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Open Cellular Therapy Studies

If you have questions about any of the studies below, please email or call 202-476-5456.

Trial #
Title
Description
Sponsor
Status
Investigator

Adoptive Cord Blood Immunotherapy using Expanded Cord Blood T cells for EBV, CMV, BKV and Adenovirus Reactivation/Infection or ProphylaxiS (CHEERS)

This is a phase I–II dose-finding trial to determine the optimal dose of intravenous (IV) injection dose of donor-derived cytotoxic T lymphocytes (CTLs) specific for CMV, EBV, BKV and Adenovirus. A maximum of 36 patients will be treated in up to 18 cohorts each of size 2, with the first cohort treated at the lowest dose level 1, all successive doses chosen by the EffTox method, and no untried dose level skipped when escalating. Pediatric and adult patients (there are no lower and upper age limits) with malignant or nonmalignant diseases who are candidates for transplant are eligible to participate. Patients must have a CB unit (or units) matched with the patient at 4, 5, or 6/6 HLA class I (serological) and II (molecular) antigens. A maximum of 36 patients will be treated.

Catherine Bollard, M.D.

Currently enrolling

Allistair Abraham, M.D.  

NCT03485963

A Phase I Study to Evaluate the Safety, Immunologic, and Virologic RESponses of HIV-Specific T-cells with non-escaped epitope targeting (HST-NEETs) as a Therapeutic Strategy in HIV-Infected Individuals on Antiretroviral Therapy During Acute And Chronic Infection (RESIST)

This is a phase I study to evaluate the safety of the administration of autologous ex vivo HIV-1 antigen specific T cell therapy (HST-NEETs) therapy in HIV-infected individuals with viral suppression on antiretroviral therapy (ART). HIV-infected men and women must be ≥ 18 and < 65 years of age and with durable viral suppression as measured on standard HIV RNA assays for ≥ one year. Eligible participants must be on stable combination ART (cART) and have a CD4 count ≥ 350 cells/mm3.

Catherine Bollard, M.D.

Currently enrolling

Michael Keller, M.D. 

NCT00062868

ALCI2: Administration of LMP-Specific Cytotoxic T-Lymphocytes to Patients with Relapsed EBV-positive Lymphoma

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 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.

Catherine Bollard, M.D.

Currently enrolling

Catherine Bollard, M.D. 

 

 

NCT01945814

MUSTAT: Multivirus-Specific Cytotoxic T-Lymphocytes for the Prophylaxis and Treatment of EBV, CMV and Adenovirus Infections Post Allogeneic Stem Cell Transplant

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.

Catherine Bollard, M.D.

Currently enrolling

Michael Keller, M.D.

NCT02510404

TREPID: Treatment of EBV, CMV and Adenovirus Infections in Primary Immunodeficiency Disorders with Viral-Specific Cytotoxic T-Lymphocytes

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.

Catherine Bollard, M.D.

Currently enrolling

Michael Keller, M.D.

NCT02510417

CHAPS: Administration of Most Closely HL A-matched Multivirus-Specific Cytotoxic T-Lymphocytes for the Treatment of EBV, CMV, Adenovirus Infections Post Allogeneic Stem Cell Transplant

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.

Catherine Bollard, M.D.

Currently enrolling

Catherine Bollard, M.D.  

NCT02789228

REST: Phase I Research Study Utilizing Expanded Multi-Antigen Specific Lymphocytes for the Treatment of Solid Tumors

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.

Catherine Bollard, M.D.

Currently enrolling

Holly Meany, M.D.  

NCT02150551

STOMP: Safety and Tolerability Of Allogeneic Mesenchymal Stromal Cells in Pediatric Inflammatory Bowel Disease

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. 

Catherine Bollard, M.D.

Currently enrolling

Laurie S. Conklin, M.D.

NCT03180216

NATS: Novel Antigens Targeted by ex vivo Expanded T-Lymphocytes for Prevention or Treatment of Viral Infections Following Hematopoietic Stem Cell Transplantation

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.

Catherine Bollard, M.D.

Currently enrolling

Michael Keller, M.D.