Safety and Efficacy of KSVCBD Injection in Autoimmune Diseases

NCT07613411 | Not Yet Recruiting Early Phase 1

• 1 other identifier: KSVCBD-R102
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

KSVCBD injection is an in vivo Chimeric Antigen Receptor T-Cell (CAR-T cell) therapy product. This single-arm, open-label, early exploratory clinical study is designed to evaluate the safety and preliminary efficacy of KSVCBD injection in patients with Autoimmune Diseases.

Conditions

Autoimmune Diseases

Keywords

Autoimmune Diseases; Immunotherapy

Outcome Measures

Primary Outcomes (4)

• Dose limited toxicity (DLT)

  DLT is defined as any of the following adverse events (AEs) related to KSVCBD infusion occurring within 28 days after KSVCBD infusion (CRS and ICANS will be graded according to the ASTCT 2019 criteria, and other AEs will be evaluated using CTCAE v6.0).

  Within 28 days post-infusion

• Adverse events (AEs) and serious adverse events (SAEs)

  Incidence and severity of AEs and SAEs

  Within 24 months post-infusion

• Adverse events of special interest (AESI)

  Incidence and severity of AESIs.AESI including grade ≥3 Cytokine Release Syndrome (CRS), Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS), and infections.

  Within 24 months post-infusion.

• Recommended Phase 2 Dose (RP2D)

  Within 24 months post-infusion

Study Arms (1)

Autoimmune Diseases

EXPERIMENTAL

Drug: KSVCBD injection

Interventions

KSVCBD injection DRUG

KSVCBD injection is an in vivo CAR-T therapy targeting CD19/BCMA and is administered by IV infusion.

Autoimmune Diseases

Eligibility Criteria

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

You may qualify if:

• Age 18-65 years (inclusive), any gender.
• Subjects diagnosed with the following autoimmune disease: moderate/severe refractory Systemic Lupus Erythematosus, elapsed/refractory Systemic Sclerosis, relapsed/refractory ANCA-Associated Vasculitis, refractory Idiopathic Inflammatory Myopathy, active Sjögren's Syndrome, chronic/refractory Immune Thrombocytopenia, refractory Antiphospholipid Syndrome, relapsed/refractory pemphigus, relapsed/refractory IgG4-Related Disease.
• Having adequate organ function as required by the protocol.:
• Voluntarily adhere to the contraception requirements as specified in the protocol.
• Willing to comply with all study procedures and voluntarily participate in this study and sign the informed consent form (ICF).

You may not qualify if:

• Previous or current active malignancy, including patients with cancer-associated polymyositis/dermatomyositis. Exceptions are cured or relapse-free for at least 3 years: cervical carcinoma in situ, non-invasive basal cell or squamous cell skin cancer, locally advanced prostate cancer after radical treatment, or ductal carcinoma in situ after radical surgery.
• Severe pulmonary disease within the past 1 year, such as moderate/severe pulmonary arterial hypertension (pulmonary artery systolic pressure \>50 mmHg on echocardiography), requirement for oxygen therapy via reservoir mask or non-invasive/invasive ventilator support at screening.
• Use of any of the protocol specified drugs or treatments within the specified timeframes.
• History or current symptoms of severe central nervous system (CNS) disease within the past 6 months.
• Known severe allergy to the study drug or any of its components.
• Presence of uncontrolled fungal, bacterial, or viral infection, or other infections considered by the investigator to make the subject unsuitable for participation.
• History of major organ transplant or hematopoietic stem cell/bone marrow transplantation.
• History of other autoimmune diseases requiring systemic treatment, other than the target indication.
• History of non-IIM conditions such as drug induced myopathy, HIV associated myopathy, thyroid myopathy, or family history of myopathy.
• Pregnant or breastfeeding women.
• Use of any live vaccines within 6 weeks before enrollment.
• Participation in another interventional clinical study and receipt of an active investigational drug within 3 months prior to signing the ICF, or intention to participate in another clinical trial or receive treatment for autoimmune diseases outside the protocol during the entire study period.
• Psychiatric disorders with depression or suicidal tendencies.
• Any other factors considered by the investigator to make the subject unsuitable for enrollment or to affect the subject's participation or completion of the study.

Sponsors & Collaborators

• Chinese PLA General Hospital: lead

Study Sites (1)

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100853, China

Location

MeSH Terms

Conditions

Autoimmune Diseases

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Officials

• Jian Zhu

  Rheumatology Department of Chinese PLA General Hospital

  PRINCIPAL INVESTIGATOR

• Weidong Han

  Biotherapeutic Department of Chinese PLA General Hospital

  PRINCIPAL INVESTIGATOR

• Yang Liu

  Biotherapeutic Department of Chinese PLA General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jian Zhu, M.D.

CONTACT

+86-010-55499314; jian_jzhu@126.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: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician and Professor

Study Record Dates

• First Submitted: May 22, 2026
• First Posted: May 29, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): March 31, 2029
• Last Updated: May 29, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)