CAR-T Cell Therapy, Mosunetuzumab and Polatuzumab for Treatment of Refractory/Relapsed Aggressive Non-Hodgkin's Lymphoma (NHL).

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorLazaros Lekakis

About this trial

The purpose of this research study is to test if a combination treatment of chimeric antigen receptor (CAR) T-cell therapy, Mosunetuzumab, and Polatuzumab Vedotin will result in tumor reduction.

Eligibility criteria

Qualifiers

Diffuse large B cell lymphoma (DLBCL) not otherwise specified. Patients with primary cutaneous DLBCL of leg-type are eligible if the lymphoma expresses cluster of differentiation 19 (CD19) and if the insurance approves the CAR-T therapy. Similarly. Large cell transformation of nodal or extra-nodal marginal zone lymphoma is eligible only if the insurance allows and the disease shows strong CD19 positivity. On the other hand, post-transplant lymphoproliferative disorders (PTLD) are not allowed due to the frequently required continuation of immunosuppression to avoid organ rejection.

Primary mediastinal B cell lymphoma (PMBCL)

Transformed follicular lymphoma (TFL). An untransformed follicular lymphoma grade 3B will be considered on a case by case basis, since the genetic signature of grade 3B follicular lymphoma frequently resemble that of DLBCL and the large lymphomatous cells just happen to be organized in a follicular pattern. Recently, Breyanzi has an FDA indication for follicular lymphoma grade 3B.

High grade B cell lymphoma (HGBL), other than B-lymphoblastic lymphoma

Disqualifiers

Patients with EBV+DLBCL, plasmablastic lymphoma, human herpesvirus-8 (HHV-8) related B cell lymphoproliferative disorders including primary effusion lymphoma, anaplastic lymphoma kinase (ALK)+ LBCL, intravascular large B cell lymphomas, DLBCL associated with chronic inflammation, lymphomatoid granulomatosis, primary DLBCL of the CNS and T cell histiocyte rich LBCL will not be allowed because of different biology, frequent lack of CD19, difficulty in interpreting toxicity (as in the case of primary central nervous system (CNS) lymphoma) or some preliminary discouraging results with CAR-T as in the case of T-cell, histiocyte-rich large B cell lymphoma and Richter transformation of chronic lymphocytic leukemia (CLL).

Primary CNS lymphoma or secondary CNS involvement by lymphoma.

Similarly, patients with conditions that increase the risk of CNS toxicity will be excluded. Such conditions include but not limited to

active seizure disorder for which an antiepileptic is taken,

Trial design

Treatments tested in this trial

  • Mosunetuzumab
  • Polatuzumab
  • CAR-T Cell Therapy

Treatment groups

22 Participants
are divided into 1 treatment group

Sponsors and collaborators

Lazaros Lekakis

Lead sponsor

University of Miami

Sponsor institution

Genentech, Inc.

Collaborator