Nirali N. Shah, M.D.

Nirali N. Shah, M.D.
Associate Research Physician

Dr. Shah focuses on the implementation and conduct of clinical trials with a specific focus on immune-based therapies, targeting relapsed refractory leukemia, especially in the treatment of patients with post-transplant relapse. Her clinical trials include several Phase I trials for the treatment of relapsed/refractory pediatric acute lymphoblastic leukemia (ALL). She also conducts an allogeneic transplant trial-utilizing donor derived activated natural killer (NK) cell infusions following transplant for patients with high-risk hematologic malignancies. Based on these trials, she has developed a niche for the translation of immunotherapy-based strategies for the treatment of relapsed/refractory leukemia. She currently serves as a Principal Investigator in the Pediatric Oncology Branch of the National Cancer Institute.

Areas of Expertise
1) pediatric acute leukemia 2) hematopoietic stem cell transplantation 3) phase I/II clinical trials 4) relapsed leukemia 5) bioethics 6) cellular therapy

Contact Info

Nirali N. Shah, M.D.
Center for Cancer Research
National Cancer Institute
Building 10-CRC, Room 1-1621
Bethesda, MD 20814-1826
Ph: 301-451-0390
nirali.shah@nih.gov

Dr. Shah is primarily involved with the implementation and conduct of clinical trials with a specific focus on immune-based therapies, targeting relapsed refractory leukemia, especially in the treatment of patients with post-transplant relapse and in the adolescent young adult population. Her clinical trial work has included implementation and conduct of several Phase 1 trials for the treatment of relapsed/refractory pediatric acute lymphoblastic leukemia (ALL). These trials have included a pediatric phase I trial of vincristine sulfates liposomal injections (Marqibo®), a pediatric phase I trial of moxetumomab pasudotox, (an anti-CD22 targeted immunotoxin based therapy), and a pilot trial using WT1 dendritic cell vaccines for the treatment of post-transplant relapsed leukemia. Results from the trials have included establishment of a safety profile, identification of a dose and an understanding of pharmacokinetics leading to development of several multicenter Phase 2 studies that she will be leading. She also serves as the current clinical principal investigator on an allogeneic transplant trial-utilizing donor derived activated natural killer (NK) cell infusions following transplant for patients with high-risk hematologic malignancies. Based on these trials, she has developed a niche for the translation of immunotherapy-based strategies for the treatment of relapsed/refractory leukemia. Having established a solid foundation for the conduct of clinical trials, she also serves as a scientific member on the National Heart, Lung and Blood Institute Institutional Review Board, to provide a pediatric perspective, specifically in the conduct of pediatric transplant trials. She is also working on developing guidelines to assist in the evaluation of minor donors for hematopoietic stem cells in the research setting. Her work was recently published and she will be leading an NCI-Pediatric Blood and Marrow Transplant Consortium sponsored conference focusing on the development of guidelines for the evaluation of minors in research in Spring 2015. 

Scientific Focus Areas:
Clinical Research

Selected Publications

  1. Shah NN, Wayne AS, Grady C, Fry T, Wendler D.
    Bone Marrow Transplant. [Epub ahead of print], 2014. [ Journal Article ]
  2. Shah NN, Borowitz MJ, Robey NC, Gamper CJ, Symons HJ, Loeb DM, Wayne AS, Chen AR
    Biol Blood Marrow Transplant. 20: 1000-7, 2014.
  3. Shah NN, Borowitz MJ, Steinberg SM, Robey NC, Gamper CJ, Symons HJ, Loeb DM, Wayne AS, Chen AR.
    Biol Blood Marrow Transplant. 20: 1033-9, 2014. [ Journal Article ]
  4. Immunotherapy for pediatric leukemia.
    Shah NN, Dave H, Wayne AS.
    Front Pediatr Oncol. 3: 166, 2013. [ Journal Article ]
  5. Haso W, Lee DW, Shah NN, Stetler-Stevenson M, Yuan CM, Pastan IH, Dimitrov DS, Morgan RA, FitzGerald DJ, Barrett DM, Wayne AS, Mackall CL, Orentas RJ
    Blood. 121: 1165-74, 2013. [ Journal Article ]

After completing undergraduate studies with a B.S. from University of Illinois in 2000, Dr. Nirali N. Shah received her M.D. from the University of Illinois College of Medicine in Chicago in 2004.  From 2004-2008, she then served as an intern and resident through the Harvard Combined Internal Medicine/Pediatrics program and trained jointly at the Children’s Hospital Boston and Massachusetts General Hospital, during which time she also served as Chief Resident. She then joined the combined Pediatric Hematology and Oncology Fellowship training program at the National Cancer Institute, Pediatric Oncology Branch (POB) and Johns Hopkins University. During her fellowship, she undertook the Clinical Research Training Program through the combined NIH-Duke University School of Medicine Program and obtained a Masters of Health Science in Clinical Research (2012) and was selected to participate in the American Society for Blood and Marrow Transplantation Clinical Research Training Course (2012). She is a member of multiple societies, including the American Society of Hematology and the American Society of Blood and Marrow Transplantation. She is also a member of the Oncology Strategy Group in the Pediatric Blood and Marrow Transplant Consortium and the Therapeutic Advances in Childhood Leukemia & Lymphoma consortium. Dr. Shah is board certified in General Internal Medicine (2008), General Pediatrics (2008) and Pediatric Hematology Oncology (2013). She currently serves as a clinical principal investigator in the Pediatric Oncology Branch of the National Cancer Institute.