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New treatment option for High Grade B-Cell Non-Hodgkin's Lymphoma
Official title Genetically Modified T-cells (CMV-Specific CD19-CAR T-cells) Plus a Vaccine (CMV-MVA Triplex) for the Treatment of Intermediate or High Grade B-Cell Non-Hodgkin Lymphoma
ClinicalTrials.gov ID: NCT05801913
What this study is testing
What is Anti-CD19-CAR CMV-specific T-lymphocytes?
Anti-CD19-CAR CMV-specific T-lymphocytes is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for high grade b-cell non-hodgkin's lymphoma.
Also referred to as Anti-CD19-CAR CMV-specific T-cells, CMV-specific CD19 CAR-T Cells.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This phase I trial studies the safety and feasibility of cytomegalovirus (CMV) specific CD19-chimeric antigen receptor (CAR) T cells in combination with the CMV-modified vaccinia Ankara (MVA) triplex vaccine following lymphodepletion in treating patients with intermediate or high grade B-cell non-Hodgkin lymphoma (NHL) that has come back after a period of improvement (relapsed) or that does not respond to treatment (refectory). CAR T cells are a type of treatment in which a patient's T cells (a type of immune system cell) are changed in the laboratory so they will attack cancer cells.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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 principal investigator (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...
You likely can't join if
- Prior allogeneic stem cell transplant unless the participant has recovered from transplantation and does not have active graft versus host disease...
- Growth factors within 14 days of enrollment
- Platelet transfusions within 7 days of enrollment
- Concurrent use of systemic steroids or chronic use of immunosuppressant medications. Recent or current use of inhaled or topical steroids in standard...
- Patients with active autoimmune disease requiring systemic immune suppressive therapy are not allowed
- Participants may not be receiving any other investigational agents or concurrent biological therapy, chemotherapy, or radiation therapy
See the full eligibility criteria
Who can join
- 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 principal investigator (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...
- Age: \>= 18 years
- Karnofsky Performance Status (KPS) \>= 70
- Life expectancy \>= 16 weeks at the time of enrollment
- Patients requiring treatment for relapsed or refractory intermediate or high-grade B cell NHL (e.g., diffuse large B-cell lymphoma [DLBCL], mantle cell lymphoma [MCL], or transformed NHL) who are not eligible for, or...
- Note: COH pathology review should confirm that research participant's diagnostic material is consistent with history of intermediate or high-grade CD19+ malignancy
- No known contraindications to leukapheresis, lymphodepleting chemotherapy, steroids or tocilizumab, smallpox vaccine and any other MVA-based vaccines
- Patient must be CMV seropositive
- Total serum bilirubin =\< 2.0 mg/dL
- 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 (ALT) \< 2.5 x ULN
- Serum creatinine =\ = 40 mL/min per the Cockcroft-Gault formula, and the participant is not on hemodialysis
- Absolute neutrophil count \>= 1000/uL (Transfusions and growth factors must not be used to meet these requirements at initial screening)
- Hemoglobin (Hb) \>= 8 g/dl (Transfusions and growth factors must not be used to meet these requirements at initial screening)
- Platelet count \>= 50,000/uL (\>= 30,000/uL if bone marrow plasma cells are \>= 50% of cellularity) (Transfusions and growth factors must not be used to meet these requirements at initial screening)
- Left ventricular ejection fraction \>= 45% within 8 weeks before enrollment
- Oxygen (O2) saturation \> 92% without requiring supplemental oxygen
- Women of childbearing potential (WOCBP): negative urine or serum pregnancy test
- If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
- Agreement by females and males of childbearing potential to use an effective method of birth control or abstain from heterosexual activity for the course of the study through at least 6 months after the last dose of...
- Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \> 1 year (women only)
What rules you out
- Prior allogeneic stem cell transplant unless the participant has recovered from transplantation and does not have active graft versus host disease (GVHD)
- Growth factors within 14 days of enrollment
- Platelet transfusions within 7 days of enrollment
- Concurrent use of systemic steroids or chronic use of immunosuppressant medications. Recent or current use of inhaled or topical steroids in standard doses is not exclusionary. Physiologic replacement of steroids...
- Patients with active autoimmune disease requiring systemic immune suppressive therapy are not allowed
- Participants may not be receiving any other investigational agents or concurrent biological therapy, chemotherapy, or radiation therapy
- Any standard contraindications to lymphodepleting chemotherapy and/or CAR T-cell therapy per standard of care practices at COH
- people with clinically significant arrhythmia or arrhythmias not stable on medical management within two weeks of screening
- people with a known history or prior diagnosis of optic neuritis or other immunologic or inflammatory disease affecting the central nervous system (CNS), including seizure disorder, any measurable masses of CNS, or any...
- Note: Research participants with a history of CNS disease that has been effectively treated to complete remission (\< 5 white blood cell [WBC]/mm\^3 and no blasts in cerebral spinal fluid [CSF]) will be eligible
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agents or cetuximab
- Known bleeding disorders (e.g., von Willebrand's disease) or hemophilia
- History of stroke or intracranial hemorrhage within 6 months prior to screening
- History of other malignancies, except for malignancy surgically resected (or treated with other modalities) with curative intent, basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin...
- Clinically significant uncontrolled illness
- Active infection requiring antibiotics
- Immunodeficiency virus (human immunodeficiency virus [HIV]) positive
- Active viral hepatitis
- Females only: Pregnant or breastfeeding
- Any other condition that would, in the investigator's judgment, contraindicate the subject's participation in the clinical study due to safety concerns with clinical study procedures
- Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)
The study team makes the final eligibility decision.
Where it's taking place
- Duarte, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Duarte, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.