Study of C-TIL052A Cell Therapy in Advanced Cervical Cancer (TIL)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Cervical Cancer
• Intervention / Treatment: Biological: Autologous Tumor Infiltrating Lymphocytes (C-TIL052A) Injection

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 Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Xiaohua Wu, MD, Ph.D; Phone Number: 021-64175590-82900; Email: docwxh@hotmail.com
• Study Contact Backup: Name: Jian Zhang, MD, Ph.D; Phone Number: 021-64175590-73546; Email: Syner2000@163.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Recruiting
      • Fudan University Shanghai Cancer Center, No. 270, Dong'an Road, Xuhui District
      • Contact: Xiaohua Wu, MD, Ph.D; Phone Number: 021-64175590-82900; Email: docwxh@hotmail.com
    • Shanghai, Shanghai, China, 201315
      • Recruiting
      • Fudan University Shanghai Cancer Center, No. 4333, Kangxin Road, Pudong New Area
      • Contact: Jian Zhang, MD, Ph.D; Phone Number: 021-64175590-73546; Email: Syner2000@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Fudan University
• Collaborators: Cellular Biomedicine Group Ltd.
• Investigators: Principal Investigator: Xiaohua Wu, MD, Ph.D, Fudan University; Principal Investigator: Jian Zhang, MD, Ph.D, Fudan University

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2022
• Primary Completion (Anticipated): July 1, 2025
• Study Completion (Anticipated): July 1, 2025

Study Registration Dates

• First Submitted: July 25, 2022
• First Submitted That Met QC Criteria: July 25, 2022
• First Posted (Actual): July 27, 2022

Study Record Updates

• Last Update Posted (Actual): July 28, 2022
• Last Update Submitted That Met QC Criteria: July 26, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Tumor Infiltrating Lymphocytes; Gynecological tumor
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Cervical Diseases; Uterine Diseases; Uterine Cervical Neoplasms
• Other Study ID Numbers: 1031-031

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No