IRB Study Number 25-621
Status Recruiting
Phase Phase 3
Institute Taussig Cancer Institute
Description
• To compare the efficacy of arlo-cel with SOC regimens (DPd or Kd) in participants with LENexposed RRMM who have received 1-3 prior LOT.
• To compare MRD-negative CR at 9 months between arlo-cel and SOC regimens (DPd or Kd) in participants with LEN-exposed RRMM who have received 1-3 prior LOT.
• To compare overall survival between arlo-cel and SOC regimens (DPd or Kd) in participants with LEN-exposed RRMM who have received 1-3 prior LOT.
• To further compare the efficacy between arlo-cel and SOC regimens (DPd or Kd) in participants with LEN-exposed RRMM who have received 1-3 prior LOT.
• Assess additional efficacy parameters of arlo-cel compared to SOC regimens (DPd or Kd) in participants with LEN-exposed RRMM who have received 1-3 prior LOT.
• Assess cellular kinetics of arlo-cel.
• Assess the impact of arlo-cel compared to SOC regimens on the changes in MM symptoms, functioning and overall health-related quality of life (HRQoL).
• Assess the impact of arlo-cel compared to SOC regimens on time to improvement in the overall HRQoL.
• Assess safety of arlo-cel compared to SOC regimens (DPd or Kd) in participants with LENexposed RRMM who have received 1-3 prior LOT. Assess additional efficacy parameters of arlo-cel compared to SOC regimens (DPd or Kd) in participants with LEN-exposed RRMM who have received 1-3 prior LOT.
• Assess the impact of arlo-cel compared to SOC regimens on the changes in the EQ-5D-5L, EORTC QLQ-C30, and EORTC QLQ-MY20.
• Assess healthcare resource utilization (HCRU).
• Assess immunogenicity of arlo-cel.
• To assess the presence of RCL.
• To assess MM antigen expression.
• To assess soluble MM pharmacodynamic biomarker and soluble factors of immune response kinetics.
• To molecularly profile CAR T cells, tumor, and Microenvironment
• To assess relationship between PK parameters and selected clinical endpoints (eg, measures of toxicities, effectiveness, immunogenicity, and/or biomarkers).
Inclusion Criteria
• Participant must be >18 years of age at the time of signing the ICF.
• Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
• Documented diagnosis of multiple myeloma as per IMWG criteria.
• Participant has received at least 1 but no greater than 3 prior MM regimens which may include a PI, an IMiD, and an anti-CD38 monoclonal antibody. Note: induction with or without autologous stem cell transplant, consolidation, or maintenance therapy is considered as one regimen.
• Participant must have undergone at least 2 consecutive cycles of treatment for each line of therapy (except for CAR T cell therapy), unless progressive disease (PD) was the best response to the regimen or in the event of unacceptable toxicity.
• Be refractory to LEN per IMWG consensus guidelines (progression on or within 60 days of completing LEN therapy). Progression on or within 60 days of the last dose of LEN given as maintenance will meet this criterion. For participants with more than 1 prior line of therapy, there is no requirement to be LEN-refractory during the most recent line of prior therapy.
• Participants must have documented disease progression during or after their last antimyeloma regimen. Participants must have measurable disease, including at least one of the criteria: Serum M-protein greater or equal to 0.5 g/dL, Urine M-protein greater or equal to 200 mg/24 h, Serum free light chain (FLC): involved FLC le
Exclusion Criteria
• Participant has known active or history of central nervous system (CNS) involvement of MM.
• Participant has active or history of plasma cell leukemia (≥5% clonal plasma cells in peripheral blood), Waldenstrom's macroglobulinemia, POEMS (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, skin changes) syndrome, or clinically significant amyloidosis.
• Participants with solitary plasmacytomas or non-secretory myeloma without other evidence of measurable disease.
• Requirement for urgent therapy for MM due to rapidly progressing disease defined as: significant worsening of renal insufficiency, anemia, or skeletal complications due to multiple myeloma, or rapid rise in M-protein or sFLC, or clinical deterioration from myeloma.
• Participant has active autoimmune disease
• Participant with prior allogeneic hematopoietic stem cell transplantation (HSCT) and has active, acute, or chronic graft-versus-host disease (GVHD) or is receiving systemic treatment for GVHD.
• Participant has prior history of malignancies, other than MM, unless the participant has been free of the disease for ≥ 2 years. Participants with myelodysplastic syndrome (MDS) of any risk category are also excluded. The following non-invasive malignancies are not exclusion criteria: Basal or squamous cell carcinoma of the skin, carcinoma in situ of the cervix or breast, incidental histologic finding of prostate cancer (low grade, or T1a or T1b using the TNM [tumor, nodes, metastasis] clinical staging system) or prostate cancer that has undergone curative therapy, other completely resected stage 1 solid tumor with low risk for recurrence, maintenance hormonal therapies are allowed in participants with a history of breast or prostate cancer.
• Participant has a history or presence of clinically significant CNS pathology such as seizure disorder, aphasia, stroke, severe brain injuries, dementia, Parkinson’s disease, or cerebellar disease, or presence of clinically active psychosis.
• Participant has active systemic fungal, bacterial, viral, or other infection despite appropriate anti-infective treatment at the time of leukapheresis, or within 7 days prior to starting LDC.
