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.
A prospective, single arm, open label, multi-center, phase II study of autologous T cells engineered against both CD19 and CD20 antigens for subjects with relapsed or refractory DLBCL after receiving at least two lines of therapy. The investigational agent is the MB-CART2019.1 cells. 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. After successful screening, subjects will undergo leukapheresis to collect product for manufacturing. In preparation for the fresh product infusion, subjects will undergo a lymphodepleting regimen with cyclophosphamide and fludarabine, or bendamustine. Cell infusion will be administered intravenously at a dose of 2.5 x 106 CAR+ cells/kg body weight. The study will start with enrollment of 3 subjects in the lead-in safety phase, and after safety is evaluated, the study will continue with enrollment of the remaining subjects. Subjects will be followed for up to 2 years, for efficacy and safety outcomes as well as health-related quality of life (HRQol). Additional long-term follow-up will be conducted for participants under a separate long-term follow-up protocol.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
248
Chimeric antigen receptor (CAR) T cell therapy
Lymphodepleting chemotherapy
Lymphodepleting chemotherapy
Lymphodepleting chemotherapy
Banner MD Anderson Cancer Center
Gilbert, Arizona, United States
RECRUITINGMayo Clinic
Phoenix, Arizona, United States
RECRUITINGUC San Diego Health
La Jolla, California, United States
RECRUITINGStanford University
Stanford, California, United States
Overall Response Rate
ORR
Time frame: through study completion, up to 2 years
Complete Response Rate
CRR
Time frame: 1 and 6 months
Duration of Response
DOR
Time frame: Up to 2 years
Overall Response Rate
ORR
Time frame: 1 and 6 months
Best Overall Response
BOR
Time frame: 2 years
Progression Free Survival
PFS
Time frame: Up to 2 years
Overall Survival
OS
Time frame: Up to 2 years
Type, frequency, and severity of adverse events
Safety
Time frame: Up to 2 years
Incidence of anti-MD-CART2019.1 antibodies
Bioanalytical
Time frame: Up to 2 years
Phenotype of MB-CART2019.1
Bioanalytical
Time frame: Up to 2 years
Persistence of MB-CART2019.1
Bioanalytical
Time frame: Up to 2 years
Quality of Life (QoL) assessments [EQ-5D-5L]
Health Outcomes - Standardized 5 question measure of health status developed by the EuroQol Group
Time frame: Up to 2 years
Patient-Reported Outcome (PRO) assessment [FACT-Lym]
Health Outcomes - To address health-related quality-of-life (HRQL) issues for Non-Hodgkin's lymphoma (NHL) patients
Time frame: Up to 2 years
Pharmacodynamics [Levels of cytokines in blood]
Bioanalytical
Time frame: Up to 2 years
Correlation of tumor CD19 and CD20 antigen expression with disease progression and relapse
Bioanalytical
Time frame: Up to 2 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Yale University
New Haven, Connecticut, United States
RECRUITINGBaptist Health Miami Cancer Institute
Miami, Florida, United States
RECRUITINGWinship Cancer Institute of Emory University
Atlanta, Georgia, United States
RECRUITINGGeorgia Cancer Center at Augusta University
Augusta, Georgia, United States
RECRUITINGRobert H Lurie Cancer Center
Chicago, Illinois, United States
RECRUITINGUniversity of Kansas Cancer Center
Westwood, Kansas, United States
RECRUITING...and 15 more locations