Study of C-TIL052A Cell Therapy in Advanced Cervical Cancer

Study Overview
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Brief Summary
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A study that aimed to assess the safety and anti-tumor activity of C-TIL052A cell therapy in subjects with persistent, recurrent and/or metastatic cervical cancer.

Detailed Description
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For patients with advanced cervical cancer who have failed the standard treatment, no recognized alternative follow-up treatment regimens are available and the prognosis is poor. The study is a single center phase I trial planning to assess the safety, tolerability and the preliminary anti-tumor activity of C-TIL052A cell therapy in persistent, recurrent and/or metastatic cervical cancer. Eligible subjects will receive injection of C-TIL052A (Autologous Tumor Infiltrating Lymphocytes, TIL) and interleukin 2 (IL-2) after lymphodepletion. All subjects will be followed up post treatment for safety and efficacy monitoring and the follow-up period will be 12 months or through study completion.

Official Title
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A Phase I Clinical Study to Evaluate Safety and Efficacy of C-TIL052A Cell Therapy (Autologous Tumor Infiltrating Lymphocytes Injection Combined With IL-2) in Subjects With Persistent, Recurrent and/or Metastatic Cervical Cancer

Conditions
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Cervical Cancer

Intervention / Treatment
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* Biological: Autologous Tumor Infiltrating Lymphocytes (C-TIL052A) Injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 18 to 70 years at screening Voluntary participation and able to sign the informed consent form Patients with histologically confirmed persistent, recurrent and/or metastatic cervical cancer who failed the standard treatment. Has access to tumor tissue and can isolate ≥1.0g of tumor tissue mass for the preparation of autologous tumor infiltrating lymphocytes At least one measurable target lesion (per RECIST v1.1) ECOG performance status score: 0 1 Expected survival ≥ 3 months Negative serum or urine pregnancy test results for females of child-bearing age at screening Exclusion Criteria: Uncontrolled CNS disease, severe cerebrovascular disease or obvious neurological symptoms (including mental disease) Symptomic chronic obstructive pulmonary disease or persistent asthma Uncontrolled cardiovascular diseases History of primary immune deficiency, autoimmune disease or chronic inflammatory disease High-risk subjects with rapid tumor progression as judged by the Investigator(s) Complicated with infectious diseases, such as hepatitis B/C, syphilis, AIDS History of organ transplantation or allogeneic cell therapy Any situation judged by the Investigator(s) that will have safety concern or interfere with the study results

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: C-TIL052A treatment group<br>C-TIL052A autologous infiltrating lymphocytes injection followed by injection of Interleukin 2 (IL-2) | Biological: Autologous Tumor Infiltrating Lymphocytes (C-TIL052A) Injection<br>* C-TIL052A injection followed by injection of IL-2<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events (AE) | To characterize the safety profile and evaluate tolerability of C-TIL052A cell therapy by collecting, analyzing the treatment emergent adverse events (TEAEs) and adverse events of special interest (AESIs) during and post treatment, especially the incidence and severity of adverse events (AE) within 28 days post TIL infusion. | up to 12 months or through study completion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective Response Rate (ORR) | Proportion of patients with response (CR+PR) per Response Evaluation Criteria in Solid Tumors (RECIST v1.1) | up to 12 months or through study completion | 
| Disease Control Rate (DCR) | Proportion of patients ever comfirmed with response or stable disease (CR+PR+SD) during the follow-up period per RECIST v1.1 | up to 12 months or through study completion | 
| Duration of Response (DOR) | The time length between the first confirmed objective response to the treatment and the subsequent disease progression per RECIST 1.1 | up to 12 months or through study completion | 
| Time to Response (TTR) | The time length between TIL infusion and confirmed subsequent disease progression per RECIST 1.1 | up to 12 months or through study completion | 
| Overall Survival（OS） | The time length of patients living from the date of TIL infusion | up to 12 months or through study completion | 
| Progression Free Survival（PFS） | The time length of patients living without progression from the date of TIL infusion | up to 12 months or through study completion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gynecological tumor, Tumor Infiltrating Lymphocytes