DCTD Programs
DCTD Seeking Project Proposals for Viral Vector and Cell Therapy Production at NCI
![Building upon its initial efforts to support the production of CAR-T cells for clinical studies, the NCI Biopharmaceutical Development Program (BDP) at Frederick National Laboratory for Cancer Research (FNLCR) is expanding its capabilities to also offer viral vector production.](20200731_DCTD_Seeking_Project_Proposals.jpg)
DCTD is currently seeking project proposals from intramural and extramural investigators in need of clinical grade vector and/or cell therapy product manufacturing.
Building upon its initial efforts to support the production of CAR-T cells for clinical studies, the NCI Biopharmaceutical Development Program (BDP) at Frederick National Laboratory for Cancer Research (FNLCR) is expanding its capabilities to also offer viral vector production. Beginning in early 2021, the BDP will have the capability to manufacture lentiviral and retroviral vectors for the genetic modification step in cell therapy production. These viral vector production projects are expected to take 9-13 months from initiation to final testing and product release.
Timeline of BDP Cell Therapy Production Capabilities
Fall 2018 | BDP begins to develop CAR-T cell production capability |
Summer 2019 | First successful IND filing for BDP CAR-T clinical production |
January 2020 | First clinical trial to administer BDP-manufactured CAR-T cells opens |
March 2020 | First patient enrolled on clinical trial receives BDP-manufactured CAR-T cells |
Estimated — Early 2021 | Availability of cGMP lentivirus production using a scalable 4-plasmid production platform |
Estimated — Mid-2021 | Availability of gamma retrovirus production |
BDP manufacturing support is offered through the following two mechanisms:
- NCI Experimental Therapeutics (NExT) Program — Investigators seeking production of clinical grade vector and/or cell therapy products can submit proposals to the NExT Program. Applications are accepted three times per year (February, June, and October).
- Cancer Therapy Evaluation Program (CTEP) — Investigators seeking clinical trial support as well as product manufacturing can submit a Letter of Intent to CTEP for acceptance into a clinical trials network such as the Experimental Therapeutics Clinical Trials Network (ETCTN).