FT819 in Subjects With B-cell Malignancies

Chronic Lymphocytic Leukemia Clinical Trial

Official title:

A Phase I Study of FT819 in Subjects With B-cell Malignancies

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04629729
• Other study ID #: FT819-101
• Status: Recruiting
• Phase: Phase 1
• Start date: July 26, 2021
• Est. completion date: September 30, 2039

Study information

• Verified date: November 2023
• Source: Fate Therapeutics
• Contact: Fate Trial Disclosure
• Phone: 866-875-1800
• Email: FateTrialDisclosure[@]fatetherapeutics.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 396
• Est. completion date: September 30, 2039
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Lymphocytic Leukemia
• Leukemia
• Leukemia, Lymphocytic, Chronic, B-Cell
• Lymphoma, B-Cell
• Precursor B-Cell Acute Lymphoblastic Leukemia
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention

Drug:
• FT819
Experimental Interventional Therapy
• Cyclophosphamide
Lympho-conditioning agent
• Fludarabine
Lympho-conditioning agent
• IL-2
Biologic response modifier
• Bendamustine
Lympho-conditioning agent

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	UC Davis	Davis	California
United States	Hackensack University Medical Center	Hackensack	New Jersey
United States	MD Anderson Cancer Center	Houston	Texas
United States	University of Iowa	Iowa City	Iowa
United States	Mayo Florida	Jacksonville	Florida
United States	UCLA Ronald Reagan Medical Center	Los Angeles	California
United States	Norton Cancer Institute, St. Matthews Campus	Louisville	Kentucky
United States	University of Wisconsin-Madison	Madison	Wisconsin
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	University of Nebraska Medical Center	Omaha	Nebraska
United States	Stanford Cancer Institute	Palo Alto	California
United States	Mayo Arizona	Phoenix	Arizona
United States	Oregon Health & Sciences University	Portland	Oregon
United States	Mayo Minnesota	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Fate Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence and nature of dose-limiting toxicities within each dose level cohort		Up to Day 29
Primary	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		Up to 15 years
Secondary	Investigator-assessed objective-response rate (ORR)		Up to approximately 2 years after last dose of FT819
Secondary	For BCL and CLL Only: Investigator-assessed duration of objective response (DOR)		Up to 15 years
Secondary	For BCL and CLL Only: Investigator-assessed duration of complete response (DoCR)		Up to 15 years
Secondary	For BCL and CLL Only: Progression-free survival (PFS)		Up to 15 years
Secondary	Overall survival (OS)		Up to 15 years
Secondary	Determination of the pharmacokinetics of FT819 cells in peripheral blood.	The PK of FT819 in peripheral blood will be reported as the relative percentage of product (FT819) DNA versus patient DNA (% chimerism) measured from blood samples at the specified time points	Study Days 1, 2, 3, 4, 5, 8, 11, 15, 22, and 29
Secondary	For B-ALL Only: Investigator-assessed relapse-free survival (RFS)		Up to 15 years

External Links

•   AACR 2020 Poster # 3245
•   ASH 2022 Abstract
•   ASH 2022 Poster Presentation
•   FT819: Translation of Off-the-Shelf TCR-Less Trac-1XX CAR-T Cells in Support of First-of-Kind Phase I Clinical Trial