Safety, Efficacy and Cellular Metabolic Dynamics of ct1192 in Patients With Moderate to Severe Refractory SLE

NCT07031713 | Recruiting Phase 1

• 1 other identifier: CT1192-CG11003_01
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

A clinical study to explore the safety, efficacy and cell metabolic kinetics of universal CD19/20 car-t cell injection in moderate to severe refractory systemic lupus erythematosus. This study is a single arm, open, exploratory dose increasing clinical study, which aims to evaluate the safety, efficacy and cell metabolic dynamics of ct1192 cells in patients with SLE.

Conditions

Systemic Lupus Erythematosus (SLE)

Outcome Measures

Primary Outcomes (2)

• To evaluate the safety and tolerability of ct1192 in participants with moderate to severe refractory SLE

  The incidence 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/SAEwithin 12 months after infusion for AESl

• Evaluate the maximum tolerable dose (MTD) and/or dose range of ct1192

  Ct1192 MTD and/or dose range

  After medication to day 28

Secondary Outcomes (15)

• Proportion of participants with SLE responder index (sri-4)

  1, 3, 6, 9 and 12 months after drug use

• Proportion of participants with low lupus disease activity status (lldas)

  1, 3, 6, 9 and 12 months after drug use

• Proportion of participants achieving disease remission (doris)

  1, 3, 6, 9 and 12 months after drug use

• Changes of SLE disease activity index (sledai-2k) score from baseline after medication

  1, 3, 6, 9 and 12 months after drug use

• After treatment, the SLE disease activity index (Selena - SLEDAI) score changed from baseline

  1, 3, 6, 9 and 12 months after drug use

Study Arms (1)

CT1192 CAR-T cells Injection

EXPERIMENTAL

CT1192 cells infusion

Biological: CAR-T Therapy

Interventions

CAR-T Therapy BIOLOGICAL

CT1192 cells infusion

CT1192 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:

• Meet the EULAR/ACR 2019 SLE classification criteria, with a medical history of ≥ 6 months;
• Voluntarily sign the Informed Consent Form (ICF); When signing the ICF, the age range is between 18 and 60 years old (including 18 and 60 years old), with no gender restrictions;
• No systemic active infections (such as infectious pneumonia or tuberculosis) within the first 2 weeks of screening;
• Women with fertility (defined as all physiologically capable women) must agree to use effective contraceptive methods from at least 28 days prior to the start of vaginal discharge until 1 year after CT1192 infusion. Egg donation is strictly prohibited within 1 year after receiving the study treatment infusion during the study period. Male partners with fertility must agree to use effective barrier contraception methods from the start of vaginal discharge until 1 year after CT1192 infusion, and should not donate semen or sperm throughout the entire study period;
• Women with fertility must have a negative serum β - human chorionic gonadotropin (β - hCG) test result within 48 hours prior to screening and gonorrhea treatment.
• Prior to screening, patients must have received a combination of glucocorticoids and immunosuppressants (including cyclophosphamide, mycophenolate mofetil, tacrolimus, methotrexate, cyclosporine, leflunomide) and/or biologics for at least 3 months, with a stable dose for at least 2 weeks and the disease still active. During screening, oral steroids must meet the following requirements:
• If hormone therapy is used alone, prednisone (or equivalent medication) should be ≥ 7.5 mg/day; When used in combination with immunosuppressants and/or biologics, there is no minimum daily dose requirement for hormones; 7. Positive for anti nuclear antibodies, anti ds DNA antibodies, and/or anti Smith antibodies during screening; 8. During the screening period, if the SLEDAI-2K score is ≥ 7 points, or if there is significant organ dysfunction, such as severe immune thrombocytopenia or lupus nephritis (histologically diagnosed as active nephritis type III or IV with or without type V); 9. Active organ involvement during screening (including kidneys, heart and lungs, musculoskeletal system, blood system, blood vessels, etc.; skin and mucosal involvement alone cannot be included); 10. Adequate organ function:
• Renal function: defined as a creatinine clearance rate (Cockcroft Gault) calculated without hydration assistance of ≥ 50 mL/min;
• Bone marrow function: defined as neutrophil count (ANC) ≥ 1.0 × 109/L and hemoglobin (Hb) ≥ 60 g/L. Blood transfusions and growth factors must not be used to meet these requirements within 7 days prior to eligibility screening;
• Liver function: defined as alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2 x upper limit of normal (ULN), total bilirubin ≤ 2 x upper limit of normal (ULN)
• Coagulation function: defined as International Normalized Ratio (INR) or Activated Partial Thromboplastin Time (APTT) ≤ 1.5 × ULN;
• Pulmonary function: Blood oxygen saturation (SpO2) ≥ 92% in indoor air (measured by pulse oximeter);
• Cardiac function: defined as a left ventricular ejection fraction (LVEF) of ≥ 50% evaluated by echocardiography (ECHO) within the first 8 weeks of screening.

You may not qualify if:

• Patients with severe lupus nephritis within the first 2 months of screening need to undergo hemodialysis or receive prednisone ≥ 100 mg/d or equivalent hormone therapy for ≥ 14 days;
• Have undergone plasma exchange, plasma separation, hemodialysis within 30 days prior to screening, or have had lupus crisis within 30 days prior to screening;
• Individuals with a history of ≥ grade 2 bleeding or requiring long-term anticoagulant therapy within the 30 days prior to screening;
• Screening for a history of any of the following cardiovascular diseases within the previous 30 days: Grade III or IV heart failure defined by the New York Heart Association (NYHA), myocardial infarction, unstable angina, uncontrolled or symptomatic atrial arrhythmias, any ventricular arrhythmias, or other clinically significant heart diseases;
• Prior to screening, central nervous system manifestations caused by lupus, including but not limited to lupus headache, epileptic seizures, cognitive impairment, impaired intellectual function, visual impairment, etc;
• Individuals with central nervous system diseases prior to screening include but are not limited to: cerebrovascular accidents, encephalitis, epilepsy, seizures/convulsions, stroke, severe brain injury, dementia, Parkinson's disease, cerebellar diseases, central nervous system vasculitis, cognitive dysfunction, organic brain syndrome, or psychiatric disorders;
• No systemic active infections, including but not limited to active tuberculosis, within 2 weeks prior to screening;
• Previously received CAR-T cell or other genetically modified T cell therapy, or have a history of major organ transplantation (such as heart, lung, kidney, liver) or hematopoietic stem cell/bone marrow transplantation;
• Allergic or intolerant reactions to Qinglin drugs, tocilizumab, or life-threatening allergic reactions, hypersensitivity reactions, or intolerance to CT1192 preparations or their excipients (including dimethyl sulfoxide (DMSO)), or previous history of other severe allergies such as anaphylactic shock;
• Screening for drugs targeting B cells, such as rituximab, that have been used within the previous 6 months;
• Within the 12 weeks prior to screening, other biologics such as taceptil and belimumab have been used for treatment;
• Hormone use ≥ 10 mg/day of prednisone (or equivalent) within 2 weeks prior to CT1192 infusion, with the use of physiological substitutes, topical and inhaled steroids allowed;
• Received immunosuppressive agents that affect T cells (mycophenolate mofetil, methotrexate, cyclosporine, azathioprine, leflunomide, tacrolimus) within 2 weeks prior to CT1192 infusion;
• Have received JAK inhibitors (tofacitinib, baritinib tablets, lukatinib, etc.) within 2 weeks prior to CT1192 infusion;
• Have received attenuated live vaccine, inactivated vaccine or RNA vaccine within one month before screening;

Sponsors & Collaborators

• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology: lead
• CARsgen Therapeutics Co., Ltd.: collaborator

Study Sites (1)

Wuhan Union Hospita

Wuhan, Hubei, 430000, China

RECRUITING

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Interventions

Immunotherapy, Adoptive

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Central Study Contacts

Qiubai Li

CONTACT

Professor 85726808 Ext.027; qiubaili@hust.edu.cn

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: Director, Head of Department of Rheumatology and Immunology, Principal Investigator, Professor, Wuhan Union Hospital

Study Record Dates

• First Submitted: June 4, 2025
• First Posted: June 22, 2025
• Study Start: July 11, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): March 31, 2027
• Last Updated: November 24, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)