Back to resultsSafety, Activity and Cell Kinetics of CYAD-211 in Patients With Relapsed or Refractory Multiple Myeloma (IMMUNICY-1)
Primary Purpose
Relapse/Refractory Multiple Myeloma
Status
Active
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
CYAD-211
Endoxan
Fludara
Sponsored by
About this trial
This is an interventional treatment trial for Relapse/Refractory Multiple Myeloma
Eligibility Criteria
- 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.
- Presence of measurable disease as per International Myeloma Working Group (IMWG) Response Criteria
- Eastern Cooperative Oncology Group (ECOG) below or equal 2
- Adequate hematologic, renal, hepatic, pulmonary, and cardiac function
Exclusion Criteria:
- History or presence of clinically relevant central nervous system (CNS) pathology.
- Autologous stem cell transplant within 12 weeks of registration or an allogeneic stem cell transplant within 6 months of starting study treatment.
- Any investigational agent within 3 weeks prior to the initiation of the non-myeloablative preconditioning chemotherapy).
- Prior systemic therapy for MM within 14 days prior to the initiation of the non-myeloablative preconditioning chemotherapy.
- Prior treatment with any BCMA-targeted therapy and which has not achieved at least a partial response.
Sites / Locations
- H. Lee Moffitt Cancer Center
- Nyu Langone Hospitals
- Universitair Ziekenhuis Antwerpen
- Institut Jules Bordet
- AZ DELTA
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
CYAD-211
Arm Description
Infusion post preconditioning non-myeloablative chemotherapy
Outcomes
Primary Outcome Measures
Occurrence of Dose Limiting Toxicities
Occurrence of Dose Limiting Toxicities
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04613557
Brief Title
Safety, Activity and Cell Kinetics of CYAD-211 in Patients With Relapsed or Refractory Multiple Myeloma
Acronym
IMMUNICY-1
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 16, 2020 (Actual)
Primary Completion Date
December 21, 2022 (Actual)
Study Completion Date
February 2037 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Celyad Oncology SA
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Relapse/Refractory Multiple Myeloma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CYAD-211
Arm Type
Experimental
Arm Description
Infusion post preconditioning non-myeloablative chemotherapy
Intervention Type
Biological
Intervention Name(s)
CYAD-211
Intervention Description
Allogeneic anti-BCMA chimeric antigen receptor (CAR) T-cell
Intervention Type
Drug
Intervention Name(s)
Endoxan
Other Intervention Name(s)
cyclophosphamide
Intervention Description
Preconditioning chemotherapy
Intervention Type
Drug
Intervention Name(s)
Fludara
Other Intervention Name(s)
Fludarabine
Intervention Description
Preconditioning chemotherapy
Primary Outcome Measure Information:
Title
Occurrence of Dose Limiting Toxicities
Description
Occurrence of Dose Limiting Toxicities
Time Frame
Up to 36 days post-infusion.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Presence of measurable disease as per International Myeloma Working Group (IMWG) Response Criteria
Eastern Cooperative Oncology Group (ECOG) below or equal 2
Adequate hematologic, renal, hepatic, pulmonary, and cardiac function
Exclusion Criteria:
History or presence of clinically relevant central nervous system (CNS) tumor involvement.
Autologous stem cell transplant within 12 weeks of registration or an allogeneic stem cell transplant within 6 months of starting study treatment.
Any investigational agent within 3 weeks prior to the initiation of the non-myeloablative preconditioning chemotherapy).
Prior systemic therapy for MM within 14 days prior to the initiation of the non-myeloablative preconditioning chemotherapy.
Prior treatment with any BCMA-targeted therapy and which has not achieved at least a partial response.
Facility Information:
Facility Name
H. Lee Moffitt Cancer Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Nyu Langone Hospitals
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Universitair Ziekenhuis Antwerpen
City
Antwerp
ZIP/Postal Code
2650
Country
Belgium
Facility Name
Institut Jules Bordet
City
Brussels
ZIP/Postal Code
1000
Country
Belgium
Facility Name
AZ DELTA
City
Roeselare
ZIP/Postal Code
8800
Country
Belgium
12. IPD Sharing Statement
Learn more about this trial
Safety, Activity and Cell Kinetics of CYAD-211 in Patients With Relapsed or Refractory Multiple Myeloma
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