NCT04613557Active, not recruitingPhase 1
Safety, Activity and Cell Kinetics of CYAD-211 in Patients With Relapsed or Refractory Multiple Myeloma
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
Source: ClinicalTrials.gov · Last updated 31 Aug 2023
Brief summary (registry, in English)
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
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 18 (actual)
- First submitted
- 28 Oct 2020
- Start date
- 16 Nov 2020
- Primary completion date
- 21 Dec 2022
- Lead sponsor
- Celyad Oncology SA
- Diseases
- Multiple myeloma
- NCT number
- NCT04613557
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 18
- From 16 Nov 2020 to the primary completion date, 21 Dec 2022
- 5 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other
- History or presence of clinically relevant central nervous system (CNS) tumor involvement.
Criteria the registry did not label
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Universitair Ziekenhuis Antwerpen Coordinator of this site? Confirm its status | Antwerp | Belgium | Unknown status |
| Institut Jules Bordet Coordinator of this site? Confirm its status | Brussels | Belgium | Unknown status |
| AZ Delta Coordinator of this site? Confirm its status | Roeselare | Belgium | Unknown status |
| NYU Langone Hospitals Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| H Lee Moffitt Cancer Center Coordinator of this site? Confirm its status | Tampa | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.