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A Clinical Study Evaluating the Safety and Efficacy of Anti-HER2-CAR-T Cells Injection in Patients With Solid Tumors

NCT06101082 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2024-03-06

No results posted yet for this study

Summary

This is a single-center, open-label clinical study of anti-HER2-CAR-T cells for HER2+ patients with locally advanced and/or metastatic solid tumors. In this study, a single-dose regimen was designed, and the investigator had the discretion to decide whether the patient received more than once CAR T-cell therapy.This study intends to include HER2+ patients with locally advanced and/or metastatic solid tumors.They will take the anti-HER2-CAR-T cell transfusion after a screening period, mononuclear cell (PBMC) collection, bridging therapy if necessary, and lymphocyte clearance pretreatment period.

Conditions

Interventions

BIOLOGICAL

Intravenous infusion anti-HER2-CAR-T cell

Anti-HER2-CAR-T cell is administered as a single intravenous infusion. Follow-up infusions are based on the investigator's decision.The dose group to be infusion was 1×10\^6 CAR-T cells/kg, 3×10\^6 CAR-T cells/kg, and 1×10\^7 CAR-T cells/kg based on the 3+3 dose escalation principle. The infusion dose refers to the number of CAR-positive cells.

Sponsors & Collaborators

  • Shanghai First Song Therapeutics Co., Ltd

    collaborator INDUSTRY

  • China Medical University, China

    lead OTHER

Principal Investigators

  • Zhenning Wang, doctor · The First Affiliated Hospital of China Medical Univeristy

  • Funan Liu, doctor · The First Affiliated Hospital of China Medical Univeristy

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-16
Primary Completion
2026-10-19
Completion
2026-10-19

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06101082 on ClinicalTrials.gov