Universal Anti-CD70 CAR-T (CHT101) Cell Therapy for Relapsed Refractory Systemic Lupus Erythematosus

NCT06946485 | Recruiting Early Phase 1

• 1 other identifier: CHT101AIIT
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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

Systemic Lupus Erythematosus (SLE)

Outcome Measures

Primary Outcomes (2)

• SRI-4 Response

  SRI-4 Response defined as a decrease of ≥4 points from baseline in the SELENA-SLEDAI score, no new BILAG-evaluated grade A organs or \<2 BILAG-evaluated grade B organs from baseline, and no deterioration in the physician's overall assessment (an increase of \<0.30 points from baseline).

  SRI-4 response at 1 month after CHT101 infusion.

• Safety Evaluation

  Safety evaluation includes the collection of adverse events (AE), serious adverse events (SAE), vital signs and physical examinations, laboratory tests, including pregnancy tests and concomitant treatments. Safety is evaluated using the NCI-CTCAE 5.0 standard. CRS is evaluated using the ASTCT Consensus Grading Criteria, ICANS is evaluated using the Adult ASTCT ICANS Consensus Grading Criteria, acute GVHD is evaluated using the 2016 Mount Sinai Acute GVHD International Consortium Grading Criteria, and chronic GVHD is evaluated using the 2020 NCCN Hematopoietic Cell Transplantation Clinical Practice Guidelines, Version 1.0.

  safety evaluation Within 12 months after CHT101 infusion.

Secondary Outcomes (4)

• Disease Activity Index

  At 1 month, 2 month, 3 month, 6 month, 9 month, 12month after CHT101 infusion.

• Organ Damage

  At 1 month, 2 month, 3 month, 6 month, 9 month, 12month after CHT101 infusion.

• BILAG 2004

  At 1 month, 2 month, 3 month, 6 month, 9 month, 12month after CHT101 infusion.

• Overall assessment of physicians

  At 1 month, 2 month, 3 month, 6 month, 9 month, 12month after CHT101 infusion.

Study Arms (1)

Universal anti-CD70 CAR-T (CHT101)

EXPERIMENTAL

Biological: Universal anti-CD70 CAR-T (CHT101)

Interventions

Universal anti-CD70 CAR-T (CHT101) BIOLOGICAL

Universal anti-CD70 CAR-T (CHT101) cell therpy

Universal anti-CD70 CAR-T (CHT101)

Eligibility Criteria

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

You may qualify 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 cyclophosphamide and ≥1 of the following immunosuppressants for \>6 months: antimalarials, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine A, and/or biologics (e.g., rituximab, belimumab, telitacicept).
• 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 function: Alanine aminotransferase (ALT) ≤3×upper limit of normal (ULN). Aspartate aminotransferase (AST) ≤3×ULN. Total bilirubin (TBIL) ≤1.5×ULN (except Gilbert's syndrome, TBIL ≤3.0×ULN); Renal function: Creatinine clearance (CrCl) ≥60 mL/min (calculated by Cockcroft-Gault formula); Coagulation: International normalized ratio (INR) ≤1.5×ULN. Prothrombin time (PT) ≤1.5×ULN; Cardiac function: Hemodynamic stability with left ventricular ejection fraction (LVEF) ≥55%.
• 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 must have a negative serum HCG test within 7 days prior to enrollment and must not be lactating.
• Voluntarily participate in the study, provide written informed consent, and demonstrate good compliance with follow-up.

You may not qualify 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.
• 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 HCV RNA; HIV antibody-positive; Syphilis-positive (RPR and TPHA positive, or TPHA positive with RPR reconfirmed positive after 4 weeks).
• 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.

Sponsors & Collaborators

• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School: lead

Study Sites (1)

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Nanjing, Jiangsu, China

RECRUITING

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

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

Study Officials

• Lingyun Sun

  The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

  STUDY CHAIR

Central Study Contacts

Xiaojun Tang

CONTACT

18021397168; xjtang09@163.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2025
• First Posted: April 27, 2025
• Study Start: April 1, 2025
• Primary Completion: February 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: October 3, 2025

Record last verified: 2025-03

Locations

CN (1)