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A Phase I Study on Autologous Tumor Infiltrating Lymphocytes Injection (GC101 TIL) for the Treatment of Advanced Malignant Solid Tumors

Primary Purpose

Tumor Infiltrating Lymphocytes, Safety, Advanced Solid Tumor

Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
TIL therapy
Sponsored by
Shanghai Juncell Therapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tumor Infiltrating Lymphocytes

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Patients must be ≥18 and ≤75 years of age at the time of consent.
  2. Patients with advanced metastatic solid tumors with clear pathological diagnosis, including melanoma, cervical cancer, head and neck squamous cell tumors, non-small cell lung cancer and breast cancer, etc.; while the expanded enrollment study plans to include those with melanoma, cervical cancer, and head and neck squamous cell tumors.
  3. At least one measurable target lesion even after resection, as defined by RECIST1.1.

    Lesions in previously irradiated areas (or other local therapy) should not be selected as target lesions, unless treatments was ≥3 months prior to Screening, and there has been demonstrated disease progression in that particular lesion.

  4. Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  5. Patients must have an estimated life expectancy of ≥3 months.
  6. In the opinion of the Investigator, patients must be able to sign the ICF and complete all study-required procedures.
  7. Patients must have the following hematologic parameters, Coagulation functions and hepatic and renal function:

    • White Blood Cell (WBC)≥2.5×10^9/L;
    • Absolute Lymphocyte Count (ANC)≥1.5×10^9/L;
    • Absolute Lymphocyte Count(ALC)≥0.7×10^9/L;
    • Platelet≥100×10^9/L;
    • International Normalized Ratio(INR)≤1.5×ULN;
    • Activated Partial Thromboplastin Time(APTT)≤1.5×ULN;
    • Serum Creatinine (Scr)≤1.5mg/dL (or 132.6μmol/L) or Creatinine Clearance≥60mL/min
    • Urinalysis: urine protein less than 2+, or 24-hour urine protein <1g;
    • Alanine aminotransferase(AST/SGOT) ≤3×ULN;
    • Alanine aminotransferase (ALT/SGPT) ≤3×ULN;
    • Total Bilirubin(TBIL)≤1.5×ULN;
  8. Patients must have a washout period ≥ 4 weeks from prior anticancer therapy(ies) to the start of the planned preconditioning regimen, including targeted therapy, chemotherapy, immunotherapy: anti-cytotoxic T lymphocyte-associated antigen 4 (CTLA-4)/anti-PD-1, other monoclonal antibody (mAb), or vaccine Palliative radiation therapy.
  9. Patients of childbearing potential or their partners of childbearing potential must be willing to take the appropriate precaution to avoid pregnancy or fathering a child for the duration of the study and practice an approved, highly effective method of birth control during treatment and for 12 months after receiving the last protocol-related therapy.
  10. Patients must have no contraindications for surgery or biopsy.
  11. Patients (or legally authorized representative) must have the ability to understand the requirements of the study, have provided written informed consent as evidenced by signature on an ICF approved by an Institutional Review Board/Independent Ethics Committee (IRB/IEC), and agree to abide by the study restrictions and return to the site for the required assessments, including the OS Follow-up Period.

Exclusion Criteria:

  1. Patients have not recovered from all prior therapy-related adverse events (AEs) to ≤ Grade 1 (per Common Terminology Criteria for Adverse Events [CTCAE] v5.0), except for alopecia or vitiligo, prior to Enrollment (tumor resection).
  2. Patients who have received an organ allograft or prior cell transfer therapy.
  3. Patients with symptomatic and/or untreated brain metastases (of any size and any number).
  4. Patients who are on chronic systemic steroid therapy for any reason.
  5. Patients who have active medical illness(es) that would pose increased risk for study participation, including: active systemic infections requiring systemic ABX, coagulation disorders, or other active major medical illnesses of the cardiovascular, respiratory, or immune system.
  6. Patients with systemic active infection requiring treatment, with positive blood culture or imaging evidence of infection, including active tuberculosis.
  7. Patients with hepatic encephalopathy, hepatorenal syndrome, Child-Pugh class B or more severe cirrhosis, or liver failure.
  8. Uncontrolled arterial hypertension(SBP≥160mmHg and/or DBP≥100mmHg)or any unstable cardiovascular or cerebrovascular disease in the recent 6 months of consent.
  9. Patients who have a left ventricular ejection fraction (LVEF) < 50% or New York Heart Association (NYHA) functional classification Class 3 or Class 4.
  10. Female patients who are pregnant or breastfeeding.
  11. Patients who are HIV positive, positive syphilis serological test, positive COVID-19 nucleic acid test, or clinically active hepatitis A, B, and C including virus carriers.

Sites / Locations

  • Chinese PLA General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Experimental: Cohort 1

Experimental: Cohort 2

Experimental: Cohort 3

Experimental: Cohort 4

Arm Description

dose escalation group: participants with advanced solid tumors using cryopreserved GC101 TIL

participants with advanced cervix tumors using cryopreserved GC101 TIL

participants with advanced malignant melanoma using cryopreserved GC101 TIL

participants with advanced HNSCC using cryopreserved GC101 TIL

Outcomes

Primary Outcome Measures

Maximal Tolerance Dose
Dose Limiting Toxicity
Adverse Events

Secondary Outcome Measures

Disease Assessment for Duration of Response
Evaluate the efficacy endpoints of DOR by the investigator with RECIST v1.1 and iRECIST
Disease Assessment for Disease Control Rate
Evaluate the efficacy endpoints of DCR by the investigator with RECIST v1.1 and iRECIST
Disease Assessment for Progression-Free Survival
Evaluate the efficacy endpoints of PFS by the investigator with RECIST v1.1 and iRECIST
Disease Assessment for Objective Response Rate
Evaluate the efficacy endpoints of ORR by the investigator with RECIST v1.1 and iRECIST
Quality of Life Assessment
Evaluate with EORTC QLQ-C30

Full Information

First Posted
May 31, 2022
Last Updated
December 19, 2022
Sponsor
Shanghai Juncell Therapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT05417750
Brief Title
A Phase I Study on Autologous Tumor Infiltrating Lymphocytes Injection (GC101 TIL) for the Treatment of Advanced Malignant Solid Tumors
Official Title
An Open, Single-armed, Phase I Study to Evaluate the Safety and Efficacy Using Autologous TIL in Patients With Advanced Malignant Solid Tumors
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 30, 2022 (Actual)
Primary Completion Date
November 7, 2023 (Anticipated)
Study Completion Date
April 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Juncell Therapeutics

4. Oversight

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

5. Study Description

Brief Summary
20-60 participants are expected to be enrolled for the Phase I clinical trial which is further divided into two parts: a "3+3" dose escalation study and an expanded enrollment study. The Phase I clinical trial is expected to be finished in 36 months. To be specific, the dose escalation study plans to include patients with advanced malignant solid tumors with clear pathological diagnosis, including melanoma, cervical cancer, head and neck squamous cell tumors, non-small cell lung cancer and breast cancer, etc.; while the expanded enrollment study plans to include those with melanoma, cervical cancer, and head and neck squamous cell tumors.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tumor Infiltrating Lymphocytes, Safety, Advanced Solid Tumor, Immunotherapy, Efficacy, Adverse Drug Event

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental: Cohort 1
Arm Type
Experimental
Arm Description
dose escalation group: participants with advanced solid tumors using cryopreserved GC101 TIL
Arm Title
Experimental: Cohort 2
Arm Type
Experimental
Arm Description
participants with advanced cervix tumors using cryopreserved GC101 TIL
Arm Title
Experimental: Cohort 3
Arm Type
Experimental
Arm Description
participants with advanced malignant melanoma using cryopreserved GC101 TIL
Arm Title
Experimental: Cohort 4
Arm Type
Experimental
Arm Description
participants with advanced HNSCC using cryopreserved GC101 TIL
Intervention Type
Drug
Intervention Name(s)
TIL therapy
Intervention Description
A tumor sample is resected from each participant and cultured ex vivo to expand the population of autologous tumor infiltrating lymphocytes injection (GC101 TIL). After lymphodepletion, patients are infused GC101 TIL followed sintilimab.
Primary Outcome Measure Information:
Title
Maximal Tolerance Dose
Time Frame
Up to Day 28
Title
Dose Limiting Toxicity
Time Frame
Up to Day 28
Title
Adverse Events
Time Frame
Maximum 360 days
Secondary Outcome Measure Information:
Title
Disease Assessment for Duration of Response
Description
Evaluate the efficacy endpoints of DOR by the investigator with RECIST v1.1 and iRECIST
Time Frame
Every 6 weeks for 12 months
Title
Disease Assessment for Disease Control Rate
Description
Evaluate the efficacy endpoints of DCR by the investigator with RECIST v1.1 and iRECIST
Time Frame
Every 6 weeks for 12 months
Title
Disease Assessment for Progression-Free Survival
Description
Evaluate the efficacy endpoints of PFS by the investigator with RECIST v1.1 and iRECIST
Time Frame
Every 6 weeks for 12 months
Title
Disease Assessment for Objective Response Rate
Description
Evaluate the efficacy endpoints of ORR by the investigator with RECIST v1.1 and iRECIST
Time Frame
Every 6 weeks for 12 months
Title
Quality of Life Assessment
Description
Evaluate with EORTC QLQ-C30
Time Frame
Every 6 weeks for 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients must be ≥18 and ≤75 years of age at the time of consent. Patients with advanced metastatic solid tumors with clear pathological diagnosis, including melanoma, cervical cancer, head and neck squamous cell tumors, non-small cell lung cancer and breast cancer, etc.; while the expanded enrollment study plans to include those with melanoma, cervical cancer, and head and neck squamous cell tumors. At least one measurable target lesion even after resection, as defined by RECIST1.1. Lesions in previously irradiated areas (or other local therapy) should not be selected as target lesions, unless treatments was ≥3 months prior to Screening, and there has been demonstrated disease progression in that particular lesion. Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. Patients must have an estimated life expectancy of ≥3 months. In the opinion of the Investigator, patients must be able to sign the ICF and complete all study-required procedures. Patients must have the following hematologic parameters, Coagulation functions and hepatic and renal function: White Blood Cell (WBC)≥2.5×10^9/L; Absolute Lymphocyte Count (ANC)≥1.5×10^9/L; Absolute Lymphocyte Count(ALC)≥0.7×10^9/L; Platelet≥100×10^9/L; International Normalized Ratio(INR)≤1.5×ULN; Activated Partial Thromboplastin Time(APTT)≤1.5×ULN; Serum Creatinine (Scr)≤1.5mg/dL (or 132.6μmol/L) or Creatinine Clearance≥60mL/min Urinalysis: urine protein less than 2+, or 24-hour urine protein <1g; Alanine aminotransferase(AST/SGOT) ≤3×ULN; Alanine aminotransferase (ALT/SGPT) ≤3×ULN; Total Bilirubin(TBIL)≤1.5×ULN; Patients must have a washout period ≥ 4 weeks from prior anticancer therapy(ies) to the start of the planned preconditioning regimen, including targeted therapy, chemotherapy, immunotherapy: anti-cytotoxic T lymphocyte-associated antigen 4 (CTLA-4)/anti-PD-1, other monoclonal antibody (mAb), or vaccine Palliative radiation therapy. Patients of childbearing potential or their partners of childbearing potential must be willing to take the appropriate precaution to avoid pregnancy or fathering a child for the duration of the study and practice an approved, highly effective method of birth control during treatment and for 12 months after receiving the last protocol-related therapy. Patients must have no contraindications for surgery or biopsy. Patients (or legally authorized representative) must have the ability to understand the requirements of the study, have provided written informed consent as evidenced by signature on an ICF approved by an Institutional Review Board/Independent Ethics Committee (IRB/IEC), and agree to abide by the study restrictions and return to the site for the required assessments, including the OS Follow-up Period. Exclusion Criteria: Patients have not recovered from all prior therapy-related adverse events (AEs) to ≤ Grade 1 (per Common Terminology Criteria for Adverse Events [CTCAE] v5.0), except for alopecia or vitiligo, prior to Enrollment (tumor resection). Patients who have received an organ allograft or prior cell transfer therapy. Patients with symptomatic and/or untreated brain metastases (of any size and any number). Patients who are on chronic systemic steroid therapy for any reason. Patients who have active medical illness(es) that would pose increased risk for study participation, including: active systemic infections requiring systemic ABX, coagulation disorders, or other active major medical illnesses of the cardiovascular, respiratory, or immune system. Patients with systemic active infection requiring treatment, with positive blood culture or imaging evidence of infection, including active tuberculosis. Patients with hepatic encephalopathy, hepatorenal syndrome, Child-Pugh class B or more severe cirrhosis, or liver failure. Uncontrolled arterial hypertension(SBP≥160mmHg and/or DBP≥100mmHg)or any unstable cardiovascular or cerebrovascular disease in the recent 6 months of consent. Patients who have a left ventricular ejection fraction (LVEF) < 50% or New York Heart Association (NYHA) functional classification Class 3 or Class 4. Female patients who are pregnant or breastfeeding. Patients who are HIV positive, positive syphilis serological test, positive COVID-19 nucleic acid test, or clinically active hepatitis A, B, and C including virus carriers.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mengmeng Tang
Phone
86-021-69110327
Email
clinicaltrials@juncell.com
Facility Information:
Facility Name
Chinese PLA General Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100039
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jianming Xu

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

A Phase I Study on Autologous Tumor Infiltrating Lymphocytes Injection (GC101 TIL) for the Treatment of Advanced Malignant Solid Tumors

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