BridgeMD
New treatment option for Autoimmune Diseases
Official title An Exploratory Clinical Study of SCAR02 Targeting BCMA and CD19 for the Treatment of Refractory Autoimmune Diseases
ClinicalTrials.gov ID: NCT06503224
What this study is testing
What is Anti-BCMA and CD19 CART cells will be injected intravenously on a one-time basis.?
Anti-BCMA and CD19 CART cells 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 refractory autoimmune diseases. This study aims to evaluate the safety and efficacy of the treatment with Anti-BCMA and CD19 CART
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
- Sign the informed consent form.
- At the time of signing the informed consent form, the age of 18 years old or above, both male and female.
- Bone marrow hematopoietic function is satisfied: white blood cell count ≥3×10\^9/L; neutrophil count ≥1×10\^9/L (not receiving colony-stimulating...
- Liver function fulfillment: ALT≤3×ULN; AST≤3×ULN; TBIL≤3×ULN.
- Renal function fulfillment: creatinine clearance CrCl ≥ 60mL/min.
You likely can't join if
- pre-screening presence of clinically significant CNS disease or pathological changes not caused by the disease itself, including, but not limited to...
- Those suffering from relatively serious heart diseases such as angina pectoris, myocardial infarction, heart failure and arrhythmia.
- History of major organ transplantation or hematopoietic stem cell/bone marrow transplantation.
- vaccination, B-cell targeted therapy within 4 weeks prior to screening.
- History of any malignant disease.
- Patients with end-stage renal failure.
See the full eligibility criteria
- Sign the informed consent form.
- At the time of signing the informed consent form, the age of 18 years old or above, both male and female.
- Bone marrow hematopoietic function is satisfied: white blood cell count ≥3×10\^9/L; neutrophil count ≥1×10\^9/L (not receiving colony-stimulating factor within 2 weeks prior to screening); hemoglobin ≥60g/L.
- Liver function fulfillment: ALT≤3×ULN; AST≤3×ULN; TBIL≤3×ULN.
- Renal function fulfillment: creatinine clearance CrCl ≥ 60mL/min.
- Coagulation function meets: international standard ratio INR \<1.5 times ULN, prothrombin time PT \<1.5 times ULN. Patients with rheumatoid arthritis must also meet the following enrollment criteria:
- Diagnosis of rheumatoid arthritis according to the 2010 ACR / EULAR diagnostic criteria.
- Fulfillment of one of the following conditions: DAS28-ESR \>3.2 or CDAI \>10 at 3 months after use of a standard treatment regimen prior to screening; inability to taper hormones (prednisone) to less than 7.5 mg/day...
- Stable treatment with 1 or 2 cs DMARD(s) prior to enrollment as follows: at least 12 weeks of methotrexate and at least 4 weeks of administration at a dose of 7.5-25 mg/week; at least 4 weeks of stable...
- Diagnosis of SLE according to the 2019 EULAR/ACR classification criteria for SLE.
- A history of SLE for at least 6 months prior to screening, with the disease remaining active 2 months after the use of a standard treatment regimen prior to screening. Standard treatment regimen is defined as stable use...
- BILAG-2004 assessment of the presence of at least 1 grade A or 2 grade B organ scores.
- Positive for at least one of the following antibodies: anti-nuclear antibody, anti-ds-DNA antibody, anti-Sm antibody.
- SLEDAI-2000 score ≥ 8 during the screening period. Patients with dry syndrome were also required to meet the following enrollment criteria:
- Diagnosis of dry syndrome according to the 2002 International Classification Criteria for Primary Dry Syndrome or the 2016 ACR/EULAR classification criteria.
- Diagnosis of pSS-TP with platelet count \<30 x 10\^9/L.
- History of dry syndrome for at least 6 months prior to screening and disease still active 2 months after use of conventional treatment regimen prior to screening. Definition of conventional therapy:Use of...
- Diagnosis of systemic sclerosis according to the 2013 ACR classification criteria for systemic sclerosis.
- Positive antinuclear antibodies at screening.
- Presence of clear evidence of HRCT progression.
- History of systemic sclerosis for at least 6 months prior to screening, and active disease 2 months after use of a conventional treatment regimen prior to screening. Definition of conventional therapy:Use of...
- pre-screening presence of clinically significant CNS disease or pathological changes not caused by the disease itself, including, but not limited to: stroke, apoplexy, aneurysm, epilepsy, convulsions, aphasia, severe...
- Those suffering from relatively serious heart diseases such as angina pectoris, myocardial infarction, heart failure and arrhythmia.
- History of major organ transplantation or hematopoietic stem cell/bone marrow transplantation.
- vaccination, B-cell targeted therapy within 4 weeks prior to screening.
- History of any malignant disease.
- Patients with end-stage renal failure.
- Presence or suspected presence of uncontrolled fungal, bacterial, viral or other infections.
- History of severe allergy to drugs used in clinical studies or raw materials of test drugs, such as cyclophosphamide, fludarabine, DMSO.
- The patient is positive for HBV surface antigen, or HBV core antibody and positive for DNA by RT-PCR; positive for HCV antibody or positive for HIV antibody or positive for syphilis or positive for CMV DNA or positive...
- Females who are pregnant or breastfeeding or who plan to have a pregnancy within 2 years of return infusion of the test drug; partners of male patients who plan to become pregnant within 2 years of treatment with the...
- Evidence of active tuberculosis infection.
- other circumstances assessed by the investigator as unsuitable for enrollment.
The study team makes the final eligibility decision.
Where it's taking place
- Changsha, Hunan, 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 Changsha, Hunan, 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.