An Open-Label, Single Center Phase 2 Study of Magrolimab, Rituximab and Radiation as Bridging Strategy Before CAR T-Cell Therapy in Patients With Relapsed or Refractory Large B-cell Lymphoma

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT05929716
Phase
PHASE2
Status
Withdrawn

Conditions

  • B-cell Lymphoma
  • Large B-cell Lymphoma

Eligibility Criteria

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

Interventions

  • Magrolimab — DRUG
    Given by IV (vein)
  • Rituximab — DRUG
    Given by IV (vein)
  • CAR T leukapheresis — DRUG
    Given by IV (vein)
  • Radiation — DRUG
    Given by IV (vein)

Study Details

To evaluate the efficacy of the combination of magrolimab, rituximab, and radiation as bridging therapy in patients with relapsed or refractory LBCL who receive CAR T-Cell Therapy (CART).

Key Dates

Start date
Sep 30, 2023
Status verified
Nov 2023
Primary completion
Mar 1, 2026
Completion
Mar 1, 2028

Study Design

Enrollment
0 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: magrolimab, rituximab, and radiation, CAR T leukapheresis
    Participants may receive radiation therapy at any time during the study. Participants will be given Magrolimab by vein once weekly for 4 doses by vein on an outpatient basis over about 180 minutes starting on Day 1 of Cycle 1. Participants will be given Rituximab by vein once weekly for 4 doses over about 3-4 hours starting on Day 1 of Cycle 1. You will be given rituximab about 30 minutes (no more than 90 minutes) after magrolimab therapy finishes. Participants will receive 1 dose of magrolimab and rituximab by vein one week before your CAR T leukapheresis and then 3 weekly doses of each drug starting 1 day after leukapheresis that will complete 1 week before lymphodepleting chemotherapy for CAR T

Primary Outcome Measure

Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0 [ Time Frame: through study completion; an average of 1 year ]

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