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NCT Number: NCT06760364

A Clinical Study of CHT102 in MSLN-Positive Advanced Pancreatic Cancer

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

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Key information

Conditions

Advanced Pancreatic Cancers

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Tianjin Medical University Cancer Institute & Hospital

Tianjin, China

Location status: Recruiting

Location contact

Jihui Hao, Ph.D

CONTACT

[email protected]

+86-02223340123

Jihui Hao, Ph.D

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CHT102

Drug

CHT 102 : MSLN UCAR-T.

Primary outcomes

  1. 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

  1. Objective response rate (ORR)

    Time frame: At 4 weeks, and overall

    The total response rate after 90 days of treatment with study drug.

  2. Disease control rate (DCR)

    Time frame: At 4 weeks, and overall

    The disease control rate after 90 days of treatment with study drug.

  3. Progress-free survival(PFS)

    Time frame: 2 years

    PFS will be assessed from the first CHT102 infusion to death from any cause or the first assessment of progression (Assessed based on RECIST criteria)

  4. Overall survival (OS )

    Time frame: 3 years

    OS will be assessed from the first CHT102 infusion to death from any cause (Assessed based on RECIST criteria)

  5. pharmacokinetics (PK)

    Time frame: 6 months

    Concentration levels of MSLN+ CAR-T cells

  6. PD

    Time frame: 6 months

    Concentration levels of MSLN U CAR-T-related serum cytokines, such as IL-2, IL-4, IL-6, IL-10, IFN-γ, TNF-α, etal

Study contacts

Contact information is provided by the study sponsor or research team.

Jihui Hao, Ph.D

CONTACT

[email protected]

+86-02223340123

Sponsors and collaborators

Lead sponsor

Tianjin Medical University Cancer Institute and Hospital

Other

Collaborators

  • Nanjing Calmhome Cell and Gene Engineering Institute Co., Ltd.

Registry information

Official study title

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

Acronym: CHAMPION

Important dates

Study start
2024
Primary completion
2027
Study completion
2039
First posted
Jan 6, 2025
Registry last updated
Apr 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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