RecruitingPhase 1Phase 2NCT07255664

A FIH, Phase I/IIa, Trial Assessing Feasibility of Administrations of TIL-based Immunotherapy in Patients With Metastatic CRC and PC

A FIH, Phase I/IIa, Open-label Trial Assessing Safety, Tolerability, and Feasibility of Repeated Administrations of a Novel Autologous TIL-based Immunotherapy in Patients With Metastatic Colorectal or Prostate Cancer


Sponsor

Curacell Holding AB

Enrollment

12 participants

Start Date

Nov 13, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This is a First-In-Human trial investigating a novel expansion protocol of an ATIMP (CC-38), composed of autologous TIL.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This first-in-human study tests a new type of immunotherapy that uses tumor-infiltrating lymphocytes (TILs) — immune cells extracted from a patient's own tumor, grown in large numbers, and given back to the patient to fight the cancer — for people with metastatic colorectal cancer or pancreatic cancer that has spread. **You may be eligible if...** - You are 18 or older - You have metastatic colorectal or pancreatic cancer - You live close enough to a qualified hospital to receive treatment and monitoring - Your cancer has progressed despite prior treatments - You meet health and organ function requirements **You may NOT be eligible if...** - You have active autoimmune disease or are on immunosuppressive medications - You have brain metastases - You have serious heart, lung, or kidney problems - You have active infections Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCC-38

CC-38 drug product is an autologous ATIMP composed of in vitro expanded tumor-infiltrating T-lymphocytes.

DRUGPembrolizumab

A concomitant IMP is pembrolizumab

DRUGCyclophosphamid

Cyclophosphamid is used as a AxMP

DRUGInterleukin-2

Interleukin-2 is used as a AxMP.

DRUGUromitexan

Uromitexan is used as a AxMP.


Locations(1)

Krankenhaus Nordwest

Frankfurt, Germany

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NCT07255664


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