Study of C-TIL052A Cell Therapy in Advanced Cervical Cancer

Phase 1

Recruiting

• Conditions: Cervical Cancer
• Interventions: Biological: Autologous Tumor Infiltrating Lymphocytes (C-TIL052A) Injection

• Registration Number: NCT05475847
• Lead Sponsor: Fudan University

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.

Study Timeline

• Status Verified: 2022-07
• Study Start: 2022-07
• Study First Submitted: 2022-07-25
• Study First Submitted QC: 2022-07-25
• Last Update Submitted: 2022-07-26
• Study First Posted: 2022-07-27
• Last Update Posted: 2022-07-28
• Primary Completion: 2025-07
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 20

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
C-TIL052A treatment group	Autologous Tumor Infiltrating Lymphocytes (C-TIL052A) Injection	C-TIL052A autologous infiltrating lymphocytes injection followed by injection of Interleukin 2 (IL-2)

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
Overall Survival（OS）	up to 12 months or through study completion	The time length of patients living from the date of TIL infusion
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
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
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)
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

Trial Locations

Locations (2)

Fudan University Shanghai Cancer Center, No. 270, Dong'an Road, Xuhui District; 🇨🇳 Shanghai, Shanghai, China

Fudan University Shanghai Cancer Center, No. 4333, Kangxin Road, Pudong New Area; 🇨🇳 Shanghai, Shanghai, China