OncoMatch/Clinical Trials/NCT06558604
Phase II Study of Glofitamab With Venetoclax +/- Zanubrutinib in High-risk Mantle-cell Lymphoma
Is NCT06558604 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Obinutuzumab and Glofitamab for lymphoma, mantle-cell.
Treatment: Obinutuzumab · Glofitamab · Venetoclax Oral Product · Zanubrutinib Oral Capsule — This open-label, multicenter, three cohorts, phase II study is designed to assess a combination of Zanubrutinib/Venetoclax/Glofitamab or Venetoclax/Glofitamab in high-risk subjects with either first line or R/R Mantle Cell Lymphoma (MCL). Three independent cohorts will be run: * Cohort A will include subjects with a primary refractory or progressive disease within 24 months from initiation of first line treatment (POD 24). * Cohort B will be open for subjects with R/R MCL and refractory or progressive to a BTK inhibitor given previously (\>24 months if first line). * Cohort C will only enrol newly diagnosed and untreated MCL subjects with very high-risk features.
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Hodgkin Lymphoma
Biomarker criteria
Allowed: TP53 mutation
TP53 mutation, del17p, or p53 expression (IHC) > 50%
Allowed: TP53 deletion
TP53 mutation, del17p, or p53 expression (IHC) > 50%
Allowed: TP53 p53 expression (IHC) > 50%
TP53 mutation, del17p, or p53 expression (IHC) > 50%
Allowed: MYC rearrangement
c-myc rearrangement (FISH)
Disease stage
Required: Stage II, III, IV
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: bispecific antibody targeting CD3 and CD20
Any prior therapy with a bispecific antibody targeting CD3 and CD20.
Lab requirements
Blood counts
ANC ≥ 1000/mm3 (≥ 500/mm3 if bone marrow involvement); Platelet ≥ 75,000/mm3 (≥ 50,000/mm3 if bone marrow involvement); Hemoglobin ≥ 8g/dL
Kidney function
creatinine clearance > 30 mL/min (Cockcroft Gault or MDRD formula)
Liver function
AST and ALT ≤ 2.5x ULN; Bilirubin < 1.5 x ULN (unless due to Gilbert's syndrome or non-hepatic origin, then < 3 x ULN)
Cardiac function
LVEF ≥ 50%; no significant cardiovascular disease (see exclusion criteria)
Adequate renal function as demonstrated by a creatinine clearance > 30 mL/min... Adequate hepatic function... AST and ALT ≤ 2.5x ULN; Bilirubin < 1.5 x ULN... Adequate bone marrow function... ANC ≥ 1000/mm3... Platelet ≥ 75,000/mm3... Hemoglobin ≥ 8g/dL... LVEF < 50% as determined by echocardiography or isotopic method [excluded].
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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