Multiple MyelomaPhase 1NCT04634435
Autologous Memory-like NK Cell Therapy With BHV-1100 and Low Dose IL-2 in Multiple Myeloma Patients
A Phase 1 study testing BHV-1100 plus cytokine induced memory-like (CIML) NK cells plus IVIG and low dose IL-2 in people with Multiple Myeloma, run by Biohaven Pharmaceuticals, Inc. at 1 site in United States.
Trial 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 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- BHV-1100 plus cytokine induced memory-like (CIML) NK cells plus IVIG and low dose IL-2
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Oct 2021to 10 Jan 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
About this study
Official title: 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.
- Conditions
- Multiple Myeloma
- Being tested
- BHV-1100 plus cytokine induced memory-like (CIML) NK cells plus IVIG and low dose IL-2
- Keywords
- 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
- Medical subject headings
- Multiple Myeloma, Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BHV-1100 plus cytokine induced memory-like (CIML) NK cells plus IVIG and low dose IL-2Combination product
Single dose infusion of BHV-1100 plus CIML NK Cells plus IVIG, followed by low dose IL-2
| Study group | Role | What they receive |
|---|---|---|
| BHV-1100 Combination Treatment | Experimental | Not described Receives: Combination Product: BHV-1100 plus cytokine induced memory-like (CIML) NK cells plus IVIG and low dose IL-2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose limiting toxicities following Combination Product administration
Measured: 90-100 days post Combination Product administration
Incidence and severity of side effects related to the Combination Product
Measured: 90-100 days post Combination Product administration
Secondary outcomes (13)
Rate of MRD (by ClonoSEQ®) conversion from positive to negative at 90-100 days after transplantation
Measured: 90-100 days post-ASCT
Rate of MRD conversion from positive to negative
Measured: 1 year post-ASCT
Rate of MRD conversion from positive to negative at any time during the maintenance phase
Measured: Start of maintenance therapy 90-100 days post ASCT until disease progression (approximately 2-3 years)
Rate of PFS
Measured: 1 year post Combination Product administration
Rate of OS
Measured: 1 year post Combination Product administration
Best overall response rate per the International Myeloma Working Group (IMWG) Uniform Response Criteria for Multiple Myeloma
Measured: 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
Measured: 100 days post Combination Product administration
Incidence and severity of other Immune-related toxicities by CTCAE version 5.0
Measured: 100 days post Combination Product administration
PK of BHV-1100 by determining plasma Tmax
Measured: 4 days post Combination Product administration
PK of BHV-1100 by determining plasma Cmax
Measured: 4 days post Combination Product administration
PK of BHV-1100 by determining plasma Cmin
Measured: 4 days post Combination Product administration
PK of BHV-1100 by determining plasma AUC
Measured: 4 days post Combination Product administration
PK of BHV-1100 by determining plasma t1/2
Measured: 4 days post Combination Product administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2020
- Study start21 Oct 2021
- Primary completion10 Jan 2025
- Study completion10 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biohaven Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Dana-Farber Cancer Institute
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04634435
- Sponsor's protocol ID
- BHV1100-101
- Status last verified
- Jan 2025
- First submitted
- 21 Oct 2020
- Last updated
- 20 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04634435
- Acronym / sponsor ID
- BHV1100-101
- Conditions
- Multiple Myeloma
- Keywords
- Cell Therapy, CIML NK cell therapy, cytokine induced memory-like natural killer cell therapy, immunotherapy, antibody-dependent cell-mediated cytotoxicity, ADCC, CD38 positive, CD38+
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Biohaven Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Dana-Farber Cancer Institute
- Study start
- 21 Oct 2021 (actual)
- Primary completion
- 10 Jan 2025 (actual)
- Study completion
- 10 Jan 2025 (actual)
- First posted
- 18 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BHV-1100 Combination Treatment | Experimental | Combination Product: BHV-1100 plus cytokine induced memory-like (CIML) NK cells plus IVIG and low dose IL-2 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BHV-1100 plus cytokine induced memory-like (CIML) NK cells plus IVIG and low dose IL-2Single dose infusion of BHV-1100 plus CIML NK Cells plus IVIG, followed by low dose IL-2 | Combination product | BHV-1100 Combination Treatment |
Primary outcome
Dose limiting toxicities following Combination Product administration
Time frame: 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
13 secondary outcomes
Rate of MRD (by ClonoSEQ®) conversion from positive to negative at 90-100 days after transplantation
Time frame: 90-100 days post-ASCT
Rate of MRD conversion from positive to negative
Time frame: 1 year 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)
Rate of PFS
Time frame: 1 year post Combination Product administration
Rate of OS
Time frame: 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)
Incidence and severity of cytokine release syndrome per ASBMT consensus grading
Time frame: 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
PK of BHV-1100 by determining plasma Tmax
Time frame: 4 days post Combination Product administration
PK of BHV-1100 by determining plasma Cmax
Time frame: 4 days post Combination Product administration
PK of BHV-1100 by determining plasma Cmin
Time frame: 4 days post Combination Product administration
PK of BHV-1100 by determining plasma AUC
Time frame: 4 days post Combination Product administration
PK of BHV-1100 by determining plasma t1/2
Time frame: 4 days post Combination Product administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BHV-1100 plus cytokine induced memory-like (CIML) NK cells plus IVIG and low dose IL-2 in people with Multiple Myeloma, run by Biohaven Pharmaceuticals, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose limiting toxicities following Combination Product administration (time frame: 90-100 days post Combination Product administration). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2025.