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CDH17 CAR-T Therapy in Advanced Malignant Solid Tumors

NCT06937567 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2025-04-22

No results posted yet for this study

Summary

The investigational product used in this study, UCLH801 cells, is a CAR-T cell therapy specifically targeting CDH17. The proposed indication includes CDH17-positive advanced solid tumors, such as but not limited to colorectal cancer, gastric cancer, pancreatic cancer, biliary tract tumors, neuroendocrine tumors, ovarian cancer, and lung cancer. The primary objective of this study is to evaluate the safety and tolerability of UCLH801 cells in patients with CDH17-positive advanced malignant solid tumors. The secondary objectives include assessing the preliminary efficacy of UCLH801 cells, their pharmacokinetics and pharmacodynamics in the body, and their immunogenicity.

This study aims to observe how the infusion of UCLH801 cells affects patients 's body, including any discomfort or changes in laboratory test results. Additionally, it will evaluate whether UCLH801 cells have any effect on tumor. Furthermore, the study will investigate how UCLH801 cells are metabolized; the mechanisms through which they exert their effects, and how to develops any immune response or rejection against UCLH801 cells.

Conditions

  • Biliary Tract Cancer
  • Colorectal Carcinoma
  • Gastric Cancer, Metastatic
  • Pancreatic Adenocarcinoma (Ductal Adenocarcinoma)
  • Multiple Cancer

Interventions

BIOLOGICAL

CDH17 CAR-T

The initial dose of cell therapy in this clinical study was set at 1.0×106/Kg and the maximum dose was set at 6.0×106/Kg.

Sponsors & Collaborators

  • UTC Therapeutics Inc.

    collaborator INDUSTRY

  • Zhejiang University

    lead OTHER

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
2024-12-26
Primary Completion
2026-09-30
Completion
2027-01-31

Countries

  • China

Study Locations

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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 NCT06937567 on ClinicalTrials.gov