A New Study Evaluating the Activity of Modular CAR T for mYeloma
This is a Phase 1 rolling 6 trial design evaluating safety of a novel BCMA Chimeric Antigen Receptor (CAR) alone and of CAR T cells engineered to co-express BCMA CAR and a CD19 CAR in patients with relapsed / refractory Multiple Myeloma. The study will assess the feasibility of generating these Advanced Therapy Investi
| Condition(s) | Multiple Myeloma |
|---|---|
| Status | Recruiting |
| Phase | Phase 1 |
| Study type | Interventional |
| Summary | This is a Phase 1 rolling 6 trial design evaluating safety of a novel BCMA Chimeric Antigen Receptor (CAR) alone and of CAR T cells engineered to co-express BCMA CAR and a CD19 CAR in patients with relapsed / refractory Multiple Myeloma. The study will assess the feasibility of generating these Advanced Therapy Investigational Products (ATIMPs) and the safety of administering the CAR T cells (either BCMA alone or co-expressed with CD19) in patients with relapsed / refractory multiple myeloma. |
| Who can participate | Inclusion Criteria: 1. Age ≥ 18 2. Relapsed/Refractory Multiple Myeloma 3. Secretory disease: PP≥5g/L and/or sFLC≥100mg/L of involved light chain with abnormal K:L ratio. 4. ≥3 prior lines of therapies (including proteasome inhibitor, IMiD, anti CD38 antibody) 5. Refractory to last line of therapy (not achieved at least PR and progressed within 60 days of last dose or achieved at least PR but progressed within 6 months of last dose) 6. Has previously received or is not suitable for ASCT 7. Eastern Cooperative Oncology Group (ECOG) performance status 0/1 8. Creatinine Clearance (CrCl)≥40ml/min, Absolute Neutrophil Count (ANC)≥1x10\^9/L, Platelets (plt)≥50x10\^9/L, Haemoglobin (Hb)≥80 /L, lymphocyte count ≥0.3x10\^9/L 9. Patients must weigh \>30 kg 10. Agreement to have a pregnancy test, use |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | University College, London |
| Locations | London, County (Optional), United Kingdom |
| Start date | 2022-04-22 |
| NCT ID | NCT04795882 |
| Official listing | https://clinicaltrials.gov/study/NCT04795882 |