Vaccine Enriched, Autologous, Activated T-Cells Directed to Tumor in Patients With Relapsed/Refractory Melanoma (MARVSmALo)
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|ClinicalTrials.gov Identifier: NCT02482532|
Recruitment Status : Recruiting
First Posted : June 26, 2015
Last Update Posted : November 18, 2016
|Condition or disease||Intervention/treatment||Phase|
|Melanoma||Biological: tvs-CTL Vaccine||Phase 1|
The rate of progression free survival at one (1) year is < 20% for patients with stage IV metastatic melanoma, despite aggressive cytotoxic chemotherapy regimens and newly approved immunomodulatory and targeted therapy. Immunotherapy seems to hold the most promise for achieving prolonged survival or even cure, therefore,efforts have focused on several different approaches. Such approaches have used tumor vaccination, adoptive transfer of tumor infiltrating lymphocytes, and even monoclonal antibodies, unconjugated or conjugated to cytokines, toxins, or radionucleotides.
The tumor-associated antigen GD2 has been noted on the surface of several tumors, most notably neuroblastoma, but is expressed on melanoma as well. Clinical studies have shown activity of a GD2-specific chimeric T-cell receptor expressed on activated, autologous, T-cells in patients with neuroblastoma. It is the investigators intention to enrich peripheral blood mononuclear cells (PBMC) of patients with stage IV metastatic melanoma with vaccine-specific T-cells through pre-harvest/ phlebotomy vaccination with common, well understood vaccines. The investigators will then modify the T-cells to attack the GD2 antigen. These tumor redirected, vaccine specific, activated T-cells will then be infused into the patient following revaccination with the common vaccines. The Investigators will monitor expansion of the modified T-cells through serial polymerase chain reaction (PCR) assays following vaccination.
The Investigators then intend to re-vaccinate with the selected vaccines one month following infusion and monitor for expansion of the modified T-cells.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||3 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I Study of Vaccine Enriched, Autologous, Activated T-Cells Redirected to the Tumor Marker GD2 in Patients With Relapsed/Refractory Melanoma|
|Study Start Date :||January 2016|
|Estimated Primary Completion Date :||June 2020|
|Estimated Study Completion Date :||December 2035|
Experimental: tvs-CTL Vaccine
Infusion of activated T-cells generated from a patient's own peripheral blood mononuclear cells.
Biological: tvs-CTL Vaccine
autologous, 14g2a.zeta chimeric receptor transduced, activated T-cells, enriched for vaccine specific cytotoxic T-lymphocytes (tvs-CTL)
- Measurement of infusion related adverse events to evaluate the safety of infused T-cells [ Time Frame: 4 weeks ]To evaluate the safety of autologous, receptor-transduced, activated T-cells, enriched for vaccine-specific cytotoxic T-lymphocytes (tvs-CTL)
- PCR measurement of retroviral construct to measure persistence of infused T-cells [ Time Frame: 4 weeks ]To evaluate how long the infused T-cells remain in the blood stream
- Measurement of replication competent retrovirus to evaluate the safety of infused T-cells [ Time Frame: 4 weeks ]To evaluate the safety of autologous, receptor-transduced, activated T-cells, enriched for vaccine-specific cytotoxic T-lymphocytes (tvs-CTL)
- PCR measurement of retroviral construct to measure the expansion of infused T-cells [ Time Frame: 12 months ]To determine the expansion of infused tvs-CTL in response to repeat vaccination with previously administered vaccines
- PCR measurement of retroviral construct to compare frequency of peripheral tvs-CTL population pre-infusion vs post-revaccination [ Time Frame: 12 months ]To compare the frequency of tvs-CTL in the peripheral blood, after revaccination, to the frequency noted in the prior study of autologous activated, CAR-transduced T-cells infused in patients with relapsed, refractory Stage IV melanoma
- Imaging studies to measure tumor response [ Time Frame: 10 weeks ]Evaluate tumor response to infusion of tvs-CTL and repeat vaccination post-infusion.
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): NCT02482532
|Contact: Gary Doolittle, MDemail@example.com|
|Contact: Kerry Hepler, RNfirstname.lastname@example.org|
|Principal Investigator:||Gary Doolittle, MD||University of Kansas Medical Center|