Individualizing Apheresis Processing Volumes Using a Predictive Algorithm: Analysis of the CAR T-Cell Collection Protocol Utilized in ACIT001/EXC002, a Phase Ib/II Trial of Decentralized Production of CAR T Cells for Treatment of Relapsed/Refractory Aggressive NHL and ALL.
Jennifer Croden, Zackariah Breckenridge, Charles Yin et al.
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In 30 seconds
This analysis of the CAR T-cell collection protocol used in the phase Ib/II ACIT001/EXC002 trial examined individualized blood-volume processing for patients with relapsed or refractory non-Hodgkin lymphoma or acute lymphoblastic leukemia. The protocol estimated the initial volume using an assumed 50% CD3-positive T-cell collection efficiency, then reassessed efficiency midway and adjusted processing. The initial estimate was adequate or conservative in 72% of procedures, and more than 75% of patients required less than the usual two to four total blood volumes. The target CD3-positive T-cell yield was achieved in 93% of patients.
Key findings
- The preliminary processing-volume estimate was adequate or conservative in 72% of procedures.
- More than 75% of patients required less than the standard two to four total blood volumes.
- The target CD3-positive T-cell yield was achieved in 93% of patients.
Why it matters
Apheresis volume is difficult to predict, and processing more blood than needed can prolong machine time and increase exposure to procedure-related risks. These trial-protocol findings suggest that reassessing collection efficiency midway may help tailor processing while still achieving the target T-cell yield, with potential benefits for resource use and patient safety.
What to keep in mind
The abstract reports findings from a specific CAR T-cell trial protocol and does not provide a comparison group or further details on the analysis.