This is a single arm, two-stage, Phase 2, open-label, multicenter study of MB-105 in patients with CD5 Positive (CD5+) Relapsed / Refractory T-cell Lymphoma (r/r TCL). This study will apply a Simon two-stage optimal design.
The first stage of the Simon two-stage design will enroll approximately 15 evaluable patients. Once the first 6 patients are enrolled, have received one dose of MB-105 at the recommended phase 2 dose (RP2D), and completed at least up to Day 30 of the study, the Independent Data Monitoring Committee (IDMC) will perform a safety analysis. The IDMC will use this analysis to confirm that the RP2D selected for this Phase 2 study is the appropriate dose of MB-105 for further clinical evaluation. The IDMC will either recommend continuing the remainder of the study at the fixed dose of 50 million (5 x 107) Chimeric antigen receptor (CAR) positive cells or recommend other actions, which could include repeating the safety run-in with either a lower or higher dose. The IDMC will not recommend a MB-105 dose greater than those found safe in the phase 1 study. During the safety analysis period after the 6th patient is treated and awaiting data analysis, patients will continue to be screened but not dosed until the IDMC recommendation is made. If the IDMC confirms the suggested RP2D is the appropriate dose for further clinical evaluation, the study will enroll an additional 9 patients to complete 15 total patients for Stage 1 to obtain a preliminary estimate of response rate per Lugano criteria for peripheral T-cell lymphoma (PTCL) and 2022 Global criteria for cutaneous cases (CTCL). At the end of Stage 1, defined as when the last patient enrolled completes study visits up to Day 56, including efficacy assessment, the IDMC will convene to review all available Stage 1 data and recommend continuation to Stage 2 or closure of enrollment. Stage 2 will enroll approximately 31 patients, for a total of 46 patients in the study. During Stage 2 the IDMC will convene at least once every 6 months to review safety and efficacy on an ongoing basis. No formal interim analysis is planned after the end of Stage 1, but since this is an open-label study, interim data extracts may be performed to support abstract submissions, presentations, or regulatory discussions. The study will end once the last patient completes at least 12 months of follow-up and end of study (EOS) visit. After EOS, all patients will be asked to participate in a separate long term follow-up (LTFU) study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
46
MB-105 is a CAR T-cell therapy that consists of autologous T-cells that express a CD5 CAR.
University of San Diego (UCSD)-Moores Cancer Center
San Diego, California, United States
RECRUITINGSCRI - Colorado Blood Cancer Institute (CBCI)
Denver, Colorado, United States
Adverse events (AEs) per Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Incidence, severity, causal relationship of AEs
Time frame: 26 months
Objective response rate (ORR)
Best objective response rate (ORR) per independent central review as defined by rate of complete response (CR) and PR using the 2014 Lugano criteria and 2022 Global criteria.
Time frame: 26 months
Duration of response (DOR)
Duration of Response (DOR), defined as time from first observation of response to the time of disease progression or death, whichever comes first (per investigator and by central review).
Time frame: 26 months
Progression-free survival (PFS)
Progression-free survival (PFS), defined as time from administration of MB-105 to the time of disease progression or death, whichever comes first (per investigator and by central review).
Time frame: 26 months
Incidence of adverse events during the safety monitoring period for acute toxicities
* All AEs from leukapheresis up to Day 30. * Related AEs from MB-105 infusion to Day 90 (i.e. excluding only AEs that are clearly an expected event from underlying condition or non-study related treatment). * SAEs and all-cause mortality from MB-105 infusion to EOS at Month 24.
Time frame: 26 months
Overall survival (OS)
Overall survival (OS), defined as time from administration of MB-105 to death.
Time frame: 26 months
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Moffitt Cancer Center Magnolia Campus
Tampa, Florida, United States
RECRUITINGUniversity of Iowa
Iowa City, Iowa, United States
RECRUITINGMassachusetts General Hospital
Boston, Massachusetts, United States
RECRUITINGUniversity of Nebraska
Omaha, Nebraska, United States
RECRUITINGMemorial Sloan Kettering Cancer Center
New York, New York, United States
RECRUITINGUniversity of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
RECRUITINGCleveland Clinic
Cleveland, Ohio, United States
NOT_YET_RECRUITINGOregan Health & Science University
Portland, Oregon, United States
NOT_YET_RECRUITING...and 2 more locations