Actively Recruiting
Single Arm Phase 2 Trial of FDA Approved Anti-CD19 CAR-T Therapy Followed by Mosunetuzumab and Polatuzumab for Refractory/Relapsed Aggressive Non-Hodgkin's Lymphoma
Led by Lazaros Lekakis · Updated on 2025-12-31
22
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
Sponsors
L
Lazaros Lekakis
Lead Sponsor
G
Genentech, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating a combination treatment involving CAR-T Cell therapy, Mosunetuzumab, and Polatuzumab Vedotin for patients with refractory or relapsed aggressive Non-Hodgkin's Lymphoma (NHL). This phase 2 trial aims to see if this combination can reduce tumors in adults with specific types of aggressive NHL who have not responded to or have relapsed after prior treatments. Participants receive the study treatment in three phases: an Induction Phase where Mosunetuzumab and Polatuzumab are given on scheduled days before CAR-T therapy; a CAR-T Treatment Phase involving lymphodepleting chemotherapy followed by an infusion of CAR-T cells; and a Consolidation Phase where Mosunetuzumab alone and then combined with Polatuzumab are administered at specified intervals after CAR-T therapy. Each drug is given via intravenous infusion at doses and days outlined by the protocol. During the study, participants will have regular clinic evaluations, laboratory tests, and imaging studies to monitor tumor response and treatment effects. Researchers will measure tumor response rates at 3 months and follow participants for up to 2 years to assess overall survival, disease progression, and treatment-related toxicities. Safety and side effects will be closely monitored throughout the study and follow-up periods, with total participation lasting until the final assessments are completed.
CONDITIONS
Brief 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 B-cell 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 of primary refractory or relapsed disease failing prior chemotherapy regimens or relapse after autologous stem cell 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
- Adequate organ function including creatinine clearance ≥50 mL/min, bilirubin and liver enzymes within defined limits, left ventricular ejection fraction ≥45%, and oxygen saturation ≥94% on room air
- Minimum blood counts on screening day: absolute neutrophil count >1000/microliter, hemoglobin >8 g/dL, absolute lymphocyte count >250/microliter, platelet count >75,000/microliter
- No recent transfusions or growth factor treatments within 5 days prior to eligibility assessment
- Signed informed consent and willingness to comply with study procedures
- Female participants must have a negative pregnancy test or confirm menopausal status
- Agreement to use effective contraception during treatment and for at least 1 year after last treatment
You will not qualify if you...
- Lymphomas with different biology or lack of CD19 including EBV+ DLBCL, plasmablastic lymphoma, primary effusion lymphoma, CNS lymphoma, and others
- Active or recent CNS involvement by lymphoma or conditions increasing CNS toxicity risk such as active seizures, demyelinating diseases, recent stroke, or neurodegenerative disorders
- Recent invasive cancers except certain localized skin and cervical cancers
- Recent myocardial infarction, unstable angina, or coronary revascularization within 6 months
- Uncontrolled hypertension above specified levels
- Uncontrolled invasive infections or certain viral loads unless treated and controlled
- History of macrophage activation syndrome or chronic active Epstein Barr Virus infection
- Prior anti-CD19 CAR-T therapy
- Autoimmune disorders requiring certain immunosuppressive treatments
- Use of prednisone above 10 mg/day or other systemic immunosuppressive agents
- Recent use of biologic agents or chemotherapy conflicting with study drugs within specified time frames
- Presence of anti-HLA antibodies making platelet transfusions ineffective
- Ongoing anticoagulant or antiplatelet therapy not allowed except low dose aspirin under conditions
- Significant cardiac disease causing symptoms or poor heart function beyond defined limits
- Uncontrolled psychosis or cognitive impairment
- Previous solid organ transplantation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for eligibility assessment
Duration - Approximately 6 weeks (Days -42 through -6)
Participants receive Mosunetuzumab and Polatuzumab infusions before CAR-T Cell therapy and are evaluated in clinic.
4 infusions of Mosunetuzumab and 1 infusion of Polatuzumab with clinic evaluation on Day -6
Duration - 6 days (Days -5 through Day 0)
Participants receive lymphodepleting chemotherapy followed by CAR-T Cell therapy infusion.
3 days of chemotherapy infusions and 1 CAR-T Cell therapy infusion
Duration - Approximately 3 months (Days +1 through +90)
Participants receive continued Mosunetuzumab and Polatuzumab infusions after CAR-T therapy to consolidate treatment.
4 infusions of Mosunetuzumab and 3 infusions of Polatuzumab on scheduled days
Trial Site Locations
Total: 1 location
1
University of Miami
Miami, Florida, United States, 33136
Actively Recruiting
Research Team
R
Robby Friedman
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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