DCTD Programs
DCTD Convenes Second Workshop on Cell-Based Immunotherapy for Solid Tumors
On December 10-11, 2020, DCTD sponsored the Second NCI Workshop on Cell-Based Immunotherapy for Solid Tumors (agenda).
Both days of the meeting are available to view (Day 1 
and Day 2
).
This virtual meeting followed the successful first workshop on this topic held in December 2018. The purpose of these meetings has been to define critical barriers in the field and identify ways in which NCI can better support the extramural community and help advance cell therapy research. A summary of both workshops was published in the Journal for ImmunoTherapy of Cancer in July 2021.
Since the first workshop, with DCTD support, NCI has:
- Opened new cGMP space for cell therapy manufacturing
- Established analytical assays to monitor cell therapy products
- Awarded six grant supplements to drive technology advancement
- Developed capacity for lentivirus vector manufacturing
- Begun working toward retrovirus vector manufacturing and development of gene editing technology
2020 Workshop Summary
The 2020 workshop reviewed cutting-edge technologies for the development of autologous and allogeneic cell-based therapies for solid tumors, including current methods for designing, testing, and manufacturing cell products. By bringing together extramural researchers, industry scientists, FDA representatives, and NCI staff, the workshop allowed NCI to gain insight on major challenges and future directions in the field.
Keynote Speakers and Co-Chairs
- Crystal Mackall, MD (Stanford University)
- Marcela Maus, MD, PhD (Harvard Medical School and Massachusetts General Hospital)
Workshop Sessions
- Choosing the Target: Specificity and Toxicity
- Reaching the Target: Modulating the Tumor Microenvironment
- Immune Cell Fitness and Persistence
- Alternative Approaches: Looking Beyond Traditional CAR-T Cells
- Cell Product Manufacturing and Characterization
- Cell Therapies: The FDA Perspective
Workshop Highlights
The workshop identified several major scientific and clinical challenges in the field. NCI will be working to address these barriers and meet the needs of the extramural research community.
| Scientific Challenge | Potential Solutions |
|---|---|
| Paucity of appropriate tumor-specific targets | Screening approaches and strategies to identify individualized and “public” neoantigens |
| Insufficient expansion and/or persistence of cell products | Strategies to overcome T cell apoptosis, exhaustion, and/or dysfunction due to chronic antigen stimulation |
| Limited understanding of how T cells behave in vivo after transfer | Enhanced imaging approaches and other monitoring strategies |
| Inadequate T cell homing to tumor | Strategies to improve cell trafficking and tumor penetration |
| Immunosuppressive effects of the tumor microenvironment (TME) | Enhanced understanding of how metabolic factors and other aspects of the TME affect immune cell fitness and function |
| Lack of informative animal models | Early-stage “proof of concept” testing on small cohorts of human subjects |
| Clinical Challenge | Potential Solutions |
|---|---|
| Low availability of GMP reagents | Improved investigator access to reagents |
| Inability to compare between different cell products | Standardized methods and assays |
| Lack of harmonization in IND-enabling studies, especially with new non-viral approaches for cell engineering | Improved dialogue with the FDA to reassess required testing, streamline the regulatory process, and reduce cost to investigators |
| Limited funding and infrastructure for small first-in-human clinical trials | Enhanced support for early phase clinical studies |