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CAR T-cell Therapy

ION251 for Multiple Myeloma

Phase 1
Waitlist Available
Research Sponsored by Ionis Pharmaceuticals, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
In need of systemic treatment for MM and either is refractory to or has failed treatment with, is intolerant to or has refused, or is not otherwise a candidate in the opinion of the Investigator, for any of the currently available established therapies known to provide clinical benefit in relapsed/refractory MM. Refractory to treatment is defined as documented MM disease progression while on or within 60 days from the last dose (LD) of treatment
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 months from the last dose of study drug
Awards & highlights

Study Summary

This trial is testing a new cancer drug to see what the highest dose is that patients can tolerate, and what the recommended dose should be for future trials.

Who is the study for?
This trial is for adults over 18 with relapsed/refractory multiple myeloma who have not responded to, cannot tolerate, or are ineligible for established therapies. Participants must have measurable MM and be in good physical condition (ECOG status of 0 or 1). They can't join if they have low blood counts, uncontrolled high blood pressure, certain other cancers or bleeding disorders, poor kidney function, or significantly elevated liver enzymes.Check my eligibility
What is being tested?
The study aims to find the safest and most effective dose of a new drug called ION251 for patients with multiple myeloma that has come back after treatment or hasn't responded to previous treatments. The focus is on determining the maximum-tolerated dose and the recommended Phase 2 dose.See study design
What are the potential side effects?
While specific side effects of ION251 are not listed here, common side effects in trials like this may include nausea, fatigue, lowered immunity leading to infections, anemia causing tiredness and weakness; as well as potential impacts on liver function which could cause jaundice.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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You have multiple myeloma and have not responded well to or cannot tolerate the standard treatments for this condition.
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You should be able to perform daily activities without any assistance or with a little help.
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You have multiple myeloma that can be measured.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 months from the last dose of study drug
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 months from the last dose of study drug for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Maximum-Tolerated Dose (MTD)
Recommended Phase 2 Dose (PR2D)
Secondary outcome measures
AUC[0-t]: Area Under the Plasma Concentration-Time Curve from Hour zero to t of ION251
Cmax: Maximum Observed Concentration ION251
Incidence of Abnormal Laboratory Values and Vital Signs
+4 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: ION251Experimental Treatment1 Intervention
In Part 1, the dose escalation phase, increased amounts of ION251 will be administered at multiple time points by intravenous (IV) infusion during 28-day cycles. In Part 2, the determined RP2D of ION251 will be administered at multiple time points by IV infusion.

Find a Location

Who is running the clinical trial?

Ionis Pharmaceuticals, Inc.Lead Sponsor
145 Previous Clinical Trials
15,242 Total Patients Enrolled

Media Library

ION251 (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04398485 — Phase 1
Multiple Myeloma Research Study Groups: ION251
Multiple Myeloma Clinical Trial 2023: ION251 Highlights & Side Effects. Trial Name: NCT04398485 — Phase 1
ION251 (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04398485 — Phase 1

Frequently Asked Questions

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

For what cohort of individuals is this clinical trial recruiting participants?

"To conduct this clinical trial, 80 suitable patients must be found. The sponsor of the study, Ionis Pharmaceuticals Inc., will oversee proceedings from various locations like UCLA Rrmc in LA and Barbara Ann Karmanos Cancer Institute in Detroit."

Answered by AI

Has ION251 received clearance from the FDA?

"The safety of ION251 is rated a 1 due to limited research indicating its efficacy, as this trial is classified as Phase 1."

Answered by AI

How many centers are overseeing this experiment?

"Participation in this trial is open at 15 different medical institutions such as UCLA Rrmc in Los Angeles, Barbara Ann Karmanos Cancer Institute in Detroit, and The University of Alabama at Birmingham Comprehensive Cancer Center. There are many other locations to consider if you wish to join the study."

Answered by AI

Are new participants being recruited for this research endeavor?

"Clinicaltrials.gov confirms that this medical research is in search of participants. The original posting was made on January 20th 2021, with the most recent update occurring on September 21st 2022."

Answered by AI
~6 spots leftby Mar 2025