Phase 1 Study of Autologous Memory-like NK Cell Therapy With 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).

SparkCures ID 1110
Trial Phase Phase 1/2
Enrollment 25 Patients
Treatments
Tags
Trial Sponsors
  • Kleo Pharmaceuticals
NCT Identifier

NCT04634435

Am I Eligible?

The following criteria is a partial list of reasons why patients may or may not be eligible to participate in this clinical trial. Further evaluation with a medical professional will be required to determine full eligibility.

The following criteria is provided for health care professionals.

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

US Trial Locations

Not Currently Accepting Patients

The following is a listing of trial locations that are not currently open and accepting patients.

Massachusetts

Resources

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