Allogeneic UCB-derived CAR-T for SLE

NCT07274059 | Recruiting Early Phase 1 DMC

• 1 other identifier: UDCAR-SLE
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this clinical trial is to learn if allogeneic, umbilical cord blood-derived chimeric antigen receptor T-cell (UCAR-T) targeting CD19 and BCMA works to treat refractory SLE in adults. It will also learn about the safety and efficacy of the UCAR-T cell product.

Conditions

SLE - Systemic Lupus Erythematosus

Keywords

allogeneic; CAR-T; umbilical cord blood; SLE

Outcome Measures

Primary Outcomes (2)

• the incidence rate of Dose limited toxicity (DLTs)

  Dose limited toxicity(DLT) was defined as the occurrence of any of the following adverse events within 28 days of the infusion of UCAR-T cells.

  Up to 28 days after infusion

• the rate of adverse events

  The number, frequency, severity, and laboratory findings of all treatment-related adverse events/serious adverse events are included.

  up to 2 months after UCAR-T injection

Secondary Outcomes (7)

• Proportion of patients achieving DORIS remission

  up to 2 years after UCAR-T injection

• the changes of SELENA-SLEDAI score

  up to 2 years after UCAR-T injection

• Proportion of patients achieving SRI-4 remission

  up to 2 years after UCAR-T injection

• Percentage of participants achieving maintenance of drug-free DORIS remission

  up to 2 years after UCAR-T injection

• Percentage of participants achieving maintenance of LLDAS

  up to 2 years after UCAR-T injection

Other Outcomes (1)

• AUC of CAR-T cells

  up to 2 months after UCAR-T injection

Study Arms (1)

UCAR-T cells treatment

EXPERIMENTAL

Drug: allogeneic umbilical cord blood-derived CAR-T targeting CD19 and BCMA

Interventions

allogeneic umbilical cord blood-derived CAR-T targeting CD19 and BCMA DRUG

intravenous injection of allogeneic umbilical cord blood-derived CAR-T targeting CD19 and BCMA

UCAR-T cells treatment

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18 to 75 years (inclusive), regardless of gender.
• Definitive diagnosis of systemic lupus erythematosus (SLE) meeting the 2019 European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) classification criteria for SLE
• Treatment refractory: failed ≥ 2 conventional SLE treatments for at least 3 months.
• Disease activity assessed by SELENA-SLEDAI score ≥ 6 with at least one British Isles Lupus Assessment Group (BILAG)-2004 Class A (severe manifestation) or two Class B (moderate manifestation) organ scores (or both); OR SELENA-SLEDAI score ≥ 8.
• Adequate function of major organs as follows:
• Bone marrow function: a. Neutrophil count ≥ 1 × 10⁹/L (no colony-stimulating factor therapy within 2 weeks prior to testing, excluding neutropenia caused by SLE); b. Hemoglobin ≥ 60 g/L.
• Liver function: Alanine aminotransferase (ALT) ≤ 3 × upper limit of normal (ULN) (excluding ALT elevation caused by SLE); Aspartate aminotransferase (AST) ≤ 3 × ULN (excluding AST elevation caused by SLE); Total bilirubin (TBIL) ≤ 1.5 × ULN (excluding TBIL elevation caused by SLE).
• Renal function: Creatinine clearance rate (CrCl) ≥ 30 mL/minute (calculated by Cockcroft/Gault formula, excluding CrCl reduction caused by SLE).
• Coagulation function: International normalized ratio (INR) ≤ 1.5 × ULN; Prothrombin time (PT) ≤ 1.5 × ULN.
• Cardiac function: Hemodynamically stable.
• Female subjects of childbearing potential and male subjects whose partners are of childbearing potential must use medically approved contraceptive methods or abstain from sexual intercourse during the study treatment period and for at least 6 months after the end of study treatment. Female subjects of childbearing potential must have a negative serum human chorionic gonadotropin (HCG) test within 7 days prior to study enrollment and must not be breastfeeding.
• Voluntarily agrees to participate in the clinical study, signs the informed consent form (ICF), and demonstrates good compliance with study procedures and follow-up.

You may not qualify if:

• History of severe drug allergies or atopic diathesis.
• Presence or suspicion of uncontrolled or treatment-requiring fungal, bacterial, viral, or other infections.
• Cardiac function insufficient to tolerate the study treatment.
• Congenital immunoglobulin deficiency.
• History of malignant tumors within the past 5 years.
• End-stage renal failure.
• Positive for hepatitis B surface antigen (HBsAg) and hepatitis B core antibody (HBcAb) with peripheral blood HBV DNA titer above the lower limit of detection; positive for hepatitis C virus (HCV) antibody with positive peripheral blood HCV RNA; positive for human immunodeficiency virus (HIV) antibody; positive syphilis test.
• History of mental illness or severe cognitive impairment.
• Use of disease-modifying immunosuppressive agents within 5 half-lives or biological agents within 4 weeks prior to enrollment.
• Pregnant females or females planning to become pregnant.
• Other conditions deemed by the investigator to preclude study participation.

Sponsors & Collaborators

• Yancheng Third People's Hospital: collaborator
• Chengdu Ucello Biotechnology Co., Ltd.: lead
• The General Hospital of Western Theater Command: collaborator

Study Sites (2)

Yancheng Third People's Hospital

Yancheng, Jiangsu, China

RECRUITING

The General Hospital of Western Theater Command

Chengdu, Sichuan, China

NOT YET RECRUITING

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Interventions

bis(3-bis(4-chlorophenyl)methyl-4-dimethylaminophenyl)amine

Condition Hierarchy (Ancestors)

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

Study Officials

• Tao Wang, M.D.

  The General Hospital of Western Theater Command

  PRINCIPAL INVESTIGATOR

• Mei Dong Jiang, M.D.

  Yancheng Third People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tao Wang, M.D.

CONTACT

+8613550080505; cdjqzyywt@126.com

Xia zhao He, M.D. & Ph.D.

CONTACT

+8613350084795; wangtaohhzx@hotmail.com

Study Design

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

Study Record Dates

• First Submitted: November 22, 2025
• First Posted: December 10, 2025
• Study Start: March 26, 2025
• Primary Completion (Estimated): December 31, 2035
• Study Completion (Estimated): December 31, 2037
• Last Updated: December 10, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Time Frame: starting 6 months after publication

Locations

CN (2)