A Phase 1/2, Multicenter, Multi-cohort, Open-label Study of an Autologous Tumor-infiltrating Lymphocytes (TIL) Regimen With IOV-5001 in Participants With Previously Treated Advanced Solid Tumors

Iovance Biotherapeutics, Inc.1 个研究点分布在 1 个国家目标入组 106 人开始时间: 2026年9月1日最近更新: 2026年9月15日

适应症

干预措施

试验速览

阶段: 1 期
状态: 尚未招募
发起方: Iovance Biotherapeutics, Inc.
入组人数: 106
试验地点: 1
主要终点: Phase 1: Safety Assessment

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

A Phase 1/2, multicenter, multi-cohort, open-label study of an autologous tumor-infiltrating lymphocytes (TIL) regimen with IOV-5001 in participants with previously treated advanced solid tumors

详细描述

This study is the first-in-human study of IOV-5001. IOV-5001 is expected to have antitumor activity through its capacity to directly target and kill the tumor cells in a manner that is similar to non-genome-edited TIL products, but with the potential for enhanced antitumor activity because IOV-5001 is genetically modified to express inducible membrane-tethered interleukin-12 (TeIL-12). IL-12 is a potent cytokine known to enhance T-cell responses. As such, IOV-5001 represents a strategy to augment the cytotoxic activity of TIL through inducible localized presentation of TeIL-12 without systemic exposure to IL-12 cytokines, thereby improving the safety profile.

研究设计

研究类型: Interventional
分配方式: Non Randomized
干预模型: Sequential
主要目的: Treatment
盲法: None

入排标准

年龄范围: 18 Years 至 70 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Participant must be ≥ 18 years of age at the time of signing the informed consent.
•NSCLC: Participant has a histologically or pathologically confirmed diagnosis of metastatic Stage IV NSCLC (squamous, nonsquamous, adenocarcinoma, large cell, or mixed histologies) without epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), or ROS proto-oncogene 1 (ROS1) genomic alterations.
•TNBC: Participant has a histologically or pathologically confirmed diagnosis of unresectable or Stage IV breast cancer.
•CRC: Participant has a histologically or pathologically confirmed diagnosis of Stage IV CRC.
•HNSCC: Participant has a histologically or pathologically confirmed diagnosis of Stage III or IV HNSCC not amenable to curative intent treatment.
•Radiographic disease progression: Participant has radiographic disease progression after the most recent line of therapy.
•Disease-specific criterion:
•NSCLC: Radiographic disease progression occurred:
•After having received platinum-based chemotherapy and an immune checkpoint inhibitor, either administered concurrently or sequentially for Stage IV disease.
•Within 6 months of completion of the platinum component of platinum-based chemotherapy in the adjuvant or neoadjuvant setting and having progressed after receiving an immune checkpoint inhibitor in the neoadjuvant, adjuvant, or metastatic setting.
•TNBC: Participant has received up to 3 prior lines of therapy. These must include at least one prior line of cytotoxic chemotherapy for unresectable or Stage IV breast cancer, regardless of ER, PR, or HER2 status at the time it was given.
•CRC: Participant has received up to 3 prior lines of therapy. These must include a fluoropyrimidine, oxaliplatin, irinotecan, an anti-VEGF therapy, an anti-EGFR therapy (for RAS/rapidly accelerated fibrosarcoma [RAF] wild-type disease if the tumor originated in the left side of the colon), and an immune checkpoint inhibitor (for microsatellite instability high [MSI-H] or deficient mismatch repair [dMMR] disease.
•HNSCC: Participant has received up to 3 prior lines of therapy. These must include an immune inhibitor and platinum-based chemotherapy unless platinum ineligible due to pre-existing hearing loss, Grade >= 2 tinnitus, Grade >= 2 peripheral neuropathy, or allergy to platinum.
•Disease-specific criterion:
•NSCLC: Participant has received up to 3 lines of prior therapy. These must include an appropriate health authority-approved targeted therapy for participants who have actionable mutations (other than EGFR, ALK, or ROS1 genomic alterations) if eligible and available.
•TNBC: Participant has progressed on or is ineligible for other standard of care therapies including, but not limited to: sacituzumab govitecan, poly(ADP-ribose) polymerase (PARP) inhibitors (if breast cancer gene [BRCA]1 or BRCA2 mutated), trastuzumab deruxtecan (if HER2low), and pembrolizumab (for PD-L1 combined positive score [CPS] >= 10).
•CRC: Microsatellite instability and/or mismatch repair mutational status must have been previously determined based on archival tumor biopsies.
•HNSCC: Participant has documented PD-L1 status.
•The participant has an ECOG performance status of 0 or 1 and an estimated life expectancy of > 6 months.
•Participant is assessed as having at least one resectable lesion (or aggregate lesions) with an estimated minimum diameter of 1.5 cm (short axis) for IOV-5001 generation.

排除标准

•Participants with symptomatic untreated brain metastases. Participants with brain metastases may be enrolled with considerations and discussion with medical monitor.
•Participant has an active medical illness(es) that, in the opinion of the investigator would pose increased risks for study participation. Participant has evidence of any active viral, bacterial, or fungal infection requiring ongoing systemic treatment or identified during screening.
•Participant has any form of primary immunodeficiency (eg, severe combined immunodeficiency disease [SCID] or AIDS).
•Participant has a history of hypersensitivity to any component of the study intervention.
•Participant had another primary malignancy within the previous 3 years (except for those that 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: in situ carcinoma of the cervix, early stage skin cancer, including non-melanoma skin cancer, ductal carcinoma in situ (DCIS) or lobular carcinoma in situ (LCIS) of the breast, prostate cancer with Gleason score ≤ 6, or superficial bladder cancer).
•Participant has a history of allogeneic organ transplant or any form of cell therapy involving prior conditioning chemotherapy within the past 20 years.
•Participant requires systemic steroid therapy > 10 mg/day of prednisone or another steroid equivalent dose. Participants receiving steroids as replacement therapy for adrenocortical insufficiency at ≤ 10 mg/day of prednisone or another steroid equivalent dose may be eligible.
•Participant received or will receive a live or attenuated vaccination within 28 days prior to the start of the NMA-LD preparative regimen.
•Concurrent enrollment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study.