Autologous Tumor Infiltrating Lymphocytes (GT101 Injection) in Patients With Recurrent or Metastatic Cervical Cancer

Adult Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06241781
• Other study ID #: GT-CD-CHN-101-02
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: January 31, 2024
• Est. completion date: January 31, 2027

Study information

• Verified date: January 2024
• Source: Grit Biotechnology
• Contact: XiaoHua Wu, PHD
• Phone: 021-64175590
• Email: wu.xh[@]fudan.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 64
• Est. completion date: January 31, 2027
• Est. primary completion date: January 31, 2027
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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 lines of 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.

Related Conditions & MeSH terms

• Adult
• Uterine Cervical Neoplasms

Intervention

Biological:
• GT101 injection
GT101 injection to treat cervical cancer

Drug:
• Gemcitabine injection
Gemcitabine injection to treat cervical cancer

Locations

Country	Name	City	State
China	The Fifth Medical Center of the General Hospital of the People's Liberation Army of China	Beijing	Beijing
China	Xiangya Second Hospital of Central South University	Changsha	Hunan
China	Sichuan University West China Second Hospital	Chengdu	Sichuan
China	Affiliated Zhongshan Hospital Dalian University	Dalian	Liaoning
China	Dalian Medical University First Affiliated Hospital	Dalian	Liaoning
China	Fujian Cancer Hospital	Fuzhou	Fujian
China	Guangxi Medical University Affiliated Cancer Hospital	Guilin	Guangxi
China	Harbin Medical University Affiliated Cancer Hospital	Ha'erbin	Heilongjjiang
China	Zhejiang Cancer Hospital	Hangzhou	Zhejiang
China	Shandong First Medical University Affiliated Cancer Hospital	Jinan	Shandong
China	Jining First People's Hospital	Jining	Shandong
China	Yun Cancer Hospital	Kunming	Yunnan
China	The First Affiliated Hospital of Henan University of Science and Technology	Luoyang	Henan
China	Jiangxi Maternal and Child Health Hospital	Nanchang	Jiangxi
China	Southeast University Affiliated Zhongda Hospital	Nanjing	Jiangsu
China	Fudan University Affiliated Obstetrics and Gynecology Hospital	Shanghai	Shanghai
China	Fudan University Shanghai Cancer Center	Shanghai	Shanghai
China	Chinese Academy of Medical Sciences Cancer Hospital Shenzhen Hospital	Shenzhen	Guangdong
China	Shanxi Cancer Hospital	Taiyuan	Shanxi
China	Tianjin Cancer Hospital	Tianjin	Tianjin
China	Hubei Cancer Hospital	Wuhan	Hubei
China	The First Affiliated Hospital of Xi'an Jiaotong University	Xi'an	Shanxi
China	Yibin Second People's Hospital	Yibin	Sichuan
China	Henan Cancer Hospital	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Grit Biotechnology

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective Response Rate	Objective Response Rate (ORR) as defined by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1)	3 years
Primary	Progression Free Survival	Defined as time from first study treatment until disease progression or death from any cause, whichever occurs first.	3 years
Secondary	Duration of Response	Defined as the time from date of the first documentation of objective tumor response (CR or PR) to the first documentation of either Progression of Disease (PD) or death due to any cause, whichever occurs first.	3 years
Secondary	Number of participants with treatment-related adverse events as assessed by CTCAE v5.0	Safety will be monitored by incidence, nature, and severity of treatment-emergent adverse events, including adverse drug reactions graded according to CTCAE version 5.0.	3 years