OncoMatch/Clinical Trials/NCT06558604
Phase II Study of Glofitamab With Venetoclax +/- Zanubrutinib in High-risk Mantle-cell Lymphoma
Is NCT06558604 recruiting? Yes, currently enrolling (Sep 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
Required: TP53 mutation
TP53 mutation, del17p, or p53 expression (IHC) > 50%
Required: TP53 deletion
TP53 mutation, del17p, or p53 expression (IHC) > 50%
Required: TP53 expression (>50%)
TP53 mutation, del17p, or p53 expression (IHC) > 50%
Required: 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; calculated by Cockcroft Gault or MDRD formula
Liver function
AST and ALT ≤ 2.5x ULN; Bilirubin < 1.5 x ULN (unless Gilbert's syndrome or non-hepatic origin, then < 3 x ULN)
Cardiac function
LVEF ≥ 50%; no clinically significant cardiovascular disease; QTc ≤ 480 ms; no Mobitz II or third-degree heart block without pacemaker; controlled hypertension
Adequate renal function as demonstrated by a creatinine clearance > 30 mL/min; Adequate hepatic function per local laboratory reference range as follow (unless if due to lymphoma involvement): AST and ALT ≤ 2.5x ULN; Bilirubin < 1.5 x ULN (unless Gilbert's syndrome or non-hepatic origin, then < 3 x ULN). Adequate bone marrow function as defined by: ANC ≥ 1000/mm3 (≥ 500/mm3 if bone marrow involvement); Platelet ≥ 75,000/mm3 (≥ 50,000/mm3 if bone marrow involvement). 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.
Does this trial require TP53?
Yes, TP53 mutation is a required biomarker for enrollment.
Does this trial require TP53?
Yes, TP53 deletion is a required biomarker for enrollment.
Does this trial require TP53?
Yes, TP53 expression is a required biomarker for 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 qualify