Clinical trial NCT04629729: FT819 in Subjects With B-cell Malignancies
Official title: A Phase I Study of FT819 in Subjects With B-cell Malignancies
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Lymphoma, B-Cell
Chronic Lymphocytic Leukemia
Precursor B-Cell Acute Lymphoblastic Leukemia
Keywords: Lymphoma
Leukemia
BCL
CLL
B-ALL
CAR-T
cellular therapy
Lead sponsor: Fate Therapeutics
Sponsor class: INDUSTRY
First posted: 2020-11-16
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: This is a Phase I dose-finding study of FT819 as monotherapy and in combination with IL-2 in subjects with relapsed/refractory B-cell Lymphoma, Chronic Lymphocytic Leukemia and Precursor B-cell Acute Lymphoblastic Leukemia. The study will consist of a dose-escalation stage and an expansion stage where participants will be enrolled into indication-specific cohorts.


Eligibility criteria: Key Inclusion Criteria:

Diagnosis of B-cell lymphoma, CLL or B-ALL as described below:

B-Cell Lymphoma:

* Histologically documented lymphomas expected to express CD19
* Relapsed/refractory disease following at least 2 prior lines of multi-agent immunochemotherapy

Chronic Lymphocytic Leukemia (CLL):

* Diagnosis of CLL per iwCLL guidelines
* Relapsed/refractory disease following at least two prior systemic treatment regimens

Precursor B-cell Acute Lymphocytic Leukemia (B-ALL):

* Diagnosis of B-ALL by flow cytometry, bone marrow histology, and/or cytogenetics
* Relapsed/refractory disease after at least 2 cycles of standard multiagent induction chemotherapy. For subjects with Philadelphia-chromosome positive (Ph+) disease, failure or intolerance to a tyrosine kinase inhibitor therapy-containing regimen

ALL SUBJECTS:

* Capable of giving signed informed consent
* Age ≥ 18 years old
* Stated willingness to comply with study procedures and duration
* Contraceptive use for women and men as defined in the protocol

Key Exclusion Criteria:

ALL SUBJECTS:

* 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 therapy within 2 weeks prior to Day 1 or five half-lives, whichever is shorter; or any investigational therapy within 28 days prior to Day 1
* Currently receiving or likely to require systemic immunosuppressive therapy
* Ongoing requirement for systemic GvHD therapy following prior allogeneic hematopoietic stem cell transplant (HSCT) or allogeneic CAR-T
* Receipt of an 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 serologic test results for HIV infection
* Positive serologic and polymerase chain reaction (PCR) test results for Hepatitis B (HBV) infection
* Positive serologic and PCR test results for Hepatitis C (HCV) infection
* Live vaccine \<6 weeks prior to start of lympho-conditioning
* Known allergy to albumin (human) or DMSO

Primary outcomes:
measure: Incidence and nature of dose-limiting toxicities within each dose level cohort
timeFrame: Up to Day 29
measure: Incidence, nature, and severity of adverse events (AEs) of FT819 as monotherapy and in combination with IL-2 in r/r B-cell lymphoma, r/r chronic lymphocytic leukemia, and r/r precursor B-cell acute lymphoblastic leukemia
timeFrame: Up to 15 years
Secondary outcomes:
measure: Investigator-assessed objective-response rate (ORR)
timeFrame: Up to approximately 2 years after last dose of FT819
measure: For BCL and CLL Only: Investigator-assessed duration of objective response (DOR)
timeFrame: Up to 15 years
measure: For BCL and CLL Only: Investigator-assessed duration of complete response (DoCR)
timeFrame: Up to 15 years
measure: For BCL and CLL Only: Progression-free survival (PFS)
timeFrame: Up to 15 years
measure: Overall survival (OS)
timeFrame: Up to 15 years
measure: Determination of the pharmacokinetics of FT819 cells in peripheral blood.
timeFrame: Study Days 1, 2, 3, 4, 5, 8, 11, 15, 22, and 29
measure: For B-ALL Only: Investigator-assessed relapse-free survival (RFS)
timeFrame: Up to 15 years
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Phoenix
country: United States
facility: Mayo Arizona
state: Arizona
city: Davis
country: United States
facility: UC Davis
state: California
city: La Jolla
country: United States
facility: Scripps Green Hospital
state: California
city: Los Angeles
country: United States
facility: UCLA Ronald Reagan Medical Center
state: California
city: Palo Alto
country: United States
facility: Stanford Cancer Institute
state: California
city: Jacksonville
country: United States
facility: Mayo Florida
state: Florida
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
city: Westwood
country: United States
facility: The University of Kansas Cancer Center
state: Kansas
city: Louisville
country: United States
facility: Norton Cancer Institute, St. Matthews Campus
state: Kentucky
city: Rochester
country: United States
facility: Mayo Minnesota
state: Minnesota
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Portland
country: United States
facility: Oregon Health & Sciences University
state: Oregon
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
city: Madison
country: United States
facility: University of Wisconsin-Madison
state: Wisconsin
Study officials:
affiliation: Fate Therapeutics
name: Fate Trial Disclosure
role: STUDY_DIRECTOR
References: