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NCT06101082

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

Recruiting now Phase 1 Last updated 6 March 2024
What this trial tests

Phase 1 trial testing Intravenous infusion anti-HER2-CAR-T cell in Solid Tumor in 9 participants. Currently enrolling.

Timeline
16 January 2024
Primary endpoint
19 October 2026
19 October 2026

Quick facts

Lead sponsorChina Medical University, China
PhasePhase 1
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment9
Start date16 January 2024
Primary completion19 October 2026
Estimated completion19 October 2026
Sites1 location across China

Drugs / interventions tested

Conditions studied

Sponsor

China Medical University, China

Who can join

Adults 18 to 70, any sex, with Solid Tumor. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Research progress on HER2-specific chimeric antigen receptor T cells for immunotherapy of solid tumors.
    Zhu L, Liu J, Li J, Wang N, et al · · 2025 · cited 3× · PMID 40469307 · DOI 10.3389/fimmu.2025.1514994
  2. CAR-T cell therapy for pancreatic cancer: Translating emerging targets and dual-targeting strategies from solid tumors.
    Shen S, Ruan Z, Jiang B, Qiu W, et al · · 2026 · PMID 42039159 · DOI 10.3389/fimmu.2026.1764452
  3. Glutamate metabotropic receptor 4 in breast cancer: a potential and specific target for chimeric antigen receptor therapy.
    Xu Y, Hayierhan A, Chen Z, Ma Y, et al · · 2025 · PMID 41573636 · DOI 10.3389/fonc.2025.1654977

Verify or expand the search:

Other recruiting trials for Solid Tumor

Currently open trials in the same condition.

Other China Medical University, China trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06101082.

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