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Keep this study
Lead
Fate Therapeutics
This is a Phase I study of FT596 in combination with 2 different schedules (standard or alternate) of R-CHOP in subjects with B-cell lymphoma who are previously untreated or have received no more than one prior line of treatment.
The study will evaluate both the clinical benefit of FT596 when combined with R-CHOP given on a standard or alternate schedule.
Subjects will be enrolled in two stages: a dose-escalation stage and a dose-expansion stage. After safety and tolerability have been assessed to define the maximum tolerated dose (MTD) (or the maximum assessed dose \[MAD\] in the absence of dose limiting toxicities \[DLTs\] defining the MTD) in the dose-escalation stage, the dose-expansion stage will further evaluate the safety and activity of FT596 in combination.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Diagnosis of B-cell lymphoma (BCL) as described below:
* Histologically documented BCL
* Previously untreated or no more than one prior systemic therapy for BCL
* At least one bi-dimensionally measurable lesion
* Subjects with \>1 measurable lesion agreement to undergo a biopsy
Capable of giving signed informed consent
Age ≥ 18 years old
Stated willingness to comply with study procedures through study duration
Contraception use for women and men as defined in the protocol
Negative serum pregnancy test within 7 days of treatment for women
You may not be if
Prior anthracycline therapy
Females who are pregnant or breastfeeding
Eastern Cooperative Oncology Group (ECOG) Performance Status ≥2
Evidence of insufficient organ function
Currently receiving or likely to receive systemic immunosuppressive therapy
Receipt of allograft organ transplant
Known active central nervous system (CNS) involvement by malignancy
Non-malignant CNS disease such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease
Clinically significant cardiovascular disease
Positive HIV test
Positive Hepatitis B (HBV) or Hepatitis C (HCV) test
Live vaccine \<6 weeks prior to start of conditioning
Allergy to human albumin or dimethyl sulfoxide (DMSO)
Clareo Health | FT596 in Combination With R-CHOP in Subjects With B-Cell Lymphoma
