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AzTrials

Malignant MelanomaEarly Phase 1NCT03649529

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

A Early Phase 1 study testing GPA-TriMAR-T in people with Malignant Melanoma, run by Timmune Biotech Inc. at 2 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 69 years
Conditions the study is for
Malignant Melanoma
What is being tested?
GPA-TriMAR-T
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
2 sitesChina
Study dates
27 Sep 2018to 1 Jan 2022
Phase
Early Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 69 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;
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  • 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);

Who cannot join

  • 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;
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  • 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.

Trial locations and contacts

2 sites in 1 country.

Haifeng Lin contact

+86 13322060949

13322060949@163.com

Bin Gao contact

+86 13910899150

bin.gaoa@timmune.com

China2 sites, 2 recruiting

  • Hainan Cancer Hospital

    Haikou, Hainan, 570100

    Yuyang Tian, +86 18686853849, tianyuyang@163.com

    Recruiting

  • The Second Affiliated Hospital of Hainan Medical University

    Haikou, Hainan, 570100

    Haifeng Lin, +86 13322060949, 13322060949@163.com

    Yasong Wu, +86 18020091931, yasong.wu@timmune.com

    Recruiting

Other trials in China

About this study

Official title: Adoptive Immunotherapy for HLA_A2 Genotype gp100 Positive Malignant Melanoma With GPA-TriMAR-T Cell

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.

Read the 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.

Being tested
GPA-TriMAR-T
Keywords
HLA-A2, gp100
Medical subject headings
Melanoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GPA-TriMAR-TBiological

    Also called TCR-mimic-CAR-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.

Study groups in NCT03649529
Study groupRoleWhat they receive
GPA-TriMAR-TExperimentalPatients' 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.
Receives: Biological: GPA-TriMAR-T

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 24 months

Secondary outcomes (5)

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

    Complete response rate per the revised International Working Group (IWG) Response Criteria

    Measured: 24 months

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

    Partial response rate per the revised International Working Group (IWG) Response Criteria

    Measured: 24 months

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

    The time from response to relapse or progression

    Measured: 24 months

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

    The time from the first day of treatment to the date on which disease progresses.

    Measured: 24 months

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

    The number of patient alive, with or without signs of cancer

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Aug 2018
  2. Study start27 Sep 2018
  3. Primary completion15 Sep 2021 (estimated)
  4. Study completion1 Jan 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
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)
Enrolment
6 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03649529
Sponsor's protocol ID
T2018-7
Status last verified
Dec 2019
First submitted
23 Aug 2018
Last updated
6 Dec 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 24389689

  • 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.

    PubMed 24100387

  • 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.

    PubMed 28925994

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing GPA-TriMAR-T in people with Malignant Melanoma, run by Timmune Biotech Inc. at 2 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 6 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Haifeng Lin (+86 13322060949, 13322060949@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

safety （Incidence of treatment-related adverse events as assessed by CTCAE v4.03） (time frame: 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03649529, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2019.

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