Clinical Trials
The Stem Cell Transplantation and Cellular Therapy department offers clinical trials for various types of cancer, infections and graft versus host disease. For more information about our clinical trials, call (713) 745-3987.
Cell Therapy
Hematologic Cancers:
2016-0641: Umbilical Cord Blood-Derived CAR-Engineered NK Cells in Conjunction with Lymphodepleting Chemotherapy for the Treatment of Patients with Relapsed/Refractory B-Lymphoid Malignancies (PI: Loretta Nastoupil, MD, Co-Chair: Chitra Hosing, MD)
2018-1092: Bispecific NK Engager AFM13 Combined with NK Cells for Patients with Recurrent or Refractory CD30 Positive Hodgkin or Non-Hodgkin Lymphomas (PI: Yago Nieto, MD, PhD)
2020-0067: A Multicenter Phase Ib Trial for Patients with Advanced Hematologic Malignancies undergoing Allogeneic Hematopoietic Cell Transplantation with Orca-T (formerly TregGraft), a T-cell-Depleted Graft with Additional Infusion of Conventional T cells and Regulatory T cells (PI: Rohtesh Mehta, MD)
2020-0068: A Phase 1, Dose Escalation and Expansion Study of Engineered Donor Grafts Derived from Mobilized Peripheral Blood (OrcaGraft), with Single-Agent Graft-Versus-Host Disease Prophylaxis, in Recipients Undergoing Myeloablative Allogeneic Hematopoietic Cell Transplantation for Hematologic Malignancies (PI: Samer Srour, MB ChB, MS)
2016-1097: A Phase 1 Study Evaluating the Safety and Efficacy of MAGE-A3/A6 T Cell Receptor Engineered T Cells (KITE-718) in HLA-DPB1*04:01 Positive Subjects with Advanced Cancers (PI: Partow Kebriaei, MD)
Solid Tumors:
2020-0151: A Phase 1, Open-Label, Multicenter, Dose Escalation and Cohort Expansion Study of the Safety and Efficacy of Allogeneic CRISPR-Cas9–Engineered T Cells (CTX130) in Adult Subjects with Advanced, Relapsed or Refractory Renal Cell Carcinoma (RCC) with Clear Cell Differentiation (PI: Samer Srour, MB ChB, MS)
2020-1245: A Phase 1 Multicenter Study Evaluating the Safety and Efficacy of ALLO-316 Following ALLO-647 Containing Regimen in Subjects with Advanced or Metastatic Clear Cell Renal Cell Carcinoma (ccRCC) (PI: Samer Srour, MB ChB, MS)
Infection:
2013-0657: Most Closely HLA Matched Allogeneic CMV Specific Cytotoxic T-Lymphocytes (CTL) to Treat CMV Infection (PI: Betul Oran, MD)
2014-0279: Phase II Study Assessing the Effect of BK Virus Specific CTL Lines Generated by ex vivo Expansion in Patients with BK Virus Infection and JC Virus Infection (PI: Amanda Olson, MD)
2017-0350: Administration of Off-the-Shelf, Expanded, Most Closely HLA Matched, Third Party Viral Specific T Cells for Therapy of Adenovirus Related Disease in Immunocompromised Patients (PI: David Marin, MD)
2020-0759: Administration of Expanded, Most Closely HLA Matched SARS-CoV-2-Specific T Cells for the Treatment of COVID-19 in Patients with Cancer (PI: David Marin, MD)
2020-0365: Study of Cord Blood Derived Mesenchymal Stem Cells for Treatment Acute Respiratory Distress Syndrome (PI: Amanda Olson, MD)
Graft Versus Host Disease (GVHD):
2019-1122: A Randomized Controlled Pilot Study of Two Doses of Cord Blood Tissue-Derived Mesenchymal Stromal Cells Combined with Ruxolitinib Versus Ruxolitinib Alone for Therapy of Steroid-Refractory Acute Graft Versus Host Disease (PI: Partow Kebriaei, MD)
2020-0068: A Phase 1, Dose Escalation and Expansion Study of Engineered Donor Grafts Derived from Mobilized Peripheral Blood (OrcaGraft), with Single-Agent Graft-Versus-Host Disease Prophylaxis, in Recipients Undergoing Myeloablative Allogeneic Hematopoietic Cell Transplantation for Hematologic Malignancies (PI: Samer Srour, MB ChB, MS)
Regenerative Medicine:
2015-0835: Randomized 3-Arm Trial with Standard of Care Alone vs Either Intravenous Infusion or Transendocardial Injection of Allogeneic Bone Marrow Derived Multipotent Mesenchymal Stromal Cells (MSCs) Plus Standard of Care in Patients with Anthracycline-Associated Cardiomyopathy (PI: Amanda Olson, MD)
2019-0481: Expanded Access Protocol: Umbilical Cord Blood Infusions for Children with Brain Injuries (PI: Kris Mahadeo, MD, MPH)
Acute Lymphoblastic Leukemia (ALL)
2018-0860: Addition of Inotuzumab Ozogamicin Pre- and Post-Allogeneic Transplantation (PI: Issa Khouri, MD)
2020-0067: A Multicenter Phase Ib Trial for Patients with Advanced Hematologic Malignancies undergoing Allogeneic Hematopoietic Cell Transplantation with Orca-T (formerly TregGraft), a T-cell-Depleted Graft with Additional Infusion of Conventional T cells and Regulatory T cells (PI: Rohtesh Mehta, MD)
2020-0068: A Phase 1, Dose Escalation and Expansion Study of Engineered Donor Grafts Derived from Mobilized Peripheral Blood (OrcaGraft), with Single-Agent Graft-Versus-Host Disease Prophylaxis, in Recipients Undergoing Myeloablative Allogeneic Hematopoietic Cell Transplantation for Hematologic Malignancies (PI: Samer Srour, MB ChB, MS)
2020-0971: Itacitinib to Prevent Graft Versus Host Disease (PI: Uday Popat, MD)
2016-0316: A Phase 1/2 Multi-Center Study Evaluating the Safety and Efficacy of KTE-X19 in Pediatric and Adolescent Subjects with Relapsed/Refractory B-Precursor Acute Lymphoblastic Leukemia or Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma (ZUMA-4) (PI: Sajad Khazal, MB ChB)
2018-0744: Managed Access Program (MAP) To Provide Access To CTL019, For Acute Lymphoblastic Leukemia (ALL) or Diffuse Large B-Cell Lymphoma (DLBCL) Patients With Out of Specification Leukapheresis Product and/or Manufactured Tisagenlecleucel Out of Specification For Commercial Release (Treatment Plan CCTL019B2003I) (PI: Sajad Khazal, MB ChB)
2018-0964: A Phase II Pilot Trial To Estimate Survival After A Non-Total Body Irradiation (TBI) Based Conditioning Regimen In Patients Diagnosed With B-Acute Lymphoblastic Leukemia (ALL) Who Are Pre-Allogeneic Hematopoietic Cell Transplantation (HCT) Next-Generation-Sequence (NGS) Minimal Residual Disease (MRD) Negative (PTCTC ONC1701) (PI: Kris Mahadeo, MD, MPH)
Acute Myeloid Leukemia (AML)
2016-0156: A Multicenter, Pivotal Phase 3 Study of Iomab-B Prior to Allogeneic Hematopoietic Cell Transplantation Versus Conventional Care in Older Subjects with Active, Relapsed, or Refractory Acute Myeloid Leukemia (PI: Partow Kebriaei, MD)
2016-0592: Phase I/II Study of Sorafenib Added to Busulfan and Fludarabine Conditioning Regimen in Patients with Relapsed/Refractory AML Undergoing Stem Cell Transplantation (PI: Uday Popat, MD)
2017-0349: A Phase I Study of Nivolumab in Combination with Ipilimumab for the Treatment of Patients with High Risk or Refractory/Relapsed Acute Myeloid Leukemia and Myelodysplastic Syndrome Following Allogeneic Stem Cell Transplantation (PI: Gheath Al-Atrash, DO, PhD)
2019-0353: A Phase II Study of Venetoclax in Combination with Azacitidine in the Post-Transplant Setting for AML, T Cell Leukemia, and Mixed Phenotype Acute Leukemia (PI: Betul Oran, MD)
2020-0281: Haplo-Identical Natural Killer (NK) Cells to Prevent Post-Transplant Relapse in AML and MDS (NK-REALM) (PI: Richard Champlin, MD)
2020-0067: A Multicenter Phase Ib Trial for Patients with Advanced Hematologic Malignancies Undergoing Allogeneic Hematopoietic Cell Transplantation with Orca-T (formerly TregGraft), a T-cell-Depleted Graft with Additional Infusion of Conventional T cells and Regulatory T cells (PI: Rohtesh Mehta, MD)
2020-0068: A Phase 1, Dose Escalation and Expansion Study of Engineered Donor Grafts Derived from Mobilized Peripheral Blood (OrcaGraft), with Single-Agent Graft-Versus-Host Disease Prophylaxis, in Recipients Undergoing Myeloablative Allogeneic Hematopoietic Cell Transplantation for Hematologic Malignancies (PI: Samer Srour, MB ChB, MS)
2020-0790: Venetoclax to Improve Outcomes of Fractionated Busulfan Regimen in Patients with High-Risk AML and MDS (PI: Uday Popat, MD)
2020-0971: Itacitinib to Prevent Graft Versus Host Disease in AML Patients Undergoing Allotransplantation (PI: Uday Popat, MD)
Myeloma
2016-1097: A Phase 1 Study Evaluating the Safety and Efficacy of MAGE-A3/A6 T Cell Receptor Engineered T Cells (KITE-718) in HLA-DPB1*04:01 Positive Subjects with Advanced Cancers (PI: Partow Kebriaei, MD)
2016-0681: Daratumumab-Based for Maintenance in Patients with Relapsed Multiple Myeloma after Salvage Autologous Stem Cell Transplantation (PI: Muzaffar Qazilbash, MD)
2017-0399: Prospective Phase I/II Trial to Jointly Optimize the Administration Schedule(s) and Dose(s) of Melphalan for Injection (Evomela) as a Preparative Regimen for Autologous Hematopoietic Stem Cell Transplantation in Patients with Newly Diagnosed Multiple Myeloma (PI: Qaiser Bashir, MD)
2020-0062: SWOG1803: Phase III Study of Daratumumab/rHUPH20 (NSC-810307) + Lenalidomide or Lenalidomide as Post-Autologous Stem Cell
Transplant Maintenance Therapy in Patients with Multiple Myeloma Using Minimal Residual Disease to Direct Therapy Duration (DRAMMATIC Study) (PI: Muzaffar Qazilbash, MD)
2020-0712: A Phase I/II Study to Evaluate the Safety and Tolerability of Adoptively Transferred Autologous T cells in Patients with Relapsed Refractory Multiple Myeloma (PI: Muzaffar Qazilbash, MD)
Myelodysplastic Syndrome (MDS)
2020-0281: Haplo-Identical Natural Killer (NK) Cells to Prevent Post-Transplant Relapse in AML and MDS (NK-REALM) (PI: Richard Champlin, MD)
2020-0067: A Multicenter Phase Ib Trial for Patients with Advanced Hematologic Malignancies Undergoing Allogeneic Hematopoietic Cell Transplantation with Orca-T (formerly TregGraft), a T-cell-Depleted Graft with Additional Infusion of Conventional T cells and Regulatory T cells (PI: Rohtesh Mehta, MD)
2020-0068: A Phase 1, Dose Escalation and Expansion Study of Engineered Donor Grafts Derived from Mobilized Peripheral Blood (OrcaGraft), with Single-Agent Graft-Versus-Host Disease Prophylaxis, in Recipients Undergoing Myeloablative Allogeneic Hematopoietic Cell Transplantation for Hematologic Malignancies (PI: Samer Srour, MB ChB, MS)
2020-0790: Venetoclax to Improve Outcomes of Fractionated Busulfan Regimen in Patients with High-Risk AML and MDS (PI: Uday Popat, MD)
2020-0971: Itacitinib to Prevent Graft Versus Host Disease in MDS Patients Undergoing Allotransplantation (PI: Uday Popat, MD)
Myeloproliferative Diseases, Including CML
2020-0971: Itacitinib to Prevent Graft Versus Host Disease in Patients Undergoing Allotransplantation (PI: Uday Popat, MD)
Lymphoma
2016-0641: Dose Escalation Study Phase I/II of Umbilical Cord Blood-Derived CAR-Engineered NK Cells in Conjunction with Lymphodepleting Chemotherapy in Patients with Relapsed/Refractory B-Lymphoid Malignancies (PI: Loretta Nastoupil, MD; Co-Chair: Chitra Hosing, MD)
2017-0073: Olaparib Combined with High-Dose Chemotherapy for Refractory Lymphomas (PI: Yago Nieto, MD, PhD)
2018-1092: Bispecific NK Engager AFM13 Combined with NK Cells for Patients with Recurrent or Refractory CD30 Positive Hodgkin or Non-Hodgkin Lymphomas (PI: Yago Nieto, MD, PhD)
2016-0316: A Phase 1/2 Multi-Center Study Evaluating the Safety and Efficacy of KTE-X19 in Pediatric and Adolescent Subjects with Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia or Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma (ZUMA-4) (PI: Sajad Khazal, MB ChB)
2018-0744: Managed Access Program (MAP) To Provide Access To CTL019, For Acute Lymphoblastic Leukemia (ALL) or Diffuse Large B-Cell Lymphoma (DLBCL) Patients With Out of Specification Leukapheresis Product and/or Manufactured Tisagenlecleucel Out of Specification For Commercial Release (Treatment Plan CCTL019B2003I) (PI: Sajad Khazal, MB ChB)
Infection
2013-0657: Most Closely HLA Matched Allogeneic CMV Specific Cytotoxic T-Lymphocytes (CTL) to Treat CMV Infection (PI: Betul Oran, MD)
2014-0279: Phase II Study Assessing the Effect of BK Virus Specific CTL Lines Generated by ex vivo Expansion in Patients with BK Virus Infection and JC Virus Infection (PI: Amanda Olson, MD)
2017-0350: Administration of Off-the-Shelf, Expanded, Most Closely HLA Matched, Third Party Viral Specific T Cells for Therapy of Adenovirus Related Disease in Immunocompromised Patients (PI: David Marin, MD)
2020-0759: Administration of Expanded, Most Closely HLA Matched SARS-CoV-2-Specific T Cells for the Treatment of COVID-19 in Patients with Cancer (PI: David Marin, MD)
2020-0365: Study of Cord Blood Derived Mesenchymal Stem Cells for Treatment Acute Respiratory Distress Syndrome (PI: Amanda Olson, MD)
2020-0375: An Open-Label, Single-Arm, Multicohort, Phase 2 Study to Assess the Efficacy and Safety of Tabelecleucel in Subjects with Epstein-Barr Virus-Associated Diseases (PI: Kris Mahadeo, MD, MPH)
2017-0771: Multicenter, Open Label, Phase 3 Study of Tabelecleucel for Solid Organ or Allogeneic Hematopoietic Cell Transplant Subjects with Epstein-Barr Virus-Associated Post-Transplant Lymphoproliferative Disease After Failure of Rituximab or Rituximab and Chemotherapy (ALLELE Study) (PI: Kris Mahadeo, MD, MPH)
2019-0079: Expanded Access Protocol for Providing Tabelecleucel to Patients With Epstein-Barr Virus-Associated Viremia or Malignancies for Whom There are No Appropriate Alternative Therapies (PI: Kris Mahadeo, MD, MPH)
2018-0664: Adoptive Cord Blood Immunotherapy Using Expanded Cord Blood T Cells for EBV, CMV, BKV and Adenovirus Reactivation/Infection or Prophylaxis (CHEERS) (PI: Amanda Olson)
Graft Versus Host Disease (GVHD)
2018-0855: A Phase 2, Randomized, Multicenter Study to Evaluate the Efficacy and Safety of KD025 in Subjects with Chronic Graft Versus Host Disease (cGVHD) After At Least 2 Prior Lines of Systemic Therapy (The ROCKstar Study) (PI: Rohtesh Mehta, MD)
2018-0489: A Phase I Study to Assess Safety of Selective JAK 1 Inhibitor, Itacitinib, in Patients with Bronchiolitis Obliterans syndrome (BOS) after Allogeneic Hematopoietic Cell Transplant (HCT) (PI: Rohtesh Mehta, MD)
2019-1002: A Randomized, Double Blind, Placebo-Controlled Multicenter Phase III Trial of Alpha 1- Antitrypsin (AAT) Combined with Corticosteroids vs Corticosteroids Alone for the Treatment of High Risk Acute Graft-versus-Host Disease (GVHD) Following Allogeneic Hematopoietic Stem Cell Transplant (PI: Amin Alousi, MD)
2019-1122: A Randomized Controlled Pilot Study of Two Doses of Cord Blood Tissue-Derived Mesenchymal Stromal Cells combined with Ruxolitinib versus Ruxolitinib alone for Therapy of Steroid-Refractory Acute Graft versus Host Disease (PI: Partow Kebriaei, MD)
2019-0125: A Phase 2/3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Study To Evaluate The Safety And Efficacy Of Alpha-1 Antitrypsin For The Prevention Of Graft-Versus Host Disease In Patients Receiving Hematopoietic Cell Transplant (MODULAATE Study) (PI: Rohtesh Mehta, MD)
BMTCTN1703/BMTCTN1801: A Randomized, Multicenter, Phase III Trial of Tacrolimus/Methotrexate versus Post-Transplant Cyclophosphamide/Tacrolimus/Mycophenolate Mofetil in Non-Myeloablative/Reduced Intensity Conditioning Allogeneic Peripheral Blood Stem Cell Transplantation (PI: Amin Alousi, MD)
2020-0068: A Phase 1, Dose Escalation and Expansion Study of Engineered Donor Grafts Derived from Mobilized Peripheral Blood (OrcaGraft), with Single-Agent Graft-Versus-Host Disease Prophylaxis, in Recipients Undergoing Myeloablative Allogeneic Hematopoietic Cell Transplantation for Hematologic Malignancies (PI: Samer Srour, MB ChB, MS)
2020-0971: Itacitinib to Prevent Graft Versus Host Disease in Patients Undergoing Allotransplantation (PI: Uday Popat, MD)
2020-1258: AGAVE-201, A Phase 2, Open-label, Randomized, Multicenter Study to Evaluate the Efficacy, Safety and Tolerability of Axatilimab at 3 Different Doses in Patients with Recurrent or Refractory Active Chronic Graft Versus Host Disease who have Received at least 2 Lines of Systemic Therapy (PI: Rohtesh Mehta, MD)
Solid Tumors
2020-0151: A Phase 1, Open-Label, Multicenter, Dose Escalation and Cohort Expansion Study of the Safety and Efficacy of Allogeneic CRISPR-Cas9–Engineered T Cells (CTX130) in Adult Subjects with Advanced, Relapsed or Refractory Renal Cell Carcinoma (RCC) with Clear Cell Differentiation (PI: Samer Srour, MB ChB, MS)
2020-1245: A Phase 1 Multicenter Study Evaluating the Safety and Efficacy of ALLO-316 Following ALLO-647 Containing Regimen in Subjects with Advanced or Metastatic Clear Cell Renal Cell Carcinoma (ccRCC) (PI: Samer Srour, MB ChB, MS)
2020-0496: A Pilot Study of Allogeneic Hematopoietic Stem Cell Transplantation for Patients with High-Risk Solid Tumors (PI: Kris Mahadeo, MD, MPH)
2020-0495: A Pilot Study of Allogeneic Hematopoietic Stem Cell Transplantation for Patients with High-Grade Central Nervous System Malignancies (PI: Kris Mahadeo, MD, MPH)
2017-0085: Ex-Vivo Expanded Allogeneic NK Cells for the Treatment of Pediatric Solid Tumors (PI: Sajad Khazal, MB ChB)
Hemoglobinopathies
2020-0171: BMT CTN PROTOCOL 1507: Reduced Intensity Conditioning for Haploidentical Bone Marrow Transplantation in Patients with Symptomatic Sickle Cell Disease (PI: Kris Mahadeo, MD, MPH)
2020-0952: Pre-Transplant Immunosuppression and Related Haploidentical Hematopoietic Cell Transplantation for Patients with Severe Hemoglobinopathies (PI: Kris Mahadeo, MD, MPH)
Immunodeficiencies
2020-0138: A Randomized Trial of Low Versus Moderate Exposure Busulfan for Infants with Severe Combined Immunodeficiency (SCID) Receiving TCRaß+/CD19+ Depleted Transplantation: A Phase II Study by the Primary Immune Deficiency Treatment Consortium (PIDTC) and Pediatric Transplantation & Cellular Therapy (PTCTC) PIDTC “CSIDE” Protocol (Conditioning SCID Infants Diagnosed Early) PTCTC NMD 1801 (PI: Kris Mahadeo, MD, MPH)