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KiroVAX in progressive/refractory hematologic malignancies
NCT02223312Phase 2
Key facts
- Status
- Withdrawn
- Start
- Jul 2017
- Primary completion
- Oct 2018
- Sponsor
- Kiromic BioPharma, Inc.
- Modality
- Whole Cell Cancer Vaccines, Dendritic Cell Vaccines
- Drugs
- KiroVax
- Conditions
- multiple myeloma (MM)Hodgkin lymphoma (HL)non-Hodgkin lymphoma (NHL)chronic lymphocytic leukemia (CLL)
01
Overview
Phase 2, open-label, single-arm trial of KiroVax in multiple myeloma (MM), Hodgkin lymphoma (HL), non-Hodgkin lymphoma (NHL) and 1 more, sponsored by Kiromic BioPharma, Inc. Primary endpoint: Number of adverse events due to toxicity. Planned start Jul 2017; status: withdrawn.
02
Design
1 arm- Study design
- Non-randomizedOpen-label
TAPA-pulsed DC vaccine
KiroVAX + Low-dose Cyclophosphamide + Low-dose GM-CSF
03
Who it enrols
Patients with progressive/refractory hematologic malignancies (MM, HD, NHL, CLL) who have failed conventional therapy, express specific TAPAs (SP17, AKAP4, Ropporin, PTTG1, Span-xb), and have HLA-A*01, A*02, or A*24.
04
Endpoints
Primary
Number of adverse events due to toxicity
Secondary
Immunological efficacy as indicated by T-cell cytokine levels
Immunological efficacy as determined by a positive delayed type hypersensitivity (DTH) skin test
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