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

Sponsor
Celyad Oncology SA (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04613557
Collaborator
(none)
12
Enrollment
5
Locations
1
Arm
182.2
Anticipated Duration (Months)
2.4
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

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
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.

Study Design

Study Type:
Interventional
Anticipated 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
Anticipated Study Start Date :
Nov 26, 2020
Anticipated Primary Completion Date :
Feb 1, 2023
Anticipated Study Completion Date :
Feb 1, 2036

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Occurrence of Dose Limiting Toxicities [Up to 36 days post-infusion.]

      Occurrence of Dose Limiting Toxicities

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 H. Lee Moffitt Cancer Center Tampa Florida United States 33612
    2 Nyu Grossman School of Medicine New York New York United States 10016
    3 Universitair Ziekenhuis Antwerpen Antwerp Belgium 2650
    4 Institute Jules Bordet Brussels Belgium 1000
    5 AZ DELTA Roeselare Belgium 8800

    Sponsors and Collaborators

    • Celyad Oncology SA

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Celyad Oncology SA
    ClinicalTrials.gov Identifier:
    NCT04613557
    Other Study ID Numbers:
    • CYAD-211-001
    First Posted:
    Nov 3, 2020
    Last Update Posted:
    Nov 30, 2020
    Last Verified:
    Nov 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Multiple Myeloma
    Neoplasms, Plasma Cell
    Cyclophosphamide
    Fludarabine
    Fludarabine phosphate

    Study Results

    No Results Posted as of Nov 30, 2020