NCT03649529

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
6

participants targeted

Target at below P25 for early_phase_1

Timeline
Completed

Started Sep 2018

Typical duration for early_phase_1

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 23, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 28, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

September 27, 2018

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2022

Completed
Last Updated

December 6, 2019

Status Verified

December 1, 2019

Enrollment Period

3 years

First QC Date

August 23, 2018

Last Update Submit

December 5, 2019

Conditions

Malignant Melanoma

Keywords

HLA-A2gp100

Outcome Measures

Primary Outcomes (1)

  • safety （Incidence of treatment-related adverse events as assessed by CTCAE v4.03）

    Incidence of treatment-related adverse events as assessed by CTCAE v4.03

    24 months

Secondary Outcomes (5)

  • Complete response rate[CR] （Complete response rate per the revised International Working Group (IWG) Response Criteria）

    24 months

  • Partial response rate [PR] （Partial response rate per the revised International Working Group (IWG) Response Criteria）

    24 months

  • Duration of Response （The time from response to relapse or progression）

    24 months

  • Progression Free Survival （The time from the first day of treatment to the date on which disease progresses.）

    24 months

  • Overall Survival （The number of patient alive, with or without signs of cancer）

    24 months

Study Arms (1)

GPA-TriMAR-T

EXPERIMENTAL

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

Interventions

GPA-TriMAR-TBIOLOGICAL

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.

Also known as: TCR-mimic-CAR-T
GPA-TriMAR-T

Eligibility Criteria

Age18 Years - 69 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All subjects must personally sign and date the consent form before initiating any study specific procedures or activities;
  • All subjects must be able to comply with all the scheduled procedures in the study;
  • HLA\_A2 genotype and gp100 positive malignant melanoma： Ⅳ stage or relapsed after surgery or chemotherapy or no available standard therapy;
  • At least one measurable lesion per RECIST V1.1;
  • Aged 18 to 69 years;
  • Expected survival ≥12 weeks; Eastern cooperative oncology group (ECOG) performance status of≤2;
  • Systematic usage of immunosuppressive drug or corticosteroid must have been stopped for more than 4 weeks;
  • All other treatment induced adverse events must have been resolved to ≤grade 1;
  • 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);

You may not qualify if:

  • 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);
  • 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;
  • Lactating women or women of childbearing age who plan to conceive during the time period;
  • Active infection with hepatitis B (HBsAG positive) or hepatitis C virus (anti-HCV positive);
  • Known history of infection with HIV;
  • Subjects need systematic usage of corticosteroid;
  • Subjects need systematic usage of immunosuppressive drug;
  • Planed operation, history of other related disease, or any other related laboratory tests restrict patients for the study;
  • Other reasons the investigator consider the patient may not be suitable for the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hainan Cancer Hospital

Haikou, Hainan, 570100, China

RECRUITING

The Second Affiliated Hospital of Hainan Medical University

Haikou, Hainan, 570100, China

RECRUITING

Related Publications (3)

  • Zhang G, Wang L, Cui H, Wang X, Zhang G, Ma J, Han H, He W, Wang W, Zhao Y, Liu C, Sun M, Gao B. Anti-melanoma activity of T cells redirected with a TCR-like chimeric antigen receptor. Sci Rep. 2014 Jan 6;4:3571. doi: 10.1038/srep03571.

    PMID: 24389689BACKGROUND

  • Zhang G, Liu R, Zhu X, Wang L, Ma J, Han H, Wang X, Zhang G, He W, Wang W, Liu C, Li S, Sun M, Gao B. Retargeting NK-92 for anti-melanoma activity by a TCR-like single-domain antibody. Immunol Cell Biol. 2013 Nov-Dec;91(10):615-24. doi: 10.1038/icb.2013.45. Epub 2013 Oct 8.

    PMID: 24100387BACKGROUND

  • Neelapu SS, Tummala S, Kebriaei P, Wierda W, Gutierrez C, Locke FL, Komanduri KV, Lin Y, Jain N, Daver N, Westin J, Gulbis AM, Loghin ME, de Groot JF, Adkins S, Davis SE, Rezvani K, Hwu P, Shpall EJ. Chimeric antigen receptor T-cell therapy - assessment and management of toxicities. Nat Rev Clin Oncol. 2018 Jan;15(1):47-62. doi: 10.1038/nrclinonc.2017.148. Epub 2017 Sep 19.

    PMID: 28925994BACKGROUND

MeSH Terms

Conditions

Melanoma

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Haifeng Lin

    The Second Affiliated Hospital of Hainan Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Haifeng Lin

CONTACT

+86 1332206094913322060949@163.com

Bin Gao

CONTACT

+86 13910899150bin.gaoa@timmune.com

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 23, 2018

First Posted

August 28, 2018

Study Start

September 27, 2018

Primary Completion

September 15, 2021

Study Completion

January 1, 2022

Last Updated

December 6, 2019

Record last verified: 2019-12

Data Sharing

IPD Sharing
Will not share

Locations

CN(2)