Autoimmune DiseasesECAR01NCT07052565
CAR-T Cells Therapy for Patients With Autoimmune Diseases
A study testing Anti-BCMA and CD19 CART cells will be injected intravenously on a one-time basis in people with Autoimmune Diseases, run by Anhui Provincial Hospital at 1 site in China.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Autoimmune Diseases
- What is being tested?
- Anti-BCMA and CD19 CART cells will be injected intravenously on a one-time basis
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteChina
- Study dates
- 20 Jul 2025to 1 Nov 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ( 1) At the time of signing the informed consent form, be at least 18 years of age, both male and female.
- 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 Rheumatology (ACR)/European League Against Rheumatism (EULAR) Classification Criteria ; 3 months after use of 1 or more csDMARDs and 1 or more bDMARDs prior to screening: 1) DAS28-ESR>3.2 or CDAI>10; or 2) the dose of the hormone (prednisone or equivalent) cannot be reduced to less than 7.5 mg/day; or 3) the number of swollen and/or tender joints ≥3; Treatment with stable 1 or more cs DMARD(s) and/or bDMARDs prior to enrollment as follows: methotrexate for at least 12 weeks and at a dose of 7.5-25mg/week for at least 4 weeks; Stable use of hydroxychloroquine dose ≤ 400 mg/day for at least 4 weeks; Stable oral sulfasalazine for at least 4 weeks 1~3 g/d; Stable oral leflunomide 10-20 mg/day for at least 4 weeks.
- (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 screening and active disease for 2 months after use of standard treatment regimens prior to screening; BILAG-2004 assesses the presence of at least 1 Grade A or 2 Grade B organ scores; Positive antinuclear antibody, or positive anti-ds-DNA antibody, or positive anti-Sm antibody; SLEDAI-2000 score ≥8 during the screening period.
- (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 count < 30×10^9/L; Sjögren's syndrome Disease Activity Index (ESSDAI) score ≥5 during the screening period; Sjögren's syndrome for at least 6 months prior to screening and active disease 2 months after use of conventional treatment regimens prior to screening. Use of immunomodulatory drugs for more than 6 months.
- (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 progression. History of systemic sclerosis prior to screening for at least 6 months and active disease for 2 months after use of conventional treatment regimens prior to screening.
Who cannot join
- (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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Anhui Provincial Hospital
Hefei
chen zhu, M.D, +86-0551-62283843, doczchen@gmail.com
About this study
Official title: An Exploratory Clinical Study of Enhanced Autologous CAR-T Cell Injection (ECAR01) Targeting BCMA and CD19 in the Treatment of Refractory Autoimmune Diseases
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
Read the detailed description
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.
- Conditions
- Autoimmune Diseases
- Being tested
- Anti-BCMA and CD19 CART cells will be injected intravenously on a one-time basis
- Keywords
- systemic sclerosis, dry syndrome, rheumatoid arthritis, systemic lupus erythematosus
- Medical subject headings
- Autoimmune Diseases, Scleroderma, Systemic, Arthritis, Rheumatoid, Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti-BCMA and CD19 CART cells will be injected intravenously on a one-time basisDrug
A single intravenous infusion of anti-BCMA and CD19 CART cells (dose-escalating infusion of 1.0-6.0 x10^5 CART cells/kg）
| Study group | Role | What they receive |
|---|---|---|
| Anti-BCMA and CD19 CART | Experimental | Patients will receive a lymphodepletion chemotherapy with cyclophosphamide and fludarabine before CART infusion. A dose of Anti-BCMA and CD19 CART will be infused on day 0. Receives: Drug: Anti-BCMA and CD19 CART cells will be injected intravenously on a one-time basis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 1 years
Secondary outcomes (12)
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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: up to 1 years
Change from baseline in ESR
ESR will be measured with blood samples
Measured: up to 1 years
ACR70 response rate
The ACR70 response indicates a 70% improvement in all criteria used in the ACR70 assessment
Measured: 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
Measured: 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
Measured: 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
Measured: up to 1 years
Change from baseline in CRP
CRP will be measured with blood samples
Measured: up to 1 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2025
- Study start20 Jul 2025 (estimated)
- Primary completion1 Nov 2028 (estimated)
- Study completion1 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autoimmune DiseasesStudies of the same condition, open and under way.
- More trials run by Anhui Provincial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anhui Provincial Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- wang xing bing, M.D, Principal investigator, Anhui Provincial Hospitalchen zhu, M.D, Principal investigator, Anhui Provincial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07052565
- Sponsor's protocol ID
- SWKCART24101501
- Acronym
- ECAR01
- Status last verified
- Jun 2025
- First submitted
- 26 Jun 2025
- Last updated
- 8 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Clinical Study of Enhanced Autologous CAR-T Cell Injection (ECAR01) Targeting BCMA and CD19 in the Treatment of Refractory Autoimmune Diseases
- ClinicalTrials.gov ID
- NCT07052565
- Acronym / sponsor ID
- ECAR01 / SWKCART24101501
- Conditions
- Autoimmune Diseases
- Keywords
- systemic sclerosis, dry syndrome, rheumatoid arthritis, systemic lupus erythematosus
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Anhui Provincial HospitalOther government
- Study start
- 20 Jul 2025 (estimated)
- Primary completion
- 1 Nov 2028 (estimated)
- Study completion
- 1 Nov 2028 (estimated)
- First posted
- 4 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Anti-BCMA and CD19 CART | Experimental | Drug: Anti-BCMA and CD19 CART cells will be injected intravenously on a one-time basisPatients will receive a lymphodepletion chemotherapy with cyclophosphamide and fludarabine before CART infusion. A dose of Anti-BCMA and CD19 CART will be infused on day 0. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- ( 1) At the time of signing the informed consent form, be at least 18 years of age, both male and female.
- (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 Rheumatology (ACR)/European League Against Rheumatism (EULAR) Classification Criteria ; 3 months after use of 1 or more csDMARDs and 1 or more bDMARDs prior to screening: 1) DAS28-ESR>3.2 or CDAI>10; or 2) the dose of the hormone (prednisone or equivalent) cannot be reduced to less than 7.5 mg/day; or 3) the number of swollen and/or tender joints ≥3; Treatment with stable 1 or more cs DMARD(s) and/or bDMARDs prior to enrollment as follows: methotrexate for at least 12 weeks and at a dose of 7.5-25mg/week for at least 4 weeks; Stable use of hydroxychloroquine dose ≤ 400 mg/day for at least 4 weeks; Stable oral sulfasalazine for at least 4 weeks 1~3 g/d; Stable oral leflunomide 10-20 mg/day for at least 4 weeks.
- (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 screening and active disease for 2 months after use of standard treatment regimens prior to screening; BILAG-2004 assesses the presence of at least 1 Grade A or 2 Grade B organ scores; Positive antinuclear antibody, or positive anti-ds-DNA antibody, or positive anti-Sm antibody; SLEDAI-2000 score ≥8 during the screening period.
- (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 count < 30×10^9/L; Sjögren's syndrome Disease Activity Index (ESSDAI) score ≥5 during the screening period; Sjögren's syndrome for at least 6 months prior to screening and active disease 2 months after use of conventional treatment regimens prior to screening. Use of immunomodulatory drugs for more than 6 months.
- (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 progression. History of systemic sclerosis prior to screening for at least 6 months and active disease for 2 months after use of conventional treatment regimens prior to screening.
Key exclusion criteria (1 listed)
- (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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anti-BCMA and CD19 CART cells will be injected intravenously on a one-time basisA single intravenous infusion of anti-BCMA and CD19 CART cells (dose-escalating infusion of 1.0-6.0 x10^5 CART cells/kg） | Drug | Anti-BCMA and CD19 CART |
Primary outcome
Adverse events
Time frame: up to 1 years
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.
12 secondary outcomes
The change of CAR copy number in peripheral blood was investigated by comparison with baseline
Time frame: up to 1 years
Disease activity was assessed by DAS28
Time frame: up to 1 years
Modified Rodnan Skin Score assesses disease activity in patients
Time frame: up to 1 years
SLEDAI assesses disease activity in patients
Time frame: up to 1 years
BILAG-2004 assesses disease activity in patients
Time frame: up to 1 years
Change from baseline in Physician's Global Assessment of Arthritis (PGA) (VAS)
Time frame: up to 1 years
Change from baseline in ESR
Time frame: up to 1 years
ACR70 response rate
Time frame: up to 1 years
Clinical response for Sjögren's Syndrome
Time frame: up to 1 years
Change from baseline in participant's assessment of pain (VAS)
Time frame: up to 1 years
HAQ health assessment
Time frame: up to 1 years
Change from baseline in CRP
Time frame: up to 1 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
wang xing bing, M.D principal investigator
Anhui Provincial Hospital
chen zhu, M.D principal investigator
Anhui Provincial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anti-BCMA and CD19 CART cells will be injected intravenously on a one-time basis in people with Autoimmune Diseases, run by Anhui Provincial Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact chen zhu, M.D (+86-0551-62283843, doczchen@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events (time frame: up to 1 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2025.