A Phase 1 Study of Autologous Memory-like Natural Killer (NK) Cell Immunotherapy With BHV-1100 (Formerly KP1237) and IVIG Followed by Low Dose IL-2 as Early Post-Autologous Transplant Consolidation in Minimal Residual Disease Positive, Multiple Myeloma (MM) Patients in First or Second Remission

Description

This is an open-label single center Phase 1a/1b study with the primary objective of establishing the safety and exploring the efficacy of infusing the ex vivo combination product of cytokine induced memory-like (CIML) NK cells plus KP1237 and low dose IL-2 in newly diagnosed MM patients who have minimal residual disease (MRD+) in first remission prior to autologous stem cell transplant (ASCT).

Trial Eligibility

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 * 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

Study Info

Interventions

Locations Recruiting

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