ClinicalTrials.gov record NCT07441525
UCAR-T Targeting CD19/BCMA in Subjects With Autoantibody-Mediated Autoimmune Benign Hematological Diseases
Clinical Study on Safety, Efficacy, and Pharmacokinetics of Universal CAR-T Cell Injection Targeting CD19/BCMA in Subjects With Autoantibody-Mediated Autoimmune Benign Hematological Diseases
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AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
This early phase 1, single‑arm, open‑label trial tests a universal CAR‑T cell product (RD06‑05) targeting CD19 and BCMA in adults with active autoimmune hematological diseases such as ITP, AIHA, and Evans syndrome. Participants receive a CAR⁺T cell infusion at a starting dose of 6 × 10⁶ CAR⁺T cells/kg; the Safety Review Committee may recommend escalation to 10 × 10⁶ CAR⁺T cells/kg. The study measures safety, pharmacokinetics/pharmacodynamics, and blood‑response outcomes with follow‑up for up to 24 months.
What it is studying. The study is testing the safety and tolerability of RD06‑05 (UCAR‑T targeting CD19/BCMA), how the product behaves in the body (pharmacokinetics and pharmacodynamics), and whether blood counts or hemolysis/platelet measures change after infusion. It will record adverse events and clinical response measures over a follow‑up period up to 24 months.
What the researchers hope to learn. Scientific goals: evaluate safety and tolerability of RD06‑05; characterize its pharmacokinetics and pharmacodynamics; document treatment‑emergent adverse events and special‑interest adverse events; and measure blood‑response outcomes (platelet and hemoglobin/hemolysis measures) in ITP, AIHA, and Evans syndrome up to 24 months.
What this study is about
The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.
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.
Interventions being studied
Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.
- Drug
- CART Infusion
Eligibility
The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.
Inclusion criteria
- Subjects voluntarily participate in this trial and sign the informed consent form.
- Aged ≥ 18 years and ≤ 75 years, regardless of gender.
- Organ function and laboratory tests:
- Liver function: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) ≤ 3 × Upper Limit of Normal (ULN); Total Bilirubin (TBIL) ≤ 2 × ULN (except for Gilbert's Syndrome).
- Renal function: Creatinine ≤ 1.5 × ULN or Creatinine Clearance Rate ≥ 40 ml/min.
- Oxygen saturation (SpO2) ≥ 92% in room air at rest.
- Echocardiography shows Left Ventricular Ejection Fraction (LVEF) ≥ 50%.
- Female subjects of childbearing potential must have a negative result in serum or urine pregnancy test at screening.
- Female subjects of childbearing potential must agree to use highly effective contraceptive methods from at least 28 days before the start of lymphodepletion to 12 months after reinfusion on RD06-05. Male subjects of childbearing potential must agree to use effective barrier contraceptive methods from the start of lymphodepletion to 12 months after reinfusion on RD06-05, and must not donate semen or sperm during the entire trial period.
- Subjects with primary Immune Thrombocytopenia (ITP), with a disease duration of at least > 6 months.
- Refractory or relapsed ITP: Subjects show no response, unsustained response, or intolerance to at least 2 different categories of standard treatments (e.g., glucocorticoids, splenectomy, intravenous immunoglobulin (IVIg), thrombopoietin receptor agonists (TPO-RA), Bruton's tyrosine kinase (BTK) inhibitors, etc.); among which, subjects must have received at least one or more treatments from IVIg, TPO-RA, or BTK inhibitors. In addition, platelet counts must be < 30,000/μL in two tests conducted within 15 days before the start of study treatment, with an interval of at least 7 days between the two tests.
- Complete blood count: Neutrophil count ≥ 1,000/µL, hemoglobin ≥ 60g/L.
- Subjects with Autoimmune Hemolytic Anemia (AIHA), including warm autoimmune hemolytic anemia (wAIHA), mixed autoimmune hemolytic anemia (mix-AIHA), and cold agglutinin disease (CAD), with a disease duration of at least > 6 months.
- Refractory or relapsed AIHA: Subjects show no response, unsustained response, or intolerance to at least 3 lines of systemic treatments (e.g., glucocorticoids, rituximab, immunosuppressants, splenectomy, complement inhibitors, etc.).
- Laboratory evidence of hemolysis: At least one of the following conditions exists in either the screening period or any test within the past 3 months: haptoglobin below the lower limit of normal, or total bilirubin (especially indirect bilirubin) above the upper limit of normal, or lactate dehydrogenase (LDH) above the upper limit of normal, and/or elevated reticulocyte count.
- Complete blood count: Neutrophil count ≥ 1,000/µL, hemoglobin (Hb) < 100g/L.
- Diagnosed with Evans Syndrome (ES), with a disease duration of at least > 6 months.
- Refractory or relapsed ES: After at least 3 lines of systemic treatments (e.g., glucocorticoids, intravenous immunoglobulin (IVIg), rituximab, immunosuppressants, splenectomy, thrombopoietin receptor agonists (TPO-RA), complement inhibitors, etc.), at least one type of cytopenia (thrombocytopenia or hemolytic anemia) still shows no response, unsustained response, or intolerance.
- Laboratory evidence of active blood cell destruction: Platelet count < 30,000/μL or manifestations of hemolysis exist during the screening period or within the past 3 months, such as haptoglobin < lower limit of normal, or total bilirubin (especially indirect bilirubin) > upper limit of normal, or LDH > upper limit of normal, and/or elevated reticulocyte count.
- Definite response to at least one previous treatment:
- Platelet (PLT) treatment response: Platelet count reaches ≥ 50,000/μL in at least 2 tests, with an increase of ≥ 20,000/μL compared to the baseline.
- Hemoglobin (Hb) treatment response: Hb increases by ≥ 10-15 g/L or hemolysis indicators improve.
Exclusion criteria
- Has a coexisting autoimmune disease that may seriously interfere with the attribution of study disease activity or pose additional safety risks. However, if the subject's condition has been clinically stable for ≥ 3 months, and it is expected not to interfere with study assessments, the subject may be enrolled after confirmation by the investigator and approval by the sponsor's medical monitor (or their designee).
- Has rapidly progressive glomerulonephritis (RPGN), defined as any of the following:
- Renal biopsy shows crescent formation in ≥ 50% of glomeruli.
- Sustained doubling of serum creatinine level within 2 months before screening.
- The investigator assesses that the subject has RPGN.
- Subjects with the following cardiac diseases will be excluded:
- History of heart failure classified as New York Heart Association (NYHA) Class III or IV.
- History of myocardial infarction, cardiovascular angioplasty or stenting, unstable angina, or other serious cardiac diseases within 12 months before enrollment.
- Has a history of severe central nervous system (CNS) diseases that may affect the subject's ability to comply with the study protocol or interfere with the accuracy of study assessments, such as: traumatic brain injury, disturbance of consciousness, epilepsy, cerebral vascular ischemia, or cerebral vascular hemorrhage.
- Has a history of malignant tumors other than cured non-melanoma skin cancer or carcinoma in situ (e.g., carcinoma in situ of the cervix, bladder, or breast), unless the subject has been disease-free for at least 3 years.
- Primary immunodeficiency.
- Has uncontrolled infection; simple urinary tract infections and upper respiratory tract infections are permitted as judged by the investigator and the sponsor's medical monitor (or their designee).
- Has a known history of infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV), or syphilis.
- Active or latent hepatitis B virus (HBV) infection.
- Positive results for Epstein-Barr virus (EBV) or cytomegalovirus (CMV) DNA or IgM antibodies during the screening period.
- Has a history of recurrent tuberculosis or known recurrent tuberculosis.
- Has a history of previous chimeric antigen receptor T-cell (CAR-T) therapy or any other genetically modified immune cell therapy.
- Has received a live-attenuated vaccine within 4 weeks before enrollment.
- Has a history of allergy to any component of the cell therapy product.
- Has a history of hypersensitivity to tacrolimus, or has experienced ≥ Grade 3 tacrolimus-related toxicity in the past (including but not limited to neurological, gastrointestinal, hepatic, renal, or hematological toxicity), especially subjects who required hospitalization will be excluded. Other cases may be considered eligible after confirmation by the investigator and the sponsor's medical monitor (or their designee).
- Has participated in another clinical trial within 30 days before screening.
- Pregnant or lactating subjects, as well as subjects of childbearing potential who cannot take effective contraceptive measures.
Study description and what participation involves
The registry record has no detailed description beyond the summary above.
AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
Participants will have screening tests and, if eligible, receive a single infusion of investigational CAR‑T cells (RD06‑05) at an initial dose of 6×10⁶ CAR+T cells/kg; the Safety Review Committee may recommend escalation to 10×10⁶ CAR+T cells/kg. There will be a period of lymphodepletion before reinfusion per the protocol, pregnancy testing and mandatory contraception rules, and regular safety and blood monitoring after infusion. Follow-up visits and safety assessments (including echocardiogram and laboratory tests) are scheduled, with monitoring reported through about 24 months after infusion. The registry specifies blood draws and non‑invasive tests; no specific invasive procedures (e.g., bone marrow biopsy or lumbar puncture) are detailed in the record.
How the study is structured. Interventional early phase 1, single‑group, open‑label study. All participants receive a single infusion of the RD06‑05 CAR‑T product, starting at 6 × 10⁶ CAR⁺T cells/kg; dose may be escalated to 10 × 10⁶ CAR⁺T cells/kg based on Safety Review Committee assessment. There is no masking. Participants are followed for safety monitoring, pharmacokinetic/pharmacodynamic testing, and disease response assessments for up to 24 months.
Questions you could ask
These questions are suggestions for a conversation with the study team or your own clinician, not advice.
- This is an early-phase study, mainly about safety and dose. What is already known about this treatment?
- The listed sites are in China. Is any of them reachable for me, and does the study help with travel?
- Which of the eligibility criteria would need to be checked with tests before I could join?
More on autoimmune hemolytic anemia
This trial is also listed on this site under Evans syndrome.
Important dates
- Study start
- Feb 3, 2026
- Primary completion
- Jan 10, 2029 (estimated)
- Study completion
- Jun 30, 2029 (estimated)
- Target enrollment
- 27 participants (estimated)
- Last updated on registry
- Mar 2, 2026
- Data verified
- Oct 10, 2026
Sponsor and research team
The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
- Collaborators
- Nanjing Bioheng Biotech Co., Ltd.
Central study contact
If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.
- Wei Xie, Attending Physician 📞 027-8572600 ✉ sherryxw@163.com
Participating sites (1)
- Union Hospital, Tongji Medical College, Huazhong University of Science & TechnologyRecruiting
Wuhan, Hubei · China
- Wei Xie, Attending Physician · 027-8572600 · sherryxw@163.com
- Heng Mei, Prof.
Terms used on this page · explanations by MedicalUpdates.ai
- single-arm
- All participants receive the same treatment or follow the same plan. There is no comparison group within the study.
- open-label
- No masking is used, so the assigned intervention is not deliberately hidden from participants or study staff.
- pharmacokinetics
- How the body absorbs, distributes, breaks down and removes a drug. It is studied by measuring drug levels or related substances at set times after a dose.
- pharmacodynamics
- What a drug does to the body, for example how it changes a blood marker or a symptom, and how that relates to the dose.
- dose escalation
- Groups of participants receive increasing doses of a treatment, one group after another, to find a dose that can be given safely.
- informed consent form
- The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
- Upper Limit of Normal
- The highest value of a blood test that a laboratory considers normal. Criteria such as '≤ 3 × ULN' mean the result must be no more than three times that value.
- Creatinine Clearance
- A measure of kidney function, calculated from a blood creatinine level together with age, weight and sex.
- Echocardiography
- An ultrasound scan of the heart. A transesophageal echocardiogram is done through a probe passed into the food pipe for a closer view.
- childbearing potential
- Studies often ask participants who could become pregnant, or could father a child, to use contraception during the study and for a period afterwards, because the effect of the treatment on a pregnancy is unknown.
- at screening
- The checks done before enrolment to see whether a person qualifies, such as tests, scans or a review of medical history.
- Refractory
- A condition that has not responded to a treatment. 'Relapsed' means it responded and then came back; 'refractory' means it did not respond in the first place.
- relapsed
- A condition that improved with treatment and has since returned or worsened.
- glucocorticoids
- Steroid medicines, such as prednisone, that reduce inflammation. Studies often require a stable dose at entry or measure whether the study treatment allows the dose to be reduced.
- Neutrophil count
- The number of neutrophils, a type of white blood cell that fights infection, in a blood sample. Studies often require it to be above a set level.
- immunosuppressants
- A medicine that reduces the activity of the immune system. Studies of autoimmune conditions often require a stable dose, a prior failure, or a washout of such medicines.
- baseline
- Measurements taken at the start of the study, before any study treatment, so that later results can be compared with them.
- sponsor
- The organisation or person that initiates the study and has authority over it. The sponsor may be a company, hospital, university, government agency or individual, and is not necessarily the organisation that funds the study.
- biopsy
- Removal of a small piece of tissue so it can be examined under a microscope. 'Biopsy-proven' or 'histologically confirmed' means the diagnosis was confirmed by examining tissue under a microscope.
- enrollment
- The number of participants a study plans to include, or has included. 'Estimated' means the planned number; 'actual' means the number who joined.
- chimeric antigen receptor
- A treatment in which a person's own immune cells (T cells) are collected, modified in a laboratory to recognise a target, and returned to the body.
- Inclusion Criteria
- The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
- Exclusion Criteria
- The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.
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