CT1190B in the Treatment of Patients With Moderate to Severe Refractory Systemic Lupus Erythematosus (SLE) or Refractory/Progressive Systemic Sclerosis (SSc)

NCT06822881 | Recruiting Phase 1

• 1 other identifier: CT1190B-CG11002_03
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

A Clinical Study Exploring CT1190B in the treatment of patients with moderate to severe refractory systemic lupus erythematosus (SLE) or refractory/progressive systemic sclerosis (SSc)

Conditions

Systemic Lupus Erythematosus (SLE); Systemic Sclerosis (SSc)

Keywords

CT1190B

Outcome Measures

Primary Outcomes (1)

• The incidence rate and severity of dose limiting toxicity (DLT), adverse events (AE), serious adverse events (SAE), and AESI (adverse events of particular concern)

  Within 28 days after infusion for DLT, within 180 days after infusion for AE/SAE, within 12 months after infusion for AESI

Secondary Outcomes (2)

• Proportion of patients who reach lupus low disease activity status (LLDAS) 6 months after infusion

  Six months

• Changes in American College of Rheumatology Composite Response Index in Systemic Sclerosis (ACR-CRISS) compared to baseline after 3 months of infusion

  3 months after infusion

Study Arms (1)

CT1190B CAR-T cells Injection

EXPERIMENTAL

CT1190B cells infusion

Drug: CAR-T Therapy

Interventions

CAR-T Therapy DRUG

CT1190B cells infusion

CT1190B CAR-T cells Injection

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Voluntary signing of the Informed Consent Form (ICF)
• Age range: At the time of signing the ICF, the age is between 18 and 60 years old (including 18 and 60 years old), regardless of gender.
• No systemic active infection within 2 weeks before screening.
• Contraceptive requirements for participants with child - bearing potential.
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• Meet the EULAR/ACR 2019 SLE classification criteria with a disease history ≥ 6 months.
• Treatment and disease activity requirements:
• o Before screening, the participant must have received treatment with glucocorticoids combined with immunosuppressive agents (including cyclophosphamide, mycophenolate mofetil, tacrolimus, methotrexate, cyclosporine, leflunomide) and/or biological agents for ≥ 3 months, with a stable dose for ≥ 2 weeks, and the disease is still in an active state. Oral corticosteroid requirements at the time of screening:
• o If treated with corticosteroids alone, prednisone (or equivalent drug) ≥ 7.5 mg/day.
• o When used in combination with immunosuppressive agents and/or biological agents, there is no minimum daily dose requirement for corticosteroids.
• Positive antibody test at screening: Positive antinuclear antibody, and/or positive anti-ds-DNA antibody, and/or positive anti-Smith antibody.
• Disease activity score or organ damage: At the screening stage, the SLEDAI - 2K score is ≥ 7 points
• Adequate organ function:
• o Renal function: Defined as a calculated creatinine clearance rate (Cockcroft - Gault) ≥ 50 mL/min without the need for hydration assistance.
• o Liver function: Defined as alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2× the upper limit of normal (ULN), and total bilirubin ≤ 2× the upper limit of normal (ULN).

You may not qualify if:

• Previous history of CAR-T cell or other genetically modified T-cell therapies, or previous major organ transplantation.
• Use of B-cell targeted drugs (such as rituximab) within 2 months before screening.
• Allergy or intolerance to lymphodepletion drugs, tocilizumab, or life-threatening allergic reactions, hypersensitivity reactions, or intolerance to the CT1190B preparation or its excipients, or a history of other severe allergies such as anaphylactic shock.
• Use of corticosteroids ≥ 10 mg/day of prednisone (or equivalent drug) within 10 days before the infusion of CT1190B.
• Use of immunosuppressive agents that affect T-cells (mycophenolate mofetil, methotrexate, cyclosporine, azathioprine, leflunomide, tacrolimus) within 10 days before the infusion of CT1190B.
• Use of JAK inhibitors (tofacitinib, baricitinib tablets, ruxolitinib, etc.) within 3 days before the infusion of CT1190B.
• Vaccination with live-attenuated vaccines, inactivated vaccines, or RNA vaccines within 1 month before screening.
• Diagnosis of cancer within 2 years before signing the ICF. Exceptions include non-melanoma skin cancer treated by radical therapy, local prostate cancer, biopsy-proven cervical carcinoma in situ or squamous intraepithelial lesions detected by cervical smear, and completely resected breast carcinoma in situ.
• Undergoing major surgery within 4 weeks before signing the ICF, or planning to undergo major surgery during the study, and the investigator deems it will pose an unacceptable risk to the participant.
• Positive test for HIV, syphilis, active hepatitis B virus infection, or active hepatitis C virus infection at screening.
• History of central nervous system diseases before screening, including but not limited to cerebrovascular accident, encephalitis, epilepsy, convulsions/seizures, stroke, severe brain injury, dementia, Parkinson's disease, cerebellar diseases, central nervous system vasculitis, cognitive impairment, organic brain syndrome, or mental illness.
• History of any of the following cardiovascular diseases within 1 month before screening: Heart failure of class III or IV as defined by the New York Heart Association (NYHA), myocardial infarction, unstable angina, uncontrolled or symptomatic atrial arrhythmia, any ventricular arrhythmia, or other heart diseases of significant clinical significance.
• Participation in other clinical studies within 3 months before screening or still within five half-lives after the last dose of the drug.
• Current presence of any uncontrolled active infection, including but not limited to active tuberculosis, etc.
• History or evidence of suicidal thoughts within 6 months before signing the ICF, or any suicidal behavior within the previous 12 months, and the investigator deems there is a significant suicide risk.

Sponsors & Collaborators

• Beijing GoBroad Hospital: lead
• CARsgen Therapeutics Co., Ltd.: collaborator

Study Sites (1)

Beijing GoBroad Hospital

Beijing, Beijing Municipality, 102200, China

RECRUITING

MeSH Terms

Conditions

Lupus Erythematosus, Systemic; Scleroderma, Systemic

Interventions

Immunotherapy, Adoptive

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Skin Diseases

Intervention Hierarchy (Ancestors)

Adoptive Transfer; Immunization, Passive; Immunization; Immunotherapy; Immunomodulation; Biological Therapy; Therapeutics; Immunologic Techniques; Investigative Techniques

Central Study Contacts

Jing Pan

CONTACT

010-50847588; panj@gobroaddhealthcare.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 7, 2025
• First Posted: February 12, 2025
• Study Start: February 20, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 10, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)