Allogeneic Hematopoietic Stem Cell Transplantation Clinical Trial
Official title:
Antigen Specific Adoptive T Cell Therapy for Refractory Opportunistic Adenovirus Infection After a Hematopoietic Stem Cell Transplantation
The purpose of this study is to determine if it is possible to treat an infection with a cell-based immunotherapy (therapy that uses the patient's own immune system to treat the infection). This treatment is called adoptive T cell therapy. Another purpose is to learn about the side effects and toxicities of adoptive T cell therapy. Adoptive T cell therapy is an investigational (experimental) therapy that works by using the blood of a donor that has immunity against the virus. The donor cells are collected and then the cells, called T cells, that are capable of defending against the virus are selected out. These selected T cells are then infused back into the patient, to try to give the immune system the ability to fight the infection. Adoptive T cell therapy is experimental because it is not approved by the Food and Drug Administration (FDA).
Status | Recruiting |
Enrollment | 20 |
Est. completion date | December 2028 |
Est. primary completion date | December 2028 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 3 Months and older |
Eligibility | Inclusion Criteria: - Patients must have received allogeneic HSCT and be greater than 30 days post-HSCT at the time of registration. - Patients must have evidence of documented HAdV infection/reactivation. Patients may be: - Symptomatic with any detectable viral load OR - Asymptomatic with viral load that is: >1000 copies/ml in peripheral blood OR qualitative detection in stool, urine and/or other specimens - Patients must have poor response and/or contraindication to therapy: - Absence of an improvement of viral load (decrease by at least 1 log, i.e. 10-fold) after = 14 days of antiviral therapy with ganciclovir, valganciclovir and/or foscarnet. OR - New, persistent and/or worsening HAdV-related symptoms, signs and/or markers of end organ compromise while on antiviral therapy with ganciclovir, valganciclovir or foscarnet. OR - Have contraindications or experience adverse effects of antiviral therapy with ganciclovir, valganciclovir, cidofovir or foscarnet. - Performance Score: Eastern Cooperative Oncology Group (ECOG) Performance Score = 3. Karnofsky (= 16 years) or Lansky (<16 years) performance score = 50 - The effects of virus-specific, antigen-selected T cells on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (double barrier method of birth control or abstinence) 4 weeks prior to study entry, for the duration of study participation and for 3 months after completing treatment. - Subjects who are 14 years and older must have the ability to understand and the willingness to sign a written informed consent document, or assent document. Exclusion Criteria: - Pregnant or breastfeeding women are excluded from this study. Because there is an unknown, but potential risk for adverse events in nursing infants secondary to treatment of the mother with the agents described above, breastfeeding should be discontinued if the mother participates in this trial. - Patients with opportunistic viral infections other than HAdV. - Patients with active, grade II-IV, acute graft versus host disease (GVHD), chronic GVHD or any condition requiring high doses of glucocorticosteroid (>0.5 mg/kg/day prednisone or its equivalent) as treatment. - Treatment with antithymocyte globulin within 28 days of planned infusion of virus - specific, antigen selected T cells. - Treatment with virus - specific T cells within 6 weeks (42 days) of planned infusion. |
Country | Name | City | State |
---|---|---|---|
United States | University Hospitals, Seidman Cancer Center, Case Comprehensive Cancer Center | Cleveland | Ohio |
Lead Sponsor | Collaborator |
---|---|
Mari Dallas |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of patients with severe adverse events | This is a measure of feasibility: Severe adverse events are related to the infusion of virus-specific, antigen selected T cells, Grade = 3 acute graft versus host disease,• Death within 30 days of the infusion of the virus-specific, antigen selected T cells that is considered by the investigators to be probably or possibly related to the T cell infusion | Up to 100 days after infusion | |
Secondary | Number of patients with viral response | Clearance: No measurable viral load after therapy Response: Decrease by = 1 log after therapy Persistence: Change by < 1 log after therapy Progression: Increase by =1 log after therapy | Up to 30 days after infusion | |
Secondary | Number of patients with clinical response | Clinical Response: Resolution of symptoms and signs of viral infection or reactivation Incomplete clinical response: Improvement, but not resolution of symptoms and signs of viral infection or reactivation Stable clinical disease: No change in symptoms or signs of viral infection Progressive clinical disease: Worsening of symptoms or signs of viral infection | Up to 30 days after infusion | |
Secondary | Time from enrollment to T cell product infusion | Up to 24 hours | ||
Secondary | Time from peripheral mononuclear cell collection to T cell product infusion | Up to 15 hours |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT03294824 -
Non Randomized Comparative Study With Control
|
||
Recruiting |
NCT04098653 -
Decitabine + BUCY vs BUCY Conditioning Regimen for Myeloid Tumors Undergoing Allo-HSCT
|
Phase 2/Phase 3 | |
Recruiting |
NCT03256071 -
Low Dose Decitabine + Modified BUCY Conditioning Regimen for High Risk Acute Myeloid Leukemia Undergoing Allo-HSCT
|
Phase 2/Phase 3 | |
Terminated |
NCT02653196 -
A Multi-Institutional Pilot Study of Allogeneic Hematopoietic Stem Cell Transplantation for Patients With Malignant Neuro-Epithelial and Other Solid Tumors
|
Early Phase 1 | |
Terminated |
NCT00429039 -
A Study to Accelerate Immune System Recovery Following Stem Cell Transplantation
|
Phase 2 | |
Recruiting |
NCT06028828 -
Risk-ADAPTed Conditioning Regimen for Allogeneic Hematopoietic Stem Cell Transplantation
|
Phase 2 | |
Recruiting |
NCT05084027 -
Venetoclax Combining With Fludarabine and Melphalan as Conditioning Regimen for Allo-HSCT
|
Phase 2 | |
Recruiting |
NCT04123392 -
Decitabine + BUCY vs BUCY Conditioning Regimen for TP53+ Myeloid Tumors Undergoing Allo-HSCT
|
Phase 2/Phase 3 | |
Recruiting |
NCT05596968 -
The Gut Microbiome and Sorafenib Maintenance Therapy in FLT3-ITD Positive AML After Allo-HSCT
|
||
Recruiting |
NCT05601895 -
The Gut Microbiome in FLT3- AL Undergoing Allo-HSCT With Or Without Sorafenib Maintenance
|
||
Recruiting |
NCT05596981 -
The Gut Microbiome in FLT3-ITD+ AML Undergoing Allo-HSCT With Or Without Sorafenib Maintenance After Allo-HSCT
|
||
Recruiting |
NCT03357172 -
Determination of Factors Involved in the Regulation of Immune Responses After Allogeneic Hematopoietic Stem Cell Transplantation
|
N/A | |
Active, not recruiting |
NCT04995653 -
A Multiple Dose Study to Evaluate Safety, Tolerability, PK, and Efficacy of SER-155 in Adults Undergoing HSCT
|
Phase 1 | |
Completed |
NCT02250300 -
MLN9708 for the Prophylaxis of Chronic Graft-versus-host Disease in Patient Undergoing Allogeneic Transplantation
|
Phase 1/Phase 2 | |
Recruiting |
NCT04372524 -
Biomarker Verification in Pediatric Chronic GvHD: ABLE 2.0 / PTCTC GVH 1901 Study
|
||
Recruiting |
NCT03593161 -
Humor Therapy and Distress After Allogeneic Stem Cell Transplantation
|
N/A | |
Recruiting |
NCT05379569 -
Comparative Study of BFC and BuCy Conditioning Regimen for Allo-PBSCT in Acute B-cell ALL
|
Phase 4 | |
Not yet recruiting |
NCT03902041 -
The Prospective Randomized Controlled Study of Eltrombopag on Hematopoietic Reconstruction After Allogeneic HSCT
|
||
Completed |
NCT02270346 -
Inspiratory Muscle Training in Allogeneic Hematopoietic Stem Cell Transplantation Recipients
|
N/A | |
Recruiting |
NCT03297528 -
Chemotherapy and DLI for Prevention of Second Relapse in Patients With Relapsed Acute Leukemia After Allotransplant
|
Phase 2 |