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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 belowSelect...
I can take care of myself but might not be able to do heavy physical work.
Select...
My multiple myeloma has not responded to at least two treatments, including IMiD and PIs.
IMMUNICY-1 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 36 days post-infusion.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 36 days post-infusion.
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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had BCMA-targeted therapy without significant improvement.I can take care of myself but might not be able to do heavy physical work.My multiple myeloma has not responded to at least two treatments, including IMiD and PIs.I have or had a brain tumor that affects my health.My blood, kidney, liver, lung, and heart functions are all within normal ranges.I had my own stem cell transplant less than 3 months ago or a donor's within the last 6 months.You have a specific amount of disease that can be measured according to certain guidelines.I haven't taken any experimental drugs in the last 3 weeks.I haven't had systemic therapy for multiple myeloma within the last 14 days.
Research Study Groups:
This trial has the following groups:- Group 1: CYAD-211
Awards:
This trial has 3 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 20 Other Conditions - This treatment demonstrated efficacy for 20 other conditions.
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.
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