CD79b-19 CAR T Cells for Relapsed/Refractory Non-Hodgkin Lymphoma
This study is testing a new treatment called CD79b-19 CAR T cells for people with Non-Hodgkin Lymphoma that has come back or not responded to previous treatments (relapsed/refractory). This treatment uses your own immune cells (T cells) to fight cancer. Before receiving the CD79b-19 CAR T cells, you will also receive standard chemotherapy drugs, fludarabine and cyclophosphamide. Researchers want to see how safe this new treatment is and what side effects it might cause. They will also look at how well participants tolerate different doses. The study plans to enroll 24 participants aged 18 or older who meet specific health criteria. This is the first time CD79b-19 CAR T cells will be given to humans, and it is not yet approved by the FDA.
- Study design
- This is a single-site, open-label study without a comparison group, divided into two parts to find the safest dose and then expand treatment at that dose. It plans to enroll 24 participants.
- What's involved
- You would voluntarily sign consent forms, undergo screening for eligibility, receive the study treatment, and attend evaluations and follow-up visits.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for adverse events and dose-limiting toxicities from the start of treatment up to 2 years after treatment.
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NCT06026319
CD79b-19 CAR T Cells in Non-Hodgkin Lymphoma
Recruiting
PHASE1Ages 18+InterventionalTreatmentMarcela V. Maus, M.D.,Ph.D.Investigator-initiated
~24 participants
Updated 2026-03-16 on ClinicalTrials.gov
What's tested:CD79b-19 CAR T cellsCyclophosphamideFludarabine
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of adverse events (AEs)
Measured over From Day 0 to 2 years post-treatment
+1 more outcome measured
Conditions
Where it's being run
1 sites across 1 statesMassachusetts1
Study leadership
- Matthew Frigault, MD · PRINCIPAL_INVESTIGATOR · Massachusetts General Hospital
Who to contact
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Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
Voluntarily sign informed consent form(s)
≥18 years of age at the time of signing informed consent
Eastern Cooperative Oncology Group (ECOG) performance status 0-2 (Karnofsky ≥60%, see Appendix A)
Diagnosis of histologically or cytologically confirmed relapsed/refractory (R/R) Non Hodgkins lymphoma as defined as one of the following (Note: only patients with indolent lymphomas that warrant treatment should be treated, this will include those with local symptoms due to progressive/bulky disease, compromised organ function, B symptoms, extra-nodal disease, cytopenias from marrow involvement and/or in the opinion of the treating physician believe that any of the above symptoms or potentially life threatening involvement will occur will be treated):
Anthracycline or bendamustine-containing chemotherapy AND
Anti-CD20 monoclonal antibody therapy AND
BTKi therapy (progression does not have to be documented on BTKi).
Subjects must have measurable disease according to appropriate disease specific criteria.
Adequate absolute lymphocyte count (ALC \> 100 cells/ul) within one week of apheresis.
Adequate bone marrow function defined by absolute neutrophil count (ANC) \>1000 cells/mm3 without growth factor support (filgrastim within 7 days or pegfilgrastim within 14 days) and untransfused platelet count \>50,000 mm3.
Left ventricular ejection fraction \> 40%
Adequate hepatic function defined by aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \< 2.5 × upper limit of normal (ULN) and direct bilirubin \< 1.5 × ULN.
Adequate renal function defined by creatinine clearance \>60 ml/min using the Cockcroft-Gault formula.
The effects of CD79b-19 CAR T cells on the developing human fetus are unknown. For this reason, women of child-bearing potential and men with partners of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to leukapheresis. Women of childbearing potential are required to use adequate contraception for up to 1 year post CD79b-19 CAR T cell infusion. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men with partners of childbearing potential treated or enrolled on this protocol must also agree to use adequate contraception prior to the study and until 6 months after last CD79b-19 CAR T cells administration.
Ability and willingness to adhere to the study visit schedule and all protocol requirements
Eastern Cooperative Oncology Group (ECOG) performance status 0-2 (Karnofsky ≥60%, see Appendix A)
No active, uncontrolled, systemic bacterial, viral, or fungal infection. If febrile, the patient must have negative blood cultures x48 hours at time of cell infusion AND on appropriate broad spectrum antibiotic therapy
Oxygen saturation \>92% on room air while awake
No additional anti-cancer therapy since leukapheresis excluding steroids at or below physiologic dosing.
Exclusion
Treatment with an any investigational cellular therapy within 8 weeks prior to apheresis.
Any systemic anti-cancer therapy within 1 weeks or 5 half-lives of leukapheresis, whichever is shortest, excluding steroids (prednisone) at or below physiologic dosing (5mg).
No bispecific T cell engagers within 6 months of leukapheresis.
No bendamustime within 6 months of leukapheresis.
Ongoing treatment with chronic immunosuppressants (e.g., cyclosporine or systemic steroids above physiologic dosing). Intermittent topical, inhaled, or intranasal corticosteroids are allowed.
Ongoing systemic immunosuppression for acute and/or chronic GVH as a result of previous allogeneic bone marrow transplant and at least 12 weeks out from prior allogeneic SCT.
Presence of active CNS disease
Significant co-morbid condition or disease which in the judgment of the Principal Investigator would place the subject at undue risk or interfere with the study; examples include, but are not limited to, cirrhotic liver disease, sepsis, and/or recent significant traumatic injury.
Active, uncontrolled, systemic bacterial, viral, or fungal infection.
Subjects with a history of class III or IV congestive heart failure or with a history of non- ischemic cardiomyopathy.
Subjects with unstable angina, myocardial infarction, or ventricular arrhythmia requiring medication or mechanical control within the previous 3 months.
Subjects with arterial vascular disease such as history of cerebrovascular accident or peripheral vascular disease requiring therapeutic anti-coagulation.
Subjects with history of a new pulmonary embolism (PE) /deep vein thrombosis (DVT) within 6 months of beginning lymphodepletion requiring ongoing anticoagulation.
Subjects with second malignancies if the second malignancy has required therapy in the last 3 years or is not in complete remission; exceptions to this criterion include successfully treated non-metastatic basal cell or squamous cell skin carcinoma, or prostate cancer that does not require therapy other than hormonal therapy.
Pregnant or lactating women. Pregnant women are excluded from this study because CAR-79b-19 T cell drug product is an agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with CAR-79b-19 T cell drug product, breastfeeding should be discontinued if the mother is treated with CAR-79b-19 T cell drug product.
Prior CD19-directed cellular therapy.
What this trial measures
- Incidence of adverse events (AEs)From Day 0 to 2 years post-treatment
Study-related adverse events (AEs) will be listed and tabulated by type and study cohort. The rate of AEs in all infused patients, both within study cohorts and overall, will be calculated and reported with exact 95% confidence intervals. A separate safety analysis will report similar information within patients infused at the target dose of 1x108 or 3x108 CD79b-19 CAR T cells.
- Incidence of Dose Limiting Toxicity (DLT)From Day 0 to 2 years post-treatment
Dose-limiting toxicities will be listed and tabulated by type and study cohort.