Actively Recruiting
Clinical Study on Safety, Efficacy, and Pharmacokinetics of Universal CAR-T Cell Injection Targeting CD19BCMA in Subjects With Autoantibody-Mediated Autoimmune Benign Hematological Diseases
Led by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Updated on 2026-03-02
27
Participants Needed
1
Research Sites
24 weeks
Total Duration
On this page
Sponsors
U
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Lead Sponsor
N
Nanjing Bioheng Biotech Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and effectiveness of RD06-05, a universal CAR-T cell therapy targeting CD19BCMA, in adults with active autoantibody-mediated autoimmune hematological diseases. This includes patients with primary immune thrombocytopenic purpura ITP, autoimmune hemolytic anemia AIHA, and Evans syndrome. The study is an early phase 1, open-label trial led by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology. Participants will receive an infusion of CAR-T cells at either 6 106 or 10 106 CART cells per kilogram of body weight. The initial dose is 6 106 CART cellskg, with a potential dose escalation to 10 106 CART cellskg based on safety and efficacy evaluations by a Safety Review Committee. All enrolled patients receive the CAR-T cell infusion, and dose adjustments depend on ongoing assessments. During the study, participants will be monitored for serious adverse events, treatment-emergent adverse events, and adverse events of special interest for up to 24 months after infusion. Researchers will also assess disease-specific responses such as platelet counts in ITP and hemoglobin levels in AIHA and Evans syndrome. Safety, pharmacokinetics, and pharmacodynamics will be tracked throughout. The total study duration for each participant includes follow-up visits and assessments over two years after treatment to evaluate long-term outcomes and safety.
CONDITIONS
Brief Title
UCAR-T Targeting CD19/BCMA in Subjects With Autoantibody-Mediated Autoimmune Benign Hematological Diseases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily agree to participate and sign informed consent
- Age between 18 and 75 years, any gender
- Liver function: ALT and AST ≤ 3 × ULN; total bilirubin ≤ 2 × ULN (except Gilbert's Syndrome)
- Renal function: Creatinine ≤ 1.5 × ULN or Creatinine Clearance ≥ 40 ml/min
- Oxygen saturation ≥ 92% in room air at rest
- Left ventricular ejection fraction ≥ 50% by echocardiography
- Female subjects of childbearing potential must have negative pregnancy test at screening
- Female subjects of childbearing potential must use highly effective contraception from 28 days before lymphodepletion to 12 months after reinfusion
- Male subjects of childbearing potential must use effective barrier contraception from lymphodepletion to 12 months after reinfusion and not donate semen
- Diagnosis of primary immune thrombocytopenia (ITP) with disease duration over 6 months
- Refractory or relapsed ITP with no or unsustained response to at least 2 standard treatments including IVIg, TPO-RA, or BTK inhibitors; platelet counts < 30,000/μL in two tests within 15 days before treatment
- Complete blood count: neutrophil count ≥ 1,000/μL, hemoglobin ≥ 60 g/L
- Diagnosis of autoimmune hemolytic anemia (AIHA) with disease duration over 6 months
- Refractory or relapsed AIHA with no or unsustained response to at least 3 systemic treatments
- Laboratory evidence of hemolysis within past 3 months
- Complete blood count: neutrophil count ≥ 1,000/μL, hemoglobin < 100 g/L
- Diagnosis of Evans Syndrome with disease duration over 6 months
- Refractory or relapsed Evans Syndrome after at least 3 systemic treatments, with ongoing cytopenia
- Laboratory evidence of active blood cell destruction during screening or past 3 months
- Documented response to at least one previous treatment with platelet or hemoglobin improvement
You will not qualify if you...
- Coexisting autoimmune disease that may interfere with study or pose safety risks unless stable for 3 months and approved
- Rapidly progressive glomerulonephritis with defined criteria
- History of severe cardiac diseases including NYHA Class III or IV heart failure, recent myocardial infarction, unstable angina, or serious cardiac events within 12 months
- History of severe central nervous system diseases affecting compliance or assessment
- History of malignant tumors except cured non-melanoma skin cancer or carcinoma in situ, unless disease-free for 3 years
- Primary immunodeficiency
- Uncontrolled infection excluding simple urinary or upper respiratory infections
- Known infection with HIV, hepatitis C, or syphilis
- Active or latent hepatitis B infection
- Positive Epstein-Barr virus or cytomegalovirus DNA or IgM antibodies during screening
- History of recurrent tuberculosis
- Previous CAR-T or genetically modified immune cell therapy
- Live-attenuated vaccine within 4 weeks before enrollment
- Allergy to components of the cell therapy product
- Hypersensitivity or severe toxicity to tacrolimus
- Participation in another clinical trial within 30 days before screening
- Pregnant or lactating, or unable to use effective contraception if of childbearing potential
Research Team
W
Wei Xie, Attending Physician
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