OncoMatch/Clinical Trials/NCT06026319
CD79b-19 CAR T Cells in Non-Hodgkin Lymphoma
Official title: A Phase I Study of Bivalent CD79b and CD19 Directed CAR T Cells in Patients With Relapsed/Refractory Non-Hodgkin Lymphoma
Is NCT06026319 recruiting? Yes, currently enrolling (Oct 2026). This Phase 1 trial studies multiple treatments including CD79b-19 CAR T cells and Cyclophosphamide for non-hodgkin lymphoma.
Treatment: CD79b-19 CAR T cells · Cyclophosphamide · Fludarabine — This research study involves the study of CD79b-19 CAR T cells for treating people with relapsed/refractory Non-Hodgkin Lymphoma and to understand the side effects when treated with CD79b-19 CAR T cells. This research study involves the study drugs: * CD79b-19 CAR T cells * Fludarabine and Cyclophosphamide: Standardly used chemotherapy drugs as part of lymphodepleting process
Check if I qualifyExtracted eligibility criteria
Treatments studied
Chemotherapy
Other
Cancer type
Non-Hodgkin Lymphoma
Diffuse Large B-Cell Lymphoma
Biomarker criteria
Allowed: TP53 mutation
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: systemic therapy — Follicular Lymphoma (grade 1, 2, 3a); Marginal Zone Lymphoma (nodal or extranodal)
R/R disease after 2 or more prior lines of systemic therapy
Must have received: systemic therapy — Diffuse Large B-Cell Lymphoma (including transformed FL, PMBCL, HGBCL, grade 3b FL)
R/R disease after 2 or more prior lines of therapy OR Relapsed following autologous SCT, OR Ineligible for autologous SCT
Must have received: systemic therapy — Mantle Cell Lymphoma
R/R disease as defined by disease progression after last regimen (including autologous SCT) OR Refractory disease as defined as failure to achieve a CR to last regimen
Must have received: anthracycline or bendamustine-containing chemotherapy — Mantle Cell Lymphoma
prior therapy may include: Anthracycline or bendamustine-containing chemotherapy
Must have received: anti-CD20 monoclonal antibody therapy — Mantle Cell Lymphoma
prior therapy may include: Anti-CD20 monoclonal antibody therapy
Must have received: BTK inhibitor — Mantle Cell Lymphoma
prior therapy may include: BTKi therapy (progression does not have to be documented on BTKi)
Must have received: zanubrutinib/obinutuzumab/venetoclax (BOVen) (zanubrutinib, obinutuzumab, venetoclax) — Mantle Cell Lymphoma with TP53 mutation
For patients with TP53 mutations, prior therapy may include: Prior therapy with BOVen (zanubrutinib, obinutuzumab, and venetoclax)
Cannot have received: chronic immunosuppressants
Exception: intermittent topical, inhaled, or intranasal corticosteroids are allowed
Ongoing treatment with chronic immunosuppressants (e.g., cyclosporine or systemic steroids above physiologic dosing). Intermittent topical, inhaled, or intranasal corticosteroids are allowed.
Cannot have received: systemic immunosuppression for acute and/or chronic GVH
Exception: at least 12 weeks out from prior allogeneic SCT
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.
Cannot have received: CD19-directed cellular therapy
Prior CD19-directed cellular therapy.
Lab requirements
Blood counts
ALC > 100 cells/ul within one week of apheresis; ANC >1000 cells/mm3 without growth factor support; untransfused platelet count >50,000 mm3
Kidney function
creatinine clearance >60 ml/min using the Cockcroft-Gault formula
Liver function
AST and ALT < 2.5 × ULN and direct bilirubin < 1.5 × ULN
Cardiac function
Left ventricular ejection fraction > 40%
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.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Massachusetts General Hospital · Boston, Massachusetts
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT06026319 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior chronic immunosuppressants, systemic immunosuppression for acute and/or chronic GVH, CD19-directed cellular therapy disqualifies patients from enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
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