OncoMatch/Clinical Trials/NCT06558604
Phase II Study of Glofitamab With Venetoclax +/- Zanubrutinib in High-risk Mantle-cell Lymphoma
Is NCT06558604 recruiting? Yes, currently enrolling (Jun 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
Treatments studied
Immunotherapy
Other
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)
Demographics
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.
Frequently asked questions
Is NCT06558604 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior bispecific antibody targeting CD3 and CD20 disqualifies patients from enrollment.
What disease stage is eligible?
Stage II or III or IV is required.
Is there an age limit?
Yes. Patients must be 79 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages