Clinical trial NCT06735690: Allogeneic CMV-Specific CD19-CAR T Cells Plus CMV-MVA Triplex Vaccine After Matched Related Donor Hematopoietic Cell Transplant for the Treatment of Patients With High-Risk Acute Lymphoblastic Leukemia
Official title: Pilot/Feasibility Study of CMV-Specific CD19-CAR T Cells Plus CMV-MVA Triplex Following Matched Related Allogeneic Hematopoietic Cell Transplantation for Patients With High-Risk Acute Lymphoblastic Leukemia
Conditions: Acute Lymphoblastic Leukemia
Summary: This early phase I trial tests the safety and side effects of allogeneic CMV-specific CD19-CAR T cells plus CMV-MVA vaccine and how well it works in treating patients with high-risk acute lymphoblastic leukemia after a matched related donor (allogeneic) hematopoietic stem cell transplant (alloHSCT). Chimeric antigen receptor (CAR) T-cell therapy is a type of treatment in which T cells (a type of immune system cell) are changed in the laboratory so they will attack cancer cells. T cells are taken from a patient's blood, in this study, the T cells are cytomegalovirus (CMV) specific. Then the gene for a special receptor that binds to a certain protein, CD19, on the patient's cancer cells is added to the CMV-specific T cells in the laboratory. The special receptor is called a CAR. Large numbers of the CAR T cells are grown in the laboratory and given to the patient by infusion for treatment of certain cancers. Vaccines made from three CMV tumor associated antigens, may help the body build an effective immune response to kill cancer cells. Giving allogeneic CMV-specific CD19-CAR T cells plus CMV-MVA vaccine after matched related alloHSCT may be safe, tolerable, and/or effective in treating patients with high-risk acute lymphoblastic leukemia.
Interventions:
description: Undergo alloHSCT
name: Allogeneic Hematopoietic Stem Cell Transplantation
other_name: Allogeneic
Allogeneic Hematopoietic Cell Transplantation
Allogeneic Stem Cell Transplantation
HSC
HSCT
Stem Cell Transplantation, Allogeneic
type: Procedure
description: Given IV
name: Anti-CD19-CAR CMV-specific T-lymphocytes
other_name: Anti-CD19-CAR CMV-specific T-cells
CMV-specific CD19 CAR-T Cells
CMV-specific CD19-CAR T Cells
type: Biological
description: Undergo blood and optional CSF sample collection
name: Biospecimen Collection
other_name: Biological Sample Collection
Biospecimen Collected
Specimen Collection
type: Procedure
description: Undergo bone marrow biopsy and aspiration
name: Bone Marrow Aspiration
type: Procedure
description: Undergo bone marrow biopsy and aspiration
name: Bone Marrow Biopsy
other_name: Biopsy of Bone Marrow
Biopsy, Bone Marrow
type: Procedure
description: Undergo CT or PET/CT
name: Computed Tomography
other_name: CAT
CAT Scan
CT
CT Scan
Computed Axial Tomography
Computerized Axial Tomography
Computerized Tomography
Computerized Tomography (CT) scan
Computerized axial tomography (procedure)
tomography
type: Procedure
description: Undergo ECHO
name: Echocardiography
other_name: EC
type: Procedure
description: Undergo leukapheresis
name: Leukapheresis
other_name: Leukocyte Adsorptive Apheresis
Leukocytopheresis
Therapeutic Leukopheresis
White Blood Cell Reduction Apheresis
type: Procedure
description: Undergo lumbar puncture
name: Lumbar Puncture
other_name: LP
Spinal Tap
type: Procedure
description: Undergo MRI
name: Magnetic Resonance Imaging
other_name: MR
MR Imaging
MRI
MRI Scan
MRIs
Magnetic Resonance
Magnetic Resonance Imaging (MRI)
Magnetic Resonance Imaging Scan
Magnetic resonance imaging (procedure)
Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
NMR Imaging
NMRI
Nuclear Magnetic Resonance Imaging
Structural MRI
sMRI
type: Procedure
description: Given IM
name: Multi-peptide CMV-Modified Vaccinia Ankara Vaccine
other_name: CMV-MVA Triplex Vaccine
Multi-antigen CMV-Modified Vaccinia Ankara Vaccine
type: Biological
description: Undergo MUGA
name: Multigated Acquisition Scan
other_name: Blood Pool Scan
Equilibrium Radionuclide Angiography
Gated Blood Pool Imaging
Gated Heart Pool Scan
MUGA
MUGA Scan
Multi-Gated Acquisition Scan
RNV Scan
RNVG
Radionuclide Ventriculogram Scan
Radionuclide Ventriculography
SYMA Scanning
Synchronized Multigated Acquisition Scanning
type: Procedure
description: Undergo PET/CT
name: Positron Emission Tomography
other_name: Medical Imaging, Positron Emission Tomography
PET
PET Scan
PT
Positron Emission Tomography Scan
Positron emission tomography (procedure)
Positron-Emission Tomography
proton magnetic resonance spectroscopic imaging
type: Procedure
description: Given HSCT conditioning regimen
name: Transplant Conditioning
other_name: conditioning regimen
type: Other
description: Undergo chest x-ray
name: X-Ray Imaging
other_name: Conventional X-Ray
Diagnostic Radiology
Medical Imaging, X-Ray
Plain film radiographs
RG
Radiographic Imaging
Radiographic imaging procedure (procedure)
Radiography
Static X-Ray
X-Ray
type: Procedure
Study arms:
design_group_description: Patients receive HSCT conditioning regimen followed by alloHSCT per standard of care. Starting 28-49 days after alloHSCT, patients receive allo CMV-specific CD19-CAR T cells IV over 10-15 minutes on day 0. Patients undergo ECHO or MUGA, blood and optional CSF sample collection and bone marrow biopsy and aspiration throughout the study. Patient may also undergo chest x-ray and lumbar puncture as needed per PI discretion and PET/CT or CT as clinically indicated throughout the study. Additionally, patients with neurological abnormalities at baseline may undergo MRI of brain throughout the study.
design_group_title: Part 1 (allo CMV-specific CD19-CAR T cells
design_group_type: Experimental
design_group_description: Patients receive HSCT conditioning regimen followed by alloHSCT per standard of care. Starting 28-49 days after alloHSCT, patients receive allo CMV-specific CD19-CAR T cells IV over 10-15 minutes on day 0. Patients receive CMV-MVA triplex vaccine IM on day 28 in the absence of DLTs and may receive an additional CMV-MVA triplex vaccine IM on day 56 in the absence of DLTs during the second evaluation period. Patients undergo ECHO or MUGA, blood and optional CSF sample collection and bone marrow biopsy and aspiration throughout the study. Patient may also undergo chest x-ray and lumbar puncture as needed per PI discretion and PET/CT or CT as clinically indicated throughout the study. Additionally, patients with neurological abnormalities at baseline may undergo MRI of brain throughout the study.
design_group_title: Part 2 (allo CMV-specific CD19-CAR T cells, CMV-MVA vaccine)
design_group_type: Experimental
Sponsor: City of Hope National Medical Center
Collaborators: National Cancer Institute
Drug name mappings:
name: Anti-CD19-CAR CMV-specific CAR-T(City of Hope Medical Center)
lang: EN
name: Multi-peptide CMV-Modified Vaccinia Ankara Vaccine(City of Hope National Medical Center)
lang: EN