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

Tianjin Medical University

Status and phase: Enrolling; Phase 1

Conditions: Advanced Pancreatic Cancers

Treatments: Drug: CHT102

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06760364

CHT102SIIT-02

Details and patient eligibility

About

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

Full 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.

Enrollment: 21 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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21 participants in 1 patient group

CHT102 infusion

Experimental group

Description:

CHT102 will be dosing by arterial infusion.

Treatment:

Drug: CHT102