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

Phase 1

Recruiting

• Conditions: Advanced Pancreatic Cancers
• Interventions: Drug: CHT102

• Registration Number: NCT06760364
• Lead Sponsor: Tianjin Medical University Cancer Institute and Hospital

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 Timeline

• Status Verified: 2024-11
• Study Start: 2024-12-25
• Study First Submitted: 2024-12-29
• Study First Submitted QC: 2024-12-29
• Study First Posted: 2025-01-06
• Last Update Submitted: 2025-04-07
• Last Update Posted: 2025-04-10
• Primary Completion: 2027-12-24
• Study Completion: 2039-12-24

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 21

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CHT102 infusion	CHT102	CHT102 will be dosing by arterial infusion.

Primary Outcome Measures

Name	Time	Method
Safety and Tolerability	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 Outcome Measures

Name	Time	Method
pharmacokinetics (PK)	6 months	Concentration levels of MSLN+ CAR-T cells
PD	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
Progress-free survival(PFS)	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)
Disease control rate (DCR)	At 4 weeks, and overall	The disease control rate after 90 days of treatment with study drug.
Objective response rate (ORR)	At 4 weeks, and overall	The total response rate after 90 days of treatment with study drug.
Overall survival (OS )	3 years	OS will be assessed from the first CHT102 infusion to death from any cause (Assessed based on RECIST criteria)

Trial Locations

Locations (1)

Tianjin Medical University Cancer Institute & Hospital; 🇨🇳 Tianjin, China