2017 Open Cellular Therapy Studies

ACTCAT2: Adoptive Transfer of Cord Blood T Cells to Prevent and Treat CMV, EBV and Adenovirus Infections After Transplantation

PI: Catherine Bollard, M.D.     

Status: Currently enrolling

Sponsor: Dr. Bollard

This is a phase 1 dose-escalation trial is designed to evaluate the feasibility of generating a sufficient number of umbilical cord blood-derived cytotoxic T lymphocytes (CTLs) specific for CMV, EBV and Adenovirus.
Any patient with malignant or nonmalignant diseases who are candidates for transplant is eligible to participate. Patients must have a Cord Blood (CB) unit (or units) matched with the patient at 4, 5 or 6/6 HLA class I (serological) and II (molecular) antigens.

ALCI2: Administration of LMP-Specific Cytotoxic T-Lymphocytes to Patients with Relapsed EBV-positive Lymphoma
PI: Catherine Bollard, M.D.
Status: Currently enrolling
Sponsor: Dr. Bollard
This is a phase 1 dose-escalation trial to determine the safety of 2 intravenous injections of allogeneic LMP-specific cytotoxic T-lymphocytes (CTL) in patients with EBV-associated Hodgkin’s Disease, lymphoma/lymphoproliferation/severe chronic EBV or or high risk for the development of PTLD.
Any patient, regardless of age or sex with above diagnosis and life expectancy greater than 6 weeks will be eligible for this study.

MUSTAT: Multivirus-Specific Cytotoxic T-Lymphocytes for the Prophylaxis and Treatment of EBV, CMV and Adenovirus Infections Post Allogeneic Stem Cell Transplant
PI: Michael Keller, M.D.
Status: Currently enrolling
Sponsor: Catherine Bollard, M.D.
This phase 1 dose-escalation trial is designed to evaluate the safety of rapidly generated multivirus-specific CTL lines with antiviral activity against EBV, CMV and Adenovirus, derived from donors who are either CMV-seropositive or CMV-seronegative. The participants will closely monitor the effects of these cells on GvHD and engraftment.
Patients will be eligible to receive cells as prophylaxis or treatment for infection following any type of allogeneic transplant. If patients are receiving steroids for treatment of GVHD or for other reasons, dosage must have been tapered to each group for safety prior to study enrollment. 

TREPID: Treatment of EBV, CMV and Adenovirus Infections in Primary Immunodeficiency Disorders with Viral-Specific Cytotoxic T-Lymphocytes
PI: Michael Keller, M.D.
Status: Currently enrolling
Sponsor: Catherine Bollard, M.D.
This phase 1 fixed dose trial is designed to evaluate the safety of third-party derived mCTL lines with antiviral activity against EBV, CMV and Adenovirus in patients with primary immunodeficiency disorders (PIDD) and refractory viral infections with EBV, CMV and/or adenovirus, prior to HSCT.
Patients with severe forms of PIDD will be eligible to receive cells as treatment for refractory infections prior to allogeneic transplant utilizing either bone marrow or peripheral blood stem cells. 

CHAPS: Administration of Most Closely HLA-matched Multivirus-Specific Cytotoxic T-Lymphocytes for the Treatment of EBV, CMV, Adenovirus Infections Post Allogeneic Stem Cell Transplant
PI: Catherine Bollard, M.D.     
Status: Currently enrolling
Sponsor: Dr. Bollard
The primary purpose of the study is to evaluate whether most closely HLA-matched multivirus-specific T cell lines obtained from a bank of allogeneic virus-specific T cell lines (VSTs) have antiviral activity against three viruses: EBV, CMV and adenovirus.
Patients will be eligible following any type of allogeneic transplant if they have CMV, adenovirus and/or EBV infection persistent despite standard therapy.

RESOLVE: Prospective phase I Research of Expanded Multi-Antigen Specifically Oriented Lymphocytes for the Treatment of Very High Risk Hematopoietic Malignancies
PI: Kirsten Williams, M.D      

Status: Currently enrolling

Sponsor: Catherine Bollard, M.D.

This phase 1 dose-escalation trial is designed to evaluate the safety of administering rapidly-generated multi-antigen-specific T lymphocytes, to HSCT recipients (group A) or future HSCT recipients (group B) for the treatment or relapsed or refractory hematopoietic malignancies.
Participants must be 6 months to 60 years.  Patients with evidence of relapsed or persistent hematopoietic malignancies (e.g. acute leukemia, Hodgkins lymphoma, CML) will be eligible for this study.  

REST: Phase I Research Study Utilizing Expanded Multi-Antigen Specific Lymphocytes for the Treatment of Solid Tumors
PI: Holly Meany, M.D.      
Status: Currently enrolling
Sponsor: Catherine Bollard, M.D.
This phase 1 dose-escalation trial is designed to determine the safety of administering rapidly generated tumor multi-antigen associated specific cytotoxic T lymphocytes (TAA CTL), to patients who have undergone allogeneic HSCT or conventional therapy for a high-risk solid tumor due to the presence of refractory, relapsed and/or residual detectable disease.
Participants must be 6 months to 60 years. Patients with high-risk solid tumors: Ewing sarcoma, Wilms tumor, neuroblastoma, rhabdomyosarcoma, soft tissue sarcomas, osteosarcoma and adenocarcinoma.  

STOMP: Safety and Tolerability Of Allogeneic Mesenchymal Stromal Cells in Pediatric Inflammatory Bowel Disease
PI: Laurie S. Conklin, M.D.       
Status: Currently enrolling
Sponsor: Catherine Bollard, M.D.
This study is a pilot phase 1 study of patients with moderately to severely active Crohn Disease (CD) and ulcerative colitis (UC).  A fixed dose will be studied: 1 x 106 cells/kg administered intravenously (IV) weekly for 8 consecutive weeks.  
This treatment protocol allows for the treatment of both male and female pediatric and young adult patients, between the ages of 12 years and 22 years, with active moderate to severe CD or UC, who have failed to respond to biologic therapy. 

CIVIC: Cellular Immunotherapy Cellular  Immunotherapy for  Viral-Induced Cancer
PI: Catherine Bollard, M.D.   
Status: Currently enrolling
Sponsor: Cell Medica, Inc.
This is an open label, phase 2 multicenter trial.  
Participants must be at least 12 years of age. Patients with history of EBV positive lymphoma or active post-transplant lymphoproliferative disease (PTLD) will be eligible.

CITADEL: Cellular Immunotherapy Treatment Antigen-Directed for EBV Lymphoma
PI: Catherine Bollard, M.D.       
Status: Currently enrolling
Sponsor: Cell Medica, Inc.
This is an open label, phase 2 multicenter trial.  
Participants must be at least 18 years of age. Patients with aggressive EBV positive extranodal NK/T-cell lymphoma (ENKTCL) will be eligible.

NATS: Novel Antigens Targeted by ex vivo Expanded T-Lymphocytes for Prevention or Treatment of Viral Infections Following Hematopoietic Stem Cell Transplantation
PI: Michael Keller, M.D.          
Status: Currently enrolling
Sponsor: Catherine Bollard, M.D. 
This phase 1 dose-escalation trial is designed to evaluate the safety of rapidly generated multivirus-specific T-cell products with antiviral activity against CMV, EBV, adenovirus, HHV6, BK virus, JC virus and human parainfluenza-3 (HPIV3), derived from eligible HSCT donors.  
Pediatric and adult patients will be eligible to receive cells as prophylaxis or treatment for infection at or after day +5 following any type of allogeneic hematopoietic stem cell transplant.

If you have any patients who may be eligible for one of these studies, please contact Divyesh Kukadiya at 202-476-6850 or DKukadiy@childrensnational.org.