Lymphoma SPORE

Project: CMV/CD19 bi-Specific CAR T cells combined with CMV vaccine as post-transplantation immunotherapy for non-Hodgkin lymphoma
Project Leaders: Stephen J. Forman, M.D., Ryotaro Nakamura, M.D., Donald J. Diamond, Ph.D., Xiuli Wang, Ph.D.

Project: Targeted immunotherapy for relapsed/refractory Hodgkin lymphoma
Project Leaders: Eileen Smith, M.D., David M. Colcher, Ph.D., Alex Herrera, M.D.

Project: Novel nucleotide-based approaches targeting the STAT3 pathway for the treatment of lymphoma
Project Leaders: Hua Yu, M.D., Marcin Kortylewski, Ph.D., Elizabeth Budde, M.D.

Core Leaders: Stephen J. Forman, M.D., and Sandra H. Thomas, Ph.D.

The Administrative Core directly supports management of SPORE projects, cores, and funds.

The Core will coordinate SPORE-related meetings, preparing and submitting annual progress reports, and make decisions regarding selection and support of the best and most promising projects. Importantly, the Administrative Core will be responsible for the oversight of the Developmental Research and Career Development Programs in the Lymphoma SPORE.

Finally, the Core will also promote patient interests and equitable access to treatment on SPORE studies by working with a patient advocate to ensure that SPORE clinical studies are patient-centered.

Core B: Biostatistics and Research Informatics: Support for Data Coordination and Biostatistical Analysis
Core Leaders: Joycelynne Palmer, Ph.D. and Joyce Niland, Ph.D.

Core C: Lymphoma Tissue Bank: Provides blood and tissue banking for SPORE Projects
Core Leaders: John Chan, M.D. and Guido Marcucci, M.D.

Leader: David Horne, Ph.D. (small molecule)

The primary objective of Core D is to provide process development, regulatory support, and well-documented cGMP-compliant clinical-grade production of characterized CAR T cell products, monoclonal antibodies (mAb), lentivirus vectors, and complex small molecules, including nanomaterials, biopolymers (peptides, siRNA-aptamers, and DNA-peptide hybrids), and complex natural products. We will apply our established project management, product development, regulatory, and manufacturing capability to the benefit of SPORE investigators by providing assistance in pre-clinical development strategy, regulatory affairs, and process devolvement.

Quality Assurance, product characterization, and compliance with regulatory requirements for process and product gained from our extensive history of cGMP manufacturing for clinical trials will ensure suitability, control, and scalability of the proposed clinical projects.

Leaders: Stephen J. Forman, M.D., Michael Caligiuri, M.D., and Smita Bhatia, M.D.

The Career Development Program is devised to attract, train, and facilitate the success of young investigators pursuing careers in translational lymphoma research as well as provide a support mechanism for established investigators to refocus their work on lymphoma. This program provides fiscal support for one to three years to two individuals per year.

The program is implemented through the Administrative Core with SPORE Steering Committee, Executive Committee and External Advisory Board oversight. This program has well delineated processes for candidate recruitment, including an intensive effort to recruit women and minorities, an application, review, and selection process, a mentoring plan, a program of educational activities, and an evaluation process.

In aggregate, this program insures that City of Hope is productive in contributing to the next generation of highly trained and lymphoma focused investigators that will contribute to translational lymphoma research.

Leaders: John Chan, M.D., and Ravi Bhatia, M.D.

The purpose of the Developmental Research Program (DRP) is to identify and support first-rate, pioneering translational projects in lymphoma that, despite their potential, are not yet mature for full program status. All members of the research community at City of Hope and University of Alabama Birmingham (UAB) are encouraged to consider the opportunity.

We have requested $50,000 per year to support this program, and City of Hope and UAB will match these funds annually by $100,000 and $25,000, respectively. At least two researchers per year receive awards, which are granted for up to two years.

Funds can be devoted to research supplies and minor equipment, personnel costs, and relevant meeting expenses. Promising investigations may replace SPORE research projects that have either acquired funding as independent R01/P01 projects, or those that have not satisfactorily progressed.