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New treatment option for Autoimmune Hemolytic Anemia
Official title UCAR-T Targeting CD19/BCMA in Subjects With Autoantibody-Mediated Autoimmune Benign Hematological Diseases
ClinicalTrials.gov ID: NCT07441525
What this study is testing
What is CART Infusion?
CART Infusion is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for autoimmune hemolytic anemia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- people 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 ×...
- Renal function: Creatinine ≤ 1.5 × ULN or Creatinine Clearance Rate ≥ 40 ml/min.
You likely can't join if
- Has a coexisting autoimmune disease that may seriously interfere with the attribution of study disease activity or pose additional safety risks...
- 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.
- people with the following cardiac diseases will be excluded:
See the full eligibility criteria
Who can join
- people 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 people of childbearing potential must have a negative result in serum or urine pregnancy test at screening.
- Female people 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 people of...
- people with primary Immune Thrombocytopenia (ITP), with a disease duration of at least \> 6 months.
- Refractory or relapsed ITP: people show no response, unsustained response, or intolerance to at least 2 different categories of standard treatments (e.g., glucocorticoids, splenectomy, intravenous immunoglobulin (IVIg)...
- Complete blood count: Neutrophil count ≥ 1,000/µL, hemoglobin ≥ 60g/L.
- people 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 \>...
- Refractory or relapsed AIHA: people show no response, unsustained response, or intolerance to at least 3 lines of systemic treatments (e.g., glucocorticoids, rituximab, immunosuppressants, splenectomy, complement...
- 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...
- 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)...
- Laboratory evidence of active blood cell destruction: Platelet count \ 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)...
What rules you out
- 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...
- 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.
- people 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...
- 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...
- Has participated in another clinical trial within 30 days before screening.
- Pregnant or lactating people, as well as people of childbearing potential who cannot take effective contraceptive measures.
The study team makes the final eligibility decision.
Where it's taking place
- Wuhan, Hubei, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Wuhan, Hubei, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.