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CAR T-cell Therapy

CYAD-211 Immunotherapy for Multiple Myeloma (IMMUNICY-1 Trial)

Phase 1
Waitlist Available
Research Sponsored by Celyad Oncology SA
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Eastern Cooperative Oncology Group (ECOG) below or equal 2
Documented diagnosis of MM with relapsed or refractory disease to at least two prior MM treatment regimens which should include exposure to IMiD and PIs either alone or in combination
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 36 days post-infusion.
Awards & highlights

IMMUNICY-1 Trial Summary

This trial is testing a new immunotherapy drug for people with relapsed or refractory multiple myeloma. The drug will be given after a lymphodepletion regimen with fludarabine and/or cyclophosphamide.

Who is the study for?
This trial is for adults with multiple myeloma that has come back or hasn't responded to at least two treatments, including IMiD and PIs. Participants must have measurable disease, be in decent physical shape (ECOG ≤2), and have good organ function. They can't join if they've had recent cancer treatment, CNS tumor involvement, a stem cell transplant too close to the study start date, or no response to previous BCMA-targeted therapy.Check my eligibility
What is being tested?
The IMMUNICY-1 study is testing CYAD-211's safety and effectiveness after patients receive lymphodepletion drugs Fludara (fludarabine) and/or Endoxan (cyclophosphamide). It aims to understand how this new therapy behaves in the body of those with relapsed/refractory multiple myeloma.See study design
What are the potential side effects?
Potential side effects may include reactions related to immune system activation such as fever or fatigue, complications from bone marrow suppression like infections or bleeding due to low blood counts, and possible damage to organs caused by the chemotherapy agents used for lymphodepletion.

IMMUNICY-1 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can take care of myself but might not be able to do heavy physical work.
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My multiple myeloma has not responded to at least two treatments, including IMiD and PIs.

IMMUNICY-1 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 36 days post-infusion.
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 36 days post-infusion. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Occurrence of Dose Limiting Toxicities

IMMUNICY-1 Trial Design

1Treatment groups
Experimental Treatment
Group I: CYAD-211Experimental Treatment3 Interventions
Infusion post preconditioning non-myeloablative chemotherapy

Find a Location

Who is running the clinical trial?

Celyad Oncology SALead Sponsor
12 Previous Clinical Trials
1,281 Total Patients Enrolled
2 Trials studying Multiple Myeloma
158 Patients Enrolled for Multiple Myeloma

Media Library

CYAD-211 (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04613557 — Phase 1
Multiple Myeloma Research Study Groups: CYAD-211
Multiple Myeloma Clinical Trial 2023: CYAD-211 Highlights & Side Effects. Trial Name: NCT04613557 — Phase 1
CYAD-211 (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04613557 — Phase 1

Frequently Asked Questions

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

What ailment is CYAD-211 typically prescribed for?

"CYAD-211 has demonstrated effectiveness in treating multiple sclerosis, mixed cell type lymphoma and acute myelocytic leukemia."

Answered by AI

Is participation in this research endeavor open to the public at present?

"Indeed, the data hosted on clinicaltrials.gov suggests that this medical experiment is actively enrolling patients and was posted/edited on 11/26/2020. 12 individuals require recruitment from 2 separate sites."

Answered by AI

Could you please outline any additional experiments utilizing CYAD-211?

"Currently, 889 trials of CYAD-211 are taking place globally. Of those experiments, 161 studies have transitioned to Phase 3. While the majority of these clinical trials occur in Philadelphia, Pennsylvania - 28446 locations across the world host research on this drug treatment."

Answered by AI

What is the enrollment capacity of this research project?

"Affirmatively, clinicaltrials.gov data implies that this study is still open for participant recruitment. It was officially announced on November 26th 2020 and the last update to the listing occurred on the same date. The exact number of participants required totals 12 individuals who will be admitted into two different medical facilities."

Answered by AI

Has CYAD-211 received clearance from the U.S. Food and Drug Administration?

"CYAD-211's safety is rated 1 due to the preliminary nature of trials, which lends limited evidence for its efficacy and security."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Safety, Activity and Cell Kinetics of CYAD-211 in Patients With Relapsed or Refractory Multiple Myeloma
2020. "Safety, Activity and Cell Kinetics of CYAD-211 in Patients With Relapsed or Refractory Multiple Myeloma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04613557.
~4 spots leftby Apr 2025
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