Clinical trial · Interventional
Autologous CD8+ T-cells Expressing an Anti-BCMA CAR in Patients With Myeloma
Phase I Safety and Feasibility Study of Autologous CD8+ T-cells Transiently Expressing a Chimeric Antigen Receptor Directed to B-Cell Maturation Antigen in Patients With Multiple Myeloma
- 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 Phase I study will test the safety and anti-myeloma activity of ascending doses of Descartes-08 (autologous CD8+ T-cells expressing an anti-BCMA chimeric antigen receptor) in eligible patients with active multiple myeloma.
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 |
|---|---|---|---|
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Descartes-08 | Biological | — | UNRESOLVED |
| Fludarabine | Drug | Fludarabine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Descartes-08 plus fludarabine/cyclophosphamide pretreat
- description
- Autologous CD8+ T-cells transiently expressing an anti-BCMA chimeric antigen receptor
- interventionNames
- Biological: Descartes-08
- Drug: Fludarabine
- Drug: Cyclophosphamide
Primary outcomes (1)
- measure
- Incidence (number) of Treatment-Emergent Adverse Events [Safety and Tolerability]
- timeFrame
- 2 weeks
- description
- Incidence (number) of Treatment-Emergent Adverse Events \[Safety and Tolerability\]. Descriptive statistics by incidence rate, body system classification, severity, and causality \[per protocol definitions\]
Secondary outcomes (1)
- measure
- Treatment response
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria (condensed): * Multiple myeloma that is double-refractory to a proteasome inhibitor (PI) and an immunomodulatory drug (IMiD) after at least 2 prior lines of therapy OR have failed at least 3 prior lines of therapy * Measurable disease activity as indicated by serum or urine M-protein, serum free light chain, biopsy-proven plasmacytoma, \>5% bone marrow plasma cells. * Adequate vital organ function as indicated by ANC (\>1000/uL), platelet count (\>50,000/uL), hemoglobin (\>8 g/dL), serum ALT and AST (each \<3.0 x upper limit of normal), total bilirubin (\<2 mg/dL), creatinine clearance (\>30 mL/min), and cardiac ejection fraction (\>45%) Exclusion Criteria (condensed): NOTE: Prior anti-BCMA or CAR-T therapy is NOT exclusionary * Active plasma cell leukemia * Pregnant or lactating * Active, uncontrolled infection * Active and severe auto-immune disease * Active arrhythmia, or obstructive or restrictive pulmonary disease * Central nervous system disease
References
Publications (0)
Data not yet available