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T-Cell Bispecific Antibody

Glofitamab + Obinutuzumab for Non-Hodgkin's Lymphoma

Phase 1 & 2
Recruiting
Research Sponsored by Hoffmann-La Roche
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
No available treatment options that are expected to prolong survival (e.g., standard chemotherapy or autologous stem cell transplant [ASCT])
Measurable disease defined as at least one bi-dimensionally measurable nodal lesion (> 1.5 cm) or at least one bi-dimensionally measurable extranodal lesion (> 1.0 cm)
Must not have
Known active infection, reactivation of a latent infection, or major episode of infection requiring hospitalization or treatment with IV antibiotics within 4 weeks of dosing
Refactoriness to an obinutuzumab-containing regimen
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial tests glofitamab, a new drug given through an IV that helps immune cells attack cancer cells. It targets patients who need new treatment options because their cancer hasn't responded to existing treatments. The drug works by connecting immune cells to cancer cells, making it easier for the immune system to destroy the cancer. Glofitamab shows promise in treating certain types of blood cancers.

Who is the study for?
This trial is for adults with relapsed/refractory B-Cell Non-Hodgkin's Lymphoma who've had at least one prior treatment and lack other survival-prolonging options. Participants must have measurable disease, be in good physical condition (ECOG 0 or 1), and have proper liver, kidney, and blood function. Pregnant women are excluded, as well as those with certain infections or a history of severe reactions to similar drugs.
What is being tested?
The study tests Glofitamab alone or combined with Obinutuzumab in patients pre-treated with a fixed dose of Obinutuzumab. It's an early-phase trial to find the safest and most effective doses (Phase I/II). The trial includes escalating doses followed by expansion cohorts once optimal dosing is determined.
What are the potential side effects?
Potential side effects include allergic reactions to the drugs, possible organ inflammation due to immune response, fatigue, changes in blood counts that could affect immunity or clotting, infusion-related reactions during drug administration, and increased risk of infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have no treatment options left that could extend my life.
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I have a tumor that can be measured with imaging tests.
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I am fully active or restricted in physically strenuous activity but can do light work.
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My blood cancer is likely to have CD20.
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My condition did not improve after at least one treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have not had a serious infection or been on IV antibiotics in the last 4 weeks.
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My condition did not improve after treatment with obinutuzumab.
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I had a stem cell transplant using my own cells less than 100 days ago.
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I have had progressive multifocal leukoencephalopathy or CNS lymphoma.
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I've had side effects from previous immune therapy.
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My condition is either CLL, Burkitt lymphoma, or lymphoplasmacytic lymphoma.
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I have or might have had HLH.
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I have a significant history of heart disease.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Side effects data

From 2021 Phase 1 trial • 23 Patients • NCT04313608
41%
Cytokine release syndrome
35%
Anaemia
35%
Diarrhoea
35%
Hypomagnesaemia
35%
Pyrexia
35%
Neuropathy peripheral
24%
Platelet count decreased
24%
Nausea
24%
Hypophosphataemia
24%
Liver function test abnormal
24%
Neutropenia
24%
Constipation
24%
Fatigue
24%
Thrombocytopenia
18%
Arthralgia
18%
Lethargy
18%
Hypokalaemia
18%
Weight decreased
18%
Neutrophil count decreased
18%
Oral candidiasis
18%
Sepsis
18%
Headache
18%
Peripheral sensory neuropathy
12%
Rectal haemorrhage
12%
Paraesthesia
12%
Flushing
12%
Superficial vein thrombosis
12%
Infusion related reaction
12%
Vomiting
12%
Blood alkaline phosphatase increased
12%
Cough
12%
Abdominal pain
12%
Pain in extremity
12%
Gastrooesophageal reflux disease
12%
Alanine aminotransferase increased
12%
Colitis
12%
Abdominal discomfort
12%
Dizziness
6%
Cytomegalovirus infection reactivation
6%
Decreased appetite
6%
Back pain
6%
Performance status decreased
6%
Chest pain
6%
Hyperlipidaemia
6%
Dyspnoea exertional
6%
Wound infection
6%
Vasospasm
6%
Gamma-glutamyltransferase increased
6%
Abdominal distension
6%
Tumour lysis syndrome
6%
Rash
6%
Thrombosis
6%
External ear cellulitis
6%
Orthostatic hypotension
6%
Cellulitis
6%
Upper respiratory tract infection
6%
Hypocalcaemia
6%
Hypogammaglobulinaemia
6%
Urinary tract infection
6%
Transient ischaemic attack
6%
Hypertension
6%
Blood creatinine increased
6%
Abdominal tenderness
6%
Seasonal allergy
6%
Adenocarcinoma
6%
Throat irritation
6%
Injury
6%
Hypoalbuminaemia
6%
Epistaxis
6%
Hyperglycaemia
6%
Oropharyngeal pain
6%
Intention tremor
6%
Rash maculo-papular
6%
Squamous cell carcinoma
6%
Photosensitivity reaction
6%
Depression
6%
Neutropenic sepsis
6%
Vision blurred
6%
Abdominal pain lower
6%
Anal haemorrhage
6%
Aspartate aminotransferase increased
6%
Groin pain
6%
Pain in jaw
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm A: Glofit-GemOx
Arm B: Mosun-GemOx

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Group I: Part III: Dose ExpansionExperimental Treatment3 Interventions
Part III will start once MTD/OBD is defined. Participants will receive Gpt 1000 mg single dose IV infusion on Day -7 (pre-treatment), followed by glofitamab at a fixed dose regimen or step-up dose regimen on a Q2W or Q3W dosing schedule as determined in Part II. A total of 12 cycles will be administered. Combination Therapy: From Cycle 2 onwards, a fixed dose of 1000 mg obinutuzumab will be administered via IV infusion in combination with glofitamab at the dosing regimen determined in Part II.
Group II: Part II: Dose EscalationExperimental Treatment3 Interventions
In each treatment regimen, participants will receive obinituzumab (Gpt) 1000 milligrams (mg) IV infusion on Day -7 (pre-treatment); or 2000 mg either administered on Day -7, or split into two 1000 mg doses on Days -1 and -7. The first glofitamab IV infusion will be given on Day 1 of Cycle 1 and a total of 12 cycles will be administered. Monotherapy, glofitamab as a single agent: ascending doses of glofitamab administered on Day 1 of every 2 or 3 week cycle until either the MTD/OBD is defined. Combination Therapy: From Cycle 2 onwards, a fixed dose of 1000 mg obinutuzumab will be administered via IV infusion in combination with ascending doses of glofitamab on Day 1 of every 3 week cycle until either the MTD/OBD is defined. Step-up dosing: Q3W, participants will receive an initial low dose of glofitamab on C1D1, followed by a higher dose on C1D8; the total dose in C1 will not exceed the previously determined MTD. Higher doses may be explored from C2 or later cycles.
Group III: Part I: Dose EscalationExperimental Treatment3 Interventions
Participants (single participant cohorts) will receive obinutuzumab (Gpt) 1000 milligrams (mg) single dose IV infusion on Day -7 (pre-treatment) followed by glofitamab IV infusion on Day 1 and Day 8 of Cycle 1. From Cycle 2 onwards, ascending doses of glofitamab will be administered on Day 1 of every 2 week cycle up to Cycle 12 (24 weeks) or until unacceptable toxicity or disease progression. Glofitamab dosing will be initiated at 5 micrograms (mcg) (flat dose) followed by doses of 15 mcg, 45 mcg, 135 mcg, 405 mcg and 810 mcg.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Glofitamab
2021
Completed Phase 1
~60
Obinutuzumab
2014
Completed Phase 3
~3470
Tocilizumab
2012
Completed Phase 4
~1840

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Non-Hodgkin's Lymphoma (NHL) include monoclonal antibodies, bispecific T-cell engagers, and chimeric antigen receptor (CAR) T-cell therapies. Monoclonal antibodies, such as rituximab and obinutuzumab, target specific antigens like CD20 on the surface of B-cells, leading to their destruction. Bispecific T-cell engagers, like Glofitamab, simultaneously bind to CD20 on B-cells and CD3 on T-cells, bringing T-cells into close proximity with B-cells to facilitate targeted killing. CAR T-cell therapies involve modifying a patient's T-cells to express receptors that specifically target and destroy cancer cells. These treatments are crucial for NHL patients as they offer targeted, effective options that can lead to better outcomes and potentially fewer side effects compared to traditional chemotherapy.

Find a Location

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor
2,450 Previous Clinical Trials
1,094,684 Total Patients Enrolled
Clinical TrialsStudy DirectorHoffmann-La Roche
2,220 Previous Clinical Trials
894,534 Total Patients Enrolled

Media Library

Glofitamab (T-Cell Bispecific Antibody) Clinical Trial Eligibility Overview. Trial Name: NCT03075696 — Phase 1 & 2
Non-Hodgkin's Lymphoma Clinical Trial 2023: Glofitamab Highlights & Side Effects. Trial Name: NCT03075696 — Phase 1 & 2
~76 spots leftby Aug 2025
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