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

Sponsor
CuraCell TX AB
Study ID
NCT07255664
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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

Key Dates

First listed
Dec 1, 2025
Start date
Nov 13, 2025
Status verified
Jun 2026
Primary completion
Apr 30, 2027
Completion
Apr 30, 2029

Study Design

Enrollment
12 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: CC-38 Drug Product
    The advanced therapy investigational medicinal product (ATIMP) of this trial is an autologous tumor infiltrating lymphocytes (TIL)/ personalized TIL administration (product name CC-38).

Primary Outcome Measure

Evaluation of safety, tolerability, and feasibility of repeated administrations of the novel ATIMP, CC-38. [ Time Frame: 42 months ]

Central Contacts

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