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

What's the purpose of this trial?

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).

This trial is currently open and accepting patients.

What will happen during the trial?

You may be able to join this trial if you:

The following criteria is a partial list of reasons why patients may be eligible to participate in this clinical trial. Further evaluation with a medical professional is required.

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

Additional Trial Information

Phase 1

Enrollment: 25 patients (estimated)

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Trial Locations

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Massachusetts

Dana-Farber Cancer Institute (Main)

Boston, MA

Open and Accepting
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