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Treatment of Malignant Melanoma With GPA-TriMAR-T Cell Therapy

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: NCT03649529
Recruitment Status : Recruiting
First Posted : August 28, 2018
Last Update Posted : December 6, 2019
Sponsor:
Collaborators:
The Second Affiliated Hospital of Hainan Medical University
Hainan Cancer Hospital
Information provided by (Responsible Party):
Timmune Biotech Inc.

Brief Summary:
Malignant melanoma have been reported to be characterized with high gp100 expression. Patients' autologous T cells will be isolated and transduced by GPA-TriMAR lentivirus to generate the GPA-TriMAR-T cells. When infused back to the patient, the GPA-TriMAR-T cells will recognize and kill target cells that express gp100(209-217) peptides in the form MHC-I complex, thus eliminating malignant melanoma from the body.

Condition or disease Intervention/treatment Phase
Malignant Melanoma Biological: GPA-TriMAR-T Early Phase 1

Detailed Description:
GPA-TriMAR is a modified chimeric antigen receptor (CAR) that consist of three subunit in it's outer membrane domain. The outer membrane domain linked to the inner membrane 4-1BB/CD3ζ domain through the transmembrane domain, thus compose the complete chimeric antigen receptor. Patients' autologous T cells will be isolated and transduced by GPA-TriMAR lentivirus to generate the GPA-TriMAR-T cells. When infused back to the patient, the modified GPA-TriMAR-T cells will recognize and kill malignant melanoma cells in the body, and in the meanwhile the other two subunits function to stimulate the innate immune system and enhance GPA-TriMAR-T cells tumor Infiltration.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 6 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Patients' autologous T cells will be isolated and transduced by GPA-TriMAR lentivirus to generate the GPA-TriMAR-T cells,and then infused back into the patient.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Adoptive Immunotherapy for HLA_A2 Genotype gp100 Positive Malignant Melanoma With GPA-TriMAR-T Cell
Actual Study Start Date : September 27, 2018
Estimated Primary Completion Date : September 15, 2021
Estimated Study Completion Date : January 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma

Arm Intervention/treatment
Experimental: GPA-TriMAR-T
Patients' autologous T cells will be isolated and transduced by GPA-TriMAR lentivirus to generate the GPA-TriMAR-T cells, and these cells will then be infused back into the patient for intervention.
Biological: GPA-TriMAR-T
Patients will undergo leukapheresis to isolate autologous T cells, these T cells will be activated and modified to express GPA-TriMAR in the manufacture facility, and eventually infused back into the body for treatment.
Other Name: TCR-mimic-CAR-T




Primary Outcome Measures :
  1. safety (Incidence of treatment-related adverse events as assessed by CTCAE v4.03) [ Time Frame: 24 months ]
    Incidence of treatment-related adverse events as assessed by CTCAE v4.03


Secondary Outcome Measures :
  1. Complete response rate[CR] (Complete response rate per the revised International Working Group (IWG) Response Criteria) [ Time Frame: 24 months ]
    Complete response rate per the revised International Working Group (IWG) Response Criteria

  2. Partial response rate [PR] (Partial response rate per the revised International Working Group (IWG) Response Criteria) [ Time Frame: 24 months ]
    Partial response rate per the revised International Working Group (IWG) Response Criteria

  3. Duration of Response (The time from response to relapse or progression) [ Time Frame: 24 months ]
    The time from response to relapse or progression

  4. Progression Free Survival (The time from the first day of treatment to the date on which disease progresses.) [ Time Frame: 24 months ]
    The time from the first day of treatment to the date on which disease progresses.

  5. Overall Survival (The number of patient alive, with or without signs of cancer) [ Time Frame: 24 months ]
    The number of patient alive, with or without signs of cancer



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. All subjects must personally sign and date the consent form before initiating any study specific procedures or activities;
  2. All subjects must be able to comply with all the scheduled procedures in the study;
  3. HLA_A2 genotype and gp100 positive malignant melanoma: Ⅳ stage or relapsed after surgery or chemotherapy or no available standard therapy;
  4. At least one measurable lesion per RECIST V1.1;
  5. Aged 18 to 69 years;
  6. Expected survival ≥12 weeks; Eastern cooperative oncology group (ECOG) performance status of≤2;
  7. Systematic usage of immunosuppressive drug or corticosteroid must have been stopped for more than 4 weeks;
  8. All other treatment induced adverse events must have been resolved to ≤grade 1;
  9. Laboratory tests must fulfill the following criteria: ANC ≥ 1000/uL, HGB>70g/L, Platelet count ≥ 50,000/uL, Creatinine clearance ≤1.5 ULN, Serum ALT/AST ≤2.5 ULN, Total bilirubin ≤1.5 ULN (except in subjects with Gilbert's syndrome);

Exclusion Criteria:

  1. Presence of fungal, bacterial, viral, or other infection that is uncontrolled or requiring iv antimicrobials for management. (Simple UTI and uncomplicated bacterial pharyngitis are permitted if responding to active treatment);
  2. Patients with symptomatic central nervous system metastasis, intracranial metastasis, and cancer cells found in cerebrospinal fluid are not recommended to participate in this study. Symptom free or post-treatment stable disease or disappearance of lesions should not be excluded. The specific selection is ultimately determined by the investigator;
  3. Lactating women or women of childbearing age who plan to conceive during the time period;
  4. Active infection with hepatitis B (HBsAG positive) or hepatitis C virus (anti-HCV positive);
  5. Known history of infection with HIV;
  6. Subjects need systematic usage of corticosteroid;
  7. Subjects need systematic usage of immunosuppressive drug;
  8. Planed operation, history of other related disease, or any other related laboratory tests restrict patients for the study;
  9. Other reasons the investigator consider the patient may not be suitable for the study.

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): NCT03649529


Contacts
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Contact: Haifeng Lin +86 13322060949 13322060949@163.com
Contact: Bin Gao +86 13910899150 bin.gaoa@timmune.com

Locations
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China, Hainan
Hainan Cancer Hospital Recruiting
Haikou, Hainan, China, 570100
Contact: Yuyang Tian    +86 18686853849    tianyuyang@163.com   
The Second Affiliated Hospital of Hainan Medical University Recruiting
Haikou, Hainan, China, 570100
Contact: Haifeng Lin    +86 13322060949    13322060949@163.com   
Contact: Yasong Wu    +86 18020091931    yasong.wu@timmune.com   
Sponsors and Collaborators
Timmune Biotech Inc.
The Second Affiliated Hospital of Hainan Medical University
Hainan Cancer Hospital
Investigators
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Principal Investigator: Haifeng Lin The Second Affiliated Hospital of Hainan Medical University

Publications:
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Responsible Party: Timmune Biotech Inc.
ClinicalTrials.gov Identifier: NCT03649529    
Other Study ID Numbers: T2018-7
First Posted: August 28, 2018    Key Record Dates
Last Update Posted: December 6, 2019
Last Verified: December 2019
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
Keywords provided by Timmune Biotech Inc.:
HLA-A2
gp100
Additional relevant MeSH terms:
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Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas