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Pediatric Immunotherapy Fellowship Program

The field of cancer immunotherapy (the targeted therapy of tumors by the immune system) has grown exponentially over the past 5-10 years. In fact, immunotherapy using targeted T cells directed at a leukemic antigen (a form of cellular immunotherapy) recently became the first FDA-approved cell therapy (arguably the breakthrough of the decade in cancer care). Despite the rapidly growing number of patients at pediatric cancer centers receiving these complex therapies, current fellowship curriculums do not specifically provide training for immunotherapy. In fact, the majority of 'cellular immunotherapy specialists' receive no formal training, yet the number of graduating hematology/oncology fellows interested in pursuing careers focused on cancer immunotherapy continues to rise.

The majority of immunotherapy options for the treatment of cancer, including monoclonal antibody therapy, checkpoint inhibition, targeted cellular therapy, gene therapy, and vaccine therapy, remains in the early phase clinical trial realm. The bench-to-bedside translation, screening of eligible patients, and clinical management/aftercare of immunotherapeutic approaches is uniquely complex, requiring a specialized skillset and infrastructure that is currently not available in the majority of current pediatric hematology/oncology fellowship programs. Texas Children's Cancer and Hematology Centers and the Center for Cell and Gene Therapy (CAGT) at Baylor College of Medicine are pioneers in the field of immunotherapy, with >20 years of experience in translating immunotherapeutic options from the laboratory to the clinic, and managing these complex patients. We are therefore uniquely positioned to train the next generation of leaders in the field of cancer immunotherapy and have developed a Pediatric Clinical Cancer Immunotherapy Fellowship Program that will equip trainees with the clinical expertise, translational research, and leadership skills, as well as proficiency in clinical trial development, approval and implementation in the field of pediatric cancer immunotherapy.

Pediatric Hematology-Oncology fellowship programs, such as that at Baylor College of Medicine and Texas Children's Hospital and Houston Methodist Hospital teach the basic principles and practice of care of patients who have undergone stem cell transplant, the original form of immunotherapy. While a small subset of trainees gain additional exposure to immunotherapy in the clinical setting while on their bone marrow transplant rotation, this exposure is limited and does not provide the specific training required to conduct and implement clinical immunotherapy trials. In order to enable interested physicians to acquire more comprehensive and advanced knowledge and skills in this subspecialty area, we propose the development of a year of postgraduate training specifically in the area of Immunotherapy/Cell and Gene Therapy within The Center for Cell and Gene Therapy at Baylor College of Medicine, Texas Children's Hospital, and Houston Methodist Hospital. The Center for Cell and Gene Therapy's infrastructure consists of a number of core facilities integral to the training program, including a:

  1. preclinical vector core,
  2. clinical gene vector facility,
  3. GMP facility for producing cellular products for clinical trials, and a
  4. regulatory affairs core.

The faculty of the CAGT are amongst the foremost leaders in the field of immunotherapy, and previous trainees have gone on to successfully lead Immunotherapy programs around the world.

Goals and Objectives

The goal of our Pediatric Clinical Cancer Immunotherapy Fellowship Program is to equip trainees with the clinical expertise, translational research, and leadership skills, as well as proficiency in clinical trial development, approval and implementation in the field of pediatric cancer and immunotherapy.

Specific clinical training goals:

  1. To gain expertise in the care of patients receiving investigational or commercially available immunotherapy treatments, including identification of eligible patients, screening and enrollment process, infusion of cell therapy products (genetically modified or peptide specific T cells, NK cells, and/or vaccines).
  2. To gain expertise in the management and aftercare of patients receiving immunotherapy treatments (investigator-initiated and commercial), including management of the unique adverse effects of these complex therapies.

Specific research objectives:

  1. To develop proficiency in development of a bench-to-bedside investigator-initiated immunotherapy protocol. Trainees will be required to participate in each step of protocol development, starting with design of an immunotherapy clinical trial, and ending with protocol submission, study activation, and in some cases subject accrual. 
  2. To acquire research skills necessary for the design of immunotherapy clinical trials including Clinical Trial Design, Clinical Trial Conduct, Introduction to Regulatory Affairs, Biostatistics for Immunotherapy Protocols, Intro to GMP, Vector Design and Development, Quality Control, Commercialization (Industry-Sponsored Trials), Multicenter studies, Correlatives and Biomarkers, Imaging, and Gene Editing.

​​​​Program Eligibility

Candidates should be American Board of Pediatrics eligible for pediatric hematology-oncology or should have received equivalent training as judged by the program director(s). Only individuals who have successfully completed an ACGME-accredited fellowship in pediatric hematology-oncology or equivalent training are eligible for this advanced training opportunity. 

Program Duration
One Year 

Program Dates
July through June  

Program Accreditation and Training Sites
Texas Medical Board: Texas Children’s Hospital

Curriculum

Block 1

Introduction to Cancer Immunotherapy

Block 2

Introduction to Protocol Development and Clinical Trial Conduct

Block 3

Focused Elective Block 1 (Protocol Development and Clinical Trials; BMT service)

Block 4

Introduction to Regulatory Affairs

Block 5

Introduction to Good Manufacturing Practice

Block 6

Focused Elective Block 2 (Bench to Bedside; BMT service)

Block 7

Commercialization: Industry-Sponsored Trials

Block 8

Correlative Studies, Biomarkers, and Imaging

Block 9

Focus on Safety

Block 10

Focused Elective Block 3 (Protocol Development; BMT service)

Block 11

Protocol Submission

Block 12

Protocol Submission

Trainees will be required to attend a minimum of two half-days per week of Immunotherapy Clinic in the Texas Children's Cancer and Hematology Centers / Center for Cell and Gene Therapy clinical areas (our inpatient/outpatient and bone marrow/stem cell transplant units), during which they will participate in the care of patients receiving effector cell infusions for a variety of malignancies and infections. Trainees will be supervised by training program faculty under the direction of the program director:

  • Observe and participate in consent conferences, eligibility determination, presentation of recommendations, infusion, and aftercare of patients.
  • Be responsible for primary patients enrolled on cell therapy protocols.
  • Participate in the aftercare of patients who have received cell therapy products including identification and management of cell therapy-specific complications such as cytokine release syndrome, neurotoxicity, and tumor lysis syndrome.
  • Obtain consent from patients and families to enroll on clinical trials and research protocols.

Didactic

The trainee will actively participate in several recurrent educational conferences:

  • Weekly Cytotoxic T-Lymphocyte (CTL) meeting
  • CAGT group-wide and project/protocol-based lab meetings
  • Immunotherapy-focused journal club
  • Dan L. Duncan Comprehensive Cancer Center committee meetings, such as the Protocol Review and Monitoring Committee (PRMC) and the Data Review Committee (DRC)

Contact Us

Address: 1102 Bates Ave., Ste. 1570 Houston, TX 77030

Program E-mail: txcheducation@texaschildrens.org

Immunotherapy Fellowship Clinical Directors:

Rayne Rouce, MD

Andras Heczey, MD


Immunotherapy Fellowship Program Director
YoungNa Lee-Kim, MD


Apply

Fellows interested in this fellowship training program must complete and submit an application along with three letters of reference, a curriculum vitae and a statement of interest. Learn more about how to apply for this fellowship.