibody; individuals positive for syphilis testing; * 11\. History of organ transplantation, including but not limited to bone marrow or hematopoietic stem cell transplantation; * 12\. Severe, progressive, uncontrolled disease of the cardiovascular, cerebrovascular, hepatic, renal, pulmonary, gastrointestinal, hematologic, endocrine, or nervous system; * 13.Psychiatric disorder or severe cognitive impairment; * 14\. Pregnant women or women planning to conceive * 15\. Subjects that the investigator believes have other reasons that make them unsuitable for inclusion in this study
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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
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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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The Second Hospital of Anhui Medical University
RECRUITINGHefei, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Experimental drug F182112 tested against Hard-to-Treat blood disorder
- Could a simple blood test predict clot risk in antiphospholipid syndrome?
- Experimental mRNA CAR-T therapy targets autoimmune diseases in first human trial
- Engineered immune cells take on rare blood disorders
- Brain scans reveal hidden thinking problems in anemia patients
- Experimental immune therapy for stubborn anemia shows early promise but trial stalls