Autologous Memory-like NK Cell Therapy With BHV-1100 and Low Dose IL-2 in Multiple Myeloma Patients

January 16, 2025 updated by: Biohaven Pharmaceuticals, Inc.

A Phase 1 Study of Autologous Memory-like Natural Killer (NK) Cell Immunotherapy With BHV-1100 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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
7

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Dana Farber Cancer Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: BHV-1100 Combination Treatment
Combination product: BHV-1100 plus cytokine induced memory-like (CIML) NK cells plus IVIG and low dose IL-2
Single dose infusion of BHV-1100 plus CIML NK Cells plus IVIG, followed by low dose IL-2

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Dose limiting toxicities following Combination Product administration
Time Frame: 90-100 days post Combination Product administration
90-100 days post Combination Product administration
Incidence and severity of side effects related to the Combination Product
Time Frame: 90-100 days post Combination Product administration
90-100 days post Combination Product administration

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Rate of MRD conversion from positive to negative
Time Frame: 1 year post-ASCT
1 year post-ASCT
Rate of PFS
Time Frame: 1 year post Combination Product administration
1 year post Combination Product administration
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)
90-100 days post-ASCT, 1 year post-ASCT, and overall during maintenance phase (approximately 3 years)
Incidence and severity of cytokine release syndrome per ASBMT consensus grading
Time Frame: 100 days post Combination Product administration
100 days post Combination Product administration
Incidence and severity of other Immune-related toxicities by CTCAE version 5.0
Time Frame: 100 days post Combination Product administration
100 days post Combination Product administration
Rate of MRD (by ClonoSEQ®) conversion from positive to negative at 90-100 days after transplantation
Time Frame: 90-100 days post-ASCT
90-100 days post-ASCT
Rate of MRD conversion from positive to negative at any time during the maintenance phase
Time Frame: Start of maintenance therapy 90-100 days post ASCT until disease progression (approximately 2-3 years)
Start of maintenance therapy 90-100 days post ASCT until disease progression (approximately 2-3 years)
Rate of OS
Time Frame: 1 year post Combination Product administration
1 year post Combination Product administration
PK of BHV-1100 by determining plasma Tmax
Time Frame: 4 days post Combination Product administration
4 days post Combination Product administration
PK of BHV-1100 by determining plasma Cmax
Time Frame: 4 days post Combination Product administration
4 days post Combination Product administration
PK of BHV-1100 by determining plasma Cmin
Time Frame: 4 days post Combination Product administration
4 days post Combination Product administration
PK of BHV-1100 by determining plasma AUC
Time Frame: 4 days post Combination Product administration
4 days post Combination Product administration
PK of BHV-1100 by determining plasma t1/2
Time Frame: 4 days post Combination Product administration
4 days post Combination Product administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Biohaven Pharmaceuticals, Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Dana-Farber Cancer Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 21, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 10, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 10, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 21, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 12, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 18, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 16, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BHV1100-101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Conditions

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