Safety, Activity and Cell Kinetics of CYAD-211 in Patients With Relapsed or Refractory Multiple Myeloma (IMMUNICY-1)

August 30, 2023 updated by: Celyad Oncology SA

Open-label Phase I, Multi-center Study to Determine the Recommended Dose of CYAD-211 After a Non-myeloablative Preconditioning Chemotherapy in Multiple Myeloma Patients With Relapsed or Refractory Disease

The purpose of the IMMUNICY-1 study is to assess the safety, activity and cell kinetics of CYAD-211 in adults with relapsed or refractory multiple myeloma after a lymphodepletion regimen with fludarabine and/or cyclophosphamide

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

This study aims to determine the recommended dose of the allogeneic CYAD-211 (anti-BCMA CAR-T) cells after a non-myeloablative preconditioning chemotherapy in multiple myeloma (MM) patients with relapsed or refractory disease.

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Antwerp, Belgium, 2650
        • Universitair Ziekenhuis Antwerpen
      • Brussels, Belgium, 1000
        • Institut Jules Bordet
      • Roeselare, Belgium, 8800
        • AZ Delta
  • United States
    • Florida
      • Tampa, Florida, United States, 33612
        • H. Lee Moffitt Cancer Center
    • New York
      • New York, New York, United States, 10016
        • NYU Langone Hospitals

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

  1. 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.
  2. Presence of measurable disease as per International Myeloma Working Group (IMWG) Response Criteria
  3. Eastern Cooperative Oncology Group (ECOG) below or equal 2
  4. Adequate hematologic, renal, hepatic, pulmonary, and cardiac function

Exclusion Criteria:

  1. History or presence of clinically relevant central nervous system (CNS) tumor involvement.
  2. Autologous stem cell transplant within 12 weeks of registration or an allogeneic stem cell transplant within 6 months of starting study treatment.
  3. Any investigational agent within 3 weeks prior to the initiation of the non-myeloablative preconditioning chemotherapy).
  4. Prior systemic therapy for MM within 14 days prior to the initiation of the non-myeloablative preconditioning chemotherapy.
  5. Prior treatment with any BCMA-targeted therapy and which has not achieved at least a partial response.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CYAD-211
Infusion post preconditioning non-myeloablative chemotherapy
Biological: CYAD-211
Allogeneic anti-BCMA chimeric antigen receptor (CAR) T-cell
Drug: Endoxan
Preconditioning chemotherapy
Other Names:
  • cyclophosphamide
Drug: Fludara
Preconditioning chemotherapy
Other Names:
  • Fludarabine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Occurrence of Dose Limiting Toxicities
Time Frame: Up to 36 days post-infusion.
Occurrence of Dose Limiting Toxicities
Up to 36 days post-infusion.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Celyad Oncology SA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 16, 2020

Primary Completion (Actual)

December 21, 2022

Study Completion (Estimated)

February 1, 2037

Study Registration Dates

First Submitted

October 28, 2020

First Submitted That Met QC Criteria

November 2, 2020

First Posted (Actual)

November 3, 2020

Study Record Updates

Last Update Posted (Actual)

August 31, 2023

Last Update Submitted That Met QC Criteria

August 30, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CYAD-211-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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