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OncoMatch/Clinical Trials/NCT07255664

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

Is NCT07255664 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments for metastatic colorectal cancer.

Phase 1/2RecruitingCuracell Holding ABNCT07255664Data as of May 2026

Treatment: CC-38 · Pembrolizumab · Cyclophosphamid · Interleukin-2 · UromitexanThis is a First-In-Human trial investigating a novel expansion protocol of an ATIMP (CC-38), composed of autologous TIL.

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Extracted eligibility criteria

Cancer type

Colorectal Cancer

Prostate Cancer

Biomarker criteria

Excluded: BRAF V600 mutation

For colorectal cancer: Patient has been diagnosed with histologically or cytologically proven BRAF-V600 positive CRC.

Disease stage

Required: Stage IV, III

colorectal cancer, which is stage IV (any T / any N / M1), not amenable to curative surgery; 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)

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Must have received: standard of care therapy — all lines considered SOC for the patient's indication according to guidelines and local practice

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 ... led to insufficient response or were medically not justified or refused by the patient.

Cannot have received: systemic cancer treatment

Patient received last previous systemic cancer treatment (including anti-testosterone treatment) within less than 4 weeks prior enrollment.

Cannot have received: palliative radiotherapy

Exception: where RECIST 1.1 evaluable metastases are within the radiation area

Patient received last palliative radiotherapy within less than 4 weeks prior enrollment - where RECIST 1.1 evaluable metastases are within the radiation area.

Cannot have received: minor surgery

Patient received minor surgery (as judged by the investigator, i.e., port implantation) within less than 3 weeks prior enrollment.

Cannot have received: investigational research products

Patient participates in any other interventional clinical trial or has been treated with any investigational research products within 4 weeks prior to the initiation of screening.

Lab requirements

Blood counts

Hemoglobin ≥ 9.0 g/dL; Absolute neutrophil count (ANC) ≥ 1.0 x 10^9 /L; Platelets ≥ 80 x 10^9 /L

Kidney function

Calculated creatinine clearance ≥ 50 mL/min (Cockcroft-Gault formula)

Liver function

Serum bilirubin ≤ 1.5 x ULN (or ≤ 2.5 x ULN in the presence of documented Gilbert's Syndrome or liver metastases); AST/ALT and alkaline phosphatase ≤ 2.5 x ULN (or ≤5 times ULN in the presence of bone and/or liver metastases), ALP ≤ 2.5 x ULN

Cardiac function

International normalized ratio (INR) ≤ 1.5 or prothrombin time (PT) ≤ ULN + 4 seconds; LVEF ≥ 45%

Patient has adequate bone marrow, hepatic and renal function in the opinion of the investigator: Hemoglobin ≥ 9.0 g/dL, ANC ≥ 1.0 x 10^9 /L, Platelets ≥ 80 x 10^9 /L, Calculated creatinine clearance ≥ 50 mL/min (Cockcroft-Gault formula), Serum bilirubin ≤ 1.5 x ULN (or ≤ 2.5 x ULN in the presence of documented Gilbert's Syndrome or liver metastases), AST/ ALT and alkaline phosphatase ≤ 2.5 x ULN (or ≤5 times ULN in the presence of bone and/or liver metastases), ALP ≤ 2.5 x ULN, INR ≤ 1.5 or PT ≤ ULN + 4 seconds.

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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