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

NCT07255664 | Recruiting Phase 1

• 2 other identifiers: CuraCell-Ger-012025-521227-70-00
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Prostate Cancer Metastatic; Prostate Cancer Locally Advanced; Metastatic Colorectal Cancer

Keywords

mCRC; aPC; TIL; Immunotherapy

Outcome Measures

Primary Outcomes (1)

• Evaluation of safety, tolerability, and feasibility of repeated administrations of the novel ATIMP, CC-38.

  Incidence of treatment-emerged adverse events (TEAE) and the occurrence of severity grade 3 or higher adverse events according to NCI CTCAE v. 5.0; proportion of patient receiving at least two CC-38 administrations without TEAEs preventing CC-38 administrations

  42 months

Secondary Outcomes (1)

• Evaluation of efficacy of repeated administrations of the novel ATIMP CC-38 in patients

  42 months

Study Arms (1)

CC-38 Drug Product

EXPERIMENTAL

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

Drug: CC-38; Drug: Pembrolizumab; Drug: Cyclophosphamid; Drug: Interleukin-2; Drug: Uromitexan

Interventions

CC-38 DRUG

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

CC-38 Drug Product

Pembrolizumab DRUG

A concomitant IMP is pembrolizumab

Also known as: Keytruda

CC-38 Drug Product

Cyclophosphamid DRUG

Cyclophosphamid is used as a AxMP

CC-38 Drug Product

Interleukin-2 DRUG

Interleukin-2 is used as a AxMP.

Also known as: Proleukin S

CC-38 Drug Product

Uromitexan DRUG

Uromitexan is used as a AxMP.

CC-38 Drug Product

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient (female or male) has signed informed consent according to ICH/GCP and national/local regulations prior to any trial-specific procedure.
• Patient is 18 years or older at the time of signing the informed consent form.
• Patient must live in an area where a hospital for care can be reached within a maximum of 50 km.
• Patient has histological or cytological confirmation of:
• colorectal cancer, which is stage IV (any T / any N / M1), not amenable to curative surgery, OR
• prostate cancer, which is stage III locally advanced, not amenable to curative surgery (T3-4 / N0 / M0 or any T / N1 / M0), or stage IV metastatic (any T / any N / M1)
• Patient has received all lines of therapy that
• are considered SOC for the patient's indication according to applicable European/national professional society medical guidelines and local medical practice at time of enrollment
• are available via the national health insurance system and the patient is considered eligible for but led to insufficient response or were medically not justified or refused by the patient.
• Patient has confirmed disease progression by radiologic imaging from the previous line of therapy.
• Patient has sufficient amount of previously not irradiated tumor tissue in adequate quality for TIL harvest and expansion, i.e., either:
• Primary or metastatic lesion has been selected for surgery (e.g., to reduce tumor burden, pain relief), Or
• Patient has consented to surgery for the purpose of tissue harvesting for TIL expansion and is considered suitable to undergo surgery for this purpose. Note: Patients with a non-justifiable anesthesiologic and/or surgical risk, as determined by the investigator, should be excluded
• Patient has a least one measurable or assessable lesion according to RECIST 1.1 remaining after tumor resection for CC-38 manufacturing has been performed.
• Patient has ECOG performance status of 0 or 1.

You may not qualify if:

• Patient as any of the following condition:
• Congestive heart failure NYHA class III or IV,
• myocardial infarction or coronary artery bypass graft within 6 months prior to enrollment,
• history of clinically significant ventricular arrhythmia or unexplained syncope, not believed to be vasovagal in nature or due to dehydration,
• history of severe non-ischemic cardiomyopathy,
• uncontrolled blood pressure as defined as systolic \> 160 mmHg, diastolic \> 100 mmHg within 3 months prior to enrollment,
• left ventricular ejection fraction (LVEF) \< 45% as assessed by echocardiogram or multiple-gated acquisition (MUGA) scan,
• any other clinically significant cardiovascular events such as unstable angina, angioplasty, stroke, or transient ischemic attack (TIA) within less than 6 months before enrolment,
• other conditions that the treating physicians believe may endanger the health of the patients by their participation in this clinical trial.
• Patient has any of the following pulmonary conditions:
• Forced expiratory volume in 1 second (FEV1)\<60%,
• Active obstructive chronic pulmonary disease,
• oxygen dependence as defined by a blood oxygen saturation that can only be maintained above 92% by oxygen inhalation (finger oxygen detection method),
• other pulmonary conditions that increase the anesthesiologic risk.
• Patient has a current or history of central nervous system (CNS) metastatic disease, leptomeningeal disease, or cord compression,

Sponsors & Collaborators

• Frankfurter Institut für Klinische Krebsforschung IKF GmbH: collaborator
• Curacell Holding AB: lead
• Zellwerk GmbH: collaborator
• Krebsforschung Rhein-Main e.V.: collaborator

Study Sites (1)

Krankenhaus Nordwest

Frankfurt, 60488, Germany

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

pembrolizumab; Cyclophosphamide; Interleukin-2; Mesna

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Interleukins; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Lymphokines; Proteins; Biological Factors; Alkanesulfonates; Alkanesulfonic Acids; Alkanes; Hydrocarbons, Acyclic; Sulfhydryl Compounds; Sulfur Compounds; Sulfonic Acids; Sulfur Acids

Study Officials

• Torbjörn Strom

  Curacell Holding AB

  STUDY CHAIR

Central Study Contacts

Dragan Kiselicki, Dr.

CONTACT

0069 7601 4420; probetility@ikf-khnw.de

Sabine Beck, Dr.

CONTACT

0069 7601 4420; probetility@ikf-khnw.de

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2025
• First Posted: December 1, 2025
• Study Start: November 13, 2025
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2029
• Last Updated: December 8, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)