OncoMatch/Clinical Trials/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
Is NCT06735690 recruiting? Yes, currently enrolling (May 2026). This Early Phase 1 trial studies multiple treatments including Anti-CD19-CAR CMV-specific T-lymphocytes and Multi-peptide CMV-Modified Vaccinia Ankara Vaccine for acute lymphoblastic leukemia.
Treatment: Anti-CD19-CAR CMV-specific T-lymphocytes · Multi-peptide CMV-Modified Vaccinia Ankara Vaccine — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Lymphoblastic Leukemia
Biomarker criteria
Required: CD19 overexpression (CD19+ by pathology report)
Pathology confirmed CD19+ ALL after the last targeted therapy if the patient has active disease or before the last therapy if the patient is in CR
Lab requirements
Kidney function
Serum creatinine ≤ 2.5 x ULN or estimated creatinine clearance of ≥ 40 mL/min per Cockcroft-Gault, not on hemodialysis
Liver function
Total serum bilirubin ≤ 2.0 mg/dL (≤ 3.0 mg/dL if Gilbert syndrome); AST < 2.5 x ULN; ALT < 2.5 x ULN
Cardiac function
QTc ≤ 480 msec; LVEF ≥ 45%
Total serum bilirubin ≤ 2.0 mg/dL (to be performed no more than 45-days prior to hematopoeitic stem cell [HSC] infusion unless otherwise stated) Participants with Gilbert syndrome may be included if their total bilirubin is ≤ 3.0 ... Aspartate aminotransferase (AST) < 2.5 x upper limit of normal (ULN) ... Alanine aminotransferase < 2.5 x ULN ... Serum creatinine ≤ 2.5 x ULN or estimated creatinine clearance of ≥ 40 mL/min per the Cockcroft-Gault formula, and the participant is not on hemodialysis ... Cardiac function (12 lead-electrocardiogram [ECG]): Corrected QT interval (QTc) must be ≤ 480 msec ... Left ventricular ejection fraction ≥ 45% within 8 weeks before protocol therapy
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- City of Hope Medical Center · Duarte, California
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