Trial Title:
FT522 With Rituximab in Relapsed/Refractory B-Cell Lymphoma (FT522-101)
NCT ID:
NCT05950334
Condition:
Relapsed/Refractory B-Cell Lymphoma
Conditions: Official terms:
Lymphoma
Lymphoma, B-Cell
Cyclophosphamide
Bendamustine Hydrochloride
Rituximab
Fludarabine
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Intervention model description:
Participants will be enrolled first into a dose-escalation stage, followed by a dose
optimization stage, and a dose-expansion stage.
Primary purpose:
Treatment
Masking:
None (Open Label)
Masking description:
The initial dose escalation stage of the study is nonrandomized; the dose optimization
stage is randomized; the dose expansion stage is nonrandomized.
Intervention:
Intervention type:
Drug
Intervention name:
FT522
Description:
FT522 drug product is administered as an intravenous infusion on Days 1, 4 and 8 of a
treatment cycle.
Arm group label:
Regimen A
Arm group label:
Regimen B
Intervention type:
Drug
Intervention name:
Rituximab
Description:
Rituximab will be administered as an IV infusion on Day -4 of the treatment cycle.
Arm group label:
Regimen A
Arm group label:
Regimen B
Other name:
RITUXAN
Other name:
TRUXIMA
Other name:
RUXIENCE
Other name:
RIABNI
Intervention type:
Drug
Intervention name:
Cyclophosphamide
Description:
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.
Arm group label:
Regimen A
Intervention type:
Drug
Intervention name:
Fludarabine
Description:
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.
Arm group label:
Regimen A
Intervention type:
Drug
Intervention name:
Bendamustine
Description:
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.
Arm group label:
Regimen A
Summary:
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Diagnosis of B-cell lymphoma (BCL) as: (1) histologically documented lymphomas
expected to express CD19 and CD20, including Grades 1 to 3B follicular lymphoma
(FL), marginal zone lymphoma (MZL), Waldenstrom macroglobulinemia (WM), mantle cell
lymphoma (MCL), transformed indolent non-Hodgkin lymphoma (tNHL), diffuse large
B-cell lymphoma (DLBCL) [not otherwise specified], high-grade BCL, primary
mediastinal BCL, and Richter transformation (RT; expansion part of study only); (2)
R/R disease following at least 1 prior systemic regimen containing an anti-CD20
monoclonal antibody (mAb) for which the participant has no available curative
treatment options; and (3) evaluable F-fluorodeoxyglucose (FDG)-avid disease, or
measurable disease defined by at least one bi dimensionally measurable lesion
- Male participants and female participants of childbearing potential who engage in
heterosexual intercourse must agree to use protocol-specified method(s) of
contraception
Exclusion Criteria:
- Females who are pregnant or breastfeeding
- Eastern Cooperative Oncology Group (ECOG) Performance Status ≥2
- Body weight <50 kg
- Evidence of insufficient organ function
- Receipt of any biological therapy, chemotherapy (except for rituximab), or any
investigational therapy within 2 weeks prior to Day 1 or five half-lives, whichever
is shorter; or localized radiation therapy to a target lesion within 14 days prior
to Day 1
- Currently receiving or likely to require systemic immunosuppressive therapy, e.g.,
prednisone >5 mg daily, for any reason from Day -5 to Day 29, with the exception of
corticosteroids as a pre medication required for conditioning chemotherapy or
rituximab
- Prior allogeneic hematopoietic stem cell transplant (HSCT) or allogeneic chimeric
antigen receptor (CAR) T-cell therapy within 6 months of Day 1, or ongoing
requirement for systemic graft-versus-host disease (GvHD) therapy
- Receipt of an allograft organ transplant
- Non-malignant central nervous system (CNS) disease such as stroke, epilepsy, CNS
vasculitis, or neurodegenerative disease or receipt of medications for these
conditions in the 2-year period leading up to study enrollment
- Clinically significant cardiovascular disease
- Clinically significant infections
- Receipt of a live vaccine <6 weeks prior to start of study intervention
- Known allergy to human albumin or DMSO
- Any medical condition or clinical laboratory abnormality that per investigator or
medical monitor judgement, precludes safe participation in and completion of the
study, or that could affect compliance with protocol conduct or interpretation of
results
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Karmanos Cancer Center
Address:
City:
Detroit
Zip:
48201
Country:
United States
Status:
Recruiting
Facility:
Name:
University of Minnesota Masonic Cancer Center
Address:
City:
Minneapolis
Zip:
55455
Country:
United States
Status:
Recruiting
Facility:
Name:
University of Nebraska Medical Center
Address:
City:
Omaha
Zip:
68198
Country:
United States
Status:
Recruiting
Facility:
Name:
OU Health Stephenson Cancer Center
Address:
City:
Oklahoma City
Zip:
73104
Country:
United States
Status:
Recruiting
Facility:
Name:
Tennessee Oncology
Address:
City:
Nashville
Zip:
37203
Country:
United States
Status:
Recruiting
Facility:
Name:
Baylor Houston Methodist Hospital
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Recruiting
Start date:
November 16, 2023
Completion date:
June 30, 2044
Lead sponsor:
Agency:
Fate Therapeutics
Agency class:
Industry
Source:
Fate Therapeutics
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05950334
