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Cellular Therapy Clinical Trials

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

TitleDescriptionKey Eligibility CriteriaSponsor  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, 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
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 PharmaceuticalsAnne 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 PharmaceuticalsHema 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 InstituteAnant Vatsayan, M.D.Relapsed or refractory B-cell Acute Lymphoblastic Leukemia