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

ENROLLING
Protocol # :
20-120
Conditions
Multiple Myeloma
Phase
I
Disease Sites
Multiple Myeloma
Principal Investigator
Bianchi, Giada
Site Research Nurses
Hogan, Sarah
Kendricken, Elizabeth

Trial 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).

Eligibility Requirements

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

20-120