Actively Recruiting
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
Led by City of Hope Medical Center · Updated on 2026-04-27
15
Participants Needed
1
Research Sites
166 weeks
Total Duration
On this page
Sponsors
C
City of Hope Medical Center
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant or legally authorized representative provides documented informed consent
- Assent obtained when appropriate per institutional guidelines
- Agreement to allow use of archival tissue from diagnostic tumor biopsies or exception approved by study PI
- Age 18 years or older
- Karnofsky performance status (KPS) of 70 or higher
- High-risk acute lymphoblastic leukemia (ALL) defined by: any complete remission with minimal residual disease positive at HSCT, blasts 5% or more at transplant, complete response 2 or higher, or requiring more than one regimen to achieve first complete remission
- Pathology confirmed CD19 positive ALL
- Planned allogeneic hematopoietic stem cell transplant (myeloablative or reduced intensity) with available 8/8 HLA allele-matched related donor
- Prior CAR T therapy allowed
- No contraindications to HSCT, leukapheresis, steroids, tocilizumab, smallpox vaccine or MVA-based vaccines
- Total serum bilirubin 2.0 mg/dL or less (up to 3.0 mg/dL allowed for Gilbert syndrome)
- Aspartate aminotransferase (AST) less than 2.5 times upper limit of normal
- Alanine aminotransferase less than 2.5 times upper limit of normal
- Serum creatinine 2.5 times upper limit of normal or less or estimated creatinine clearance at least 40 mL/min; not on hemodialysis
- Corrected QT interval 480 msec or less
- Left ventricular ejection fraction 45% or greater
- Oxygen saturation above 92% without supplemental oxygen
- Negative tests for HIV, hepatitis C and B, syphilis, COVID-19, human herpes virus-6, and tuberculosis
- Women of childbearing potential must have negative pregnancy test and agree to use effective birth control or abstain from heterosexual activity during study and 6 months after last dose
- Donor must be original stem cell donor, CMV seropositive, negative for hepatitis B surface antigen and hepatitis C antibody or PCR negative, HIV negative, KPS 70 or higher, and willing to undergo leukapheresis
- Donor screening per FDA and institutional guidelines including testing for EBV, HHV6, HHV7, HHV8, parvovirus B19, and COVID-19
You will not qualify if you...
- Use of systemic steroids currently or recently (physiologic replacement doses allowed)
- Active autoimmune disease requiring systemic immune suppressive therapy
- Contraindications to standard conditioning transplant regimens
- Clinically significant or unstable arrhythmias within two weeks
- History of immunologic or inflammatory CNS disease, uncontrolled seizures, or active CNS disease (except effectively treated CNS disease in remission)
- Uncontrolled illnesses including symptomatic heart failure, unstable angina, poorly controlled lung disease, or psychiatric/social situations limiting compliance
- History of allergic reactions to similar compounds to study agents
- Stroke or intracranial hemorrhage within 3 months
- Known bleeding disorders such as von Willebrand's disease or hemophilia
- Active viral hepatitis
- History of malignancies except certain treated cancers with no active disease for 2 years
- Clinically significant uncontrolled illness
- Active infection not responding to antibiotics
- Pregnant or breastfeeding females
- Any condition that contraindicates participation due to safety concerns
- Inability to comply with study procedures as judged by investigator
AI-Screening
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Trial Site Locations
Total: 1 location
1
City of Hope Medical Center
Duarte, California, United States, 91010
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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