Actively Recruiting
A Phase I Study of Bivalent CD79b and CD19 Directed CAR T Cells in Patients With Relapsed/Refractory Non-Hodgkin Lymphoma
Led by Marcela V. Maus, M.D.,Ph.D. · Updated on 2026-03-16
24
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating CD79b-19 CAR T cells as a treatment for people with relapsed or refractory Non-Hodgkin Lymphoma. This Phase 1 study aims to assess the safety and side effects of this investigational therapy, which uses the patient's own immune cells to target cancer. The study includes patients with various subtypes of Non-Hodgkin Lymphoma who have previously undergone multiple treatments. The research is conducted in two parts: dose escalation to find the safe maximum dose and dose expansion to treat more participants at that dose. Participants will undergo leukapheresis to collect white blood cells about three weeks before treatment. They will then receive chemotherapy with fludarabine and cyclophosphamide for three days to prepare their body for the CAR T cell infusion. On day 0, participants receive a single intravenous infusion of CD79b-19 CAR T cells, with the dose depending on earlier participant tolerability. The infusion lasts about one hour. After treatment, participants will be monitored regularly for up to two years. During the study, participants will have evaluations and follow-up visits to assess their health and response to treatment. Researchers will monitor for adverse events and dose-limiting toxicities over the two-year period. They will also track outcomes such as overall response, survival, and progression-free survival at multiple intervals. Participants must meet specific health and laboratory criteria to join and will be closely observed for safety and treatment effects throughout the study.
CONDITIONS
Brief Title
CD79b-19 CAR T Cells in Non-Hodgkin Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily sign informed consent form(s)
- 18 years of age or older at the time of signing informed consent
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2 (Karnofsky 60%)
- Histologically or cytologically confirmed relapsed/refractory Non-Hodgkin Lymphoma of specific subtypes including Follicular Lymphoma grades 1-3a, Marginal Zone Lymphoma, Diffuse Large B-cell lymphoma and related types, Mantle Cell Lymphoma
- Relapsed or refractory disease after 2 or more prior systemic therapy lines or specific transplant status as detailed
- Measurable disease according to appropriate criteria
- Adequate absolute lymphocyte count (>100 cells/ul) within one week of apheresis
- Adequate bone marrow function with specific neutrophil and platelet counts
- Left ventricular ejection fraction greater than 40%
- Adequate liver function with AST and ALT less than 2.5 times upper limit normal and direct bilirubin less than 1.5 times upper limit normal
- Adequate kidney function with creatinine clearance greater than 60 ml/min
- Use of adequate contraception for women of childbearing potential and men with partners of childbearing potential prior to leukapheresis and for specified periods after infusion
- Ability and willingness to follow study visit schedule and protocol requirements
- No active, uncontrolled infections at treatment initiation
- No additional anti-cancer therapy since leukapheresis excluding low-dose steroids
- Meeting criteria to start lymphodepletion and cell infusion as detailed
You will not qualify if you...
- Treatment with investigational cellular therapy within 8 weeks prior to leukapheresis
- Systemic anti-cancer therapy within 1 week or 5 half-lives before leukapheresis excluding low-dose steroids
- Use of bispecific T cell engagers or bendamustine within 6 months of leukapheresis
- Ongoing treatment with chronic immunosuppressants beyond allowed steroids
- Systemic immunosuppression for graft versus host disease within 12 weeks of prior allogeneic SCT
- Presence of active central nervous system disease
- Significant co-morbid conditions such as cirrhotic liver disease, sepsis, or recent trauma
- Active, uncontrolled systemic infections
- History of severe heart failure or certain cardiac conditions within the last 3 months
- History of arterial vascular disease requiring therapeutic anticoagulation
- Recent pulmonary embolism or deep vein thrombosis requiring anticoagulation
- Second malignancies requiring recent therapy or not in remission except certain skin or prostate cancers
- Pregnant or breastfeeding women
- Prior CD19-directed cellular therapy for Part B, Arm B.2 participants
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)
Duration - Approximately 3 weeks
Participants undergo leukapheresis to collect white blood cells approximately 3 weeks before treatment, followed by lymphodepletion chemotherapy over 3 days to prepare the body for CAR T cell infusion.
Multiple visits during Week -3 and Days -5 to -3
Duration - 1 day
Participants receive one intravenous infusion of CD79b-19 CAR T cells on Day 0 as the investigational treatment for Non-Hodgkin Lymphoma.
1 infusion visit (in-person)
Duration - Up to 2 years
Participants are monitored for safety, adverse events, and treatment response through scheduled follow-up visits up to 2 years after treatment.
Scheduled visits at 1 month, 6 months, 12 months, and 24 months post-treatment
Trial Site Locations
Total: 1 location
1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
Research Team
M
Matthew Frigault, MD
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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