Cervical Cancer
Conditions
Keywords
Gynecological tumor, Tumor Infiltrating Lymphocytes
Brief summary
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
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.
Interventions
BIOLOGICALAutologous Tumor Infiltrating Lymphocytes (C-TIL052A) Injection
C-TIL052A injection followed by injection of IL-2
Sponsors
Shanghai AbelZeta Ltd.
Fudan University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events (AE) | up to 12 months or through study completion | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disease Control Rate (DCR) | up to 12 months or through study completion | Proportion of patients ever comfirmed with response or stable disease (CR+PR+SD) during the follow-up period per RECIST v1.1 |
| Duration of Response (DOR) | up to 12 months or through study completion | The time length between the first confirmed objective response to the treatment and the subsequent disease progression per RECIST 1.1 |
| Objective Response Rate (ORR) | up to 12 months or through study completion | Proportion of patients with response (CR+PR) per Response Evaluation Criteria in Solid Tumors (RECIST v1.1) |
| Overall Survival（OS） | up to 12 months or through study completion | The time length of patients living from the date of TIL infusion |
| Progression Free Survival（PFS） | up to 12 months or through study completion | The time length of patients living without progression from the date of TIL infusion |
| Time to Response (TTR) | up to 12 months or through study completion | The time length between TIL infusion and confirmed subsequent disease progression per RECIST 1.1 |
Countries
China
Contacts
Primary ContactXiaohua Wu, MD, Ph.D
Backup ContactJian Zhang, MD, Ph.D
Outcome results
None listed