A Study of Glofitamab and Lenalidomide in People With Mantle Cell Lymphoma

NCT06192888 | Active Not Recruiting Phase 1 FDA Drug

• 1 other identifier: 23-319
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 10

Brief Summary

The purpose of this study is to find out whether the combination of glofitamab and lenalidomide is an effective treatment for relapsed or refractory Mantle Cell Lymphoma

Conditions

Mantle Cell Lymphoma; MCL

Keywords

Mantle Cell Lymphoma; MCL; Memorial Sloan Kettering Cancer Center; 23-319

Outcome Measures

Primary Outcomes (1)

• Proportion of participants who successfully receive glofitamab

  Treatment feasibility defined as the proportion of participants who successfully receive glofitamab during cycles 1-3 without any dose delays of glofitamab for greater than 7 days

  1 year

Study Arms (1)

Participants with Mantle Cell Lymphoma

EXPERIMENTAL

Participants will be diagnosed with relapsed, refractory (R/R) mantle cell lymphoma (MCL) with prior BTK inhibitor (BTKi) failure

Drug: Glofitamab; Drug: Obinutuzumab; Drug: Lenalidomide

Interventions

Obinutuzumab DRUG

IV Obinutuzumab

Participants with Mantle Cell Lymphoma

Lenalidomide DRUG

Oral Lenalidomide

Participants with Mantle Cell Lymphoma

Glofitamab DRUG

IV Glofitamab

Participants with Mantle Cell Lymphoma

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 at the time of signing Informed Consent
• ECOG 0-2
• Histologic diagnosis confirmed as relapsed/refractory mantle cell lymphoma according to WHO guidelines, confirmed by the pathology department at the treating institution
• If the patient previously received CD20 directed therapy, there must be evidence of CD20 expression on neoplastic cells according to instutitional pathology department guidelines. This must be confirmed on a biopsy of Relapsed/Refractory Mantle Cell Lymphoma performed after receipt of the last CD20 directed therapy.
• At minimum 10 unstained slides or tissue block from tumor containing FFPE biospecimen sample from a Relapsed/Refractory Mantle Cell Lymphoma biopsy is required for tumor genomic profiling and MRD testing. If adequate archival tissue is not available, then a repeat biopsy will be required. This requirement can be waived (i.e. if site of disease is inaccessible) after discussion with the MSKCC Principal Investigator
• Tumor genomic profiling from a biopsy sample collected within 6 months of signing informed consent form is required. For MSK patients, this will be done via MSK IRB#12-245 (Integrated Mutation Profiling of Actionable Cancer Targets (IMPACT)) within 6 months prior to signing Informed Consent form, and preferably repeated for patients who did not have IMPACT performed after discontinuing their last line of treatment. Patients at external sites will run genomic profiling per institutional guidelines. If sites do not have an approved assay available, they may send archival tissue to MSK. Details included in lab manual
• Previously treated with at least one prior line of systemic therapy for mantle cell lymphoma. Prior BTKi failure is required. BTKi failure is defined as progression of disease during BTKi therapy or patients must have progressed or relapsed after completing BTK inhibitor therapy, or failed to achieve a PR following 12 weeks of BTK inhibitor therapy.
• Presence of evaluable disease
• Adequate bone marrow and organ function:
• Absolute neutrophil count (ANC) ≥1,000 cells/mcL, unless felt to be secondary to underlying MCL (minimum ANC 500 cells/mcL)
• Hgb ≥ 8 g/dL without transfusional support for 7 days before first treatment, unless felt to be secondary to underlying MCL (minimum Hgb 7.0 g/dL) without transfusional support for 7 days before first treatment)
• Platelet count ≥50,000 cells/mcL without transfusional support for 7 days before first treatment, unless felt to be secondary to underlying MCL (minimum platelet count 25,000 cells/mcL) without transfusional support for 7 days before first treatment)
• Renal function assessed by calculated Cockcroft-Gault creatinine clearance (CrCl; see Appendix A) ≥ 30 ml/min. See lenalidomide Treatment Plan, (Table 10-1), for lenalidomide dose adjustment for CrCl ≥ 30 mL/min and \< 60 mL/min
• Adequate hepatic function as determined by:
• Total bilirubin ≤1.5X upper limit of normal (ULN) unless secondary to Gilbert's syndrome or documented liver involvement by lymphoma. Patients with Gilbert's syndrome or documented liver involvement by lymphoma may be included if their total bilirubin is ≤ 5 x ULN

You may not qualify if:

• Investigational agent or anticancer therapy within 5 half-lives prior to start of study therapy except therapeutic monoclonal antibody treatment must be discontinued a minimum of 4 weeks prior to study therapy. An exception is BTKi therapy, which can be continued to prevent disease flare up until 1 day prior to start of study therapy.
• Major surgery within 4 weeks prior to planned start of study therapy.
• Radiotherapy within 7 days of the start of study therapy.
• CART infusion within 30 days prior to Day 1 of Cycle 1
• Active hepatitis B or C, as defined below:
• HBV surface antigen positive
• HBV surface antigen negative, HBV core antibody positive and detectable HBV viral DNA. Note: subjects who are HBV core antibody positive and viral DNA negative are eligible. (Prophylactic anti-viral treatment is required for subjects who are HBV core antibody positive)
• HCV antibody positive and HCV RNA positive.
• History of human immunodeficiency virus (HIV) unless all of the following criteria are met:
• CD4+ T cell count ≥ 250 cells/mcL
• No acquired immunodeficiency syndrome (AIDS)-defining opportunistic infections within 1 year prior to signing Informed Consent Form
• Stable (no change in regimen for ≥ 4 weeks) and effective antiretroviral regimen, and HIV viral load \< 400 copies/mL within 4 weeks prior to signing Informed Consent form
• Active concurrent malignancy requiring active therapy within the last 3 years with the exception of basal cell carcinoma limited to the skin, squamous cell carcinoma limited to the skin, carcinoma in situ of the cervix or breast, adequately treated lentigo maligna melanoma, or localized prostate cancer. Adjuvant or maintenance therapy to reduce the risk of recurrence of other malignancy previously treated for curative intent is permitted.
• Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) at study enrollment, or any major episode of infection requiring treatment with IV antibiotics or hospitalization (relating to the completion of the course of antibiotics) within 4 weeks prior to cycle 1, day 1.
• Clinically significant history of liver disease, including active viral or other hepatitis or current uncontrolled alcohol use disorder that would compromise patient's ability to safely participate in the trial, per clinician's judgment

Sponsors & Collaborators

• Genentech, Inc.: collaborator
• Memorial Sloan Kettering Cancer Center: lead

Study Sites (10)

Dana Farber Cancer Institute (Data Collection and Specimen Analysis)

Boston, Massachusetts, 02115, United States

Location

Mayo Clinic (Data Collection Only)

Rochester, Minnesota, 55905, United States

Location

Washington University (Data Collection Only)

St Louis, Missouri, 63110, United States

Location

Memorial Sloan Kettering Cancer Center at Basking Ridge (Limited Protocol Activities)

Basking Ridge, New Jersey, 07920, United States

Location

Memorial Sloan Kettering Monmouth (Limited protocol activities)

Middletown, New Jersey, 07748, United States

Location

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Montvale, New Jersey, 07645, United States

Location

Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities)

Commack, New York, 11725, United States

Location

Memorial Sloan Kettering Westchester (Limited protocol activities)

Harrison, New York, 10604, United States

Location

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, 10065, United States

Location

Memorial Sloan Kettering Nassau (All protocol activities)

Rockville Centre, New York, 11553, United States

Location

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Lymphoma, Mantle-Cell

Interventions

glofitamab; obinutuzumab; Lenalidomide

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

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Anita Kumar, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2023
• First Posted: January 5, 2024
• Study Start: January 8, 2024
• Primary Completion (Estimated): January 8, 2028
• Study Completion (Estimated): January 8, 2028
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share

Locations

US (10)