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

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-70
SponsorTianjin Medical University Cancer Institute and Hospital

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

  • CHT102

    Drug

    CHT 102 : MSLN UCAR-T.

Treatment groups

21 Participants
are divided into 1 treatment group
Group A: CHT102 infusionExperimental treatment 1 intervention

Trial outcomes

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)

Time frame
2 years

Secondary outcomes

1

Objective response rate (ORR)

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

Time frame
At 4 weeks, and overall
2

Disease control rate (DCR)

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

Time frame
At 4 weeks, and overall
3

Progress-free survival(PFS)

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)

Time frame
2 years
4

Overall survival (OS )

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

Time frame
3 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tianjin Medical University Cancer Institute and Hospital

Lead sponsor

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

Collaborator