Treatment of advanced pancreatic cancer using CHT102
A Single-Arm, Open-Label, Phase I Study of CHT102 for MSLN-Positive Advanced Pancreatic Cancer
This study is testing a new CAR-T cell therapy called CHT102 to see if it can safely help people with advanced pancreatic cancer.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 21 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Tianjin Medical University Cancer Institute and Hospital Academic / other |
| Locations | 1 site (Tianjin) |
| Trial ID | NCT06760364 on ClinicalTrials.gov |
What this trial studies
This clinical study evaluates the safety and efficacy of CHT102, an allogeneic CAR-T cell therapy targeting mesothelin, in patients with advanced pancreatic cancer. The study consists of a dose escalation phase with three planned cohorts, followed by a dose expansion phase after a safety review. Participants will be monitored for safety, pharmacokinetics, and preliminary efficacy data throughout the trial.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 70 with histopathologically confirmed advanced or metastatic pancreatic cancer that expresses mesothelin and who have failed or are intolerant to standard treatments.
Not a fit: Patients with pancreatic cancer that does not express mesothelin or those who have not failed standard treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced pancreatic cancer who have not responded to standard treatments.
How similar studies have performed: While CAR-T cell therapies have shown promise in other cancers, this specific approach targeting mesothelin in pancreatic cancer is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / 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.
Where this trial is running
Tianjin
- Tianjin Medical University Cancer Institute & Hospital — Tianjin, China (Recruiting)
Study contacts
- Study coordinator: Jihui Hao, Ph.D
- Email: haojihui@tjmuch.com
- Phone: +86-02223340123
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.