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New treatment option for Autoimmune Diseases
Official title Anti CD19/BCMA CAR Gene Therapy for Autoimmune Diseases
ClinicalTrials.gov ID: NCT07121777
What this study is testing
What is Anti-CD19/BCMA CAR gene vector injection will be injected intravenously on a one-time basis?
Anti-CD19/BCMA CAR gene vector injection will be injected intravenously on a one-time basis is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for autoimmune diseases.
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 an open label, single-site, dose-escalation study in up to 18 participants with treatment of Refractory Autoimmune Diseases. This study aims to evaluate the safety and efficacy of the treatment with an Anti- CD19/BCMA CAR gene vector injection
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- ( 1) At the time of signing the informed consent form, be at least 18 years of age, both male and female.
- (2) Bone marrow hematopoietic function satisfies: white blood cell count≥3×10\^9/L; Centrocyte count ≥1×10\^9/L (no colony-stimulating factor...
- (3)ALT≤3×ULN; AST≤3×ULN； TBIL≤3×ULN。 (4) Renal function satisfaction: creatinine clearance CrCl≥30mL/min. (5) INR≤1.5×ULN , PT≤1.5×ULN...
- (7)systemic lupus erythematosus : Diagnosis of systemic lupus erythematosus according to the SLE classification criteria of the 2019 EULAR/ACR...
- (8)Sjögren's syndrome : Diagnosis of Sjögren's syndrome according to the 2002 International Classification of Primary Sjögren's Syndrome or the 2016...
You likely can't join if
- (1) Clinically significant central nervous system diseases or pathological changes not caused by the disease itself before screening, including but...
- (2) Those with relatively serious heart disease, such as angina, myocardial infarction, heart failure and arrhythmia.
- (3) History of major organ transplantation or hematopoietic stem cell/bone marrow transplantation.
- (4) Vaccination, B-cell targeted therapy within 4 weeks prior to screening. (5) History of any malignant neoplastic disease. (6) Patients with...
- (8) History of severe allergy to drugs used in clinical studies or raw and excipient materials of experimental drugs, such as cyclophosphamide...
- (9) Patient has active HBV infection or HCV antibody positivity or HIV antibody positivity or syphilis positivity or CMV DNA positivity or EBV DNA...
See the full eligibility criteria
- ( 1) At the time of signing the informed consent form, be at least 18 years of age, both male and female.
- (2) Bone marrow hematopoietic function satisfies: white blood cell count≥3×10\^9/L; Centrocyte count ≥1×10\^9/L (no colony-stimulating factor received within 2 weeks prior to screening); Hemoglobin ≥ 60g/L.
- (3)ALT≤3×ULN; AST≤3×ULN； TBIL≤3×ULN。 (4) Renal function satisfaction: creatinine clearance CrCl≥30mL/min. (5) INR≤1.5×ULN , PT≤1.5×ULN. (6)RA:Documented diagnosis of RA which fulfills the 2010 American College of...
- (7)systemic lupus erythematosus : Diagnosis of systemic lupus erythematosus according to the SLE classification criteria of the 2019 EULAR/ACR; History of systemic lupus erythematosus for at least 6 months prior to...
- (8)Sjögren's syndrome : Diagnosis of Sjögren's syndrome according to the 2002 International Classification of Primary Sjögren's Syndrome or the 2016 ACR/EULAR classification criteria; Diagnosed with pSS-TP and platelet...
- (9)systemic sclerosis : Diagnosis of systemic sclerosis according to the 2013 ACR classification criteria for systemic sclerosis. Positive antinuclear antibody at screening. Presence of clear evidence of HRCT...
- (1) Clinically significant central nervous system diseases or pathological changes not caused by the disease itself before screening, including but not limited to: stroke, stroke, aneurysm, epilepsy, convulsions...
- (2) Those with relatively serious heart disease, such as angina, myocardial infarction, heart failure and arrhythmia.
- (3) History of major organ transplantation or hematopoietic stem cell/bone marrow transplantation.
- (4) Vaccination, B-cell targeted therapy within 4 weeks prior to screening. (5) History of any malignant neoplastic disease. (6) Patients with end-stage renal failure. (7) The presence or suspicion of uncontrollable...
- (8) History of severe allergy to drugs used in clinical studies or raw and excipient materials of experimental drugs, such as cyclophosphamide, fludarabine, DMSO, etc.
- (9) Patient has active HBV infection or HCV antibody positivity or HIV antibody positivity or syphilis positivity or CMV DNA positivity or EBV DNA positivity.
- (10) Pregnant or lactating females, or planning to become pregnant within 2 years after reinfusion of the trial drug; The partner of the male patient plans to become pregnant within 2 years of receiving the trial drug.
- (11) Evidence of active tuberculosis infection. (12) Other conditions assessed by the investigator as unsuitable for enrollment.
The study team makes the final eligibility decision.
Where it's taking place
- Hefei, Anhui, 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 and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hefei, Anhui, 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.