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

NCT07255664 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2025-12-08

No results posted yet for this study

Summary

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

Conditions

Interventions

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.

Sponsors & Collaborators

  • Zellwerk GmbH

    collaborator UNKNOWN

  • Frankfurter Institut für Klinische Krebsforschung IKF GmbH

    collaborator UNKNOWN

  • Krebsforschung Rhein-Main e.V.

    collaborator UNKNOWN

  • Curacell Holding AB

    lead INDUSTRY

Principal Investigators

  • Torbjörn Strom · Curacell Holding AB

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-13
Primary Completion
2027-04-30
Completion
2029-04-30

Countries

  • Germany

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07255664 on ClinicalTrials.gov