DALY II USA/ MB-CART2019.1 for DLBCL (NCT04792489) | Clinical Trial Compass
RecruitingPhase 2
DALY II USA/ MB-CART2019.1 for DLBCL
United States248 participantsStarted 2021-05-25
Plain-language summary
DALY II USA is a phase II, multi-center, single arm study to evaluate the efficacy, safety, and pharmacokinetics of zamtocabtagene autoleucel (MB-CART2019.1) in patients with relapsed and/or refractory diffuse large B cell lymphoma (DLBCL) after receiving at least two lines of therapy. Additional cohorts include subjects with B-cell primary or secondary central nervous system (CNS) lymphoma (PCNSL) and (SCNSL), mantle cell lymphoma (MCL) and Richter's transformation (RT) after receiving at least one line of therapy.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Histologically confirmed B-cell non-Hodgkin's lymphoma:
* DLBCL DLBCL or associated subtype, defined by WHO 2016 classification:
* DLBCL not otherwise specified (NOS)
* High-grade B cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements
* High-grade B cell lymphoma (NOS)
* Primary mediastinal (thymic) large B cell lymphoma
* Transformed lymphoma (e.g., transformed follicular, or marginal zone lymphoma, follicular lymphoma (FL Grade 3)
* CNS Cohort only: B-cell primary or secondary central nervous system lymphoma (PCNSL or SCNSL)
* Mantle Cell Lymphoma (MCL) Cohort: Histologically confirmed MCL determined by overexpression of cyclin D1 or presence of t(11;14) (q13; q32) translocation
* Richter's Transformation (RT) Cohort: Histologically confirmed Richter's transformation (RT) to a diffuse large B-cell lymphoma (DLBCL) subtype from underlying CLL (clonally related)
* Relapsed or refractory disease is defined for DLBCL (and associated subtypes) population as failure of 2 or more lines of chemotherapy including rituximab or equivalent and anthracycline and either having failed autologous stem cell transplant (ASCT), or ineligible, not intended for or not consenting to ASCT
* Chemotherapy-refractory disease is defined as persistent disease after last line of therapy or relapsed or persistent disease after prior ASCT for lymphoma
* Disease relapse in subjects without prior ASCT is defined as relapse of disease after the last dose of most recent therapy r…
What they're measuring
1
Overall Response Rate
Timeframe: through study completion, up to 2 years