GLORY: Glofit-GemOx With Liso-Cel For Lymphoma

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Massachusetts General Hospital
Study ID
NCT07711483
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • B-cell Lymphomas
  • Large B-cell Lymphoma
  • Lymphoma
  • Relapsed/Refractory Large B-cell Lymphoma

Eligibility Criteria

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

Interventions

  • Obinutuzumab — DRUG
    Intravenous infusion received once, 5 days prior to receiving the first doses of glotfitamab, gemcitabine, and oxaliplatin.
  • Glofitamab — DRUG
    Intravenous infusion received on days 1, 3, 8, and 15 of cycle 1 and on day 15 of the optional cycle 2 (each cycle is 21 days).
  • Gemcitabine & oxaliplatin — DRUG
    Intravenous infusions received on day 1 of cycle 1 and an optional cycle 2 (each cycle is 21 days).
  • Leukapheresis — PROCEDURE
    Procedure to collect stem cells for modification that will occur 2 days prior to administration of the first doses of glofitamab, gemcitabine, and oxaliplatin.
  • Lymphodepleting chemotherapy — DRUG
    Intravenous infusions of cyclophosphamide and fludarabine administered for 3 consecutive days 3-5 days prior to receive lisocabtagene maraleucel.
  • LISOCABTAGENE MARALEUCEL — DRUG
    Intravenous infusion of participant's re-manufactured stem cells administered one 3-5 days after completing lymphodepleting chemotherapy.

Study Details

The goal of this clinical trial is to assess the clinical efficacy of bridging therapy with glofitamab/gemcitabine/oxaliplatin (Glofit-GemOx) followed by lisocabtagene maraleucel (liso-cel) in relapsed/refractory large B-cell lymphomas. This clinical trial also aims to investigate other efficacy parameters of the combination of Glofit-GemOx plus liso-cel and assess the safety of the combination of Glofit-GemOx bridging plus liso-cel. The main questions it aims to answer are: * How effective Glofit-GemOx bridged to liso-cel therapy is compared to liso-cel alone? * How will Glofit-GemOx bridged to liso-cel therapy affect other factors such as how long treatment effects last, how long patients survive after treatment, re-hospitalization rates, and more? * How many patients receiving Glofit-GemOx bridging to liso-cel will experience side effects of differing severities? Participants will receive an obinutuzumab intravenous infusion 3 days prior to undergoing a leukapheresis procedure. 2 days after leukapheresis, participants will receive 1-2 cycles of Glofit-GemOx therapy via intravenous infusion. After completing Glofit-GemOx therapy, participants will receive lymphodepleting chemotherapy via intravenous infusion for 3 consecutive days, 3-5 days prior to then receiving an intravenous infusion of liso-cel.

Key Dates

First listed
Jul 17, 2026
Start date
Oct 14, 2026
Status verified
Jul 2026
Primary completion
Oct 1, 2028
Completion
Oct 1, 2030

Study Design

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

Arms

  • Experimental: Liso-Cel after Glofit-GemOx bridging therapy
    Participants will receive obinutuzumab at the pre-determined dose 4 days prior to undergoing leukapheresis. After leukapheresis, participants will receive glofitamab, gemcitabine, and oxaliplatin (Glofit-GemOx) at the pre-determined doses over 3 weeks for 1-2 treatment cycles (each cycle is 21 days). Participants will then receive lymphodepleting chemotherapy of fludarabine and cyclophosphamide at the pre-determined doses for 3 consecutive days. Lsiocabtagene maraleucel (liso-cel) will be administered 2-7 days after the participants completes lymphodepleting chemotherapy.

Primary Outcome Measure

Complete Response Rate (CRR) to lisocabtagene maraleucel [ Time Frame: Screening to start of another non-study anticancer therapy or for up to 2 years from the day the last participant is enrolled, whichever occurs first. ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Beth Israel Deaconess Medical CenterBostonMassachusetts02215
Jon Arnason, MD
[email protected]
617-667-9235
Jon Arnason, MD (PRINCIPAL_INVESTIGATOR)
Massachusetts General HospitalBostonMassachusetts02114
Jeremy Abramson, MD, MMSc
[email protected]
617-726-8566
Jeremy Abramson, MD, MMSc (PRINCIPAL_INVESTIGATOR)

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By research site
Beth Israel Deaconess Medical Center· Boston, MAMassachusetts General Hospital· Boston, MA

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