Actively Recruiting
Universal Anti-CD70 CAR-T (CHT101) Cell Therapy for Relapsed Refractory Systemic Lupus Erythematosus
Led by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School · Updated on 2026-04-07
15
Participants Needed
1
Research Sites
99 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This investigator-initiated trial aims to evaluate the safety and efficacy of universal anti-CD70 CAR-T (CHT101) in patients with relapsed refractory systemic lupus erythematosus.
CONDITIONS
Official Title
Universal Anti-CD70 CAR-T (CHT101) Cell Therapy for Relapsed Refractory Systemic Lupus Erythematosus
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Meet the 2019 EULAR/ACR classification criteria for systemic lupus erythematosus (SLE).
- Have a SLEDAI-2000 score greater than 6.
- Have at least one BILAG-2004 Grade A or two Grade B organ domain scores, or both.
- Have failed to respond to conventional therapy or experienced disease relapse after remission.
- Be aged between 18 and 65 years.
- Have adequate organ function including bone marrow, liver, kidney, coagulation, and cardiac function as specified.
- Agree to use effective contraception methods during the study and for one year after treatment; females of childbearing potential must have a negative serum HCG test within 7 days prior to enrollment and not be lactating.
- Voluntarily participate and provide written informed consent with good compliance to follow-up.
You will not qualify if you...
- Presence of neuropsychiatric lupus (NPSLE).
- History of thrombotic thrombocytopenic purpura (TTP) or thrombotic microangiopathy (TMA).
- History of severe drug allergies or hypersensitivity.
- Active or suspected uncontrolled infections requiring treatment.
- Central nervous system disorders caused by autoimmune or non-autoimmune diseases.
- Severe cardiac diseases.
- Congenital immunoglobulin deficiency.
- History of malignancy except certain non-melanoma skin cancers or carcinomas with disease-free survival over 5 years.
- End-stage renal failure.
- Positive tests for hepatitis B, hepatitis C, HIV, or syphilis infections as specified.
- Psychiatric disorders or severe cognitive impairment.
- Participation in other clinical trials within 3 months prior.
- Pregnant or planning pregnancy.
- Other conditions deemed by the investigator to preclude participation.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Nanjing, Jiangsu, China
Actively Recruiting
Research Team
X
Xiaojun Tang
CONTACT
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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