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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year post-asct

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year post-asct

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year post-asct

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year post-asct for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Dose limiting toxicities following Combination Product dministration

Incidence and severity of side effects related to the Combination Product

Secondary outcome measures

Best overall response rate per the International Myeloma Working Group (IMWG) Uniform Response Criteria for Multiple Myeloma

Incidence and severity of cytokine release syndrome per ASBMT consensus grading

Incidence and severity of other Immune-related toxicities by CTCAE version 5.0

+8 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Newly diagnosed multiple myeloma patientsExperimental Treatment1 Intervention

Newly diagnosed MM patients who have minimal residual disease (MRD+) in first remission prior to autologous stem cell transplant (ASCT)

0 / 11Eligibility criteria met

Find a Location

Who is running the clinical trial?

Dana-Farber Cancer InstituteOTHER

1,079 Previous Clinical Trials

340,923 Total Patients Enrolled

51 Trials studying Multiple Myeloma

34,297 Patients Enrolled for Multiple Myeloma

Biohaven Pharmaceuticals, Inc.Lead Sponsor

47 Previous Clinical Trials

37,110 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: Newly diagnosed multiple myeloma patients

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this study have an age limit for participants?

"This clinical trial is enrolling candidates who are of age (18+) and less than 75 years old."

Answered by AI

Are CIML NK Cells plus KP1237 and low dose IL-2 a new combination for clinical trials?

"At present, there are 32 ongoing studies investigating CIML NK Cells plus KP1237 and low-dose IL-2. None of those live studies are in Phase 3. While the many trials for CIML NK Cells plus KP1237 and low-dose IL-2 are based in Wuxi, Jiangsu, there are 72 locations running studies for this treatment globally."

Answered by AI

How many people are receiving care through this program?

"Yes, you're right. The listing on clinicaltrials.gov says that the research team is actively recruiting subjects for this study. The trial was first posted on October 21st, 2021 and was last updated on October 4th, 2022. Currently, they are looking for 25 individuals to enroll at a single site."

Answered by AI

Can new patients join the trial at this time?

"That is correct. The clinicaltrials.gov website contains information suggesting that the trial is still looking for patients. This particular trial was originally posted on October 21st, 2021 and updated as recently as October 4th, 2022. So far, 25 people have been enrolled at a single location."

Answered by AI

What are the inclusion criteria for this experiment?

"This study is looking for 25 people with multiple myeloma who meet the following criteria: they must be eligible for a transplant, willing to undergo ASCT in first remission, have an ECOG performance status score of less than 2, have no evidence of active or decompensated heart failure, no recent history (past 6 months) of acute myocardial infarction, no evidence of severe valvular disease and must have a LVEF over 50% at the time of transplant evaluation, achieve partial response or better with induction chemotherapy prior to ASCT according to the International Myeloma Working Group (IMWG"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2021. "Autologous Memory-like NK Cell Therapy With BHV-1100 (Formerly KP1237), Low Dose IL-2 in Multiple Myeloma Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04634435.

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