This is a Phase 1, first-in-human (FIH), open-label, multicenter, study of LB1901 administered to adult subjects with histologically confirmed CD4+ relapsed or refractory Peripheral T-cell lymphoma (PTCL) (PTCL not otherwise specified \[PTCL-NOS\] and angioimmunoblastic \[AITL\]), or relapsed or refractory cutaneous T-cell lymphoma (CTCL) (Sézary syndrome \[SS\] and mycosis fungoides \[MF\]).
Study Design: This is a Phase 1, first-in-human (FIH), open-label, multicenter, multicohort study of LB1901 administered to adult subjects with histologically confirmed CD4+ relapsed or refractory Peripheral T-cell lymphoma (PTCL) (PTCL not otherwise specified \[PTCL-NOS\] and angioimmunoblastic \[AITL\]), or relapsed or refractory cutaneous T-cell lymphoma (CTCL) (Sézary syndrome \[SS\] and mycosis fungoides \[MF\]).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
LB1901 - an autologous CD4-targeted CAR-T immunotherapy
Mayo Clinic
Rochester, Minnesota, United States
MD Anderson Cancer Center
Houston, Texas, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
To characterize the safety and tolerability of LB1901 and determine the optimal dose or recommended dose for expansion (RDE).
Multiple doses will be tested to establish a recommended dose.
Time frame: Up to 2 years
To further characterize the safety and tolerability of LB1901 with the RDE identified in the dose escalation and determine the recommended Phase 2 dose (RP2D).
Treatment of additional patients at the recommended dose as identified in the initial dose escalation part of the study.
Time frame: Up to 2 years
Over all Response
Based on International Working Group Response Criteria for PTCL. Global Composite Response for CTCL
Time frame: Up to 4 years
Time to response (TTR)
Based on International Working Group Response Criteria for PTCL. Global Composite Response for CTCL
Time frame: Up to 4 years
Duration of response (DOR)
Based on International Working Group Response Criteria for PTCL. Global Composite Response for CTCL
Time frame: Up to 4 years
Disease control rate (DCR)
Based on International Working Group Response Criteria for PTCL. Global Composite Response for CTCL
Time frame: Up to 4 years
Progression-free survival (PFS)
Based on International Working Group Response Criteria for PTCL. Global Composite Response for CTCL
Time frame: Up to 4 years
Overall survival (OS)
Based on International Working Group Response Criteria for PTCL. Global Composite Response for CTCL
Time frame: Up to 4 years
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