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

Primary Purpose

Cervical Cancer

Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Autologous Tumor Infiltrating Lymphocytes (C-TIL052A) Injection
Sponsored by
Fudan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervical Cancer focused on measuring Gynecological tumor, Tumor Infiltrating Lymphocytes

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Fudan University Shanghai Cancer Center, No. 270, Dong'an Road, Xuhui DistrictRecruiting
  • Fudan University Shanghai Cancer Center, No. 4333, Kangxin Road, Pudong New AreaRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

C-TIL052A treatment group

Arm Description

C-TIL052A autologous infiltrating lymphocytes injection followed by injection of Interleukin 2 (IL-2)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Objective Response Rate (ORR)
Proportion of patients with response (CR+PR) per Response Evaluation Criteria in Solid Tumors (RECIST v1.1)
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
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
Time to Response (TTR)
The time length between TIL infusion and confirmed subsequent disease progression per RECIST 1.1
Overall Survival（OS）
The time length of patients living from the date of TIL infusion
Progression Free Survival（PFS）
The time length of patients living without progression from the date of TIL infusion

Full Information

First Posted
July 25, 2022
Last Updated
July 26, 2022
Sponsor
Fudan University
Collaborators
Cellular Biomedicine Group Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05475847
Brief Title
Study of C-TIL052A Cell Therapy in Advanced Cervical Cancer
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 2022 (Anticipated)
Primary Completion Date
July 2025 (Anticipated)
Study Completion Date
July 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fudan University
Collaborators
Cellular Biomedicine Group Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancer
Keywords
Gynecological tumor, Tumor Infiltrating Lymphocytes

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
C-TIL052A treatment group
Arm Type
Experimental
Arm Description
C-TIL052A autologous infiltrating lymphocytes injection followed by injection of Interleukin 2 (IL-2)
Intervention Type
Biological
Intervention Name(s)
Autologous Tumor Infiltrating Lymphocytes (C-TIL052A) Injection
Intervention Description
C-TIL052A injection followed by injection of IL-2
Primary Outcome Measure Information:
Title
Adverse Events (AE)
Description
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.
Time Frame
up to 12 months or through study completion
Secondary Outcome Measure Information:
Title
Objective Response Rate (ORR)
Description
Proportion of patients with response (CR+PR) per Response Evaluation Criteria in Solid Tumors (RECIST v1.1)
Time Frame
up to 12 months or through study completion
Title
Disease Control Rate (DCR)
Description
Proportion of patients ever comfirmed with response or stable disease (CR+PR+SD) during the follow-up period per RECIST v1.1
Time Frame
up to 12 months or through study completion
Title
Duration of Response (DOR)
Description
The time length between the first confirmed objective response to the treatment and the subsequent disease progression per RECIST 1.1
Time Frame
up to 12 months or through study completion
Title
Time to Response (TTR)
Description
The time length between TIL infusion and confirmed subsequent disease progression per RECIST 1.1
Time Frame
up to 12 months or through study completion
Title
Overall Survival（OS）
Description
The time length of patients living from the date of TIL infusion
Time Frame
up to 12 months or through study completion
Title
Progression Free Survival（PFS）
Description
The time length of patients living without progression from the date of TIL infusion
Time Frame
up to 12 months or through study completion

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Aged 18 to 70 years at screening Voluntary participation and able to sign the informed consent form Patients with histologically confirmed persistent, recurrent and/or metastatic cervical cancer who failed the standard treatment. Has access to tumor tissue and can isolate ≥1.0g of tumor tissue mass for the preparation of autologous tumor infiltrating lymphocytes At least one measurable target lesion (per RECIST v1.1) ECOG performance status score: 0~1 Expected survival ≥ 3 months Negative serum or urine pregnancy test results for females of child-bearing age at screening Exclusion Criteria: Uncontrolled CNS disease, severe cerebrovascular disease or obvious neurological symptoms (including mental disease) Symptomic chronic obstructive pulmonary disease or persistent asthma Uncontrolled cardiovascular diseases History of primary immune deficiency, autoimmune disease or chronic inflammatory disease High-risk subjects with rapid tumor progression as judged by the Investigator(s) Complicated with infectious diseases, such as hepatitis B/C, syphilis, AIDS History of organ transplantation or allogeneic cell therapy Any situation judged by the Investigator(s) that will have safety concern or interfere with the study results
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaohua Wu, MD, Ph.D
Phone
021-64175590-82900
Email
docwxh@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jian Zhang, MD, Ph.D
Phone
021-64175590-73546
Email
Syner2000@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiaohua Wu, MD, Ph.D
Organizational Affiliation
Fudan University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jian Zhang, MD, Ph.D
Organizational Affiliation
Fudan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fudan University Shanghai Cancer Center, No. 270, Dong'an Road, Xuhui District
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaohua Wu, MD, Ph.D
Phone
021-64175590-82900
Email
docwxh@hotmail.com
Facility Name
Fudan University Shanghai Cancer Center, No. 4333, Kangxin Road, Pudong New Area
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
201315
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jian Zhang, MD, Ph.D
Phone
021-64175590-73546
Email
Syner2000@163.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Study of C-TIL052A Cell Therapy in Advanced Cervical Cancer

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