OncoMatch/Clinical Trials/NCT06357676
Glofitamab Plus Ibrutinib With Obinutuzumab for the Treatment of Patients With Mantle Cell Lymphoma, IGNITE MCL Trial
Is NCT06357676 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1/2 trial studies multiple treatments including Glofitamab and Obinutuzumab for mantle cell lymphoma.
Treatment: Glofitamab · Ibrutinib · Obinutuzumab — This phase IB/II trial tests the safety, side effects and effectiveness of glofitamab plus ibrutinib with obinutuzumab for the treatment of patients with mantle cell lymphoma (MCL). Glofitamab is in a class of medications called bispecific monoclonal antibodies. It works by killing cancer cells. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). In the body, glofitamab binds to a receptor called CD3 on T-cells (a type of immune cells) and a receptor called CD20 on B-cells, a receptor that is often over-expressed on the surface of cancerous B-cells. When glofitamab binds to CD3 and CD20 receptors, it causes an immune response against the CD20-expressing cancerous B-cells. Ibrutinib is in a class of medications called kinase inhibitors. It works by blocking the action of the abnormal protein that signals cancer cells to multiply. This helps stop the spread of cancer cells. Obinutuzumab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Glofitamab plus ibrutinib with obinutuzumab may be safe tolerable and/or effective in treating patients with MCL.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Targeted therapy
Cancer type
Non-Hodgkin Lymphoma
Biomarker criteria
Required: CCND1 overexpression
overexpression of cyclin D1 in association with other relevant markers
Required: CCND1 t(11;14)(q13;q32)
chromosome translocation t(11;14)(q13;q32)
Required: SOX11 overexpression
Cyclin D1 negative or t(11,14) negative/SOX 11 positive MCL patients can be enrolled if eligibility criteria are otherwise satisfied
Required: TP53 aberration (mutation[s] by next generation sequencing [NGS] and/or 17p deletion)
High risk mutational variants including p53 aberrations (mutation[s] by next generation sequencing [NGS] and/or 17p deletion)
Required: KMT2D mutation
High risk mutational variants including ... KMT2D
Required: NSD2 mutation
High risk mutational variants including ... NSD2
Required: NOTCH1 mutation
High risk mutational variants including ... NOTCH1
Required: CDKN2A mutation
High risk mutational variants including ... CDKN2A
Required: NOTCH2 mutation
High risk mutational variants including ... NOTCH2
Required: SMARCA4 mutation
High risk mutational variants including ... SMARCA4
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Lab requirements
Blood counts
ANC ≥ 1.0 × 10^9/L independent of growth factor support; Platelets ≥ 100 × 10^9/L (≥ 50 × 10^9/L if bone marrow involvement), independent of transfusion support
Kidney function
Estimated creatinine clearance ≥ 50 mL/min by Cockcroft Gault method
Liver function
ALT and AST ≤ 3 × ULN; total bilirubin ≤ 1.5 × ULN (unless due to Gilbert's syndrome or of non hepatic origin)
ANC ≥ 1.0 × 10^9/L independent of growth factor support; Platelets ≥ 100 × 10^9/L (≥ 50 × 10^9/L if bone marrow [BM] involvement), independent of transfusion support in either situation; ALT and AST ≤ 3 × ULN; total bilirubin ≤ 1.5 × ULN (unless due to Gilbert's syndrome or of non hepatic origin); Estimated creatinine clearance ≥ 50 mL/min by Cockcroft Gault method
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- OHSU Knight Cancer Institute · Portland, Oregon
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT06357676 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Does this trial require CCND1?
Yes, CCND1 overexpression is a required biomarker for enrollment.
Does this trial require CCND1?
Yes, CCND1 t(11;14)(q13;q32) is a required biomarker for enrollment.
Does this trial require SOX11?
Yes, SOX11 overexpression is a required biomarker for enrollment.
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