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

Study Purpose

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).

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 75 Years
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04634435
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Biohaven Pharmaceuticals, Inc.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry, Other
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Multiple Myeloma
Arms & Interventions

Arms

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)

Interventions

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Dana Farber Cancer Institute, Boston, Massachusetts

Status

Recruiting

Address

Dana Farber Cancer Institute

Boston, Massachusetts, 02215

Site Contact

Giada Bianchi, MD

clinicaltrials@biohavenpharma.com

203-404-0410