A Phase 1, Multicenter, Open-label, 2-stage, Single-arm Study to Evaluate the Safety and Tolerability of an Autologous Tumor-infiltrating Lymphocytes (TIL) Regimen and Preliminary Antitumor Activity of TIL in Pediatric, Adolescent, and Young Adult Participants With Relapsed or Refractory Solid Tumors

Iovance Biotherapeutics, Inc.7 个研究点分布在 1 个国家目标入组 40 人2024年3月28日

适应症Soft Tissue Sarcoma Primary Central Nervous System Carcinoma Melanoma Rhabdomyosarcoma Ewing Sarcoma

干预措施LN-145/LN-144

概览

阶段: 1 期
干预措施: LN-145/LN-144
疾病 / 适应症: Soft Tissue Sarcoma
发起方: Iovance Biotherapeutics, Inc.
入组人数: 40
试验地点: 7
主要终点: Incidence rate of Treatment-Emergent Adverse Events
状态: 进行中（未招募）
最后更新: 26天前

概览研究者入排标准研究组 & 干预措施结局指标研究点相似试验

概览

简要总结

This study is planned to test the safety and tolerability of the TIL regimen. The study will also test how well TIL fights cancer. The study will enroll children, teenagers, and young adults with solid tumors that have returned or are not responding to treatment for whom no effective standard-of-care treatment options exist.

Study details include:

The study will last up to 2 years after the TIL infusion (Day 0) for each person.
The treatment will last up to 10 days for each person.
Study visits will be every 2 weeks until Day 42, every 6 weeks until Month 6, and every 3 months until Year 2.

注册库

clinicaltrials.gov

开始日期

2024年3月28日

结束日期

2028年7月1日

最后更新

26天前

研究类型

Interventional

研究设计

Parallel

性别

All

研究者

发起方

Iovance Biotherapeutics, Inc.

责任方

Sponsor

入排标准

入选标准

•Participant is ≥ 8 kg and ≤ 21 years of age at the time of informed consent and assent.
•Histologically or cytologically confirmed recurrent or refractory solid tumor (Rhabdomyosarcoma, Ewing sarcoma, primary CNS malignancies, melanoma) after standard therapy which has failed all available curative therapy.
•Acceptable performance status and an estimated life expectancy of \> 6 months.
•At least one resectable lesion (solitary or aggregate lesions) for TIL generation.
•Following tumor resection for TIL generation, the participant will have at least one remaining measurable lesion for response assessment.
•Preplanned surgical procedure(s) will take place at least 14 days (for major operative procedures) prior to the tumor resection.
•All prior anticancer treatment-related AEs should be recovered, exceptions are peripheral neuropathy, alopecia, vitiligo, or medically controlled endocrine dysfunction.
•Agreement to abide by the protocol indicated contraception use, including refraining from donating sperm or eggs (ova, oocytes), as appropriate for the age and sexual activity of pediatric, adolescent, and young adult participants and as required by local regulations.
•Signed informed consent and assent when applicable.
•Written authorization for use and disclosure of protected health information.

排除标准

•Participant with a non-CNS tumor has symptomatic untreated brain metastases and/or carcinomatous meningitis.
•Participant has an active or uncontrolled intercurrent illness(es) that would pose increased risks for study participation.
•Participants are not eligible if they experience uncontrolled seizures.
•Participants with history of intracranial hemorrhage/spinal cord hemorrhage.
•Participant has active uveitis that requires active treatment.
•Participant has significant psychiatric disease or substance abuse in the investigator's opinion that would prevent adequate informed consent.
•Participant has any form of primary or acquired immunodeficiency.
•History of clinically significant chronic obstructive pulmonary disease, asthma, interstitial lung disease, or other chronic lung disease.
•History of hypersensitivity reaction to any components of the study intervention.
•Any other condition that in the investigator's judgment would significantly increase the risks of participation.