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
This study is a single-center, single-arm, non-blinded, 3+3 dose-escalation designed investigator initiated trial study, evaluating the safety, efficacy, and therapeutic assessment of ECAR01 injection in patients with refractory autoimmune diseases. The specific research protocol can be adjusted by the researchers based on the patient's condition. Patients with refractory autoimmune diseases who meet the inclusion and exclusion criteria are included. After peripheral blood collection and chemotherapy pretreatment, the subjects undergo CAR-T cell infusion. The three dose groups are the low-dose group (1×10\^5/kg, number of CAR-T cells per kg of subject's weight, the same below), the medium-dose group (3×10\^5/kg), and the high-dose group (6×10\^5/kg). Clinicians can also adjust the drug dose based on actual conditions. Given the particularity of cell preparation doses, each dose group allows for a ±20% fluctuation in the actual drug dose.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
18
A single intravenous infusion of anti-BCMA and CD19 CART cells (dose-escalating infusion of 1.0-6.0 x10\^5 CART cells/kg)
Anhui Provincial Hospital
Hefei, China
RECRUITINGAdverse 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 years
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 years
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 years
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 years
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.
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Time frame: up to 1 years
BILAG-2004 assesses disease activity in patients
BILAG-2004 score: BILAG-2004 was used to evaluate the disease activity of patients with systemic lupus erythematosus, and the clinical manifestations of patients in 10 systemic domains were scored according to the involvement of each domain according to the five grades of A (very severe), B (moderately severe), C (mild), D (in the past, now none), and E (never), and the scores in each domain were comprehensively weighted, and the higher the score, the worse the disease status of systemic lupus erythematosus.
Time frame: up to 1 years
Change from baseline in Physician's Global Assessment of Arthritis (PGA) (VAS)
The investigator/sub-investigator assesses the participant's disease activity on a VAS of 0 - 3 mm on the physician assessment table
Time frame: up to 1 years
Change from baseline in ESR
ESR will be measured with blood samples
Time frame: up to 1 years
ACR70 response rate
The ACR70 response indicates a 70% improvement in all criteria used in the ACR70 assessment
Time frame: up to 1 years
Clinical response for Sjögren's Syndrome
Sjögren's tool for assessing response (STAR): Min/Max Value: Not specified; a decrease in score indicates improvement; higher scores indicate worse outcome
Time frame: up to 1 years
Change from baseline in participant's assessment of pain (VAS)
Using the VAS pain visual analog scale to visually display the patient's pain level, using a 10cm long scale, there are 10 scales from 0 to 10, 0 represents no pain, 10 represents severe pain, and let the patient choose a scale that meets his pain feelings
Time frame: up to 1 years
HAQ health assessment
The HAQ health assessment questionnaire was used to assess disease activity, and 8 questions of daily activities were set up for patients to answer, with each question scoring 0-3, 0 points indicating no difficulty, 1 point being somewhat difficult, 2 points being difficult or needing help, and 3 points being unable to complete. The higher the patient's score, the worse the function
Time frame: up to 1 years
Change from baseline in CRP
CRP will be measured with blood samples
Time frame: up to 1 years