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
Eligible age
18+ yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
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About this study
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.
Sponsor: City of Hope Medical Center
You may qualify if…
- ✓ Documented informed consent of the participant and/or legally authorized representative
- ✓ Assent, when appropriate, will be obtained per institutional guidelines
- ✓ Agreement to allow the use of archival tissue from diagnostic tumor biopsies
- ✓ If unavailable, exceptions may be granted with study PI approval
- ✓ Note: For research participants who do not speak English, a short form consent may be used with a City of Hope (COH) certified interpreter/translator to proceed with screening and leukapheresis, while the request for a translated full consent is processed
- ✓ Age: ≥ 18 years
- ✓ Karnofsky performance status (KPS) ≥ 70
- ✓ Participants with high-risk ALL defined as:
You may not qualify if…
- ✕ Concurrent use of systemic steroids. Recent or current use of inhaled or topical steroids in standard doses is not exclusionary. Physiologic replacement of steroids (prednisone ≤ 0.5 mg /day, or equivalent doses of other corticosteroids) is allowed
- ✕ Participants with active autoimmune disease requiring systemic immune suppressive therapy are not allowed
- ✕ Any contraindications to standard conditioning transplant regimens per standard of care practices at COH
- ✕ Subjects with clinically significant arrhythmia or arrhythmias not stable on medical management within two weeks of screening
- ✕ History or prior diagnosis of other immunologic or inflammatory disease affecting the central nervous system (CNS), including uncontrolled seizure disorder, any measurable masses of CNS, or any other active CNS disease. Note: Research participants with a history of CNS disease that has been effectively treated to complete remission (\< 5 white blood cells \[WBC\]/mm\^3 and no blasts in CSF) will be eligible
- ✕ Participants should not have any uncontrolled illness including symptomatic congestive heart failure, unstable angina pectoris, poorly controlled pulmonary disease, or psychiatric illness/social situations that would limit compliance with study requirements
- ✕ History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agent
- ✕ History of stroke or intracranial hemorrhage within 3 months prior to screening
Where it's recruiting
Duarte
Source: ClinicalTrials.gov · NCT06735690 · last updated 2026-04-27