Clinical trial NCT06241781: Autologous Tumor Infiltrating Lymphocytes (GT101 Injection) in Patients with Recurrent or Metastatic Cervical Cancer
Official title: A Phase 2, Multicenter Randomized Controlled Open-label Study of Autologous Tumor Infiltrating Lymphocytes (GT101 Injection) in Patients with Recurrent or Metastatic Cervical Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Adult
Lead sponsor: Grit Biotechnology
Sponsor class: INDUSTRY
First posted: 2024-02-05
Enrollment: 83
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a Phase II, multicenter, open-label, randomized, parallel group, treatment study to assess the efficacy and safety of Autologous Tumor Infiltrating Lymphocytes (GT101 injection) compared with Gemcitabine in participants with recurrent or metastatic cervical cancer.


Eligibility criteria: Inclusion Criteria:

* 1. The Patients (or legally authorized representative) Patients (or legally authorized representative) must have the ability to understand the requirements of the study, have provided written informed consent as evidenced by signature on an informed consent form (ICF) approved by an Institutional Review Board/Independent Ethics Committee (IRB/IEC) ,must have the ability to understand the requirements of the study);
* 2. The patient must be 18 to 70 years of age at the time of consent;
* 3. Must have a confirmed diagnosis of malignancy of their receptive histologies or cytology: unresectable recurrent or metastatic cervical carcinomas and previously received≥ 1 prior systemic therapy;
* 4. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;
* 5. Expected survival time of ≥ 12 weeks;
* 6. Adequate normal organ and marrow function;
* 7. Before tumor resection, the confirmatory imaging of disease progress since last treatment should be documented.
* 8.Patients must have measurable disease measured by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria (in addition to the resected lesion).

Exclusion Criteria:

* 1.Patients with uncontrollable tumor-related pain as judged by the investigator; participants requiring painkiller must already have had a stable pain management options at the time of study entry; symptomatic lesions suitable for palliative radiotherapy should be completed prior to study entry;
* 2.Patients who have psychiatric disorders, alcohol, drug or substance abuse;
* 3.Women who are pregnant or breastfeeding, or planning to become pregnant within 1 year after cell infusion;
* 4.Participate in other clinical trials within 4 weeks prior to screening, or planning to participate in this study and other clinical trials at the same time;
* 5.Any other conditions that would make the patient unsuitable candidate for the study at the discretion of the investigator.

Primary outcomes:
measure: Progression Free Survival
timeFrame: 3 years
Secondary outcomes:
measure: Duration of Response
timeFrame: 3 years
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
timeFrame: 3 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: The Fifth Medical Center of the General Hospital of the People's Liberation Army of China
state: Beijing
city: Fuzhou
country: China
facility: Fujian Cancer Hospital
state: Fujian
city: Shenzhen
country: China
facility: Chinese Academy of Medical Sciences Cancer Hospital Shenzhen Hospital
state: Guangdong
city: Guilin
country: China
facility: Guangxi Medical University Affiliated Cancer Hospital
state: Guangxi
city: Ha'erbin
country: China
facility: Harbin Medical University Affiliated Cancer Hospital
state: Heilongjjiang
city: Luoyang
country: China
facility: The First Affiliated Hospital of Henan University of Science and Technology
state: Henan
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
state: Henan
city: Wuhan
country: China
facility: Hubei Cancer Hospital
state: Hubei
city: Changsha
country: China
facility: Xiangya Second Hospital of Central South University
state: Hunan
city: Nanjing
country: China
facility: Southeast University Affiliated Zhongda Hospital
state: Jiangsu
city: Nanchang
country: China
facility: Jiangxi Maternal and Child Health Hospital
state: Jiangxi
city: Dalian
country: China
facility: Affiliated Zhongshan Hospital Dalian University
state: Liaoning
city: Dalian
country: China
facility: Dalian Medical University First Affiliated Hospital
state: Liaoning
city: Jinan
country: China
facility: Shandong First Medical University Affiliated Cancer Hospital
state: Shandong
city: Jining
country: China
facility: Jining First People's Hospital
state: Shandong
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
state: Shanghai
city: Shanghai
country: China
facility: Fudan University Affiliated Obstetrics and Gynecology Hospital
state: Shanghai
city: Taiyuan
country: China
facility: Shanxi Cancer Hospital
state: Shanxi
city: Xi'an
country: China
facility: The First Affiliated Hospital of Xi'an Jiaotong University
state: Shanxi
city: Chengdu
country: China
facility: Sichuan University West China Second Hospital
state: Sichuan
city: Yibin
country: China
facility: Yibin Second People's Hospital
state: Sichuan
city: Tianjin
country: China
facility: Tianjin Cancer Hospital
state: Tianjin
city: Kunming
country: China
facility: Yun Cancer Hospital
state: Yunnan
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
state: Zhejiang
Study officials:
References: