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 (May 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
Cancer type
Non-Hodgkin Lymphoma
Biomarker criteria
Allowed: CCND1 overexpression
overexpression of cyclin D1 in association with other relevant markers
Allowed: CCND1 t(11;14)(q13;q32)
chromosome translocation t(11;14)(q13;q32)
Allowed: SOX11 overexpression
SOX 11 positive MCL patients can be enrolled if eligibility criteria are otherwise satisfied
Allowed: TP53 aberration
High risk mutational variants including p53 aberrations (mutation[s] by next generation sequencing [NGS] and/or 17p deletion)
Allowed: KMT2D mutation
High risk mutational variants including ... KMT2D
Allowed: NSD2 mutation
High risk mutational variants including ... NSD2
Allowed: NOTCH1 mutation
High risk mutational variants including ... NOTCH1
Allowed: CDKN2A mutation
High risk mutational variants including ... CDKN2A
Allowed: NOTCH2 mutation
High risk mutational variants including ... NOTCH2
Allowed: SMARCA4 mutation
High risk mutational variants including ... SMARCA4
Allowed: CCND1 mutation
High risk mutational variants including ... CCND1
Allowed: TP53 overexpression
p53 expression on immunohistochemistry (IHC), defined as ≥ 50%
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: systemic anticancer therapy
Exception: corticosteroids (up to 20 mg dexamethasone or equivalent daily) allowed prior to and during screening; all steroids for disease control must be discontinued within 7 days before starting study treatment except for doses ≤ 20 mg per day of prednisone or equivalent; ongoing steroids as premedications or for CRS management are allowed
No prior systemic anticancer therapies for MCL
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)
Absolute neutrophil count (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 × upper limit of normal (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
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