Consolidation Therapy in Patients With Hematologic Malignancies

NCT02709993 | Withdrawn Phase 1 DMC FDA Drug

• 2 other identifiers: KiroVAX001BSK01 Dendritic cell vaccine
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the safety and efficacy of Tumor Associated Peptide Antigen (TAPA) pulsed dendritic cell (DC) vaccines in the treatment of hematologic malignancies.

Conditions

Cancer; Hematologic Malignancies

Outcome Measures

Primary Outcomes (1)

• Number of adverse events due to administration of TAPA-pulse DC vaccine

  Number of adverse events due to administration of TAPA-pulse DC vaccine

  every 7 days up to 5 months

Secondary Outcomes (2)

• Immunological efficacy as indicated by T-cell cytokine levels

  up to 5 months

• Immunological efficacy as determined by a positive delayed type hypersensitivity (DTH) skin test

  up to 5 months

Study Arms (1)

TAPA-pulsed DC vaccine

EXPERIMENTAL

The subject will take low-dose cyclophosphamide by mouth for 5 days starting 7 days prior to the vaccine cycle. The vaccine contains 1 x 10\^7 TAPA-pulsed dendritic cells and is administered SQ with low-dose GM-CSF following the low-dose cyclophosphamide cycle. A total of six (6) cycles of cyclophosphamide and six (6) DC vaccines cycles will be administered alternating every 14 days.

Biological: TAPA-pulsed DC vaccine

Interventions

TAPA-pulsed DC vaccine BIOLOGICAL

A cycle of low-dose cyclophosphamide (100mg/day) by mouth for 5 days starting seven 7 days prior to the DC vaccine cycle to reduce Treg activity. Low-dose cyclophosphamide will be taken every 14 days for six 6 cycles. A total of 6 vaccines containing 1 x 10\^7 TAPA-pulsed DC will be administered SQ every 14 days. The DC vaccine is given on Day 1 of the DCV cycle plus low-dose GM-CSF 50mcg/day SQ x 5 days (Day 1 to Day 4). GM-CSF is administered for 5 days to increase monocyte production and dendritic cell precursors to optimize immune responses.

TAPA-pulsed DC vaccine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ability to provide informed consent.
• Patients at least eighteen (18) years of age with histologically or cytologically proven Multiple Myeloma (MM), Hodgkins Disease (HD), Non-Hodgkins Lymphoma (NHL), Chronic Myelogenous Leukemia (CML), Acute Lymphocytic Leukemia (ALL), Acute Myelogenous Leukemia (AML) and Chronic Lymphocytic Leukemia (CLL), who have responded to standard, first-line antineoplastic therapy, as defined using standard response criteria for the specific hematologic malignancy (HM), and have no additional potentially curative therapeutic intervention available, will be eligible to participate in this study.
• Expression of one (1) or more of the following TAPAs: SP17, AKAP4, Ropporin, PTTG1 and Span-xb, by either reverse transcriptase polymerase chain reaction (RT-PCR) and/or immunocytochemistry, Western blotting or ELISA, in neoplastic cells and/or blood.
• Presence of measurable or evaluable disease (unless patient has achieved a complete response (CR) following first-line antineoplastic therapy).
• Patients must not have any active infectious process.
• Patients must have a negative test for HIV, Hepatitis A, B, and C.
• Patients must not be receiving active immunosuppressive therapy.
• Patients must have discontinued systemic antineoplastic therapy (including systemic corticosteroids and excluding tyrosine kinase inhibitors for CML) at least four (4) weeks prior to enrollment.
• Patients may not have any known allergy to CYP and/or GM-CSF.
• Patients must be willing to provide at least 250 mL, and up to 500 mL, of whole blood obtained by phlebotomy and/or consent to leukapheresis for DC generation.
• Adequate renal and hepatic function (creatinine ≤ 2.0 mg/dl, bilirubin ≤ 2.0 mg/dl, aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 4X upper limit of normal range).
• Adequate hematologic function (Platelets ≥ 60,000/mm3, lymphocytes ≥ 1,000/mm3, neutrophils ≥ 750/mm3, hemoglobin ≥ 10 g/dl).
• Karnofsky performance status ≥ 70%.
• Expected survival ≥ 6 months.
• Patient Human Leukocyte Antigen (HLA) typing should demonstrate HLA-A\*01, and/or HLA-A\*02, and/or HLA-A\*24 restriction.

You may not qualify if:

• Patients with HM who have undergone myeloablative systemic therapy are ineligible to participate in this study.
• Patients without measurable or evaluable disease (unless patients achieved a complete response (CR) following 1st-line antineoplastic therapy).
• Patients receiving cytotoxic therapy, radiation therapy, immunotherapy or non-topical steroids for HM within four (4) weeks of enrollment, excluding tyrosine kinase inhibitors in patients with CML.
• Active immunosuppressive or cytotoxic therapy (excluding topical steroids) for any other condition.
• Persistent fever (\>24 hours) documented by repeated measurement or active, uncontrolled infection within 4 weeks of enrollment.
• Active ischemic heart disease or history of myocardial infarction within six months.
• Active autoimmune disease, including, but not limited to, Systemic Lupus Erythematosus (SLE), Multiple Sclerosis (MS), Ankylosing Spondylitis (AS), and Rheumatoid Arthritis (RA).
• Pregnancy or breast feeding.
• Patients with an active second invasive malignancy, other than basal cell carcinoma of the skin.
• Life expectancy of less than 6 months.
• Patients with contraindications to CYP and/or GM-CSF.
• Patients who have received organ transplantations.
• Patients with psychological or geographic conditions that prevent adequate follow-up or compliance with the study protocol.
• Patients diagnosed with primary central nervous system (CNS) or with CNS metastases/involvement, at any time during the disease course, are excluded from the study.
• Patients with HLA-A alleles not belonging to any of the following subtypes: HLA-A\*01, or HLA-A\*02, or HLA-A\*24.

Sponsors & Collaborators

• Kiromic BioPharma Inc.: lead

Study Sites (1)

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Neoplasms; Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Naval G Daver, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2016
• First Posted: March 16, 2016
• Study Start: July 28, 2017
• Primary Completion: October 31, 2020
• Study Completion: October 31, 2020
• Last Updated: October 14, 2019

Record last verified: 2019-08

Locations

US (1)