NCT06760364

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

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

Enrollment
21

participants targeted

Target at P25-P50 for phase_1

Timeline
166mo left

Started Dec 2024

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress9%
Dec 2024Dec 2039

Study Start

First participant enrolled

December 25, 2024

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

December 29, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 6, 2025

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 24, 2027

Expected
12 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 24, 2039

Last Updated

April 10, 2025

Status Verified

November 1, 2024

Enrollment Period

3 years

First QC Date

December 29, 2024

Last Update Submit

April 7, 2025

Conditions

Advanced Pancreatic Cancers

Keywords

Allogeneic CAR-TSafetyEfficacyPK

Outcome Measures

Primary Outcomes (1)

  • Safety and Tolerability

    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)

    2 years

Secondary Outcomes (6)

  • Objective response rate (ORR)

    At 4 weeks, and overall

  • Disease control rate (DCR)

    At 4 weeks, and overall

  • Progress-free survival(PFS)

    2 years

  • Overall survival (OS )

    3 years

  • pharmacokinetics (PK)

    6 months

  • +1 more secondary outcomes

Study Arms (1)

CHT102 infusion

EXPERIMENTAL

CHT102 will be dosing by arterial infusion.

Drug: CHT102

Interventions

CHT102DRUG

CHT 102 : MSLN UCAR-T.

CHT102 infusion

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tianjin Medical University Cancer Institute & Hospital

Tianjin, China

RECRUITING

Central Study Contacts

Jihui Hao, Ph.D

CONTACT

+86-02223340123haojihui@tjmuch.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 29, 2024

First Posted

January 6, 2025

Study Start

December 25, 2024

Primary Completion (Estimated)

December 24, 2027

Study Completion (Estimated)

December 24, 2039

Last Updated

April 10, 2025

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)