Multiple Myeloma
Conditions
Keywords
MUC1, ImMucin, Vaccine, Multiple Myeloma
Brief summary
The scientific approach behind this study is to develop novel anti-cancer therapeutic vaccine to induce a robust cellular immune response mediated via both CD4+ and CD8+ T lymphocytes populations and can be be applicable to the majority of the target population.
Interventions
BIOLOGICALImMucin, hGM-CSF
* Six biweekly Intradermal or subcutaneous injections of 100 micrograms ImMucin * After six injections, if response will not be observed, or if response will not be sufficient, Immucin dose will be escalated to 250 micrograms for six additional injections. * In addition, each immunization, hGM-CSF with a total dose of 250 microgram will be injected.
Sponsors
Vaxil Therapeutics Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. All\* patients must have a histological or cytological diagnosis of metastatic disease or hematological malignancies expressing the MUC1. Patients must have metastatic disease, and have failed at least one regimen of standard based chemotherapy for metastatic disease as indicated in the following table. Patients must have disease considered to be incurable by surgical or radiological intervention. 2. Patients must be \> 18 years of age, consenting to participate in the study. 3. Patients must have at least one site of measurable tumor or measurable tumor marker. 4. Radiological and other relevant imaging studies, such as CT scans, must be performed within 4 weeks of the first treatment as a baseline to document extent of disease. 5. Patients should be at least 4 weeks beyond any major surgery or chemoradiotherapy and have recovered from drug induced toxicity. 6. Patients must have a performance status of 70% or greater on the Karnofsky scale (ECOG 0-2) and a minimal life expectancy of 12 months. 7. Patients must sign an informed consent, and be mentally responsible. * In Multiple Myeloma, MUC1 expression will be tested after confirming that all inclusion/
Exclusion criteria
are met and within the screening period.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety of intradermal or subcutaneous administration of the ImMucin peptide | 6 months | Determine the safety and initial feasibility of intradermal or subcutaneous administration of the ImMucin peptide combined with hGM-CSF for maximal stimulation of T cell response. The patients will receive six or twelve biweekly injections of Imucin (3 or 6 months). Post Treatment visit will be performed 4 weeks after administration of last vaccination. FU telephone calls will be made up to 6 months following the last vaccination in order to assess the status of the disease. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assess efficacy of study treatment | 6 months | Assessment of respose to treatment during treatment period (3 or 6 months).Post Treatment visit will be performed 4 weeks after administration of last vaccination. FU telephone calls will be made up to 6 months following the last vaccination in order to assess the status of the disease. |
Countries
Israel
Outcome results
None listed