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

A Clinical Study of the Safety and Efficacy of Universal Anti-CD70 CAR-T (CHT101) for the Treatment of Relapsed and Refractory Systemic Lupus Erythematosus

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.

Study Overview

• Status: Recruiting
• Conditions: Systemic Lupus Erythematosus (SLE)
• Intervention / Treatment: Biological: Universal anti-CD70 CAR-T (CHT101)

Detailed Description

This study is a non-randomized, open-label, single-arm clinical trial designed to assess the efficacy and safety of universal anti-CD70 CAR-T (CHT101) in patients with relapsed refractory systemic lupus erythematosus.

• Study Type: Interventional
• Enrollment (Estimated): 15
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Xiaojun Tang; Phone Number: 18021397168; Email: xjtang09@163.com

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China
      • Recruiting
      • The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Meet the 2019 EULAR/ACR classification criteria for systemic lupus erythematosus (SLE).
2. SLEDAI-2000 score >6.
3. Have at least one BILAG-2004 Grade A or two Grade B organ domain scores, or both.
4. 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).
5. Aged 18-65 years; both genders eligible.
6. 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%.
7. 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.
8. Voluntarily participate in the study, provide written informed consent, and demonstrate good compliance with follow-up.

Exclusion Criteria:

1. Presence of neuropsychiatric lupus (NPSLE).
2. History of thrombotic thrombocytopenic purpura (TTP) or thrombotic microangiopathy (TMA).
3. History of severe drug allergies or hypersensitivity.
4. Active or suspected uncontrolled infections requiring treatment (including fungal, bacterial, viral, or other pathogens).
5. Central nervous system disorders caused by autoimmune diseases (ADs) or non-ADs.
6. Severe cardiac diseases.
7. Congenital immunoglobulin deficiency.
8. History of malignancy (except non-melanoma skin cancer, in situ cervical/bladder/breast/thyroid carcinoma with disease-free survival >5 years).
9. End-stage renal failure.
10. 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).
11. Psychiatric disorders or severe cognitive impairment.
12. Participation in other clinical trials within 3 months prior to enrollment.
13. Pregnant women or those planning pregnancy.
14. Other conditions deemed by the investigator to preclude study participation.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Universal anti-CD70 CAR-T (CHT101)	Biological: Universal anti-CD70 CAR-T (CHT101); Universal anti-CD70 CAR-T (CHT101) cell therpy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Organ Damage	The score was based on the SLE International Cooperation Group Injury Index (SDI). The higher the index, the worse the prognosis.	At 1 month, 2 month, 3 month, 6 month, 9 month, 12month after CHT101 infusion.
BILAG 2004	The absence of new organ Class A scores or two organ Class B scores indicates improvement.	At 1 month, 2 month, 3 month, 6 month, 9 month, 12month after CHT101 infusion.
Overall assessment of physicians	The mitigation indicator was a baseline increase of less than 0.3 on a 3-point scale.	At 1 month, 2 month, 3 month, 6 month, 9 month, 12month after CHT101 infusion.
DORIS remission	The remission of SLE was based on the DORIS 2021 criteria, namely: SLEDAI=0 and PGA < 0.5 (0-3 points), serology was not considered, and patients could use antimalarial drugs, low-dose glucocorticoids (prednisolone ≤5mg/ day), and/or immunosuppressants including biologics.	At 1 month, 2 month, 3 month, 6 month, 9 month, 12month after CHT101 infusion.
Lupus Low Disease Activity State (LLDAS) remission	requiring simultaneous fulfillment of all the following criteria: SLEDAI-2K score ≤4, with no active involvement of major organs (kidneys, central nervous system, heart/lungs, gastrointestinal tract, vasculitis, or fever);; PGA score ≤1;; No new lupus-related symptoms;; Maintenance dose of prednisone (or equivalent) ≤7.5 mg/day.	At 1 month, 2 month, 3 month, 6 month, 9 month, 12month after CHT101 infusion.
Overall Renal Response (ORR)	Evaluated only in participants with lupus nephritis, encompassing those achieving either complete renal response (CRR) or partial renal response (PRR).	At 1 month, 2 month, 3 month, 6 month, 9 month, 12month after CHT101 infusion
Complete Renal Response (CRR)	Evaluated only in participants with lupus nephritis; participants meeting all the following criteria are considered to have achieved CRR: Urinary protein excretion <0.5 g/24 h or urine protein-to-creatinine ratio (UPCR) <0.5 g/g;; Estimated glomerular filtration rate (eGFR) decline ≤10-15% from baseline or eGFR ≥60 mL/min/1.73 m²;; No use of rescue medications exceeding protocol-specified thresholds prior to assessment.	At 1 month, 2 month, 3 month, 6 month, 9 month, 12month after CHT101 infusion.
Partial Renal Response (PRR)	Evaluated only in participants with lupus nephritis; participants meeting all the following criteria are considered to have achieved PRR: eGFR decline ≤10-15% from baseline or eGFR ≥60 mL/min/1.73 m²;; Improvement in 24-hour UPCR:For participants with baseline UPCR ≤3.0 g/g: UPCR <1.0 g/g;For participants with baseline UPCR >3.0 g/g: >50% reduction from baseline and UPCR <3.0 g/g;; No use of rescue medications exceeding protocol-specified thresholds prior to assessment.	At 1 month, 2 month, 3 month, 6 month, 9 month, 12month after CHT101 infusion.
Primary Efficacy Renal Response (PERR)	Evaluated only in participants with lupus nephritis; participants meeting all the following criteria are considered to have achieved PERR: UPCR ≤0.7 g/g;; eGFR decline ≤20% from baseline or eGFR ≥60 mL/min/1.73 m²;; No use of rescue medications exceeding protocol-specified thresholds prior to assessment.	At 1 month, 2 month, 3 month, 6 month, 9 month, 12month after CHT101 infusion.

Collaborators and Investigators

• Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
• Investigators: Study Chair: Lingyun Sun, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: April 2, 2025
• First Submitted That Met QC Criteria: April 20, 2025
• First Posted (Actual): April 27, 2025

Study Record Updates

• Last Update Posted (Actual): April 7, 2026
• Last Update Submitted That Met QC Criteria: April 1, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Skin and Connective Tissue Diseases; Lupus Erythematosus, Systemic
• Other Study ID Numbers: CHT101AIIT-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No