Equecabtagene Autoleucel Injection (Eque-cel) for Relapsed/Refractory Systemic Lupus Erythematosus (SLE)

NCT06902844 | Recruiting

• 1 other identifier: CT103ACI002
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single-center, open-label, exploratory clinical study to evaluate the efficacy and safety of Equecabtagene Autoleucel Injection (Eque-cel) in patients with Relapsed /refractory systemic lupus erythematosus (SLE).

Conditions

Systemic Lupus Erythematosus (SLE); Lupus Nephritis (LN)

Keywords

CAR T; SLE; LN

Outcome Measures

Primary Outcomes (1)

• Response rate of SRI-4 at 6 months after Eque-cel infusion

  SLE Responder Index (SRI)-4 is defined as follows with all criteria compared to Baseline: * ≥ 4-point reduction in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score. * No worsening of the overall condition (\< 0.3 point increase in Physician's Global Assessment \[PhGA\]) . * No new British Isles Lupus Assessment Group (BILAG) A or more than 1 new BILAG B disease activity scores.

  6 months post Eque-cel infusion.

Secondary Outcomes (13)

• lupus low disease activity state (LLDAS) rate through 2 years after Eque-cel infusion

  up to 2 years from Eque-cel infusion

• Definitions of Remission in SLE (DORIS) rate through 2 years after Eque-cel infusion

  up to 2 years from Eque-cel infusion

• Complete and Partial Renal Response（Lupus Nephritis Patients）through 2 years after Eque-cel infusion

  up to 2 years from Eque-cel infusion

• Safety Endpoint -Adverse Events（AEs）

  up to 2 years from Eque-cel infusion

• Pharmacokinetic Endpoint-Cmax

  up to 2 years from Eque-cel infusion

Other Outcomes (8)

• Immunogenicity

  up to 2 years from Eque-cel infusion

• C-reactive protein (CRP)

  up to 2 years from Eque-cel infusion

• Ferritin

  up to 2 years from Eque-cel infusion

Study Arms (1)

1.0 x 10^6 CAR+ T cells

EXPERIMENTAL

Experimental: Equecabtagene Autoleucel Injection （Eque-cel ） Drug:Equecabtagene Autoleucel Injection

Drug: Equecabtagene Autoleucel Injection

Interventions

Equecabtagene Autoleucel Injection DRUG

dosage form: injection, dosage: 1.0×10\^6 CAR-T/kg, frequency: single dose.

1.0 x 10^6 CAR+ T cells

Eligibility Criteria

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

You may qualify if:

• Age≥18 years old, male or female;
• Subjects with relapsed/refractory SLE:
• Subjects must be diagnosed with SLE according to the 2019 European League Against Rheumatism (EULAR) / American College of Rheumatology (ACR) classification criteria, or the 2012 Systemic Lupus International Collaborating Clinics (SLICC) criteria; the Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score ≥8, with a British Isles Lupus Assessment Group 2004 (BILAG-2004) activity score of A in ≥1 organ at screening, or a BILAG-2004 activity score of B in ≥2 organs.
• Subjects with lupus nephritis (LN) must be diagnosed with active, biopsy-confirmed lupus nephritis of type III, IV, or V, or type III/IV combined with type V according to the 2018 International Society of Nephrology/Renal Pathology Society (ISN/RPS) criteria; the SLEDAI-2000(SLEDAI-2K) score ≥8;
• Regular treatment with glucocorticoids and at least two immunosuppressants，immunomodulators, antimalarials, or biologics for at least 3 months, but withpoorly-controlled symptoms or intolerance to treatment.
• Disease-related pathogenic antibody positive: anti-nuclear antibody (ANA) positive and/or anti-dsDNA positive and/or anti-Smith positive.
• After signing the informed consent form, subjects and their partners must be willing to use effective and reliable method of contraception, devices or medicines, within one year post Eque-cel infusion (excluding contraception safety periods).
• Subjects must provide written informed consent before the study begin.

You may not qualify if:

• Disease involved the nervous system with a BILAG-2004 activity score of Class A.
• History of solid organ transplantation.
• History of autologous or allogeneic stem cell transplantation.
• History of prior cell therapy or treatment of BCMA-targeted drug.
• Known history of primary immunodeficiency (innate or acquired). 6）Concomitant other autoimmune diseases that may interfere with the study evaluation.
• \) Subjects who have received the following drugs/non-drug treatment:
• Subjects who have used therapeutic doses of corticosteroids (defined as \>20 mg/day of prednisone or equivalent) within 1 week prior to enrollment. Corticosteroids must be tapered gradually according to clinical circumstances (e.g., duration and dose of treatment, severity of disease progression, and patient condition) before discontinuation，until reaching the allowable dose range specified in the protocol. Physiological replacement therapy, topical use, and inhaled corticosteroids are permitted.
• Subjects who have used immunosuppressants other than corticosteroids within 1 week prior to enrollment.
• Subjects who received biologic therapies or JAK/BTK/TYK inhibitors within 2 months prior to cell infusion, including but not limited to rituximab, belimumab, or baricitinib.
• Subjects who underwent plasmapheresis or double filtration within 1 week prior to enrollment.
• Subjects who received investigational drugs from another interventional clinical trial within 1 month before signing the informed consent form (ICF).
• Subjects who received treatment of the study disease with any unlisted drugs within at least 5 half-lives prior to cell infusion.
• )Major operation or surgical treatment caused by any reason that occurred or was planned within 4 weeks before enrollment or within 12 weeks after cell infusion.
• )History of psychoactive drug abuse and failed to withdraw, or have a history of psychiatric disorders.
• )Subjects have uncontrolled active fungal, viral, bacterial, or other infections (with persistent infection-related signs/symptoms that have not improvedafter appropriate anti-infective therapy) or infections requiring intravenous anti-infective therapy.

Sponsors & Collaborators

• Tongji Hospital: lead
• Nanjing IASO Biotechnology Co., Ltd.: collaborator

Study Sites (1)

Tongji Hospital

Wuhan, Hubei, 430030, China

RECRUITING

MeSH Terms

Conditions

Lupus Erythematosus, Systemic; Lupus Nephritis

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Central Study Contacts

Lingli Dong, MD

CONTACT

+862783665519; tjhdongll@163.com

Ziwei Hu, MD

CONTACT

13237100403; 836048369@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Director,Head of rheumatology department

Study Record Dates

• First Submitted: March 5, 2025
• First Posted: March 30, 2025
• Study Start: April 5, 2025
• Primary Completion (Estimated): October 31, 2027
• Study Completion (Estimated): January 10, 2028
• Last Updated: March 30, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Access Criteria: upon reasonable request

Locations

CN (1)