A Phase 1 interventional study of FT596 and Cyclophosphamide in Lymphoma, B-Cell and Chronic Lymphocytic Leukemia, sponsored by Fate Therapeutics. Terminated at 9 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-10-26.
Sponsored by Fate Therapeutics · Phase 1, Interventional, and Treatment
This is a Phase I dose-finding study of FT596 as monotherapy and in combination with Rituximab or Obinutuzumab in subjects with relapsed/refractory B-cell Lymphoma or Chronic Lymphocytic Leukemia. The study will consist of a dose-escalation stage and an expansion stage where participants will be enrolled into indication-specific cohorts.
5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.
This study's enrollment of 98 is above the median of 40 across 4,508 interventional studies indexed under Lymphoma.
Browse Lymphoma studies →Fate Therapeutics is the lead sponsor of 25 studies on the registry; 5 are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Diagnosis of B-cell lymphoma or CLL as described below:
B-Cell Lymphoma:
Chronic Lymphocytic Leukemia (CLL):
ALL SUBJECTS:
Key Exclusion Criteria:
ALL SUBJECTS:
FT596 monotherapy in adult subjects with r/r B-cell Lymphoma
Drug: FT596 · Drug: Cyclophosphamide · Drug: Fludarabine · Drug: Bendamustine
FT596 in combination with Rituximab in adult subjects with r/r B-cell Lymphoma
Drug: FT596 · Drug: Cyclophosphamide · Drug: Fludarabine · Drug: Rituximab · Drug: Bendamustine
FT596 in combination with Obinutuzumab in adult subjects with r/r B-cell Lymphoma
Drug: FT596 · Drug: Cyclophosphamide · Drug: Fludarabine · Drug: Obinutuzumab · Drug: Bendamustine
FT596 monotherapy in adult subjects with r/r CLL
Drug: FT596 · Drug: Cyclophosphamide · Drug: Fludarabine · Drug: Bendamustine
FT596 in combination with Obinutuzumab in adult subjects with r/r CLL
Drug: FT596 · Drug: Cyclophosphamide · Drug: Fludarabine · Drug: Obinutuzumab · Drug: Bendamustine
Experimental Interventional Therapy
Lympho-conditioning agent
Lympho-conditioning agent
Monoclonal Antibody
Also known as: Rituxan, Truxima, Ruxience
Monoclonal Antibody
Also known as: Gazyva
Conditioning agent
Also known as: Bendeka, Treanda
Incidence of dose-limiting toxicities within each dose level cohort
Time frame: Day 29
Nature of dose-limiting toxicities within each dose level cohort
Time frame: Day 29
Incidence, nature, and severity of adverse events (AEs) of FT596 as monotherapy and in combination with rituximab or obinutuzumab in r/r B-cell lymphomas and r/r chronic lymphocytic leukemia, with severity determined according to NCI CTCAE, v5.0
Time frame: Up to 15 years
Investigator-assessed objective-response rate (ORR)
Proportion of subjects who achieve a partial response (PR) or complete response (CR) per Lugano 2014 classification for lymphomas, a partial remission (PR) or complete remission (CR) per revised iwCLL guidelines for CLL.
Time frame: From baseline tumor assessment up to approximately 2 years after last dose of FT596
Investigator-assessed duration of objective response (DOR)
Defined as the duration from the first occurrence of a documented objective response (DOR) until the time of disease progression or relapse, or death from any cause, whichever occurs first, per Lugano 2014 classification for lymphomas or revised iwCLL guidelines for CLL.
Time frame: Up to 15 years
Investigator-assessed duration of complete response (DoCR)
Defined as the duration from the first occurrence of a documented complete response (CR) per Lugano 2014 classification for lymphomas or complete remission (CR) per revised iwCLL guidelines for CLL, until the time of disease progression or relapse, or death from any cause, whichever occurs first.
Time frame: Up to 15 years
Progression-free survival (PFS)
Defined as the time from from first dose of lympho-conditioning to progressive disease (PD), or to the day of death for any reason, whichever occurs earlier, based on Lugano 2014 classification for lymphomas or revised iwCLL guidelines for CLL
Time frame: Up to 15 years
Overall survival (OS), defined as the time from first dose of lympho-conditioning to death from any cause.
Time frame: Up to 15 years
The pharmacokinetics of FT596 in peripheral blood will be reported as the relative percentage of product (FT596) DNA versus patient DNA (% chimerism) measured from blood samples at the specified time points
Time frame: Study Days: 1, 2, 4, 8, 11, 15, 18, 22, 29
Plan to share: No
This study is terminated, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Fate Therapeutics