Study of C-TIL052A Cell Therapy in Advanced Cervical Cancer

Cervical Cancer Clinical Trial

— TIL  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05475847
• Other study ID #: 1031-031
• Status: Recruiting
• Phase: Phase 1
• Start date: July 2022
• Est. completion date: July 2025

Study information

• Verified date: July 2022
• Source: Fudan University
• Contact: Xiaohua Wu, MD, Ph.D
• Phone: 021-64175590-82900
• Email: docwxh[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: July 2025
• Est. primary completion date: July 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Cervical Cancer
• Uterine Cervical Neoplasms

Intervention

Biological:
• Autologous Tumor Infiltrating Lymphocytes (C-TIL052A) Injection
C-TIL052A injection followed by injection of IL-2

Locations

Country	Name	City	State
China	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

Sponsors (2)

Lead Sponsor	Collaborator
Fudan University	Cellular Biomedicine Group Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Overall Survival(OS)	The time length of patients living from the date of TIL infusion	up to 12 months or through study completion
Secondary	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