Adult
Conditions
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.
Interventions
BIOLOGICALGT101 injection
GT101 injection to treat cervical cancer
Gemcitabine injection to treat cervical cancer
Sponsors
Grit Biotechnology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression Free Survival | 3 years | Defined as time from first study treatment until disease progression or death from any cause, whichever occurs first. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of Response | 3 years | 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. |
| Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 | 3 years | 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. |
Countries
China
Contacts
Primary ContactXiaoHua Wu, PHD
Backup ContactJing Wang, PHD
Outcome results
None listed