How cell therapy developers are future-proofing clinical monitoring of B-cell aplasia

July 11, 2024

Liesbet Vervoort, PhD

As cell therapies become more complex, the pressures facing clinical developers are rising. A greater number and diversity of cell therapy products are progressing to clinical stages, all requiring comprehensive, accurate, and yet rapid characterization to ensure that the journey from bench to bedside is as fast, safe, and effective as possible.

To accommodate this ever-growing number of new cell therapy concepts, clinical developers need robust, adaptive, affordable testing strategies for extensive yet efficient characterization. To realize these, developers are turning to complementary methods and modularized testing, and working to identify the most high-value readouts. Taking such an approach allows developers to assess aspects such as B-cell aplasia, even as the parameters monitored in B-cell populations expand as cell therapies address new indications.

Our new Cell Therapy Trend Report reveals how clinical testing is adapting to the rapidly changing cell therapy landscape. Download the report now to learn more and explore several broad trends to be aware of within the space, spanning the testing areas of HLA typing, cytokine profiling, cell enumeration and vector copy number determination, single-cell analytics, and B-cell aplasia.

Bringing complementary testing to B-cell aplasia

We anticipate that B-cell monitoring will soon become a standard part of clinical testing programs for new cell therapies and indications. Because of this, identifying the most efficient, effective, and appropriate monitoring approaches is of undeniable value.

Complementarity in particular offers huge promise here. By leveraging the synergies and capabilities of different established testing methods, developers can evaluate B-cell therapies more comprehensively to paint a detailed picture of how cell therapies act against B-cells. Such an approach could help to identify differences in body tissues, discriminate between on- and off-tumor activity, and shed light on off-tumor effects (such as the depletion of healthy B cells).

Additionally, as cell therapies increasingly address new indications and therapeutic areas — including autoimmune diseases and solid tumors — complementary assays can adapt to address a wider array of parameters, creating exciting new opportunities for in-depth analysis. Developers will also be able to mine the knowledge gleaned from previous testing to inform the design of new adaptive assays, enhance their clinical testing, and improve specificity.

B-cell aplasia: Understanding its role in cell therapy clinical testing

As well as improving our understanding of how cell therapies act against B cells, the fast, unambiguous enumeration of B cell populations and their depletion can…

• Inform study inclusion
• Help reveal the mechanisms behind autoreactivity
• Support the development of new therapies
• Potentially serve complementary purposes in the assessment of therapeutic efficacy and disease progression

Complementarity and other approaches to optimize and future-proof the clinical characterization of novel cell therapies, are discussed in our Cell Therapy Trend Report. Download the report now, or contact our team to speak to an expert about your cell therapy clinical testing needs.

 

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