A Clinical Study Exploring the Safety, Efficacy and Cell Metabolic Dynamics of Universal CD19 / 20 Car-t Cell Injection in Moderate to Severe Refractory Systemic Lupus Erythematosus

NCT07339332 | Recruiting Early Phase 1

• 1 other identifier: CT1195E-CG11009
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a single arm, open, exploratory dose escalation clinical study to evaluate the safety, efficacy, and cellular metabolic dynamics of ct1195e cells in patients with SLE.

Conditions

Systemic Lupus Erythematosus (SLE)

Outcome Measures

Primary Outcomes (5)

• severity of dose limiting toxicity (DLT)

  Within 28 days after infusion

• Incidence of dose limiting toxicity (DLT)

  Within 28 days after infusion

• Evaluate the maximum tolerable dose (MTD) and/or dose range of ct1195E

  Ct1195E MTD and/or dose range

  After medication to day 28

• severity of adverse events (AES)

  Within 180 days after infusion

• Incidence of adverse events (AES)

  Within 180 days after infusion

Secondary Outcomes (14)

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

  1, 2,3, 6, 9 and 12 months after drug use

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

  1, 2,3, 6, 9 and 12 months after drug use

• Proportion of participants achieving disease remission (doris)

  1, 2, 3, 6, 9 and 12 months after drug use

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

  1,2,3,6,9 and 12 months after drug use

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

  1, 2, 3, 6, 9 and 12 months after drug use

Study Arms (1)

CT1195E CAR-T cells Injection

EXPERIMENTAL

CT1195E cells infusion

Other: CAR-T Therapy

Interventions

CAR-T Therapy OTHER

CT1195E cells infusion

CT1195E CAR-T cells Injection

Eligibility Criteria

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

You may qualify if:

• Voluntary signing of Informed Consent Form (ICF): I fully understand and am informed of this study, and I have signed the Informed Consent Form, expressing my willingness to follow and complete all research procedures;
• When signing the ICF, the age should be between 18 and 65 years old (inclusive), with no gender restrictions;
• No systemic active infection (such as infectious pneumonia, tuberculosis) within 2 weeks before screening;
• Females with fertility (defined as all females who are physiologically capable of becoming pregnant) must agree to use highly effective contraception from at least 28 days before the start of self-cleaning to 1 year after CT1195E infusion, and absolutely prohibit egg donation within 1 year after receiving study treatment during the study period. Their male partners with fertility must agree to use effective barrier contraception from the start of self-cleaning to 1 year after CT1195E infusion, and should not donate semen or sperm during the entire study period;
• Females with fertility must have a negative serum beta-human chorionic gonadotropin (β-hCG) test result at screening and within 48 hours prior to the initiation of chemotherapy.
• Meet the EULAR/ACR 2019 classification criteria for SLE, with a disease history of ≥6 months;
• Prior to screening, patients must have received treatment with glucocorticoids combined with immunosuppressants (including cyclophosphamide, mycophenolate mofetil, tacrolimus, methotrexate, cyclosporine, leflunomide) and/or biologics for ≥3 months, with a stable dosage for ≥2 weeks, and the disease must still be in an active state. During screening, oral steroids must meet the following requirements:
• If treated with hormone therapy 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 dosage requirement for steroids;
• During screening, positive for antinuclear antibody, and/or positive for anti-ds-DNA antibody, and/or positive for anti-Smith antibody;
• During the screening period, patients with a SLEDAI-2K score of ≥7, or those with concurrent significant organ dysfunction, such as severe immune-mediated thrombocytopenia, lupus nephritis (histologically diagnosed as active nephritis type III or IV with or without type V);
• During screening, involvement of active organs (including kidneys, heart and lungs, musculoskeletal system, blood system, blood vessels, etc.; involvement of skin and mucous membranes alone is not included) is present;
• Adequate organ function:
• Renal function: defined as creatinine clearance rate (Cockcroft-Gault) calculated without hydration assistance ≥ 50 mL/min;

You may not qualify if:

• Liver function: defined as alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels ≤2× upper limit of normal (ULN), and total bilirubin levels ≤2× upper limit of normal (ULN)
• Coagulation function: defined as an international normalized ratio (INR) or activated partial thromboplastin time (APTT) ≤1.5×ULN;
• Lung function: When exposed to indoor air, the blood oxygen saturation (SpO2) is ≥92% (measured by a pulse oximeter);
• Cardiac function: defined as having a left ventricular ejection fraction (LVEF) of ≥50% as assessed by echocardiography (ECHO) within the 8 weeks prior to screening.
• Those who have suffered from severe lupus nephritis within the previous 2 months and require hemodialysis, or have received prednisone ≥100 mg/d or equivalent hormone treatment for ≥14 days;
• Those who have undergone plasma exchange, plasma separation, hemodialysis within the previous 30 days, or those who have suffered from lupus crisis within the previous 30 days;
• Screen for individuals with a history of ≥ Grade 2 bleeding within the previous 30 days or those requiring long-term anticoagulant therapy;
• History of any of the following cardiovascular diseases within 30 days prior to screening: heart failure of NYHA class III or IV, myocardial infarction, unstable angina, uncontrolled or symptomatic atrial arrhythmias, any ventricular arrhythmias, or other clinically significant heart diseases;
• Before screening, there were manifestations of the central nervous system caused by lupus, including but not limited to lupus headache, seizures, cognitive impairment, impaired intellectual function, and visual impairment;
• Individuals with central nervous system diseases prior to screening include, but are not limited to: cerebrovascular accident, encephalitis, epilepsy, convulsion/seizure, stroke, severe brain injury, dementia, Parkinson's disease, cerebellar disease, central nervous system vasculitis, cognitive dysfunction, brain organic syndrome, or psychosis;
• Screen for the absence of systemic active infections within the previous 2 weeks, including but not limited to active tuberculosis;
• Previous exposure to CAR-T cell therapy or other gene-modified T cell therapies, or a history of major organ transplantation (such as heart, lung, kidney, liver) or hematopoietic stem cell/bone marrow transplantation;
• Allergic or intolerant to diuretics, tocilizumab, or experiencing life-threatening allergic reactions, hypersensitivity reactions, or intolerance to CT1195E formulation or its excipients (including dimethyl sulfoxide (DMSO)), or having a history of other severe allergies such as anaphylactic shock;
• Screen for individuals who have used targeted B-cell drugs such as rituximab within the previous 3 months;
• Within 2 weeks prior to the infusion of CT1195E, the use of prednisone (or equivalent drugs) at a dosage of ≥10 mg/day is allowed. Physiological substitutes, topical, and inhaled steroids are also permitted;

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: early 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: November 18, 2025
• First Posted: January 14, 2026
• Study Start: January 16, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: January 14, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)