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New treatment option for Systemic Lupus Erythematosus (SLE)
Official title Universal Anti-CD70 CAR-T (CHT101) Cell Therapy for Relapsed Refractory Systemic Lupus Erythematosus
ClinicalTrials.gov ID: NCT06946485
What this study is testing
What is Universal anti-CD70 CAR-T (CHT101)?
Universal anti-CD70 CAR-T (CHT101) is an investigational medicine, being studied as a potential treatment for systemic lupus erythematosus (sle).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- Meet the 2019 EULAR/ACR classification criteria for systemic lupus erythematosus (SLE).
- SLEDAI-2000 score \>6.
- Have at least one BILAG-2004 Grade A or two Grade B organ domain scores, or both.
- Failure to respond to conventional therapy or disease relapse after remission. Conventional therapy: Glucocorticoids (≥1 mg/kg/day) combined with...
- Aged 18-65 years; both genders eligible.
You likely can't join if
- 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 (including fungal, bacterial, viral, or other pathogens).
- Central nervous system disorders caused by autoimmune diseases (ADs) or non-ADs.
- Severe cardiac diseases.
See the full eligibility criteria
- Meet the 2019 EULAR/ACR classification criteria for systemic lupus erythematosus (SLE).
- SLEDAI-2000 score \>6.
- Have at least one BILAG-2004 Grade A or two Grade B organ domain scores, or both.
- Failure to respond to conventional therapy or disease relapse after remission. Conventional therapy: Glucocorticoids (≥1 mg/kg/day) combined with cyclophosphamide and ≥1 of the following immunosuppressants for \>6...
- Aged 18-65 years; both genders eligible.
- Adequate organ function:Bone marrow function: White blood cell count ≥3×10⁹/L. Absolute neutrophil count ≥1×10⁹/L (without colony-stimulating factor therapy within 2 weeks prior to testing). Hemoglobin ≥60 g/L; Liver...
- Agrees to use double barrier methods, condoms, oral or injectable contraceptives, or intrauterine devices during the study period and for one year after taking the study medication. Females of childbearing potential...
- Voluntarily participate in the study, provide written informed consent, and demonstrate good compliance with follow-up.
- 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 (including fungal, bacterial, viral, or other pathogens).
- Central nervous system disorders caused by autoimmune diseases (ADs) or non-ADs.
- Severe cardiac diseases.
- Congenital immunoglobulin deficiency.
- History of malignancy (except non-melanoma skin cancer, in situ cervical/bladder/breast/thyroid carcinoma with disease-free survival \>5 years).
- End-stage renal failure.
- Participants meeting any of the following: Hepatitis B surface antigen (HBsAg)-positive or hepatitis B core antibody (HBcAb)-positive with detectable HBV DNA; Hepatitis C virus (HCV) antibody-positive with detectable...
- Psychiatric disorders or severe cognitive impairment.
- Participation in other clinical trials within 3 months prior to enrollment.
- Pregnant women or those planning pregnancy.
- Other conditions deemed by the investigator to preclude study participation.
The study team makes the final eligibility decision.
Where it's taking place
- Nanjing, Jiangsu, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nanjing, Jiangsu, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.