Status:
NOT_YET_RECRUITING
CD318-targeted CAR-T Cell Therapy in Patients With Pancreatic Cancer (ResCPa)
Lead Sponsor:
University Hospital Tuebingen
Collaborating Sponsors:
University Hospital Freiburg
Technical University of Munich
Conditions:
Carcinoma, Pancreatic Ductal
Pancreatic Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
Pancreatic ductal adenocarcinoma (PDAC) is one of the most lethal cancers, with limited therapeutic options and a five-year survival rate below 10 % in advanced stages. Standard treatments, such as mu...
Detailed Description
Pancreatic ductal adenocarcinoma (PDAC) is one of the most lethal malignancies, with a steadily increasing incidence and a poor prognosis. Standard chemotherapy regimens such as FOLFIRINOX or gemcitab...
Eligibility Criteria
Inclusion
- Age ≥ 18 years at the time of informed consent
- Histologically confirmed PDAC (metastatic or locally advanced, unresectable)
- Measurable disease according to RECIST v1.1
- Disease progression during or after at least one prior line of systemic standard therapy for advanced PDAC
- CD318 expression in tumor tissue confirmed by central immunohistochemistry (IHC)
- ECOG performance status of 0 or 1
- Adequate bone marrow, renal, and hepatic function as defined in the protocol
- Life expectancy of at least 12 weeks
- Willingness and ability to comply with study procedures and follow-up
- Written informed consent obtained prior to any study-specific procedures-
Exclusion
- Prior treatment with CAR T cells or other genetically modified cell therapies
- Active uncontrolled infection, including active hepatitis B or C infection or HIV infection
- Known symptomatic or untreated central nervous system (CNS) metastases
- Clinically significant cardiovascular disease, including recent myocardial infarction (within 6 months), unstable angina, or uncontrolled arrhythmia
- History of autoimmune disease requiring systemic immunosuppressive therapy
- Current or recent (within 4 weeks) participation in another interventional clinical trial
- Pregnant or breastfeeding women
- Any condition that, in the opinion of the investigator, would interfere with the patients ability to comply with study requirements or would compromise safety
Key Trial Info
Start Date :
July 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2028
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT07153289
Start Date
July 1 2026
End Date
December 1 2028
Last Update
September 3 2025
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