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

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ClinicalTrials.gov Identifier: NCT04634435
Recruitment Status : Recruiting
First Posted : November 18, 2020
Last Update Posted : August 29, 2023
Sponsor:
Collaborator:
Dana-Farber Cancer Institute
Information provided by (Responsible Party):
Biohaven Pharmaceuticals, Inc.

Study Description
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Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Multiple Myeloma Combination Product: CIML NK Cells plus KP1237 and low dose IL-2 Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: N/A
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : October 21, 2021
Estimated Primary Completion Date : October 2025
Estimated Study Completion Date : October 2026

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Arms and Interventions
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Arm Intervention/treatment
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)
 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


Outcome Measures
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Primary Outcome Measures :
  1. Dose limiting toxicities following Combination Product dministration [ Time Frame: 100 days post Combination Product administration ]
  2. Incidence and severity of side effects related to the Combination Product [ Time Frame: 100 days post Combination Product administration ]

Secondary Outcome Measures :
  1. Rate of MRD conversion from positive to negative [ Time Frame: 90-100 days post-ASCT ]
  2. Rate of MRD conversion from positive to negative [ Time Frame: 1 year post-ASCT ]
  3. 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) ]
  4. Rate of PFS [ Time Frame: 1 year post Combination Product administration ]
  5. Rate of OS [ Time Frame: 1 years post Combination Product administration ]
  6. 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) ]
  7. Incidence and severity of cytokine release syndrome per ASBMT consensus grading [ Time Frame: 100 days post Combination Product administration ]
  8. Incidence and severity of other Immune-related toxicities by CTCAE version 5.0 [ Time Frame: 100 days post Combination Product administration ]
  9. PK of the KP1237 by determining plasma Cmax [ Time Frame: 4 days post Combination Product administration ]
  10. PK of the KP1237 by determining plasma Cmin [ Time Frame: 4 days post Combination Product administration ]
  11. PK of the KP1237 by determining plasma AUC [ Time Frame: 4 days post Combination Product administration ]
  12. PK of the KP1237 by determining plasma t1/2 [ Time Frame: 4 days post Combination Product administration ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04634435


Contacts
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Contact: Chief Medical Officer 203-404-0410 clinicaltrials@biohavenpharma.com

Locations
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United States, Massachusetts
Dana Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
Contact: Giada Bianchi, MD         
Sponsors and Collaborators
Biohaven Pharmaceuticals, Inc.
Dana-Farber Cancer Institute
More Information
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Responsible Party: Biohaven Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT04634435    
Other Study ID Numbers: BHV1100-101 (formerly KP001)
First Posted: November 18, 2020    Key Record Dates
Last Update Posted: August 29, 2023
Last Verified: August 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Biohaven Pharmaceuticals, Inc.:
Cell Therapy
CIML NK cell therapy
cytokine induced memory-like natural killer cell therapy
immunotherapy
antibody-dependent cell-mediated cytotoxicity
ADCC
 CD38 positive
CD38+
plasma cells
multiple myeloma
hematological malignancies
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
 Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases