Study of C-TIL052A Cell Therapy in Advanced Cervical Cancer

• Sponsor: Fudan University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05475847
• Collaborator: Cellular Biomedicine Group Ltd. (Industry)
• Enrollment: 20
• Locations: 2
• Arm: 1
• Anticipated Duration (Months): 36
• Patients Per Site: 10
• Patients Per Site Per Month: 0.3

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Cervical Cancer	Biological: Autologous Tumor Infiltrating Lymphocytes (C-TIL052A) Injection	Phase 1

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Anticipated Study Start Date: Jul 1, 2022
• Anticipated Primary Completion Date: Jul 1, 2025
• Anticipated Study Completion Date: Jul 1, 2025

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

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)

2. 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

3. 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

4. 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

5. Overall Survival（OS） [up to 12 months or through study completion]

   The time length of patients living from the date of TIL infusion

6. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: Female
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fudan University Shanghai Cancer Center, No. 270, Dong'an Road, Xuhui District	Shanghai	Shanghai	China	200032
2	Fudan University Shanghai Cancer Center, No. 4333, Kangxin Road, Pudong New Area	Shanghai	Shanghai	China	201315

Sponsors and Collaborators

• Fudan University
• Cellular Biomedicine Group Ltd.

Investigators

• Principal Investigator: Xiaohua Wu, MD, Ph.D, Fudan University
• Principal Investigator: Jian Zhang, MD, Ph.D, Fudan University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Xiaohua Wu MD, Professer, Fudan University
• ClinicalTrials.gov Identifier: NCT05475847
• Other Study ID Numbers: 1031-031
• First Posted: Jul 27, 2022
• Last Update Posted: Jul 28, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Xiaohua Wu MD, Professer, Fudan University: Gynecological tumor; Tumor Infiltrating Lymphocytes
• Additional relevant MeSH terms: Uterine Cervical Neoplasms

Study Results

No Results Posted as of Jul 28, 2022