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

Last updated: December 5, 2019
Sponsor: Timmune Biotech Inc.
Overall Status: Active - Recruiting

Phase

1

Condition

Malignant Melanoma

Melanoma

Treatment

N/A

Clinical Study ID

NCT03649529
T2018-7
  • Ages 18-69
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. All subjects must personally sign and date the consent form before initiating anystudy 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 aftersurgery 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) performancestatus of≤2;

  7. Systematic usage of immunosuppressive drug or corticosteroid must have been stoppedfor 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

Exclusion Criteria:

  1. Presence of fungal, bacterial, viral, or other infection that is uncontrolled orrequiring iv antimicrobials for management. (Simple UTI and uncomplicated bacterialpharyngitis 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 inthis study. Symptom free or post-treatment stable disease or disappearance of lesionsshould not be excluded. The specific selection is ultimately determined by theinvestigator;

  3. Lactating women or women of childbearing age who plan to conceive during the timeperiod;

  4. Active infection with hepatitis B (HBsAG positive) or hepatitis C virus (anti-HCVpositive);

  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 laboratorytests restrict patients for the study;

  9. Other reasons the investigator consider the patient may not be suitable for the study.

Study Design

Total Participants: 6
Study Start date:
September 27, 2018
Estimated Completion Date:
January 01, 2022

Study 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.

Connect with a study center

  • Hainan Cancer Hospital

    Haikou, Hainan 570100
    China

    Active - Recruiting

  • The Second Affiliated Hospital of Hainan Medical University

    Haikou, Hainan 570100
    China

    Active - Recruiting

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