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New treatment option for Metastatic Colorectal Cancer
Official title A FIH, Phase I/IIa, Trial Assessing Feasibility of Administrations of TIL-based Immunotherapy in Patients With Metastatic CRC and PC
ClinicalTrials.gov ID: NCT07255664
What this study is testing
What is CC-38?
CC-38 is an investigational medicine, being studied as a potential treatment for metastatic colorectal cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a First-In-Human trial investigating a novel expansion protocol of an ATIMP (CC-38), composed of autologous TIL.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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
You likely can't join 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,
See the full eligibility criteria
Who can join
- 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...
- 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.
- Patient has a minimum life expectancy of 6 months in the opinion of the investigator from the time of consent date.
- Patient has adequate bone marrow, hepatic and renal function in the opinion of the investigator:
- Hemoglobin ≥ 9.0 g/dL,
- Absolute neutrophil count (ANC) ≥ 1.0 x 109 /L,
- Platelets ≥ 80 x 109 /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 [unconjugated hyperbilirubinemia] 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,
- International normalized ration (INR) ≤ 1.5 or prothrombin time (PT) ≤ ULN + 4 seconds.
- Female patients must be post-menopausal or use contraceptive methods with a failure rate of \< 1% 6 months after last administration of CC-38, whatever is later, to prevent pregnancy. Male patients with fertile female...
- Successful tumor tissue sampling by surgery, including presence of TILs in the tumor tissue in the pathological evaluation.
- Successful TIL expansion defined as obtaining the final CC-38 drug product
What rules you out
- 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,
- Patient has ulcers in the upper GI tract, untreated or incompletely treated esophageal varices with high risk of bleeding in the investigator's discretion.
- Patient requiring therapeutic anticoagulant therapy or having other increased risk of bleeding events.
- Patient has any severe acute or chronic medical condition that places the patient at increased risk or interferes with the interpretation of trial results in the opinion of the investigator.
- Patient has any form of primary immunodeficiency (such as severe combined immunodeficiency disease [SCID] and acquired immune deficiency syndrome [AIDS]).
- Patient has active or history of autoimmune or inflammatory disorders. Note: Patients may be eligible if they have been assessed in discussion between Principal Investigator, Chief Medical Officer and Senior Medical...
- Patient receiving immunosuppressive concomitant medications (≥ 10 mg prednisone daily or other equivalent). Steroid medications are allowed if they are used as substitution or are administrated topically or as...
- Patient has received an organ and/or allogenic stem cell transplant.
- Patient has known acute or chronic infection with hepatitis B or C virus.
- Patient has known HIV infection (seropositive for HIV antibody).
- Patient has known infection with syphilis.
- Patient has known bone-marrow aplasia.
- Patient has known (chronical) urinary tract infection and/ or acute urothelial toxicity from previous cytotoxic chemotherapy or radiation therapy or urinary flow obstructions.
- Female patient, who is pregnant or breast-feeding, or plan to become pregnant within 12 months after cyclophosphamide or 6 months after last dose of CC-38, whichever last. Women of childbearing potential must have a...
- Patient is unable to comply with trial procedures, restrictions, or requirements.
- Patient received last previous systemic cancer treatment (including anti-testosterone treatment) within less than 4 weeks prior enrollment. Note: Bridging therapies (specified in trial design [section 2 - subsection...
- Patient received last palliative radiotherapy within less than 4 weeks prior enrollment - where RECIST 1.1 evaluable metastases are within the radiation area.
- Patient received minor surgery (as judged by the investigator, i.e., port implantation) within less than 3 weeks prior enrollment.
- Patient with AEs from previous treatment that have not recovered to CTCAE v5.0 ≤ grade 1 Note: Clinically insignificant grade 2 AEs that may be allowable if discussed between and approved by Principal Investigator...
- Patient participates in any other treatment clinical trial or has been treated with any investigational research products within 4 weeks prior to the initiation of screening.
- Patient has bone metastasis only.
- Patient has known hypersensitivity to any component of the trial regimen.
- For colorectal cancer: Patient has been diagnosed with histologically or cytologically proven BRAF-V600 positive CRC.
- Patient has any further contraindication to the IMP pembrolizumab or any of the auxiliary medicinal products (i.e., IL-2, cyclophosphamide, uromitexan) as per current EU SmPCs to the respective product.
The study team makes the final eligibility decision.
Where it's taking place
- Frankfurt, Germany
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Frankfurt, Germany. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.