Adoptive Cord Blood Immunotherapy using Expanded Cord Blood T cells for EBV, CMV, BKV and Adenovirus Reactivation/Infection or Prophylaxis (CHEERS)
NCT03594981 | This is a phase I–II dose-finding trial to determine the optimal dose of donor-derived cytotoxic T lymphocytes (CTLs) specific for CMV, EBV, BKV and Adenovirus. | - Pediatric and adult patients with malignant or nonmalignant diseases who are candidates for transplant.
- 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.
| Catherine Bollard, M.D. | Allistair Abraham, M.D. | CMV, EBV, BKV and Adenovirus infections |
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)
NCT03485963 | 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). | - Eligible participants must be on continuous combination ART (cART) and have a CD4 count ≥ 350 cells/mm3.
- HIV infected men and women must be ≥18 and ≤70 years of age and with durable viral suppression.
| Catherine Bollard, M.D. | Michael Keller, M.D. | HIV |
Prospective Phase I Research of Expanded Multi-antigen Specifically Oriented Lymphocytes for the Treatment of Very High Risk Hematopoietic Malignancies (RESOLVE)
NCT02203903 | Phase I dose-escalation trial designed to evaluate the safety of administering rapidly generated tumor multi-antigen associated specific cytotoxic T lymphocytes, to HSCT recipients or future HSCT recipients for the treatment of high-risk or relapsed or refractory hematopoietic malignancies. | - Prior or anticipated myeloablative or non-myeloablative allogeneic hematopoietic stem cell transplant to treat Acute lymphoblastic leukemia (ALL), Acute myeloid leukemia (AML), Ambiguous lineage leukemia or lymphoma, Chronic Myelogenous leukemia, MDS
- Participants must be 6 months to 80 years
| Catherine Bollard, M.D. | David Jacobsohn, M.D. | AML, MDS, ALL
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Novel Antigens Targeted by ex vivo Expanded T-Lymphocytes for Prevention or Treatment of Viral Infections Following Hematopoietic Stem Cell Transplantation (NATS)
NCT03180216 | Phase I dose-escalation trial 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. | - Patients must be risk of developing or with confirmed active infection(s) of EBV, CMV, adenovirus, HHV6, BKV, JCV, and/or HPIV3 that has failed to resolve with at least 14 days of standard antiviral therapy.
- Pediatric and adult patients are eligible.
| Catherine Bollard, M.D. | Michael Keller, M.D. | EBV, CMV, adenovirus, HHV6, BKV, JCV and/or HPIV3 infections |
Phase I Study Utilizing Tumor Associated Antigen Specific T cells (TAA-T) with PD1 Inhibitor Nivolumab for Relapsed/Refractory Lymphoma (SUSTAIN)
NCT03843294 | Phase I, open-label multi-site trial designed to evaluate the safety of administering rapidly-generated multi-antigen-specific T lymphocytes with Nivolumab, to relapsed/refractory (rel/ref) lymphoma patients with measurable disease or as adjunctive therapy following autologous HSCT | - Patients with Measurable Disease, Relapsed/Refractory Hodgkin Lymphoma (HL) and Diffuse Large B Cell Lymphoma (DLBCL) or with consolidation after auto-HSCT for high risk for relapse.
- Participants must be 12 years to 80 years
| Catherine Bollard, M.D. | Hema Dave, M.D. | HL, DLBCL |
Antiviral Cellular Therapy for Enhancing T-cell Reconstitution Before or After Hematopoietic Stem Cell Transplantation (ACES)
NCT03475212 | Phase I/II study designed to determine the feasibility, safety, and antiviral efficacy of administering partially HLA-matched VSTs to mediate antiviral activity in HSCT recipients with persistent viral reactivations or infections. HLA-matched multivirus-specific T cell lines obtained from a bank of allogeneic virus-specific T cell lines (VSTs) against three viruses: EBV, CMV and adenovirus. | - Patients with simultaneous infections with CMV, EBV and/or Adenovirus infections are eligible if one or more infection(s) is persistent or relapsed. Patients must have received prior myeloablative or non-myeloablative allogeneic stem cell transplant within the previous 18 months OR have a diagnosed primary immunodeficiency disorder and not undergone stem cell transplant
| Children's Hospital Los Angeles | Blachy Davila Saldana, M.D. | CMV, EBV and adenovirus infections |
Phase I Research Study Utilizing Expanded Multi-Antigen Specific Lymphocytes for the Treatment of Solid Tumors (REST)
NCT02789228 | Phase 1 dose-escalation trial designed to determine the safety of administering rapidly generated tumor multi-antigen associated specific cytotoxic T lymphocytes (TAA CTL) in patients with high risk solid tumors. | - Patients with high-risk solid tumors: Ewing sarcoma, Wilms tumor, neuroblastoma, rhabdomyosarcoma, soft tissue sarcomas, osteosarcoma and adenocarcinoma.
- Patients must have undergone allogeneic HSCT or conventional therapy.
- Participants must be 6 months to 60 years.
| Catherine Bollard, M.D. | Holly Meany, M.D. | High-risk solid tumors |
Phase I Research on Multi-antigen T cell Infusion against Neuro-oncologic Disease (ReMIND)
NCT03652545 | Phase I dose-escalation trial designed to evaluate the safety of administering rapidly generated TAA-T to patients who have either newly diagnosed DIPG after standard radiation therapy, or for patients with recurrent, progressive, or refractory high grade CNS malignancies.
| - Patients must have new diagnosis of DIPG or recurrent, progressive or refractory disease after standard treatment high-grade glioma, medulloblastoma, ependymoma, embryonal tumors, choroid plexus carcinoma, other aggressive CNS malignancies.
- Participants must be 6 months to 80 years of age at enrollment.
| Catherine Bollard, M.D. | Eugene Hwang, M.D. | High-risk CNS tumors |
Mesenchymal Stromal Cells Delivery through Cardiopulmonary Bypass in Pediatric Cardiac Surgery (MeDCaP)
NCT04236479 | Prospective, open-label, single-center, phase 1 trial of designed toassess safety and feasibility of administering allogeneic bone marrow-derived mesenchymal stromal cell (BM-MSC) delivered through cardiopulmonary bypass (CPB) in a homogeneous population of infants with congenital heart disease (CHD) who will be undergoing a two-ventricle repair within the first six months of life. | - Participants must be neonatal and young infantile patients who are ≤ 3 months of age scheduled to undergo reparative two-ventricle repair for congenital heart defects.
| Catherine Bollard, M.D. | Richard Jonas, M.D. | Congenital heart disease |
A Phase II Trial of Tisagenlecleucel In First-Line High-Risk (HR) Pediatric and Young Adult Patients with B-Cell Acute Lymphoblastic Leukemia (B-ALL) Who Are Minimal Residual Disease (MRD) Positive at the End of Consolidation (EOC) Therapy (Cassiopeia/AALL1721)
NCT03876769 | Phase II open label trial to assess the efficacy and safety of CAR-T in high risk pediatric and young adult patients with B-ALL who received first-line treatment and are minimal residual disease (MRD) positive (≥0.01%) at the end of consolidation therapy. | - Patients must have high risk B-ALL at diagnosis
- EOC MRD positive
- Adequate organ function
- Patients ≤25 years of age
| Novartis Pharmaceuticals | Anne Angiolillo, M.D. | Relapsed B-cell Acute Lymphoblastic Leukemia |
A Phase II Trial to Determine the Safety and Efficacy of Tisagenlecleucel (CAR-T) in Patients with Relapsed or Refractory Mature B-cell non-Hodgkin Lymphoma (BIANCA)
NCT03610724 | A Phase II prospective open label trial to determine the efficacy of tisagenlecleucel(CAR-T) as measured by objective response rate and determined by local investigator assessments in subjects with aggressive relapsed/refractory B-cell Non- Hodgkin lymphoma. | - Includes B-cell non-Hodgkin lymphoma (B-cell NHL) including the following subtypes; Burkitt Lymphoma (BL), Diffuse Large B-Cell Lymphoma (DLBCL), Primary Mediastinal B-Cell Lymphoma (PMBCL), Gray Zone lymphoma (GZL), Follicular Lymphoma (FL), & Burkitt leukemia
- Relapsed after 1 or more prior therapies or refractory after primary therapy
- Patients ≤25 years of age
| Novartis Pharmaceuticals | Hema Dave, M.D. | Relapsed or refractory mature B-cell non-Hodgkin Lymphoma |
A Phase 1 Feasibility and Safety Study of Dual Specificity CD19 and CD22 CAR-T Cell Immunotherapy for CD19+CD22+ Leukemia (PLAT-05)
NCT03684889 | This Phase 1 open-label, non-randomized study to assess the safety, feasibility and efficacy of dual targeting (against CD19 and CD22 antigen) autologous CAR-T cells in pediatric and young adult patients (<31 years old) with relapsed or refractory CD19+ CD22+ leukemia with and without prior history of allogeneic stem cell transplant. | - Relapsed.refractory B cell Acute Lymphoblastic Leukemia(B-ALL) or ≥0.01% disease following allogeneic transplant CD19+22+
- Participants age ≥18 and <31 years.
| Seattle Children’s Hospital and Research Institute | Anant Vatsayan, M.D. | Relapsed or refractory B-cell Acute Lymphoblastic Leukemia |