Understanding Logistics of Outpatient CAR T Administration

Krina Patel, MD, MSc, MD Anderson Cancer Center, evaluated the potential of outpatient CAR T-cell therapy administration during a discussion of her presentation of the phase 2 iMMagine-1 study (NCT05396885).

iMMagine-1 is a phase 2 registrational trial evaluating anitocabtagene autoleucel (anito-cel), an autologous anti-BCMA CAR T-cell therapy, for patients with relapsed and/or refractory multiple myeloma (RRMM). The therapy utilizes a novel D-domain binder, which facilitates high transduction efficiency, stable CAR expression, and a decreased risk of tonic signaling.

The study enrolled eligible patients who were triple-class exposed, had progressed after at least 3 prior lines of therapy (L)T), and were refractory to their last LOT. All 117 infused patients (100%) were refractory to their last LOT, and 86% were triple-class refractory. The median age of the patients was 64 years, and the median prior LOT was 3. Following leukapheresis and manufacturing, patients received lymphodepletion chemotherapy and a single anito-cel infusion. The primary end point is overall response rate (ORR).

At a data cut-off of May 1, 2025, with a median follow-up of 12.6 months, the results demonstrated deep and durable efficacy. The investigator-assessed ORR was 97% (114/117) by IMWG criteria, with a complete response/stringent complete response rate of 68%. Of the evaluable patients, 93% achieved MRD negativity at the 10^–5 level, and 78% achieved it at the 10^–6 level. The 12- and 18-month progression-free survival (PFS) rates were 79% and 66%, respectively, while 12- and 18-month overall survival (OS) rates were 95% and 90%, respectively. Median PFS and OS were not reached¹¹.

Anito-cel showed a manageable safety profile¹².

• Cytokine Release Syndrome (CRS): Any grade CRS occurred in 85% of patients, predominantly grade 1 (70%). Only 1 patient (1%) experienced grade 5 CRS.
• Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS): Any grade ICANS was observed in 8% of patients, with only 1% being grade 3.
• Toxicity: The most common grade 3/4 treatment-emergent adverse events were cytopenias (neutropenia 66%, anemia 24%, thrombocytopenia 24%).
• Absence of Long-Term Neurotoxicity: Critically, no delayed or non-ICANS neurotoxicities, such as Parkinsonism, cranial nerve palsies, or Guillain-Barré syndrome, have been observed in either the phase 1 or phase 2 studies to date No IEC-associated enterocolitis or secondary primary malignancies of T-cell origin have been reported.