Study of C-TIL052A Cell Therapy in Advanced Cervical Cancer

Fudan University20 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Cervical Cancer

Interventions

Autologous Tumor Infiltrating Lymphocytes (C-TIL052A) InjectionBIOLOGICAL

C-TIL052A injection followed by injection of IL-2

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Aged 18 to 70 years at screening 2. Voluntary participation and able to sign the informed consent form 3. Patients with histologically confirmed persistent, recurrent and/or metastatic cervical cancer who failed the standard treatment. 4. Has access to tumor tissue and can isolate ≥1.0g of tumor tissue mass for the preparation of autologous tumor infiltrating lymphocytes 5. At least one measurable target lesion (per RECIST v1.1) 6. ECOG performance status score: 0\~1 7. Expected survival ≥ 3 months 8. Negative serum or urine pregnancy test results for females of child-bearing age at screening Exclusion Criteria: 1. Uncontrolled CNS disease, severe cerebrovascular disease or obvious neurological symptoms (including mental disease) 2. Symptomic chronic obstructive pulmonary disease or persistent asthma 3. Uncontrolled cardiovascular diseases 4. History of primary immune deficiency, autoimmune disease or chronic inflammatory disease 5. High-risk subjects with rapid tumor progression as judged by the Investigator(s) 6. Complicated with infectious diseases, such as hepatitis B/C, syphilis, AIDS 7. History of organ transplantation or allogeneic cell therapy 8. Any situation judged by the Investigator(s) that will have safety concern or interfere with the study results

Locations (2)

Fudan University Shanghai Cancer Center, No. 270, Dong'an Road, Xuhui District

Shanghai, Shanghai Municipality, China

RECRUITING

Fudan University Shanghai Cancer Center, No. 4333, Kangxin Road, Pudong New Area

Shanghai, Shanghai Municipality, China

RECRUITING

Outcomes

Primary Outcomes

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.