Cellular Therapy Program

Cellular Therapy Clinical Trials

Cellular Therapy Program
Clinical Trials (current page)

Cellular Therapy Clinical Trials

For questions about cellular therapy clinical trials, please email us or call 202-476-5456.

T Cell Therapy Opposing Novel Coronavirus Infection in Immunocompromised Patients (TONI)

Title	Description	Key Eligibility Criteria	Sponsor	Investigator	Disease Type
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, MD	Susan Conway, MD	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)

Title	Description	Key Eligibility Criteria	Sponsor	Investigator	Disease Type
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, MD	Amy Hont, MD	High-risk solid tumors

Title

Description

Key Eligibility Criteria

Sponsor

Investigator

Disease Type

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, MD

Amy Hont, MD

High-risk solid tumors

Adoptive T Lymphocyte Administration for Chronic Norovirus Treatment in Immunocompromised Hosts (ATLANTIC)

Title	Description	Key Eligibility Criteria	Sponsor	Investigator	Disease Type
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 immunodeficiency (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, MD	Michael Keller, MD	Norovirus

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

Title	Description	Key Eligibility Criteria	Sponsor	Investigator	Disease Type
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, MD	Allistair Abraham, MD	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)

Title	Description	Key Eligibility Criteria	Sponsor	Investigator	Disease Type
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, MD	David Jacobsohn, MD	AML, MDS, ALL

Phase I Research on Multi-antigen T cell Infusion against Neuro-oncologic Disease (ReMIND)

Title	Description	Key Eligibility Criteria	Sponsor	Investigator	Disease Type
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, MD	Eugene Hwang, MD	High-risk CNS tumors

Mesenchymal Stromal Cells Delivery through Cardiopulmonary Bypass in Pediatric Cardiac Surgery (MeDCaP)

Title	Description	Key Eligibility Criteria	Sponsor	Investigator	Disease Type
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, MD	Richard Jonas, MD	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)

Title	Description	Key Eligibility Criteria	Sponsor	Investigator	Disease Type
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, MD	Relapsed or refractory B-cell Acute Lymphoblastic Leukemia

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