Autologous Memory-like NK Cell Therapy With BHV-1100 (Formerly KP1237), Low Dose IL-2 in Multiple Myeloma Patients

This is an interventional treatment trial for Multiple Myeloma focused on measuring Cell Therapy, CIML NK cell therapy, cytokine induced memory-like natural killer cell therapy, immunotherapy, antibody-dependent cell-mediated cytotoxicity, ADCC, CD38 positive, CD38+, plasma cells, multiple myeloma, hematological malignancies Read More

Inclusion Criteria:

• Had measurable disease according to Standard Diagnostic Criteria at the time of initial Multiple Myeloma diagnosis
• Meets criteria for symptomatic multiple myeloma at the time of induction chemotherapy
• Is transplant eligible based on clinician judgement
• Willing to undergo ASCT in first remission
• Achieve partial response or better with induction chemotherapy prior to ASCT according to the International Myeloma Working Group (IMWG) Uniform Response Criteria for Multiple Myeloma
• Be MRD+ disease upon restaging prior to stem cell collection and ASCT
• Eastern Cooperative Oncology Group (EGOG) performance status score of less than 2
• Life expectancy greater than six months
• Have no evidence of active or decompensated heart failure, no recent history (past 6 months) acute myocardial infarction, no evidence of severe valvular disease and must have a LVEF over 50% at the time of transplant evaluation
• Adequate kidney function
• No evidence of moderate/severe restrictive or obstructive lung disease at the time of transplant evaluation
• Adequate bone marrow function
• Be willing to undergo CD34+ cell collection for stem cell transplant
• Be willing to undergo leukapherisis
• Adequate hepatic function
• If of child-bearing potential, be willing to follow birth control and pregnancy testing practice as recommended
• Be willing to undergo bone marrow aspirate and biopsy as per treatment plan

Exclusion Criteria:

• Prior autologous or allogeneic hematopoietic stem cell transplant
• Prior cellular therapies, including NK cell therapy
• Prior treatment with monoclonal antibodies
• Prior treatment with melphalan
• Prior treatment with immunosuppressive or immunomodulatory agents within 30 days of enrollment
• Disease progression at the time of enrollment
• Non secretory multiple myeloma (defined as normal serum and urine immunofixation and normal serum free light chain assay)
• History of plasma cell leukemia at any time prior to enrollment
• Patients seropositive for the human immunodeficiency virus (HIV)
• Uncontrolled, Hepatitis C Virus or Hepatitis B Virus infection
• Patient receiving other investigational or anti-myeloma drugs within 30 days of enrollment
• Patients with active clinically significant autoimmune diseases
• Patients with active, clinically significant cancer other than multiple myeloma
• Patients with neurological conditions that make difficult the assessment of neurologic toxicity of the Combination Product