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

NOT 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 BHV-1100 plus cytokine induced memory-like (CIML) NK cells plus IVIG and low
dose IL-2 in the peri-transplant setting in MM patients with minimal residual disease
(MRD+) in first or second remission.

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 or second remission

- Achieve partial response or better with induction chemotherapy prior to ASCT
according to the IMWG Uniform Response Criteria for Multiple Myeloma

- Be MRD+ 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 a creatinine clearance > 45 mL/min/m2 at the time of transplant evaluation

- If frozen stem cells from earlier mobilized leukapheresis are unavailable at the
time of mobilized leukapheresis, patients must meet parameters/criteria according to
institutional SOP for autologous stem cell apheresis

- Be willing and clinically stable to undergo stem-cell mobilized and collect enough
CD34+ cells sufficient for 2 ASCT per institutional guidelines or investigator
discretion or have sufficient frozen cells from a SoC collection prior to signing
study consent

- Be willing and clinically stable to undergo a non-mobilized MNC-Apheresis while
admitted to the hospital to generate CIML NK cells

- Be willing to undergo maintenance after ASCT per NCCN guidelines based on disease
risk

- If a woman 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

- Patients must meet adequate organ function/reserve based on institutional SOP for
autologous stem cell transplant eligibility

- Non-secretory MM can participate if they have measurable disease in the bone marrow
and are amenable to be followed by MRD testing

Exclusion Criteria:

- Prior autologous or allogeneic hematopoietic stem cell transplant

- Prior cellular therapies, including NK cell therapy

- Prior treatment with monoclonal antibodies, within 28 days of MCN apheresis

- Prior treatment with high dose melphalan

- Prior treatment with immunosuppressive or immunomodulatory agents with exception of
5 mg or less of prednisone daily, within 14 days of MCN-Apheresis

- Disease progression at the time of study treatment

- 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 therapy

- Patients with active, clinically significant autoimmune diseases

- Patients with active, clinically significant cancer other than multiple myeloma

- Patients with severe, uncontrolled psychiatric or neurological conditions that make
difficult the assessment of neurologic toxicity of the study treatment

- Patients who have received anti-MM therapy (with the exclusion of monoclonal
antibodies) within 14 days of study treatment

- More than two prior lines of anti-myeloma therapy, with induction therapy followed
by maintenance being considered as one line and CyBorD to RVD transition in the
absence of progressive disease being considered as one line

20-120