Inspired by ASCO: The Cell Therapy Promise in Action

By PSI cell therapy team led by Rhonda Critchlow

We’re back from the 2025 ASCO Annual Meeting — inspired and energized.

Next-generation technologies are reshaping the field of immunotherapy: cell therapy shows promise beyond hematology-oncology, bispecific antibodies demonstrate response in traditionally cold tumors, and novel combinations are poised to change the treatment landscape. We are also seeing companies taking the first steps in tackling the challenging burdens of lymphodepletion and treatment delay with promising initial results using in vivo CAR T-cell therapies.

With seven CAR-T therapies approved for hematologic malignancies and two recent FDA drug approvals in solid tumors, the potential for cell therapy is finally expanding beyond melanoma and synovial sarcoma.

Barriers such as an immunosuppressive tumor microenvironment and physical obstacles to T-cell infiltration remain significant, but it’s encouraging to see growing activity and innovation in this promising field.

“In many ways, the approval of lifileucel could potentially mark the beginning of a future revolution in TIL immunotherapy similar to that seen with checkpoint inhibitors over the past 15 years.” — PSI Scientific Advisory Board Member

The immuno-oncology space is booming with innovative ideas; however, we often find ourselves waiting too long to learn what really works. Every delay in a clinical trial doesn’t just slow science; it means patients wait longer for potentially life-changing treatments. And with each delay, the cost of developing these therapies grows, adding to the financial toxicity.

We can’t afford slow. The science is ready — our systems need to be, too.

Here are a few things to keep in mind as you start planning a pivotal clinical trial in this challenging space:

Global Site Selection: A Challenge as Complex as the Therapy Itself

Cell therapy studies require top-tier institutions with cell therapy units; the possibility for ICU admission and 24/7 monitoring; experience with high-dose chemotherapy and (if applicable) Interleukin-2; and multidisciplinary teams that include cell therapists, surgeons, medical oncologists, and nursing staff.

• • When selecting sites for your study, it’s important that you check the turnover rate of the department that will be running the trial and whether the site would allow data entry assistance from a temporary employee or third-party vendor in the event of staff turnover.

• • Their ability to adhere to the strict timelines and procedures set by the study in relation to the biopsy, shipment of cells, and cell therapy administration will be key.

• • In addition to understanding which departments at the site will need to be involved in the trial, it will be important to include all these departments in the delegation of authority (DOA). We have found that some sites may have departments that decline to sign the DOA — a red flag indicating that the coordination of the various departments responsible for running the trial will not be smooth.

• • Investigator motivation is sometimes underestimated. Engaged investigators — those who are responsive and attend monitoring calls — are typically the ones who deliver. To ensure and maintain motivation, regular sponsor engagement is critical. We’ve also designed several early engagement campaigns that have been successful in maintaining momentum.
    
    
  • While all of these components are important, the ability of a site to export samples to other countries is one of the most important factors that’s often overlooked. The rules around exporting samples to the US may vary based on country or even site regulations.

” … the ability of a site to export samples to other countries is one of the most important factors that’s often overlooked.”

Cell Therapy Logistics: From Chaos to Control

Understanding and maintaining the timelines for cell therapy manufacturing and administration can make or break a clinical study. Clinical deterioration happens in a lot of patients scheduled for cell therapy, and keeping the timelines as short as possible is key.

• • Tracking every step of the cell therapy process — from tumor resection or leukapheresis to shipment, facility receipt, manufacturing, return shipment, site receipt, and final administration — is absolutely critical. The chain of identity and chain of custody must be meticulously maintained. Careful planning is essential, including accounting for weekends, holidays, and the scheduled treatment day. This ensures smooth coordination of hospital admissions, patient visits, and manufacturing timelines, ultimately supporting both operational success and patient care.

• • Samples for patients are likely obtained by various individuals depending on the location and timing (such as phlebotomy, research team, or nursing). Sites appreciate having lab worksheets to plan both who will be doing the labs and at what time to avoid protocol deviations for both safety and research labs.

• • When managing international shipments, work with proven couriers that specialize in managing complex clinical trial shipments, provide support for customs documentation and regulatory compliance, and have backup plans for potential delays such as flight cancellations and strikes.
    
    
  • A dedicated global Clinical Logistics Coordination Team is key:
    
    
    • • They ensure that sites can directly communicate with someone in the same time zone for any urgent matters
        
        
    • • They proactively engage with the cell therapy manufacturer for seamless collaboration on timelines and tracking of samples from the time of sample collection through receipt of the investigational product at the site for dosing.
        
        
      • They define the days when shipments can be performed and help with the preparation and review of manual/instructions for tumor tissue preparation and shipment; they maintain a live cell tracking system and, importantly, develop a plan in case of cell production failure.

Patient Enrollment & Retention: A Delicate Dance of Care and Complexity

Given the high level of complexity of such studies, a team of highly trained site support specialists should work directly with investigators and teams to ensure smooth screening, enrollment, and dosing of patients.

• • They understand the fragile state of these patients and know they will require incredible caregiver support, proximity to the hospital, and commitment to this complex study, both for their own safety and to gather outcomes data for the study overall. Dedicated site support teams can help the site prepare to set expectations with patients and families, as well as coordinate the complex logistics of study procedures.

• • Patient pathway matters: It’s important to plan out with each consented patient the key dates, cell collection, lymphodepletion, re-infusion, and beyond/follow-up. Each step must be carefully coordinated to ensure proper timing for cell collection, shipping, and manufacturing, as well as patient admission/bed allocation and clinical team readiness. Close coordination, communication, and oversight with the site team will be vitally important to reduce the number of subjects who will need to withdraw/fail during the manufacturing period.

• • As safety and AEs are a priority for both the care of the patient and the study endpoints, we recommend additional training to the study team on preparation for side effects and emergency management, the communication pathway, and documentation.

• • When managing toxicities, including cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS), and immune effector cell-associated HLH-like syndrome (IEC-HS), it’s important to understand the differences in toxicities and discuss pre-emptive and supportive measures with the site staff. This is especially true in CAR-T due to the high tumor antigen expression and tonic signaling of CARs.

Patient pathway matters.

As we continue managing cell therapy studies, we look forward to ongoing innovation — uncovering mechanisms of response and resistance, enhancing durability, and identifying new targets for cell-based therapies.