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Autologous Tumor-infiltrating Lymphocyte Injection (GT201) for the Treatment of Metastatic/Recurrent Advanced Solid Tumors (GT201)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05430360
Recruitment Status : Recruiting
First Posted : June 24, 2022
Last Update Posted : June 30, 2022
Sponsor:
Information provided by (Responsible Party):
Grit Biotechnology

Brief Summary:

This study is a single-center, single-arm phase I clinical trial. A total of 30 subjects (20 evaluable cases are expected) from 1 cohort will be enrolled in this study.

An "autologous tumor-infiltrating lymphocyte therapy" dosing regimen consisting of lymphodepleting chemotherapy (FC regimen: cyclophosphamide + fludarabine), infusion of autologous tumor-infiltrating lymphocyte injection, and interleukin-2 injection will be used.The study process is divided into: screening period, sampling and production period, clearing and chemotherapy period, treatment and observation period, and follow-up period


Condition or disease Intervention/treatment Phase
Solid Tumor Biological: GT201 Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Single-center, Single-arm Phase I Clinical Study of Autologous Tumor-infiltrating Lymphocyte Injection (GT201) for the Treatment of Metastatic/Recurrent Advanced Solid Tumors
Actual Study Start Date : January 4, 2022
Estimated Primary Completion Date : May 2025
Estimated Study Completion Date : May 2025

Arm Intervention/treatment
Experimental: GT201 treatment group
Autologous tumor infiltrating lymphocyte injection
Biological: GT201
Autologous tumor infiltrating lymphocyte injection




Primary Outcome Measures :
  1. Safety Profile Measured by Grade ≥3 TEAEs [ Time Frame: 3 years ]
    To characterize the safety profile of autologous TIL injection(GT201) in patients with relapsed/metastatic advanced solid tumor as measured by the incidence of Grade ≥ 3 treatment-emergent adverse events (TEAEs)


Secondary Outcome Measures :
  1. Objective response rate [ Time Frame: 3 years ]
    To evaluate efficacy parameters such Objective Response Rate (ORR) per RECIST 1.1, as assessed by the Investigator

  2. Progression-free survival [ Time Frame: 3 years ]
    To evaluate efficacy parameters such Progression-Free Survival (PFS) per RECIST 1.1, as assessed by the Investigator

  3. Overall survival [ Time Frame: 3 years ]
    To evaluate efficacy parameters such Overall Survival (OS)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Voluntarily enrolled in the study, signed an informed consent form, and willing and able to comply with the study protocol
  2. Malignant tumor determined by histological or cytological examination
  3. At least one lesion (preferably superficial lymph nodes) that has not been treated with radiation, has not received other local therapies, has access to tumor tissue, and can isolate at least a mass ≥ 1.0 g of tissue mass (either single lesion source or multiple lesions combined) for the preparation of autologous tumor-infiltrating lymphocytes
  4. Eastern Collaborative Oncology Group (ECOG) physical fitness status score of 0 or 1.

Exclusion Criteria:

  1. Failure of surgery and/or radiation therapy to relieve spinal cord compression is not eligible for enrollment
  2. People with uncontrolled tumor-related pain as judged by the investigator
  3. Risk of major bleeding as assessed by investigators
  4. Have interstitial pneumonia or clinically significant active pneumonia at screening, or other respiratory disease that severely affects lung function
  5. Any active autoimmune disease 14 days prior to clear lymphatic chemotherapy, history of autoimmune disease, or disease requiring systemic steroid hormone or immunosuppressive drug therapy 6:History of allergic reaction to any component of the drugs to be used in the study (including but not limited to autologous tumor infiltrating lymphocytes, cyclophosphamide, fludarabine, interleukin-2, dimethyl sulfoxide (DMSO), human serum albumin (HSA), dextran-40, antibiotics (beta-lactam antibiotics, gentamicin));

7:Women who are pregnant or breastfeeding; or women who are pregnant, breastfeeding, or planning to become pregnant within 1 year of the cell return.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05430360


Contacts
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Contact: Weijia Fang, PhD 137 5821 1655 weijiafang@zju.edu.cn

Locations
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China, Zhejiang
The First Hospital of Zhejiang University Recruiting
Hangzhou, Zhejiang, China
Contact: Weijia Fang, PhD         
Sponsors and Collaborators
Grit Biotechnology
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Responsible Party: Grit Biotechnology
ClinicalTrials.gov Identifier: NCT05430360    
Other Study ID Numbers: GRIT-CO-FA-022
First Posted: June 24, 2022    Key Record Dates
Last Update Posted: June 30, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasms