An Open Label, Phase 1 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 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.
• Age ≥ 18
• Relapsed/Refractory Multiple Myeloma
• Secretory disease: PP≥5g/L and/or sFLC≥100mg/L of involved light chain with abnormal K:L ratio.
• ≥3 prior lines of therapies (including proteasome inhibitor, IMiD, anti CD38 antibody)
• 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)
• Has previously received or is not suitable for ASCT
• Eastern Cooperative Oncology Group (ECOG) performance status 0/1
• 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
• Patients must weigh \>30 kg
⁃ Agreement to have a pregnancy test, use adequate contraception (if applicable)
⁃ Written informed consent