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

Overview

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).

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Sequential Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: October 2025

Interventions

  • Combination Product: CIML NK Cells plus KP1237 and low dose IL-2
    • Single dose infusion of CIML NK Cells plus KP1237 followed by low dose IL-2

Arms, Groups and Cohorts

  • Experimental: Newly diagnosed multiple myeloma patients
    • Newly diagnosed MM patients who have minimal residual disease (MRD+) in first remission prior to autologous stem cell transplant (ASCT)

Clinical Trial Outcome Measures

Primary Measures

  • Dose limiting toxicities following Combination Product dministration
    • Time Frame: 100 days post Combination Product administration
  • Incidence and severity of side effects related to the Combination Product
    • Time Frame: 100 days post Combination Product administration

Secondary Measures

  • Rate of MRD conversion from positive to negative
    • Time Frame: 90-100 days post-ASCT
  • Rate of MRD conversion from positive to negative
    • Time Frame: 1 year post-ASCT
  • Rate of MRD conversion from positive to negative during the maintenance phase
    • Time Frame: Start of maintenance therapy 90-100 days post ASCT until disease progression (approximately 2-3 years)
  • Rate of PFS
    • Time Frame: 1 year post Combination Product administration
  • Rate of OS
    • Time Frame: 1 years post Combination Product administration
  • Best overall response rate per the International Myeloma Working Group (IMWG) Uniform Response Criteria for Multiple Myeloma
    • Time Frame: 90-100 days post-ASCT, 1 year post-ASCT, and overall during maintenance phase (approximately 3 years)
  • Incidence and severity of cytokine release syndrome per ASBMT consensus grading
    • Time Frame: 100 days post Combination Product administration
  • Incidence and severity of other Immune-related toxicities by CTCAE version 5.0
    • Time Frame: 100 days post Combination Product administration
  • PK of the KP1237 by determining plasma Cmax
    • Time Frame: 4 days post Combination Product administration
  • PK of the KP1237 by determining plasma Cmin
    • Time Frame: 4 days post Combination Product administration
  • PK of the KP1237 by determining plasma AUC
    • Time Frame: 4 days post Combination Product administration
  • PK of the KP1237 by determining plasma t1/2
    • Time Frame: 4 days post Combination Product administration

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Biohaven Pharmaceuticals, Inc.
  • Collaborator
    • Dana-Farber Cancer Institute
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • Chief Medical Officer, 203-404-0410, clinicaltrials@biohavenpharma.com

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