Phase I/II Study: Allogeneic NK-cell Therapy With Chemotherapy for Post-Surgery PDA or Cholangiocarcinoma Patients
Recruiting
Phase 1
Phase 2
Interventional Study
Pancreatic Carcinoma Stage II
Cholangiocarcinoma Resectable
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 1/2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 42 (estimated)
- Sponsor
- Medigen Biotechnology Corporation · Industry
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About This Trial
This is a phase I/II study which intends to characterize the safety, tolerability, and preliminary efficacy of Allogeneic Magicell-NK infusion in PDA or cholangiocarcinoma patients after surgery. Subjects will receive a total of 6 intravenous (IV) infusions of the IP on the 11th day of each chemotherapy cycle. A total of 6 cycles of IP infusions are planned.
The phase I part of the study is a fir…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Dated and signed informed consent.
2. Either sex, aged older than 18 years old (inclusive) at date of consent.
3. Subject with a macroscopic resection of the primary tumor and residual primary tumor that satisfies all of the items below according to the Union for Internationa…
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