Status:
WITHDRAWN
Therapy for Progressive and/or Refractory Hematologic Malignancies
Lead Sponsor:
Kiromic BioPharma Inc.
Conditions:
Cancer
Hematologic Malignancies
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this study is to evaluate the safety and effectiveness of Tumor Associated Peptide Antigen (TAPA) pulsed dendritic cell (DC) vaccines in the treatment of progressive and/or refractory h...
Detailed Description
Patients diagnosed with progressive and/or refractory hematologic malignancies, who have failed conventional therapy and have no potentially curative therapeutic options available, will be candidates ...
Eligibility Criteria
Inclusion
- Ability to provide informed consent.
- Patients at least eighteen (18) years of age diagnosed with the following histologically proven, progressive and/or refractory HM following standard therapy: Multiple Myeloma (MM), Hodgkins Disease (HD), Non-Hodgkins Lymphoma (NHL) and Chronic Lymphocytic Leukemia (CLL), and without potentially curative therapeutic options, will be eligible.
- Expression of one (1) or more of the following TAPAs: SP17, AKAP4, Ropporin, PTTG1 and Span-xb, by either RT-PCR and/or immunocytochemistry, Western blotting or ELISA, in neoplastic cells and/or blood.
- Presence of measurable or evaluable disease.
- 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) at least four (4) weeks prior to enrollment.
- Patients may not have any known allergy to 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, AST and 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 Leucocyte Antigen (HLA) typing should demonstrate HLA-A\*01, and/or HLA-A-\*02, and/or HLA-A\*24 restriction.
- Either a female or male of reproductive capacity wishing to participate in this study must be using, or agree to use, one or more types of birth control during the entire study and for 3 months after completing the study. Birth control methods may include condoms, diaphragms, birth control pills, spermicidal gels or foams, anti-gonadotropin injections, intrauterine devices (IUD), surgical sterilization, or subcutaneous implants. Another choice is for a subject's sexual partner to use one of these birth control methods. Women of reproductive capacity will be required to undergo a urine pregnancy test before completion of the post-screening informed consent process.
Exclusion
- Patients without confirmed progressive and/or refractory MM, HD, NHL and CLL, or those with confirmed progressive and/or refractory MM, HD, NHL and CLL but who have a potentially curative therapeutic intervention available, are excluded from the study.
- Patients without measurable or evaluable disease.
- Patients receiving cytotoxic therapy, radiation therapy, immunotherapy or non-topical steroids for HM within four (4) weeks of enrollment.
- 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.
- 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 with documented primary or secondary central nervous system (CNS) involvement at any time during disease course are excluded from the study.
- Patient with HLA-A alleles not belonging to any of the following subtypes: HLA-A\*01, or HLA-A\*02, or HLA-A\*24.
Key Trial Info
Start Date :
July 28 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 31 2019
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT02223312
Start Date
July 28 2017
End Date
January 31 2019
Last Update
August 28 2018
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