Clinical trial · Interventional
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
NCT04613557CI-TRIAL-00069241IMMUNICY-1active not recruitingPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Relapse/Refractory Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CYAD-211 | Biological | — | UNRESOLVED |
| Endoxan | Drug | Cyclophosphamide | ALIAS |
| Fludara | Drug | Fludarabine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- CYAD-211
- description
- Infusion post preconditioning non-myeloablative chemotherapy
- interventionNames
- Biological: CYAD-211
- Drug: Endoxan
- Drug: Fludara
Primary outcomes (1)
- measure
- Occurrence of Dose Limiting Toxicities
- timeFrame
- Up to 36 days post-infusion.
- description
- Occurrence of Dose Limiting Toxicities
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.