Cellular Therapy Clinical Trials

ClinicalTrials.gov Identifier: NCT02203903

Title

• Prospective Phase I Research of Expanded Multi-antigen Specifically Oriented Lymphocytes for the Treatment of Very High Risk Hematopoietic Malignancies (RESOLVE)

Description

• Phase I dose-escalation trial designed to evaluate the safety of administering rapidly generated tumor multi-antigen associated specific cytotoxic T lymphocytes (TAA-T cells), to allogeneic hematopoietic stem cell transplant recipients  or future HSCT recipients, for the treatment of high-risk AML and MDS. T M-T will be infused any time after neutrophil 
  engraftment post-HSCT or day 30, whichever comes first. All infusions will be within 5 months post-HSCT. 

Key Eligibility Criteria 

• Prior or anticipated myeloablative or non-myeloablative allogeneic hematopoietic stem cell transplant to treat Acute myeloid leukemia (AML),or myelodysplastic syndrome (MDS). Once patient receives allo HSCT, they must remain minimal residual disease (MRD) negative (i.e., no evidence of hematologic relapse) to be eligible for TAA-T infusion. 
• Participants must be 6 months to 80 years old and have an allogeneic BMT donor who is willing to also serve as the donor for manufacturing the investigational TAA-T cell product. 

Sponsor 

• Catherine Bollard, MD

Investigator 

• Keri Toner, MD

Disease Type

• High risk AML or MDS and patients undergoing or early post allo-HSCT

ClinicalTrials.gov Identifier: NCT04691622

Title: 

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

Description:

• 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.

Key Eligibility Criteria

• 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.

Sponsor

• Catherine Bollard, MD

Investigator

• Michael Keller, MD

Disease Type

• Norovirus

ClinicalTrials.gov Identifier: NCT05141058

Title

• T Cell Therapy Opposing Novel Coronavirus Infection in Immunocompromised Patients

Description

• 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).

Key Eligibility Criteria 

• Currently only enrolling adolescent and adult patients (> or = 12 years old through 80 years old). Enrollment to kids is on hold until demonstrating safety in those > or = 12 years old first

Sponsor

• Catherine Bollard, MD

Investigator 

• Susan Conway, MD

Disease Type 

• COVID

 

Title

• 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)

Description

• 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. 

Key Eligibility Criteria

• 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.

Sponsor

• Catherine Bollard, MD

Investigator

• Amy Hont, MD

Disease Type

• High-risk solid tumors

ClinicalTrials.gov ID: NCT06193759

Title

• Immunotherapy for Malignant Pediatric brain tumors employing Adoptive Cellular Therapy  (IMPACT)

Description

• This is a Phase I dose-escalation study testing the safety and feasibility of generating and infusing multi-tumor antigen specific cytotoxic T lymphocytes (TSA-T) directed against proteogenomically determined personalized tumor-specific antigens, after standard of care treatment in children less than 4 years of age with embryonal brain tumors.
• This is a single site study, only available at Children's National Hospital, treating children with residual measurable tumor after definitive resection surgery. Researchers will take some of your child's tumor tissue from this surgery and try to figure out at least 2 protein targets on your child's tumor that are unique. They will then collect some immune cells that are already in your child, and train them in the lab to attack those targets.
• Once these specialized TSA-T cells are manufactured and your child has completed their standard of care chemotherapy and stem cell rescue, the TSA-Ts would be infused into your child directly through a CNS intraventricular access, if your child remains eligible.
• Your child would then be closely watched for over a month to see how they do after the infusion. 

Key Eligibility Criteria

• Participants must be less than 5 years old at enrollment and must have new diagnosis of CNS embyronal tumor for which they are getting a tumor resection surgery (inclusive of medulloblastoma, ETMR, pineoblastoma, atypical teratoid/rhabdoid tumor or embryonal tumor NOS). We need sufficient tumor tissue from that surgery to be able to try to proteogenomically determine tumor specific antigens, against which we would design the special T cells.  Patients must also be deemed surgical candidates for placement of ventricular reservoir, for this will be the route of administration for infusing the TSA-Ts.

Sponsor

• Catherine Bollard, MD

Investigator

• Brian Rood, MD

Disease Type

• Newly diagnosed Embryonal CNS tumors
• Medulloblastoma
• Embryonal tumor with multilayered rosettes (ETMR)
• Pineoblastoma
• Atypical teratoid/rhabdoid tumor
• Embryonal tumor, not otherwise specified (NOS)