CAR-T Cells Therapy for Patients With Autoimmune Diseases
ConditionAutoimmune Diseases
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAnhui Provincial Hospital
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
( 1) At the time of signing the informed consent form, be at least 18 years of age, both male and female.
Disqualifiers
(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, aphasia, severe head injury, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome or mental disorder.(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 fungal, bacterial, viral, or other infections.(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.
Trial design
Design model
Sequential
Treatments tested in this trial
Anti-BCMA and CD19 CART cells will be injected intravenously on a one-time basis
DrugA single intravenous infusion of anti-BCMA and CD19 CART cells (dose-escalating infusion of 1.0-6.0 x10\^5 CART cells/kg）
Treatment groups
18 Participants
are divided into 1 treatment groupGroup A: Anti-BCMA and CD19 CARTExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Adverse events
Total number, incidence and severity of adverse events (AEs) in patients of SCAR02 infusion. The AEs will be assessed according to the 2019 Consensus on Cytokine Release Syndrome and Immune-cell-associated Neurotoxicity published by the American Society of Transplantation and Cell Therapy (ASTCT), the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0 and EBMT 2019 consensus.
Time frame
up to 1 yearsSecondary outcomes
1
The change of CAR copy number in peripheral blood was investigated by comparison with baseline
Peripheral blood CAR copy concentrations (copies/µL) will be detected using QPCR
Time frame
up to 1 years2
Disease activity was assessed by DAS28
DAS28 was used to assess disease activity, and the number of swelling and tenderness in 28 joints was examined, Min/Max Value: Not specified,with higher scores representing worse disease status.
Time frame
up to 1 years3
Modified Rodnan Skin Score assesses disease activity in patients
Disease activity was assessed by Modified Rodnan Skin Score Modified Rodnan Skin Score: The modified Rodnan Skin Score was used to assess the degree of skin involvement in patients with systemic sclerosis, and the thickness and hardness of the skin on the patient's head and neck, upper limbs, fingers, chest, abdomen, lower limbs, feet, etc., each part was divided into 0 (normal), 1 (mild thickening), 2 (moderate thickening), and 3 (severe thickening) according to the skin involvement, and the scores of each part were added together to obtain a total score, The higher the score, the worse the skin lesion status in patients with systemic sclerosis.
Time frame
up to 1 years4
SLEDAI assesses disease activity in patients
SLEDAI was used to evaluate the disease activity of patients with systemic lupus erythematosus, and the clinical symptoms and laboratory examination indicators of the patients were quantitatively scored.The SLEDAI score ranges from 0\~105 points, and the higher the score, and the higher the score, the worse the disease status of systemic lupus erythematosus.
Time frame
up to 1 yearsSponsors and contacts
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Source ClinicalTrials.gov