T Cell Therapy Opposing Novel Coronavirus Infection in Immunocompromised Patients
NCT05141058 | Open label, phase I dose-escalation study to evaluate the safety of coronavirus–specific T cell (CST) therapy for prevention of SARS-CoV-2 infection in immunocompromised patients following hematopoietic stem cell transplantation (HSCT). | - Participants must have received an HSCT ≥28 days and <4 months before study infusion.
- Participants must be within 18 years of age to 80 years to be enrolled in Arm A or 12 years of age and <18 years of age to be enrolled in arm B.
| Catherine Bollard, M.D. | Susan Conway, M.D. | COVID |
| Phase I Research Study Utilizing Allogeneic Multi Tumor-Associated Antigen-Specific T lymphocytes to Advance the Care of Patients with High-Risk Solid Tumors (ATTACK) | Phase I dose-escalation study to evaluate the safety of partially human leukocyte antigen (HLA)-matched multi tumor-associated antigen–specific T cell (TAA-T) therapy for patients with high-risk solid tumors due to the presence of refractory, relapsed and/or minimal residual detectable disease following conventional therapy. | - Participants must be diagnosed with high-risk solid tumors with known positivity for two or more targeted Tumor-Associated Antigens (TAA) (Wilms tumor 1 (WT1), Preferentially Expressed Antigen of Melanoma (PRAME), and/or Survivin) and relapsed, refractory, and/or minimal residual disease following conventional therapy.
- Participants must be age 18 years to 60 years old to enroll in arm A or 6 to 18 years old to enroll in arm B.
| Catherine Bollard, M.D. | Amy Hont, M.D. | High-risk solid tumors |
Adoptive T Lymphocyte Administration for Chronic Norovirus Treatment in Immunocompromised Hosts (ATLANTIC)
NCT04691622 | Open label, phase I dose-escalation study to evaluate the safety of norovirus –specific T cell (NST) therapy for chronic norovirus infection in participants following hematopoietic stem cell transplantation (HSCT) or with primary immunodeficiency disorders (PID) who have not undergone HSCT. | - Participants must meet one of the following criteria, have a primary inmunodeficiency (PID) and have not undergone HSCT, undergo HSCT but do not have available donor-derived NSTs, or
have donors from whom NSTs cannot be generated due to norovirus seronegativity.
| Catherine Bollard, M.D. | Michael Keller, M.D. | Norovirus |
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 |
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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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 to assess 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 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 |