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Clinical Trials/NCT06760364
NCT06760364RecruitingPhase 1

A Single-Arm, Open-Label, Phase I Study of CHT102 for MSLN-Positive Advanced Pancreatic Cancer

Tianjin Medical University Cancer Institute and Hospital1 site in 1 country21 target enrollmentStarted: December 25, 2024Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Recruiting
Enrollment
21
Locations
1
Primary Endpoint
Safety and Tolerability

Study Overview

Brief Summary

Evaluate the safety and efficacy of mesothelin-targeting UCAR-T cells in the treatment of mesothelin-positive advanced pancreatic cancer

Detailed Description

3 planned dose cohorts will be evaluated during dose escalation phase. The dose expansion will be initiated after SRC (safety review committee) review the avaliable safety, PK and preliminary efficacy data.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 70 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Ability to understand and sign a written informed consent documen;
  • At the date of signing ICF, 18 ~70 years old, male or female;
  • Histopathological confirmed advanced or metastatic pancreatic cancer patients who have failed to standard treatment or intolerance with standard treatment;
  • Positive mesothelin expression;
  • At least one measurable lesion at baseline per RECIST version 1.1;
  • The expected survival time is more than 12 weeks;
  • ECOG 0-1 points;
  • Adequate organ functions.

Exclusion Criteria

  • Not provided

Arms & Interventions

CHT102 infusion

Experimental

CHT102 will be dosing by arterial infusion.

Intervention: CHT102 (Drug)

Outcomes

Primary Outcomes

Safety and Tolerability

Time Frame: 2 years

Treatment-related adverse events were recorded and assessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0)

Secondary Outcomes

  • pharmacokinetics (PK)(6 months)
  • PD(6 months)
  • Progress-free survival(PFS)(2 years)
  • Disease control rate (DCR)(At 4 weeks, and overall)
  • Objective response rate (ORR)(At 4 weeks, and overall)
  • Overall survival (OS )(3 years)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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