A Phase 2 Trial of Glofitamab for Minimal Residual Disease in Patients With Large B-cell Lymphoma

NCT06670105 | Withdrawn Phase 2 FDA Drug

• 3 other identifiers: 2024-1314NCI-2024-09090NCI-2025-06734
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical research study is to learn if glofitamab can help to prevent recurrence of LBCL in patients who have achieved CR after standard first-line therapy but have tested positive for MRD. The safety of glofitamab will also be studied.

Conditions

B-cell Lymphoma

Outcome Measures

Primary Outcomes (1)

• Safety and Adverse Events (AEs)

  Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

  Through study completion; an average of 1 year

Study Arms (1)

Glofitamab

EXPERIMENTAL

Participants will enter a screening period to determine eligibility for the study

Drug: Glofitamab

Interventions

Glofitamab DRUG

Given by vein

Glofitamab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years
• Histologically diagnosed
• Diffuse large B-cell lymphoma, not otherwise specified (NOS) or
• High grade B-cell lymphoma (NOS or MYC and BCL2 rearrangements) or
• Transformed large B-cell lymphoma from indolent lymphomas (but not Waldenstrom macroglobulinemia/Lymphoplasmacytic lymphoma)
• Have received first line standard of care anthracycline-based chemoimmunotherapy for 6 cycles (with or without 2 more cycles of rituximab) for previously untreated disease
• R-CHOP (cyclophosphamide, doxorubicin, vincristine sulfate, and prednisone)
• DA-EPOCH-R
• Polatuzumab-R-CHP
• Have achieved complete metabolic response by Lugano criteria4 at the end of treatment response evaluation after first line treatment
• MRD Positive at the end of first line treatment
• Performance status ≤2 on the ECOG scale
• Patients must have adequate organ and marrow function as defined below:
• Absolute neutrophil count (ANC) ≥0.5 x 109/L \*
• ¡ \*Growth factor permitted during screening

You may not qualify if:

• Having radiologically confirmed relapsed/refractory disease.
• Patients who have not recovered from non-hematological AEs due to prior first line therapy (i.e., have residual toxicities \> Grade 1) with the exception of alopecia.
• Known central nervous system lymphoma or leptomeningeal disease.
• Suspicious case at end of treatment from first line treatment should be evaluated with brain MRI with or without lumber puncture.
• Any prior history of other malignancy besides 8-NHL, unless the patient has been free of disease for ≥ 3 years and felt to be at low risk for recurrence by the treating physician, except:
• Adequately treated localized skin cancer without evidence of disease.
• Adequately treated cervical carcinoma in situ without evidence of disease.
• Any life-threatening illness, medical condition, or organ system dysfunction which, in the investigator's opinion, could compromise the subject's safety, or put the study outcomes at undue risk.
• Uncontrolled human immunodeficiency virus (HIV), or active Hepatitis C Virus, or active Hepatitis B Virus infection, or any uncontrolled active significant infection, including suspected or confirmed JC virus infection and SARS-CoV2.
• Patients with inactive hepatitis B infection must adhere to hepatitis B reactivation prophylaxis unless contraindicated. The treatment and monitoring of hepatitis B will follow the institutional standard of practice. Hepatitis B or C serologic status: subjects who are hepatitis B core antibody (anti-HBc) positive and who are surface antigen negative will need to have a negative polymerase chain reaction (PCR). Those who are hepatitis B surface antigen (HbsAg) positive or hepatitis B PCR positive will be excluded. Subjects who are hepatitis C antibody positive will need to have a negative PCR result. Those who are hepatitis C PCR positive will be excluded. Subjects with a history of Hepatitis C who received antiviral treatment are eligible as long as PCR is negative.
• History of severe allergic or anaphylactic reactions or intolerance to anti-CD20 monoclonal antibody therapy or any bispecific antibody.
• History of immunodeficiency (with the exception of hypogammaglobulinemia) or concurrent systemic immunosuppressant therapy (e.g., cyclosporine, tacrolimus, etc., or chronic administration glucocorticoid equivalent of \>10mg/day of prednisone) within 28 days of the first dose of study drug with exception of steroid used for IV contrast allergy. In addition, use of inhaled, topical, intranasal corticosteroids or local steroid injection (eg, intra- articular injection) is permitted.
• Clinically significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of Screening, or any Class 3 (moderate) or Class 4 (severe) cardiac disease as defined by the New York Heart Association (NYHA) Functional Classification. Subjects with controlled, asymptomatic heart failure during screening can enroll on study.
• History of stroke, seizure disorder or patients requiring antiepileptic therapy or intracranial hemorrhage within 18 months prior to study entry.
• Lactating or pregnant subjects. Pregnant women are excluded from this study for unknown potential for teratogenic or abortifacient effects by glofitamab. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with glofitamab, breastfeeding should be discontinued if the mother is treated with glofitamab. These potential risks may also apply to other agents used in this study.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Genentech, Inc.: collaborator

Study Sites (1)

The University of Texas M. D. Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• MD Anderson Cancer Center Website

MeSH Terms

Conditions

Lymphoma, B-Cell

Interventions

glofitamab

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Dai Chihara, MD,PHD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2024
• First Posted: November 1, 2024
• Study Start: June 6, 2025
• Primary Completion (Estimated): January 6, 2030
• Study Completion (Estimated): January 6, 2032
• Last Updated: September 17, 2025

Record last verified: 2025-09

Locations

US (1)