Actively Recruiting
UCAR-T Targeting CD19/BCMA 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
177 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
This is a single-arm, open-label, investigator-initiated trial (IIT) designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and efficacy of RD06-05 in subjects with autoantibody-mediated autoimmune hematological diseases. The enrolled population consists of patients with active autoimmune hematological diseases, including primary immune thrombocytopenic purpura (ITP), autoimmune hemolytic anemia (AIHA), and Evans syndrome. This study sets two dose groups: 6 × 10⁶ CAR⁺T cells/kg and 10 × 10⁶ CAR⁺T cells/kg, with the initial dose being 6 × 10⁶ CAR⁺T cells/kg. To reduce efficacy risks, the dose may be escalated to 10 × 10⁶ CAR⁺T cells/kg following evaluation and recommendation by the Safety Review Committee (SRC). The SRC's recommendation on dose escalation will be based on a comprehensive assessment of all available safety, pharmacokinetic (PK), pharmacodynamic (PD), and preliminary efficacy data.
CONDITIONS
Official 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...
- Participants must voluntarily agree to join the trial and sign informed consent.
- Age between 18 and 75 years, any gender.
- Liver function with ALT and AST at or below 3 times the upper normal limit; total bilirubin at or below 2 times the upper normal limit unless Gilbert's Syndrome.
- Kidney function with creatinine at or below 1.5 times upper normal limit or creatinine clearance rate at least 40 ml/min.
- Oxygen saturation of 92% or higher at rest in room air.
- Left ventricular ejection fraction of 50% or higher on echocardiography.
- Female participants of childbearing potential must have a negative pregnancy test and agree to use effective contraception from 28 days before lymphodepletion through 12 months after reinfusion.
- Male participants of childbearing potential must agree to use barrier contraception during the same period and not donate sperm.
- For primary Immune Thrombocytopenia (ITP): disease duration over 6 months, refractory or relapsed after at least two standard treatments including IVIg, TPO-RA, or BTK inhibitors, and platelet counts below 30,000/µL on two tests spaced at least 7 days apart within 15 days before treatment start.
- Neutrophil count at least 1,000/µL and hemoglobin at least 60 g/L.
- For Autoimmune Hemolytic Anemia (AIHA): disease duration over 6 months, refractory or relapsed after at least three lines of systemic treatments.
- Laboratory evidence of hemolysis within the past 3 months or screening period.
- Neutrophil count at least 1,000/µL and hemoglobin below 100 g/L.
- For Evans Syndrome: disease duration over 6 months, refractory or relapsed after at least three lines of systemic treatments, with ongoing cytopenia.
- Laboratory evidence of active blood cell destruction during screening or past 3 months.
- Demonstrated response to at least one previous treatment with platelet or hemoglobin improvement.
You will not qualify if you...
- Presence of coexisting autoimmune disease that may seriously affect study disease activity or safety, unless stable for at least 3 months and approved.
- Rapidly progressive glomerulonephritis, defined by renal biopsy, serum creatinine doubling within 2 months, or investigator assessment.
- History of serious heart conditions including NYHA class III or IV heart failure, recent myocardial infarction, cardiovascular procedures, or unstable angina within 12 months.
- History of severe central nervous system diseases affecting study compliance or assessments.
- History of malignant tumors except cured non-melanoma skin cancer or carcinoma in situ unless disease-free for at least 3 years.
- Primary immunodeficiency.
- Uncontrolled infection except mild urinary tract or upper respiratory infections.
- Known infections with HIV, hepatitis C, or syphilis.
- Active or latent hepatitis B infection.
- Positive Epstein-Barr virus or cytomegalovirus tests during screening.
- History of recurrent tuberculosis.
- Prior CAR-T or genetically modified immune cell therapy.
- Received live-attenuated vaccine within 4 weeks before enrollment.
- Allergy to components of the cell therapy.
- History of severe tacrolimus-related toxicity.
- Participation in another clinical trial within 30 days before screening.
- Pregnant, breastfeeding, or unable to use effective contraception.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Union Hospital, Tongji Medical College, Huazhong University of Science & Technology
Wuhan, Hubei, China
Actively Recruiting
Research Team
W
Wei Xie, Attending Physician
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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