Testing the Anti-cancer Drug, Glofitamab, in Patients With Mantle Cell Lymphoma (A Type of Blood Cancer) Whose Disease Returned After CAR-T Cell Therapy

Part of paid clinical trials in Duarte, California.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT07003295
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Recurrent Mantle Cell Lymphoma
  • Refractory Mantle Cell Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Biospecimen Collection — PROCEDURE
    Undergo blood sample collection
  • Computed Tomography — PROCEDURE
    Undergo PET/CT
  • Glofitamab — BIOLOGICAL
    Given IV
  • Obinutuzumab — BIOLOGICAL
    Given IV
  • Positron Emission Tomography — PROCEDURE
    Undergo PET/CT

Study Details

This phase II trial tests the safety and side effects of glofitamab and obinutuzumab and how well they work in treating patients with mantle cell lymphoma that has come back after a period of improvement (relapsed) or that has not responded to previous treatment (refractory) after receiving CD19-directed chimeric antigen receptor (CAR) T-cell therapy. CAR T-cell therapy is a form of immunotherapy where the immune system cell, T-cell, is changed to attack cancer cells. Glofitamab is a bispecific antibody that can bind to two different antigens at the same time. Glofitamab binds to CD3, a protein found on T cells (a type of white blood cell), and CD20 a protein found on B cells (another type of white blood cell) and some lymphoma cells. This may help the immune system kill cancer cells. Obinutuzumab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. 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). Giving glofitamab and obinutuzumab may be safe, tolerable, and/or effective in treating patients with relapsed or refractory mantle cell lymphoma after receiving CD19-directed CAR T-cell therapy.

Key Dates

Start date
Aug 14, 2026
Status verified
May 2026
Primary completion
Aug 31, 2027
Completion
Aug 31, 2027

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (obinutuzumab, glofitamab)
    Patients receive obinutuzumab IV on day 1 or on days 1 and 2 of cycle 1 and glofitamab IV over 8 hours on days 8 and 15 of cycle 1 then over 2-8 hours on day 1 of cycles 2-12. Cycles repeat every 21 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo blood sample collection and PET/CT throughout the study.

Primary Outcome Measure

Objective response rate [ Time Frame: Up to 2 years ]

Locations (7)

FacilityCityStateZIPSite coordinators
City of Hope Comprehensive Cancer CenterDuarteCalifornia91010
Site Public Contact
[email protected]
800-826-4673
Victor M. Orellana-Noia (PRINCIPAL_INVESTIGATOR)
Emory Saint Joseph's HospitalAtlantaGeorgia30342
Site Public Contact
404-851-7115
Jonathon B. Cohen (PRINCIPAL_INVESTIGATOR)
Emory University Hospital MidtownAtlantaGeorgia30308
Site Public Contact
888-946-7447
Jonathon B. Cohen (PRINCIPAL_INVESTIGATOR)
Emory University Hospital/Winship Cancer InstituteAtlantaGeorgia30322
Site Public Contact
404-778-1868
Jonathon B. Cohen (PRINCIPAL_INVESTIGATOR)
Ohio State University Comprehensive Cancer CenterColumbusOhio43210
Site Public Contact
[email protected]
800-293-5066
Kami J. Maddocks (PRINCIPAL_INVESTIGATOR)
University of Pittsburgh Cancer Institute (UPCI)PittsburghPennsylvania15232
Site Public Contact
412-647-8073
Jing-Zhou Hou (PRINCIPAL_INVESTIGATOR)
Vanderbilt University/Ingram Cancer CenterNashvilleTennessee37232
Site Public Contact
800-811-8480
Shakthi Bhaskar (PRINCIPAL_INVESTIGATOR)

Find similar trials in Duarte, CA

By research site
City of Hope Comprehensive Cancer Center· Duarte, CAEmory Saint Joseph's Hospital· Atlanta, GAEmory University Hospital Midtown· Atlanta, GAEmory University Hospital/Winship Cancer Institute· Atlanta, GAOhio State University Comprehensive Cancer Center· Columbus, OHUniversity of Pittsburgh Cancer Institute (UPCI)· Pittsburgh, PA

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