TIL CELLS for High-grade epithelial ovarian carcinoma | Fallopian tube carcinoma | Primary peritoneal carcinoma

Inclusion criteria

• {"criterion_text":"- Adults ≥18 years of age on the day of signing the ICF. Follow local regulatory requirements if the legal age of consent for trial participation is >18 years old.\n- Participants of reproductive/childbearing potential must agree to use a highly effective form of contraception or avoid intercourse during trial intervention and for at least 7 months after the last dose of trial intervention\n- Has histologically confirmed diagnosis of epithelial high-grade ovarian, fallopian tube, or primary peritoneal carcinoma (serous, endometrioid, clear cell, carcinosarcoma, or mucinous)\n- Is newly diagnosed FIGO Stage III (extension cohort only) or IV.\n- Is a deemed candidate/eligible to neoadjuvant carboplatin end paclitaxel per standard of care and Investigator discretion (not deemed candidates for upfront surgery/ PDS) are eligible.\n- Possibility to upfront collect tumor tissue for TIL isolation and expansion\n- Presence of measurable progressive disease according to RECIST version 1.1 or elevated CA125>2 times the upper normal limit (UNL) within 3 months and confirmed\n- Has an ECOG PS of 0 or 1.\n- Within the last 4 weeks prior to study day 0, vital laboratory parameters should be within normal range, except for the following laboratory parameters, which should be within the ranges specified: Hemoglobin ≥ 6,0 mmol/l , Granulocytes ≥ 1,500/μl, Lymphocytes ≥ 700/μl, Platelets ≥ 100,000/μl, Creatinine clearance ≥ 50 min/ml,Serum bilirubin ≤ 40 mol/l, ASAT and ALAT ≤ 5 x the normal upper limit, • Viral tests: - Negative for HIV type 1/2, HTLV and TPHA - No HBV (hepatitis B virus) antigen or antibodies against HBc in the serum - No antibodies against HCV (hepatitis C virus) in the serum\n- Able and willing to give valid written informed consent."}

Exclusion criteria

• {"criterion_text":"- Patients with brain metastases\n- Serious acute or chronic illnesses, e.g. significant heart disease (NYHA Class III or IV), active infections requiring antibiotics, bleeding disorders, or other conditions requiring concurrent medications not allowed during this study.\n- Active immunodeficiency disease or autoimmune disease requiring immune suppressive drugs. Vitiligo is not an exclusion criterion.\n- Other active malignancy within 2 years prior to entry into the study, except for treated non-melanoma skin cancer or curatively treated in-situ disease.\n- Mental impairment that may compromise the ability to give informed consent and comply with the requirements of the study.\n- Lack of availability for follow-up assessments\n- Pregnancy or breastfeeding"}

Primary endpoints

• {"endpoint_text":"- mmunotherapy related grade III/IV NCI-CTC toxicity","definition_or_measurement_approach":"Assessment of immunotherapy-related toxicity using NCI CTCAE v5.0 (toxicity grade > III) to determine dose-limiting toxicities and recommended phase II dose."}

Secondary endpoints

• {"endpoint_text":"- All grade NCI CTC toxicity","definition_or_measurement_approach":"Safety assessment according to NCI CTCAE v5.0 (all grades)."}
• {"endpoint_text":"- CD8/CD4/MDSC, M1/2, Treg","definition_or_measurement_approach":"Immune monitoring including assessment of T cell and myeloid cell subsets and TCR clonotypes (immune monitoring as a secondary objective)."}

Netherlands

Earliest CTIS Part Ii Submission Date

01-12-2025

Latest Decision Or Authorization Date

03-12-2025

Processing Time Days

2

Number Of Sites

1

Number Of Participants

30

Primary sponsor

Full Name

Leids Universitair Medisch Centrum (LUMC)

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Netherlands