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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 69 Years
Gender All
More Inclusion & Exclusion 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03649529
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Early Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Timmune Biotech Inc.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Haifeng Lin
Principal Investigator Affiliation The Second Affiliated Hospital of Hainan Medical University
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry, Other
Overall Status Recruiting
Countries China
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Malignant Melanoma
Additional Details

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.

Arms & Interventions

Arms

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.

Interventions

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Hainan Cancer Hospital, Haikou, Hainan, China

Status

Recruiting

Address

Hainan Cancer Hospital

Haikou, Hainan, 570100

Site Contact

Yuyang Tian

tianyuyang@163.com

+86 18686853849

Haikou, Hainan, China

Status

Recruiting

Address

The Second Affiliated Hospital of Hainan Medical University

Haikou, Hainan, 570100

Site Contact

Haifeng Lin

13322060949@163.com

+86 13322060949

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