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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04613557
Recruitment Status : Recruiting
First Posted : November 3, 2020
Last Update Posted : November 30, 2020
Sponsor:
Information provided by (Responsible Party):
Celyad Oncology SA

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Relapse/Refractory Multiple Myeloma Biological: CYAD-211 Drug: Endoxan Drug: Fludara Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: N/A
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Estimated Study Start Date : November 26, 2020
Estimated Primary Completion Date : February 2023
Estimated Study Completion Date : February 2036

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma
Drug Information available for: Fludarabine

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 Name: cyclophosphamide

Drug: Fludara
Preconditioning chemotherapy
Other Name: Fludarabine




Primary Outcome Measures :
  1. Occurrence of Dose Limiting Toxicities [ Time Frame: Up to 36 days post-infusion. ]
    Occurrence of Dose Limiting Toxicities



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
  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) pathology.
  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04613557


Contacts
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Contact: Celyad Oncology Medical Monitor, MD, PhD +3210394100 clinicaltrials@celyad.com

Locations
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United States, Florida
H. Lee Moffitt Cancer Center Not yet recruiting
Tampa, Florida, United States, 33612
Contact: Taiga Nishihori    813-745-8156    Taiga.Nishihori@moffitt.org   
United States, New York
Nyu Grossman School of Medicine Not yet recruiting
New York, New York, United States, 10016
Contact: Ahmad Al-Homsi, MD         
Belgium
Universitair Ziekenhuis Antwerpen Recruiting
Antwerp, Belgium, 2650
Contact: Sébastien ANGUILLE, MD    +3238213250    sebastien.anguille@uza.be   
Institute Jules Bordet Not yet recruiting
Brussels, Belgium, 1000
Contact: Nathalie MEULEMAN, MD    +3225413237    nathalie.meuleman@bordet.be   
AZ DELTA Not yet recruiting
Roeselare, Belgium, 8800
Contact: Dries DEEREN, MD    +3251237322    Dries.Deeren@azdelta.be   
Sponsors and Collaborators
Celyad Oncology SA
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Responsible Party: Celyad Oncology SA
ClinicalTrials.gov Identifier: NCT04613557    
Other Study ID Numbers: CYAD-211-001
First Posted: November 3, 2020    Key Record Dates
Last Update Posted: November 30, 2020
Last Verified: November 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Cyclophosphamide
Fludarabine
Fludarabine phosphate
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antimetabolites, Antineoplastic
Antimetabolites