A phase 2, Multicenter Study of TILs Treatment in Advanced Tumors with Alterations in the SWI/SNF Complex: the TILTS Study
- Conditions
- Advanced solid tumorsMedDRA version: 21.1Level: LLTClassification code: 10065147Term: Malignant solid tumor Class: 10029104Therapeutic area: Diseases [C] - Neoplasms [C04]
- Registration Number
- CTIS2023-504632-17-00
- Lead Sponsor
- Fundacio Institut D Investigacio Biomedica De Bellvitge IDIBE
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 11
3.All patients must have a pathologically confirmed diagnosis of solid tumors associated with SWI/SNFc-mutated monogenic diseases. These solid tumors include, but are not limited to: -Epithelioid sarcoma -Malignant rhabdoid tumor -Small cell carcinoma of the ovary, hypercalcemic type (SCCOHT) -Renal medullary carcinoma -Epithelioid malignant peripheral nerve sheath tumor (EMPNST) -Myoepithelial carcinoma -Extra-skeletal myxoid chondrosarcoma -Poorly differentiated chordoma -Sinonasal basaloid carcinoma, 4. Patients must have a measurable disease as defined by RECIST 1.1: -Lesions in previously irradiated areas should not be selected as target lesions unless there has been demonstrated progression in those lesions. -Lesions that are partially resected for TIL generation that are still measurable per RECIST may be selected as target lesions, 11.Patients must have a washout period from prior anticancer therapy(ies) of a minimum duration, as detailed below prior to the first study treatment (ie, start of NMA-LD). - Chemotherapy: adjuvant, neoadjuvant or definitive chemotherapy/ chemoradiation is allowed provided the washout is a minimum of 21 days, prior to the start of treatment. - Prior immunotherapy, checkpoint-targeted therapy, other monoclonal antibodies (mAbs), or vaccines are allowed if disease progression is confirmed prior to or within the washout period of =21 days prior to the start of NMA-LD, 12.Palliative radiation therapy: prior external beam radiation is allowed at least 2 weeks before TILs infusion provided all radiation-related toxicities are resolved to Grade 1 or baseline, excluding alopecia, skin pigmentation change, or other clinically insignificant events, eg, small area radiation dermatitis or rectal or urinary urgency.
1.Patients who have received an organ allograft or prior cell transfer therapy that included a nonmyeloablative or myeloablative chemotherapy regimen within the past 20 years, 2.Patients with symptomatic and/or untreated brain metastases: - Patients with definitively-treated brain metastases will be considered for enrollment if, prior to the start of treatment the patient is clinically stable for = 2 weeks, there are no new brain lesions via magnetic resonance imaging (MRI) post-treatment, and the patient does not require ongoing corticosteroid treatment., 3.Patients requiring regular treatment with steroids at a dose higher than prednisone 10mg/day (or equivalent), 6.Patients may not have active or prior documented autoimmune or inflammatory disorders (including pneumonitis, inflammatory bowel disease [eg, colitis or Crohn’s disease], diverticulitis [with the exception of diverticulosis], systemic lupus erythematosus, sarcoidosis syndrome, or Wegener syndrome [granulomatosis with polyangiitis, Graves’ disease, rheumatoid arthritis, hypophysitis, uveitis, etc.])., 9.Patients with a history of hypersensitivity to any of the folowing drugs including, but not limited to, the components of the study drugs and any component of TIL product formulation: -NMA-LD (cyclophosphamide, mesna, and fludarabine) -Proleukin®, aldesleukin, IL-2 -Antibiotics of the aminoglycoside group (ie, streptomycin, gentamicin [excluding those who are skin-test negative for gentamicin hypersensitivity]) -Any component of the TIL product formulation including dimethyl sulfoxide [DMSO], human serum albumin [HSA], IL-2, and dextran-40, 10.Patients who have a left ventricular ejection fraction (LVEF) <45% or who are New York Heart Association (NYHA) Class II or higher, 11.Patients who have obstructive or restrictive pulmonary disease and have a documented FEV1 (forced expiratory volume in 1 second) =50% of predicted normal, 12.Patients who have had another primary malignancy within the previous 3 years (except for those which do not require treatment or have been curatively treated >1 year ago, and in the judgment of the Investigator, does not pose a significant risk of recurrence including, but not limited to, non-melanoma skin cancer, DCIS, LCIS, prostate cancer Gleason score =6 or bladder cancer).
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method