RecruitingEarly Phase 1NCT06735690

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

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


Sponsor

City of Hope Medical Center

Enrollment

15 participants

Start Date

Dec 30, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of a CAR T-cell therapy (immune cells engineered to fight leukemia) plus a specialized vaccine after a stem cell transplant, in patients with high-risk acute lymphoblastic leukemia (ALL) — an aggressive blood cancer. **You may be eligible if...** - You have high-risk acute lymphoblastic leukemia (ALL) - You are receiving a matched related donor stem cell transplant as part of your treatment - You or your legal representative can provide informed consent - Archival tumor tissue is available (or an exception may be granted) **You may NOT be eligible if...** - You are receiving a donor transplant from an unrelated or mismatched donor - You do not have high-risk ALL - Your condition is too unstable to undergo the transplant and follow-on therapy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREAllogeneic Hematopoietic Stem Cell Transplantation

Undergo alloHSCT

BIOLOGICALAnti-CD19-CAR CMV-specific T-lymphocytes

Given IV

PROCEDUREBiospecimen Collection

Undergo blood and optional CSF sample collection

PROCEDUREBone Marrow Aspiration

Undergo bone marrow biopsy and aspiration

PROCEDUREBone Marrow Biopsy

Undergo bone marrow biopsy and aspiration

PROCEDUREComputed Tomography

Undergo CT or PET/CT

PROCEDUREEchocardiography

Undergo ECHO

PROCEDURELeukapheresis

Undergo leukapheresis

PROCEDURELumbar Puncture

Undergo lumbar puncture

PROCEDUREMagnetic Resonance Imaging

Undergo MRI

BIOLOGICALMulti-peptide CMV-Modified Vaccinia Ankara Vaccine

Given IM

PROCEDUREMultigated Acquisition Scan

Undergo MUGA

PROCEDUREPositron Emission Tomography

Undergo PET/CT

OTHERTransplant Conditioning

Given HSCT conditioning regimen

PROCEDUREX-Ray Imaging

Undergo chest x-ray


Locations(1)

City of Hope Medical Center

Duarte, California, United States

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NCT06735690


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