NCT07255664

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

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Curacell Holding AB · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

T-cell therapies have demonstrated successful responses in solid tumors, most frequently studied in malignant melanomas. In the present trial, we include patients with metastatic colorectal cancer and metastatic prostate cancer, two cancer forms that have not been well studied in T-cell therapy studies, yet. In the ProbeTILity trial we hypothesize that in patients with metastatic CRC or metastatic prostate cancer ex vivo expansion of repeated re-administration of TIL establishes a more long-term persistence of TILS in the patient´s blood stream, that could increase the likelihood of tumor infiltration by TILs.

Conditions

• Metastatic Colorectal Cancer
• Prostate Cancer Metastatic
• Prostate Cancer Locally Advanced

Interventions

Type	Name	Description
DRUG	CC-38	CC-38 drug product is an autologous ATIMP composed of in vitro expanded tumor-infiltrating T-lymphocytes.
DRUG	Pembrolizumab	A concomitant IMP is pembrolizumab
DRUG	Cyclophosphamid	Cyclophosphamid is used as a AxMP
DRUG	Interleukin-2	Interleukin-2 is used as a AxMP.
DRUG	Uromitexan	Uromitexan is used as a AxMP.

Timeline

• Start date: 2025-11-13
• Primary completion: 2027-04-01
• Completion: 2029-04-01
• First posted: 2025-12-01
• Last updated: 2025-12-08

Locations

1 site across 1 country: Germany