Actively Recruiting
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
Led by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Updated on 2026-01-14
12
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
Sponsors
U
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Lead Sponsor
C
CARsgen Therapeutics Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, effectiveness, and cell metabolism of ct1195e cells in adults with moderate to severe refractory Systemic Lupus Erythematosus (SLE). This early phase 1 study explores dose levels and cellular responses to better understand this therapy's potential. The trial aims to find the maximum tolerated dose and assess side effects and disease activity over time. Participants receive infusions of CT1195E CAR-T cells in a two-stage process: an initial dose escalation phase with three planned dose levels (3.0 x 10^8, 4.5 x 10^8, and 6.0 x 10^8 cells) followed by a dose expansion phase selecting one or more dose groups for further evaluation. Dose decisions are based on safety, tolerance, and cell metabolism, with a 28-day dose-limiting toxicity observation period after infusion. During the study, participants are monitored through assessments of toxicity, adverse events, and SLE disease activity using various clinical scores and biomarker changes. Follow-up includes evaluations at multiple time points up to one year to measure cell gene presence and immune function. Safety data and disease responses guide ongoing treatment decisions and participant management throughout the trial.
CONDITIONS
Brief Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntary signing of informed consent form (ICF)
- Age between 18 and 65 years inclusive, no gender restrictions
- No systemic active infection within 2 weeks before screening
- Females with fertility must use effective contraception from 28 days before treatment to 1 year after infusion; male partners must also use barrier contraception
- Negative serum beta-human chorionic gonadotropin test for females with fertility at screening and before chemotherapy
- Meet EULAR/ACR 2019 classification criteria for SLE with disease history of 6 months or more
- Prior treatment with glucocorticoids combined with immunosuppressants or biologics for at least 3 months with stable dosage for 2 weeks, and active disease
- Positive for antinuclear antibody, anti-ds-DNA antibody, or anti-Smith antibody during screening
- SLEDAI-2K score of 7 or higher or significant organ dysfunction during screening
- Active organ involvement excluding skin and mucous membranes alone
- Adequate organ function including kidney, bone marrow, liver, coagulation, lung, and cardiac function as defined
You will not qualify if you...
- Severe lupus nephritis in past 2 months requiring hemodialysis or high-dose prednisone (≥100 mg/day) for 14 days or more
- Plasma exchange, hemodialysis, or lupus crisis within past 30 days
- History of significant bleeding or requiring long-term anticoagulant therapy
- Recent serious cardiovascular diseases within 30 days before screening
- Neurological manifestations caused by lupus or other central nervous system diseases
- Active systemic infections within 2 weeks before screening
- Previous CAR-T or gene-modified T cell therapy or major organ/bone marrow transplantation
- Allergy or intolerance to study drug formulation or excipients
- Use of targeted B-cell drugs within past 3 months or other biologics within 12 weeks
- Use of prednisone ≥10 mg/day or T-cell affecting immunosuppressants within 2 weeks before infusion
- Use of JAK inhibitors within 2 weeks before infusion
- Vaccination with live, inactivated, or RNA vaccines within one month before screening
- Malignant tumor within 2 years except certain treated cancers
- Major surgery within 4 weeks before consent or planned surgery during study
- Evidence of HIV, syphilis, or active hepatitis B or C infection
- Participation in other clinical studies within past 3 months or within five half-lives of last dose
- Uncontrolled major chronic diseases increasing risk for participants
- History or evidence of suicidal thoughts or behavior
- Pregnant or lactating women
- Poor compliance or unwillingness to follow study protocol
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 28 days for dose limiting toxicity (DLT) observation period after first infusion
Participants receive CT1195E CAR-T cell infusion with dose escalation and dose expansion phases to evaluate safety, tolerance, and preliminary effectiveness.
Multiple visits during the first 28 days after infusion for safety and tolerance monitoring
Duration - Up to 12 months
Participants are monitored for adverse events and efficacy outcomes for up to 12 months after treatment.
Visits at 1, 2, 3, 6, 9, and 12 months after treatment
Trial Site Locations
Total: 1 location
1
Wuhan Union Hospita
Wuhan, Hubei, China, 430000
Actively Recruiting
Research Team
Q
Qiubai Li
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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