Multiple Myeloma Clinical Trial
Official title:
A Pilot Trial of a WT1 Analog Peptide Vaccine in Patients With Multiple Myeloma Following Autologous Stem Cell Transplantation
Verified date | January 2020 |
Source | Sellas Life Sciences Group |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to see if the investigator can help the immune system to work
against myeloma through the use/administration of a peptide vaccine (immunotherapy agent)
directed against the Wilms Tumor 1 (WT1) protein called galinpepimut-S (or GPS, for brief).
Because cancer is produced by the patient's own body, the immune system does not easily
recognize and fight cancer cells. The immune system needs to be "trained" to do this; the
latter goal is accomplished by using a vaccine consisting of selected fragments of the target
antigen, in this case, WT1.
This disease has been selected for this study because the WT1 protein is often present in
myeloma cells. WT1 is a gene that is involved in the normal development of kidneys and other
organs. When the WT1 gene becomes abnormal, it can make proteins involved in the development
of cancer, i.e., can acquire the properties of a true "oncogene". This study will determine
whether the vaccine against the WT1 antigen (present in malignant plasmacytes) can cause an
immune response which is safe, but also able to keep the myeloma from either coming back or
progressing.
Status | Active, not recruiting |
Enrollment | 22 |
Est. completion date | August 2020 |
Est. primary completion date | June 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Symptomatic multiple myeloma, ISS stage 1-3 with confirmed diagnosis of multiple myeloma at MSKCC - Patients must be eligible to undergo autologous stem cell transplantation by standard institutional criteria - Patients must have documented WT1 positive disease. For purpose of this study, this is defined as detectable presence of WT1 expression by immunohistochemistry or by WT1 transcript via RT-PCR on a bone marrow or other plasma cell-related biopsy specimen prior to autologous stem cell transplantation. Bone marrow or other biopsy specimen from time of diagnosis from patients diagnosed at MSKCC or outside hospital may be requested for assessment of WT1 expression by IHC - Age > or = to 18 years - Karnofsky performance status > or = to 50% - Hematologic parameters: - Absolute neutrophil count (ANC) > or = to 1,000/µl - Platelets > 50,000/µl - Biochemical parameters: - Total bilirubin < than or = to 2.0 mg/dl - AST and ALT < than or = to 2.5 x upper limits of normal (ULN) - Creatinine < than or = to 2.0 mg/dl Exclusion Criteria: - Pregnant or lactating women - Patients with active infection requiring systemic antimicrobials - Patients taking systemic corticosteroids - Patients with serious unstable medical illness - Concurrent malignancies |
Country | Name | City | State |
---|---|---|---|
United States | Memorial Sloan Kettering Cancer Center | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Sellas Life Sciences Group |
United States,
Koehne G, Devlin S, Korde N, Mailankody S, Landau H, Hassoun H, Lesokhin A, Lendvai N, Chung D, Sarlis N, Giralt S, Landgren O. Galinpepimut-S, a WT1-Targeting Immuno-Oncology Treatment, Induces Specific, Robust and Durable Immune Responses (IRs) in Patie
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Antigen-specific T-cell immune response (IR) - early | The level of induction of T-cell (CD4+ and CD8+) immune responses against WT1 peptides within the galinpepimut-S vaccine mixture - as compared to baseline (t=0; before vaccine administration)- will be measured by intracellular interferon-? production assay and MHC tetramer analyses - the latter, if available for patient's HLA-type. | 12 weeks after the initial GPS vaccine (end of first series [GPS x 6 administrations]) | |
Primary | Antigen-specific T-cell immune response (IR) - late | The level of induction of T-cell (CD4+ and CD8+) immune responses against WT1 peptides within the galinpepimut-S vaccine mixture - as compared to baseline (t=0; before vaccine administration) - will be measured by intracellular interferon-? production assay and MHC tetramer analyses - the latter, if available for patient's HLA-type. | 38 weeks after the initial GPS vaccine (end of booster series [GPS x 12 administrations]) | |
Secondary | Progression-free survival (PFS) | From time of registration to the time of documented myeloma progression (as defined by the International Myeloma Working Group [IMW] consensus criteria; Kumar S et al. Lancet Oncol. 2016) or subject death. | 2 years | |
Secondary | Overall survival (OS) | From time of registration to the time of subject death. | 2 years | |
Secondary | Toxicity profile | Toxicity will be graded in accordance with Common Toxicity Criteria, version 4.0 (CTCAE 4.0) The only toxicities captured outside of the SAEs reported will be all Grade 1-5 toxicities deemed definitely, probably, or possibly related to the portion of the study. relevant to the active administration of galinpepimut-S. | 2 years | |
Secondary | WT1 expression level quantification | Protein expression analysis for WT antigens will be done by immunohistochemistry (IHC) as follows: Monoclonal antibodies to CD138/Syndecan, co-express WT1 when staining WT1 mAB 6F-H2 will employed by the study specified research lab on MSKCC S-631. | 2 years |
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