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