Efficacy and Safety of TILs in Treatment of Patients With Advanced or Metastatic Refractory Gynecological Cancer

NCT05152797 | Not Yet Recruiting Phase 1 DMC

• 1 other identifier: PRO2021-1428
• Study Type: interventional
• Target: 91
• Locations: 0 countries
• Sites: N/A

Brief Summary

Prospective, multicenter, single-arm, open label, interventional basket trial to evaluate autologous tumor-infiltrating lymphocytes (TILs) infusion followed by IL-2 after a non-myeloablative (NMA) lymphodepletion preparation for the treatment of patients with advanced or metastatic refractory gynecological cancer including cervical, ovarian, endometrial and breast carcinoma.

Conditions

Tumor Infiltrating Lymphocytes

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate

  To evaluate the efficacy of TILs in patients with advanced or metastatic refractory malignant gynecological cancer including cervical, ovarian, endometrial and breast carcinoma based on the objective response rate (ORR) as assessed by the Independent Review Committee (IRC) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

  Up to 6 months

Secondary Outcomes (4)

• Disease Control Rate

  Up to 60 months

• Progression-Free Survival

  Up to 60 months

• Overall Survival

  Up to 60 months

• Adverse Events

  Up to 60 months

Study Arms (1)

TILs infusion

EXPERIMENTAL

Enrolled patients will be infused with their autologous TILs followed by IL-2 administration after post- NMA lymphodepletion

Biological: Autologous tumor-infiltrating lymphocytes

Interventions

Autologous tumor-infiltrating lymphocytes BIOLOGICAL

Fresh tumor samples will be resected from enrolled patients. Autologous TILs will be extracted and reinfused to corresponding patients after ex vivo stimulation, activation and extensive expansion.

TILs infusion

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18-75 years old at the time of consent
• Participants are diagnosed with advanced or metastatic cervical cancer, ovarian cancer, endometrial cancer or breast cancer with radiology and pathology confirmation.
• Failure of two or more Lines of Chemotherapy, or not amenable to curative treatment.
• At least one resectable lesion (or aggregate of lesions resected) of a minimum 1.5 cm in diameter post-resection to extract TIL
• At least one measurable target lesion, that can be accurately measured in at least one dimension with longest diameter ≥20 mm, as defined by RECIST v1.1
• All the chemotherapy or radiotherapy targeting the malignant tumors must be discontinued at least 28 days prior to the tumor resection.
• No serious abnormality of complete blood count and Cardiac, Liver, and Kidney function

You may not qualify if:

• Participants who have received organ transplantation or prior cell transfer therapy
• Any active autoimmune disease or history of autoimmune disease, or history of primary immunodeficiency.
• Patients who are taking systemic steroid therapy
• Patients with confirmed HIV infection, or other uncontrolled active viral infections, or serious system infections
• Patients with serious complications of heart, lung, liver, kidney, not suitable for enrollment.
• Patients with suspicious or confirmed brain metastases of any size and any number.
• Suffered from any other malignancy within 5 years (except for fully treated in situ malignant such as breast cancer, bladder cancer, cutaneous basal cell carcinoma or squamous cell carcinoma)
• Patients who are pregnant or breastfeeding
• Any other conditions judged by the researcher will significantly increase the risk of participation.

Sponsors & Collaborators

• Women's Hospital School Of Medicine Zhejiang University: lead
• Tongji Hospital: collaborator
• Qilu Hospital of Shandong University: collaborator
• Sun Yat-sen University: collaborator

Study Officials

• Hui Wang, MD

  Women's Hospital School Of Medicine Zhejiang University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Songfa Zhang, MD

CONTACT

+86(571)89992145; zhangsongfa@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2021
• First Posted: December 10, 2021
• Study Start: January 1, 2022
• Primary Completion: January 1, 2024
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 10, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share