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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 below

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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:

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

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

0 / 20Eligibility criteria met

Find a Location

Who is running the clinical trial?

Dana-Farber Cancer InstituteOTHER

1,108 Previous Clinical Trials

357,186 Total Patients Enrolled

54 Trials studying Multiple Myeloma

44,305 Patients Enrolled for Multiple Myeloma

Biohaven Pharmaceuticals, Inc.Lead Sponsor

48 Previous Clinical Trials

37,573 Total Patients Enrolled

Media Library

CIML NK Cells (NK Cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04634435 — Phase 1

Multiple Myeloma Research Study Groups: BHV-1100 Combination Treatment

Multiple Myeloma Clinical Trial 2023: CIML NK Cells Highlights & Side Effects. Trial Name: NCT04634435 — Phase 1

CIML NK Cells (NK Cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04634435 — Phase 1

~0 spots leftby Dec 2024

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