Active — Not RecruitingPhase 2

Zanubrutinib and CAR T-cell Therapy for the Treatment of Recurrent or Refractory Aggressive B-cell Non-Hodgkin's Lymphoma or Transformed Indolent B-cell Lymphoma

United States24 participantsStarted 2022-03-21

Plain-language summary

This phase II trial studies the effect of zanubrutinib and CAR T-cell therapy in treating patients with aggressive B-cell non-Hodgkin's lymphoma or transformed indolent B-cell lymphoma that has come back (recurrent) or does not respond to treatment (refractory). Zanubrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. T cells are infection fighting blood cells that can kill tumor cells. The T cells given in this study will come from the patient and will have a new gene put in them that makes them able to recognize CAR, a protein on the surface of cancer cells. These CAR-specific T cells may help the body's immune system identify and kill cancer cells. Giving zanubrutinib together with CAR T-cell therapy may kill more cancer cells.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients must have a histo-pathologically confirmed diagnosis of an aggressive B-cell non-Hodgkin lymphoma or transformed indolent B-cell lymphoma that is recurrent or refractory to standard therapy and with intent to treat with standard of care CAR T-cell therapy (meeting Food and Drug Administration \[FDA\] approved indications for the respective CAR T-cell construct being used). Standard of care /FDA approved CARTs for this population include axicabtagene ciloleucel, tisagenlecleucel or lisocabtagene maraleucel, any of which may be used for this study and provider dependent. For the purpose of this study, aggressive B-cell NHL histologies should conform to the label indications for the respective CART being utilized. Accordingly, CART eligible histologies include the following groups according to the 2016 revision of the World Health Organization (WHO) classification of lymphoid neoplasms * High-grade B-cell lymphoma, with MYC and BCL2 and/or BCL6 rearrangements * High-grade B-cell lymphoma, not otherwise specified (NOS) * Diffuse large B-cell lymphoma (DLBCL), NOS * Diffuse large B-cell lymphoma (DLBCL), NOS; Germinal center B-cell type * Diffuse large B-cell lymphoma (DLBCL), NOS; Activated B-cell type * Large B-cell lymphoma with IRF4 rearrangement * T-cell/histiocyte-rich large B-cell lymphoma (subtype of DLCBL) * Primary cutaneous DLBCL, leg type (subtype of DLCBL) * Epstein-Barr virus (EBV)+ DLBCL, NOS (subtype of DLCBL) * …

What they're measuring

Change in 6-month complete response rates

Timeframe: At 6 months from initiation of maintenance zanubrutinib treatment

Trial details

NCT IDNCT05202782

SponsorNorthwestern University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-10-09