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NK Cell Therapy
Memory-like NK Cell Therapy + BHV-1100 for Multiple Myeloma
Phase 1
Recruiting
Research Sponsored by Biohaven Pharmaceuticals, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be MRD+ disease upon restaging prior to stem cell collection and ASCT
Meets criteria for symptomatic multiple myeloma at the time of induction chemotherapy
Must not have
Prior autologous or allogeneic hematopoietic stem cell transplant
Prior cellular therapies, including NK cell therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a new treatment for multiple myeloma that involves infusing patients with a combination of cytokine-induced memory-like natural killer cells and KP1237, with low-dose IL-2. The primary objective is to establish the safety of this treatment, and to explore its efficacy in patients who have minimal residual disease in first remission prior to autologous stem cell transplant.
Who is the study for?
This trial is for newly diagnosed Multiple Myeloma patients who are transplant eligible, have responded to initial chemotherapy, still have minimal residual disease, and meet specific health criteria like good heart and kidney function. They must not have had certain prior treatments or other active cancers.
What is being tested?
The study tests a combination of CIML NK cells with KP1237 and low dose IL-2 in patients before they undergo an autologous stem cell transplant. It aims to establish safety and potential effectiveness in reducing remaining cancer cells.
What are the potential side effects?
While the trial's main focus is on safety, possible side effects may include reactions related to immune system activation such as fever or fatigue, infusion-related reactions, and effects from low-dose IL-2 like nausea or skin rashes.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My disease shows minimal residual disease before stem cell collection and transplant.
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I have symptoms of multiple myeloma and am starting chemotherapy.
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My lungs are functioning well enough for a transplant evaluation.
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I am willing to have a procedure to collect stem cells for a transplant.
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I am willing to undergo a procedure to collect white blood cells.
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I am willing to have a stem cell transplant in my first remission.
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I am willing to have bone marrow tests as part of my treatment.
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My multiple myeloma improved with initial chemotherapy before stem cell transplant.
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My initial multiple myeloma diagnosis was confirmed with measurable disease.
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I can do most of my daily activities without help.
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My heart is healthy with no recent heart attacks or severe valve issues.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have had a stem cell transplant before.
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I have previously received cellular therapies, such as NK cell therapy.
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I have been treated with monoclonal antibodies before.
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My condition is getting worse at the time of joining the study.
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I have an uncontrolled hepatitis B or C infection.
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I have an active cancer that is not multiple myeloma.
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I have never had plasma cell leukemia.
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I have been treated with melphalan before.
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I have a neurological condition that could interfere with assessing treatment side effects.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: BHV-1100 Combination TreatmentExperimental Treatment1 Intervention
Find a Location
Who is running the clinical trial?
Dana-Farber Cancer InstituteOTHER
1,110 Previous Clinical Trials
358,273 Total Patients Enrolled
54 Trials studying Multiple Myeloma
44,305 Patients Enrolled for Multiple Myeloma
Biohaven Pharmaceuticals, Inc.Lead Sponsor
48 Previous Clinical Trials
37,576 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My disease shows minimal residual disease before stem cell collection and transplant.I have symptoms of multiple myeloma and am starting chemotherapy.My lungs are functioning well enough for a transplant evaluation.I have had a stem cell transplant before.I have previously received cellular therapies, such as NK cell therapy.My kidneys are working well.I am willing to have a procedure to collect stem cells for a transplant.I have been treated with monoclonal antibodies before.My bone marrow is working well.I am willing to undergo a procedure to collect white blood cells.My condition is getting worse at the time of joining the study.I have an uncontrolled hepatitis B or C infection.I am willing to have a stem cell transplant in my first remission.I have an active cancer that is not multiple myeloma.My liver is working well.I am willing to have bone marrow tests as part of my treatment.I haven't taken any immune system altering drugs in the last 30 days.My multiple myeloma improved with initial chemotherapy before stem cell transplant.I have never had plasma cell leukemia.You have a serious autoimmune disease that is currently active.I haven't taken any experimental or myeloma drugs in the last 30 days.You are expected to live for at least six more months.My initial multiple myeloma diagnosis was confirmed with measurable disease.I can do most of my daily activities without help.My heart is healthy with no recent heart attacks or severe valve issues.I have been treated with melphalan before.You have tested positive for HIV.I have a neurological condition that could interfere with assessing treatment side effects.
Research Study Groups:
This trial has the following groups:- Group 1: BHV-1100 Combination Treatment
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.