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

Recruiting in Palo Alto (17 mi)

Overseen byPaolo Strati, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: M.D. Anderson Cancer Center

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

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).

Eligibility Criteria

Inclusion Criteria

≥ 18 years of age because no dosing or adverse event data are currently available on the use of magrolimab in combination with rituximab and radiation in patients <18 years of age, children are excluded from this study

At least two weeks or 5 half-lives, whichever is shorter, must have elapsed since any prior systemic therapy at the time the subject is planned for leukapheresis, except for systemic immune checkpoint inhibitory/immune stimulatory therapy. At least 3 half-lives must have elapsed from any prior systemic immune checkpoint inhibitory/immune stimulatory therapy at the time the subject is planned for leukapheresis

Creatinine clearance (as estimated by Cockcroft Gault) ≥ 30 mL/min

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Exclusion Criteria

History of Richter's transformation of chronic lymphocytic leukemia (CLL)

Subjects with known detectable cerebrospinal fluid malignant cells or known active brain malignant lesions

History of autoimmune disease (e.g. Crohns, rheumatoid arthritis, systemic lupus) resulting in end organ injury or requiring systemic immunosuppression/systemic disease modifying agents within the last year considered significant in the opinion of the principal investigator

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Treatment Details

Interventions

CAR T leukapheresis (CAR T-cell Therapy)
Magrolimab (Monoclonal Antibodies)
Radiation (Radiation)
Rituximab (Monoclonal Antibodies)

Participant Groups

1Treatment groups

Experimental Treatment

Group I: magrolimab, rituximab, and radiation, CAR T leukapheresisExperimental Treatment4 Interventions

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