Clinical trial · Interventional
Descartes-15 for Patients With Relapsed/Refractory Multiple Myeloma
NCT06304636CI-TRIAL-00097861DC15-MM-01terminatedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Phase 1 enrollment completed. Further clinical development terminated
Summary
Brief summary (as posted)
This is a Phase I dose-escalation study to evaluate the safety, tolerability and preliminary efficacy of an autologous BCMA-targeting RNA-engineered CAR T-cell therapy in patients with Relapsed/Refractory Multiple Myeloma. The cell product is referred to as Descartes-15
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Refractory Multiple Myeloma | Multiple Myeloma | CURATED_BROADER | 0.78 |
| Relapsed Multiple Myeloma | Multiple Myeloma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Descartes-15 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Part 1 Descartes-15 with lymphodepletion
- description
- Intra-patient dose escalation arm with three dose levels over the course of six infusions of cell product. Patients will receive lymphodepletion prior to initiating cell therapy.
- interventionNames
- Drug: Descartes-15
- type
- EXPERIMENTAL
- label
- Part 2 Arm 1 Descartes-15 with lymphodepletion
- description
- Descartes-15 infusions at the maximum tolerated dose level from Part 1. Patients will receive lymphodepletion prior to initiating cell therapy.
- interventionNames
- Drug: Descartes-15
- type
- EXPERIMENTAL
- label
- Part 2 Arm 2 Descartes-15 without lymphodepletion
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria * Patients must be 18 years of age or older at the time of enrollment. * Patients must be diagnosed with active and measurable relapsed/refractory multiple myeloma. * Patients must have failed at least 3 prior lines of therapy which must have included an immunomodulatory drug, a proteasome inhibitor, and an anti-CD38 drug or biologic. Failure of treatment and measurable myeloma disease are defined as per 2016 IMWG criteria. * Patients must have clinical performance status of ECOG 0-2. * Patients must have adequate vital organ function as defined by: * Hemoglobin ≥8 g/dL * Absolute neutrophil count \> 1000/ mm3 * Platelets \> 50,000/mm3 * ALT/AST levels lower than 3-fold of normal * Creatinine clearance ≥45 mL/min/1.73 m2 * Normal cardiac and pulmonary function * No thromboembolic events in the past 3 months * No heparin allergy or active infection Exclusion Criteria * Patients who have any active and uncontrolled infection. * Ongoing treatment with chronic immunosuppressants (e.g., cyclosporine or systemic steroids above 40 mg/day prednisone equivalent). * Patients who have active central nervous system disease.
References
Publications (0)
Data not yet available
No reference posted for this study.