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Indiana University School of Medicine
Indiana University Office of Clinical Research
Roadmap

Cellular Therapy & Immune Effector Cell Trials

Cellular Therapy and Immune Effector Cell investigational products (IP), such as CAR T-cell Therapy, Engineered T-cell Receptor Therapy, Tumor Infiltrating Lymphocytes Therapy, Natural Killer Cell Therapy, etc.), must undergo additional requirements prior to the completion of study activation. All Cellular Therapy and Immune Effector Cell Trials across IU research, regardless of disease or condition treated, need to be assessed by the Cancer Center’s Cellular Therapy Pipeline Committee for feasibility. This review process is not limited to oncology trials only. Any study team that may need to utilize IU and/or IU Health resources, units, or departments to complete their trial must submitfor review to the Cancer Center’s Cellular Therapy Pipeline Committee. This might include the use of inpatient or research units, apheresis or cellular therapy lab support, or Brown Center manufacturing resources.

The Cancer Center’s Cellular Therapy Pipeline Committee serves as an initial introduction to the requirements and regulations associated with appropriately conducting Cellular Therapy and Immune Effector Cell trials within the IU and IU Health research communities. The purpose for this committee’s review is not to limit research but to facilitate studies and assist investigators with connecting to the appropriate departments necessary to support their protocol. Cellular Therapy and Immune Effector Cell trials require coordination with multiple different entities within IU and IU Health, as well as outside entities (such as sponsor industry manufacturers). Please note that at this current time, Cellular Therapy and Immune Effector Cell trials can only be conducted at downtown IU Health locations (University Hospital & IU Simon Cancer Comprehensive Cancer Center and Riley Hospital). The following IU and IU Health units and/or departments may need to be involved in the execution of a Cellular Therapy or Immune Effector Cell study:

  • Potential collection (apheresis) of Participant or Donor cells = IU Health Apheresis Team- contact Dave Schwering at dschwering@iuhealth.org.
  • Potential shipping and receipt of IP, IP storage, IP accountability, and assistance with IP administration = IU Health CTL (Cell Therapy Lab) — contact Dave Schwering at dschwering@iuhealth.org.
    • If your study has additional IPs that are not cellular therapy or immune effector cell in nature, then you may also need to use IDS services. Please see the IDS page for more information.
  • Potential administration of leukodepletion chemo to adult patients = IU Health Inpatient Teams — initial contact at Cat Root at catroot@iu.edu.
  • Potential Participant Monitoring & Study Procedure Execution adult patients = IU Health Inpatient Teams — initial contact at Cat Root at catroot@iu.edu.
  • LD Chemo for pediatric patients = Pediatric Hematology/Oncology/Stem Cell Clinical Research Team at rileyphosresearchteam@iuhealth.org.
  • Participant Monitoring for pediatric patients = Pediatric Hematology/Oncology/Stem Cell Clinical Research Team at rileyphosresearchteam@iuhealth.org.

If applicable: The Cancer Center’s Cellular Therapy Pipeline Committee website offers an overview of the Cellular Therapy Pipeline process, as well as an intake form to start the Cellular Therapy Pipeline Committee review process. More information regarding each of the units/departments/resources mentioned above is also outlined in more detail. Please note that each of these entities may have additional approval processes, forms, and/or requirements to safely conduct a Cellular Therapy or Immune Effector Cell trial. Further details on these requirements can be found here.

For questions, contact the Cellular Therapy Pipeline Committee at CTCRPC@iu.edu.

IU Simon Comprehensive Cancer Center (IUSCCC) Additional Information

For Cancer Center trials (studies involving cancer patients), the review by the Cancer Center Cellular Therapy Pipeline must be conducted prior to submission to Cancer Center’s Scientific Review Committee (SRC). 

For studies involving the Pediatric Hematology/Oncology/Stem Cell Clinical Research Team, please reach out to rileyphosresearchteam@iuhealth.org for support with the pediatric cellular therapy trials.

Cellular Therapy Pipeline Committee Review is only one component of study activation. Additional requirements should be reviewed using the Clinical Research Roadmap.