Loncastuximab Tesirine and Rituximab as Bridging Therapy Before Standard-of-care CAR-T Therapy in Patients With Large B-cell Lymphoma (CORAL)

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Utah

About this trial

The purpose of this clinical trial is to learn if the study treatment Loncastuximab tesirine and Rituximab is safe and efficient before standard of care chimeric antigen receptor T-cell (CAR-T) therapy in patients with relapsed or refractory large B-cell lymphoma.

Eligibility criteria

Qualifiers

Subject aged ≥ 18 years.

Intended to receive commercial CD19-directed CAR-T cell therapy (axi-cel and liso-cel).

Need for bridging therapy as deemed clinically necessary by the treating physician.

Relapsed or refractory DLBCL, tFL or PMBCL as defined by the 2016 World Health Organization classification (including patients with DLBCL transformed from indolent lymphoma), or high-grade B-cell lymphoma (HGBL), not otherwise specified, and HGBL with MYC and BCL2 and/or BCL6 rearrangements.

Disqualifiers

Previous treatment with any anti-CD19 therapy including lonca or prior CD19 CAR T-cell therapy

Subjects receiving investigational CAR-T products

Major surgery within 4 weeks prior to starting study therapy.

History of bleeding diathesis (e.g., von Willebrand's disease), hemophilia, or active bleeding.

Trial design

Treatments tested in this trial

  • Loncastuximab Tesirine
  • Rituximab

Treatment groups

29 Participants
are divided into 1 treatment group

Sponsors and collaborators

University of Utah

Lead sponsor

ADC Therapeutics S.A.

Collaborator