Actively Recruiting
CAR-T Cell Therapy, Mosunetuzumab and Polatuzumab for Treatment of Refractory/Relapsed Aggressive Non-Hodgkin's Lymphoma (NHL).
Led by Lazaros Lekakis · Updated on 2025-12-31
22
Participants Needed
1
Research Sites
315 weeks
Total Duration
On this page
Sponsors
L
Lazaros Lekakis
Lead Sponsor
G
Genentech, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
The purpose of this research study is to test if a combination treatment of chimeric antigen receptor (CAR) T-cell therapy, Mosunetuzumab, and Polatuzumab Vedotin will result in tumor reduction.
CONDITIONS
Official Title
CAR-T Cell Therapy, Mosunetuzumab and Polatuzumab for Treatment of Refractory/Relapsed Aggressive Non-Hodgkin's Lymphoma (NHL).
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 80 years
- Histologic diagnosis of specific aggressive lymphomas including diffuse large B cell lymphoma, primary mediastinal B cell lymphoma, transformed follicular lymphoma, high grade B cell lymphoma, mantle cell lymphoma, or Burkitt lymphoma with CD19 positivity
- Lymphoma status must be primary refractory, relapsed after specific chemotherapy regimens, or relapse after autologous stem cell transplantation with at least 3 months since transplant
- At least one measurable lymphoma lesion (nodal lesion ≥1.5 cm or extra-nodal lesion ≥1.0 cm)
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Creatinine clearance ≥ 50 mL/min
- Total Bilirubin less than 1.5 times upper normal limit unless liver infiltration allows higher values with approval
- Left ventricular ejection fraction (LVEF) ≥ 45%
- Oxygen saturation on room air ≥ 94%
- Adequate blood counts: neutrophils >1000/µL, hemoglobin >8 g/dL, lymphocytes >250/µL, platelets >75,000/µL
- No recent transfusions or use of certain blood growth factors within 5 days before eligibility assessment
- Signed informed consent and willingness to comply with study procedures, including hospitalization and invasive procedures
- Female participants must have a negative pregnancy test or confirm menopausal status or previous relevant surgeries
- Both men and women of childbearing potential must agree to use effective contraception during treatment and for at least one year after
You will not qualify if you...
- Diagnosis of certain lymphoma subtypes including EBV+ DLBCL, plasmablastic lymphoma, HHV-8 related disorders, primary CNS lymphoma, and others
- Secondary CNS lymphoma involvement or conditions increasing CNS toxicity risk such as active seizures, demyelinating diseases, recent stroke, neurodegenerative disorders, cerebral edema, or hydrocephalus
- History of invasive sarcoma or carcinoma within last 3 years except certain skin or cervical cancers
- Recent myocardial infarction, unstable angina, or coronary procedures within 6 months
- Uncontrolled systemic hypertension (≥160/100 despite treatment)
- Uncontrolled invasive infections including certain fungal infections or viral viremia unless treated
- History of macrophage activation syndrome or chronic active Epstein Barr Virus infection
- HIV infection with viral load ≥ 200 copies/µL or without antiretroviral therapy
- Uncontrolled or untreated hepatitis B or C infections
- Autoimmune disorders requiring significant treatment or affecting lungs
- Other immunodeficiencies beyond common variable immunodeficiency or IgA deficiency
- Presence of external drains such as pericardial or pleural drains
- Use of prednisone >10 mg/day or other systemic immunosuppressants
- Recent use of biologics, chemotherapy, or radiation within specified timeframes prior to study drugs
- Presence of anti-HLA antibodies causing platelet transfusion refractoriness
- Use of systemic antiplatelet or anticoagulant therapy that cannot be stopped
- Cardiac disease causing symptoms or functional impairment beyond LVEF <45%
- Previous anti-CD19 CAR-T therapy
- Uncontrolled psychosis or cognitive impairment preventing informed consent
- Previous solid organ transplantation precluding participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of Miami
Miami, Florida, United States, 33136
Actively Recruiting
Research Team
R
Robby Friedman
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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