This is a phase 1 study of FT522 administered with rituximab in participants with relapsed/refractory B-cell lymphoma (R/R BCL). The primary objectives of the study are to evaluate the safety and tolerability of FT522 in combination with rituximab, and to determine the recommended phase 2 dose (RP2D) of FT522 in combination with rituximab; each objective will be assessed with or without conditioning chemotherapy.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
20
FT522 drug product is administered as an intravenous infusion on Days 1, 4 and 8 of a treatment cycle.
Rituximab will be administered as an IV infusion on Day -4 of the treatment cycle.
Cyclophosphamide will be administered as an IV infusion at a dose of 500 mg/m\^2 on Day -5, Day -4, and Day -3 of the treatment cycle.
Advent Health
Orlando, Florida, United States
Karmanos Cancer Center
Detroit, Michigan, United States
University of Minnesota Masonic Cancer Center
Minneapolis, Minnesota, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
Number of participants with dose limiting toxicities (DLTs)
The number of participants experiencing ≥1 DLT will be reported.
Time frame: From Day 1 through Day 29 of Cycle 1
Severity of DLTs
The severity of DLTs will be determined according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE, v5.0).
Time frame: From Day 1 through Day 29 of Cycle 1
Overall Response Rate (ORR)
Participants will be classified into the following tumor response categories: complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD), or not evaluable (NE) according to the Lugano 2014 criteria. The best overall response (BOR) will be summarized for the efficacy evaluable population. ORR is defined as the percentage of participants who achieve a PR or better during the study prior to any subsequent off-protocol anti-cancer therapy.
Time frame: Up to approximately 24 months
Duration of Response (DOR)
The DOR is defined as the time from first objective response to disease progression or death from any cause.
Time frame: Up to approximately 18 months
Duration of Complete Response (DOCR)
The DOCR is defined as the time from first CR to disease progression or death from any cause.
Time frame: Up to approximately 18 months
Progression-Free Survival (PFS)
PFS is defined as the time from first study intervention to progressive disease or death from any cause.
Time frame: Up to approximately 18 months
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Fludarabine will be administered as an IV infusion at a dose of 30 mg/m\^2 on Day -5, Day -4, and Day -3 of the treatment cycle.
Bendamustine will be administered as an IV infusion at a dose of 90 mg/m\^2 on Day -5 and Day -4 of the treatment cycle. Bendamustine may be administered as an alternative to cyclophosphamide/fludarabine.
OU Health Stephenson Cancer Center
Oklahoma City, Oklahoma, United States
Tennessee Oncology
Nashville, Tennessee, United States
Baylor Houston Methodist Hospital
Houston, Texas, United States
Overall Survival (OS)
OS is defined as the time from first dose of study intervention to death from any cause.
Time frame: Up to approximately 18 months
Area Under the Plasma-Concentration Time Curve (AUC) of FT522
The plasma AUC of FT522 will be reported.
Time frame: Cycle 1, Up to Day 29
Maximum Plasma Concentration (Cmax) of FT522
The plasma Cmax of FT522 will be reported.
Time frame: Cycle 1, Up to Day 29