An Exploratory Clinical Study of SCAR02 Targeting BCMA and CD19 for the Treatment of Refractory Autoimmune Diseases

NCT06503224 | Recruiting DMC

• 1 other identifier: SWKCART24031101
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Autoimmune Diseases

Keywords

rheumatoid arthritis; systemic lupus erythematosus; dry syndrome; systemic sclerosis

Outcome Measures

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.

  up to 2 years

Secondary Outcomes (19)

• The persistence, accumulation, and migration of Anti-BCMA and CD19 CART cells

  up to 2 years

• Erythrocyte Sedimentation Rate

  Day-1, 14, 21, 28 and Month2, 3, 6, 9, 12, 18, 24

• American College of Rheumatology (ACR) criteria 20, 50, 70 response rate

  Day-1, 14, 21, 28 and Month2, 3, 6, 9, 12, 18, 24

• Swollen and tender joint count

  Day-1, 14, 21, 28 and Month2, 3, 6, 9, 12, 18, 24

• Visual Analogue Scale

  Day-1, 14, 21, 28 and Month2, 3, 6, 9, 12, 18, 24

Study Arms (1)

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.

Drug: Anti-BCMA and CD19 CART cells will be injected intravenously on a one-time basis.

Interventions

Anti-BCMA and CD19 CART cells will be injected intravenously on a one-time basis. DRUG

A single intravenous infusion of anti-BCMA and CD19 CART cells (dose-escalating infusion of 0.5-3 x10\^6 CART cells/kg）.

Anti-BCMA and CD19 CART

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 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; and number of swollen joints and/or number of joints with tenderness ≥3. Standard treatment regimen is defined as the stable use of any of the following (alone or in combination): corticosteroids, nonsteroidal anti-inflammatory drugs ( NSAIDs) and csDMARDs, including methotrexate, leflunomide, hydroxychloroquine, salazosulfapyridine, elamodex, tretinoin, and paeonia lactiflora total, as well as biological agents (including TNF inhibitors, non-TNF inhibitors, and JAK inhibitors).
• 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 hydroxychloroquine doses of ≤400 mg/d; at least 4 weeks of stable oral salicylazosulfapyridine 1 to 3 g/d; at least 4 weeks of stable oral leflunomide 10-20 mg /d.
• Patients with SLE will also be required to meet the following enrollment criteria:
• 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 of any of the following (alone or in combination): corticosteroids, antimalarials, nonsteroidal anti-inflammatory drugs (NSAIDs), and other immunosuppressive or biologic agents, including azathioprine, mertiomaxolide, cyclophosphamide, methotrexate, leflunomide, tacrolimus, cyclosporine, belimumab, rituximab, and tetracycline.
• 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.

You may not qualify if:

• 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 craniocerebral injury, dementia, Parkinson's disease, cerebellar disorders, organic brain syndromes, or insanity.
• 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 for EBV DNA.
• 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 test drug.
• Evidence of active tuberculosis infection.
• other circumstances assessed by the investigator as unsuitable for enrollment.

Sponsors & Collaborators

• The First Affiliated Hospital of University of Science and Technology of China: lead

Study Sites (1)

Hunan Siweikang Therapeutic Co.Ltd

Changsha, Hunan, 410119, China

RECRUITING

MeSH Terms

Conditions

Autoimmune Diseases; Arthritis, Rheumatoid; Lupus Erythematosus, Systemic; Scleroderma, Systemic

Condition Hierarchy (Ancestors)

Immune System Diseases; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Study Officials

• zhu chen, M.D

  The First Affiliated Hospital of University of Science and Technology of China

  PRINCIPAL INVESTIGATOR

• xingbing wang, M.D

  The First Affiliated Hospital of University of Science and Technology of China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

zhu chen, M.D

CONTACT

860551-62283843; doczchen@gmail.com

xiaojuan zhao, master

CONTACT

+86 15955139303; zhaoxiaojuan198694@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2024
• First Posted: July 16, 2024
• Study Start: April 9, 2024
• Primary Completion: April 30, 2026
• Study Completion (Estimated): April 30, 2028
• Last Updated: April 24, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)