NCT06762119

Brief Summary

The purpose of this study is to assess the safety and efficacy of CAR-T cell therapy in Subjects with autoimmune diseases.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for early_phase_1

Timeline
19mo left

Started Jan 2025

Typical duration for early_phase_1

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress46%
Jan 2025Nov 2027

First Submitted

Initial submission to the registry

January 1, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 7, 2025

Completed
3 days until next milestone

Study Start

First participant enrolled

January 10, 2025

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 5, 2027

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2027

Last Updated

January 7, 2025

Status Verified

January 1, 2025

Enrollment Period

2.6 years

First QC Date

January 1, 2025

Last Update Submit

January 1, 2025

Conditions

Autoimmune Diseases

Outcome Measures

Primary Outcomes (2)

  • Dose Limiting Toxicity

    0~28 day after treatment

  • Frequency of AEs, SAEs

    0 day to 24 months after treatment

Study Arms (1)

CAR-T treatment

EXPERIMENTAL
Drug: CAR-T cell

Interventions

CAR-T cellDRUG

CAR-T cell

CAR-T treatment

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female, between 18 and 65 years old;
  • Diagnosed with Autoimmune Diseases, such as Systemic Lupus Erythematosus, Systemic Sclerosis, Idiopahic Inflammatory Myopathies, Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis, Sjögren's Syndrome, Antiphospholipid Syndrome, Immune Thrombocytopenia；
  • Good organ functions;
  • Voluntary participates this trial and can comprehend and sign ICF.

You may not qualify if:

  • Had or has active malignancy;
  • Had been subjected to treatment by CD19 targeted therapy or CAR-T therapy or any gene therapy;
  • Combined with other autoimmune disease that needs treatment;
  • Pregnant or lactating women;
  • Has other factors that deemed not suitable by investigator.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

First Affiliated Hospital of Zhejiang University

Hangzhou, China

Location

MeSH Terms

Conditions

Autoimmune Diseases

Interventions

Immunotherapy, Adoptive

Condition Hierarchy (Ancestors)

Immune System Diseases

Intervention Hierarchy (Ancestors)

Adoptive TransferImmunization, PassiveImmunizationImmunotherapyImmunomodulationBiological TherapyTherapeuticsImmunologic TechniquesInvestigative Techniques

Central Study Contacts

He Huang, MD/PhD

CONTACT

+（86）0571-87236703hehuangyu@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
Professor

Study Record Dates

First Submitted

January 1, 2025

First Posted

January 7, 2025

Study Start

January 10, 2025

Primary Completion (Estimated)

August 5, 2027

Study Completion (Estimated)

November 15, 2027

Last Updated

January 7, 2025

Record last verified: 2025-01

Locations

CN(1)