We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    ft-819
Previous Study | Return to List | Next Study

FT819 in Subjects With B-cell Malignancies

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04629729
Recruitment Status : Recruiting
First Posted : November 16, 2020
Last Update Posted : July 29, 2022
Sponsor:
Information provided by (Responsible Party):
Fate Therapeutics

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.

Condition or disease Intervention/treatment Phase
Lymphoma, B-Cell Chronic Lymphocytic Leukemia Precursor B-Cell Acute Lymphoblastic Leukemia Drug: FT819 Drug: Cyclophosphamide Drug: Fludarabine Drug: IL-2 Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 297 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Study of FT819 in Subjects With B-cell Malignancies
Actual Study Start Date : July 26, 2021
Estimated Primary Completion Date : September 30, 2024
Estimated Study Completion Date : September 30, 2039


Arm Intervention/treatment
Experimental: FT819 Single-Dose Monotherapy, B-Cell Lymphoma
FT819 single-dose monotherapy in adult subjects with r/r B-cell Lymphoma
Drug: FT819
Experimental Interventional Therapy

Drug: Cyclophosphamide
Lympho-conditioning agent

Drug: Fludarabine
Lympho-conditioning agent

Experimental: FT819 Single-Dose in Combination with IL-2, B-Cell Lymphoma
FT819 single-dose in combination with IL-2 in adult subjects with r/r B-cell Lymphoma
Drug: FT819
Experimental Interventional Therapy

Drug: Cyclophosphamide
Lympho-conditioning agent

Drug: Fludarabine
Lympho-conditioning agent

Drug: IL-2
Biologic response modifier
Other Name: Interleukin-2

Experimental: FT819 Step Fractionated Monotherapy, B-Cell Lymphoma
FT819 monotherapy administered as step-fractionated dosing in adult subjects with r/r B-cell Lymphoma
Drug: FT819
Experimental Interventional Therapy

Drug: Cyclophosphamide
Lympho-conditioning agent

Drug: Fludarabine
Lympho-conditioning agent

Experimental: FT819 Single-Dose Monotherapy, CLL
FT819 single-dose monotherapy in adult subjects with r/r CLL
Drug: FT819
Experimental Interventional Therapy

Drug: Cyclophosphamide
Lympho-conditioning agent

Drug: Fludarabine
Lympho-conditioning agent

Experimental: FT819 Single-Dose in Combination with IL-2, CLL
FT819 single-dose in combination with IL-2 in adult subjects with r/r CLL
Drug: FT819
Experimental Interventional Therapy

Drug: Cyclophosphamide
Lympho-conditioning agent

Drug: Fludarabine
Lympho-conditioning agent

Drug: IL-2
Biologic response modifier
Other Name: Interleukin-2

Experimental: FT819 Step Fractionated Monotherapy, CLL
FT819 monotherapy administered as step-fractionated dosing in adult subjects with r/r CLL
Drug: FT819
Experimental Interventional Therapy

Drug: Cyclophosphamide
Lympho-conditioning agent

Drug: Fludarabine
Lympho-conditioning agent

Experimental: FT819 Single-Dose Monotherapy, B-ALL
FT819 single-dose monotherapy in adult subjects with r/r B-ALL
Drug: FT819
Experimental Interventional Therapy

Drug: Cyclophosphamide
Lympho-conditioning agent

Drug: Fludarabine
Lympho-conditioning agent

Experimental: FT819 Single-Dose in Combination with IL-2, B-ALL
FT819 single-dose in combination with IL-2 in adult subjects with r/r B-ALL
Drug: FT819
Experimental Interventional Therapy

Drug: Cyclophosphamide
Lympho-conditioning agent

Drug: Fludarabine
Lympho-conditioning agent

Drug: IL-2
Biologic response modifier
Other Name: Interleukin-2

Experimental: FT819 Step Fractionated Monotherapy, B-ALL
FT819 monotherapy administered as step-fractionated dosing in adult subjects with r/r B-ALL
Drug: FT819
Experimental Interventional Therapy

Drug: Cyclophosphamide
Lympho-conditioning agent

Drug: Fludarabine
Lympho-conditioning agent




Primary Outcome Measures :
  1. Incidence and nature of dose-limiting toxicities within each dose level cohort [ Time Frame: Day 29 ]
  2. 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 [ Time Frame: Up to 15 years ]

Secondary Outcome Measures :
  1. Investigator-assessed objective-response rate (ORR) [ Time Frame: From baseline assessment up to approximately 2 years after last dose of FT819 ]
  2. For BCL and CLL Only: Investigator-assessed duration of objective response (DOR) [ Time Frame: Up to 15 years ]
  3. For BCL and CLL Only: Investigator-assessed duration of complete response (DoCR) [ Time Frame: Up to 15 years ]
  4. For BCL and CLL Only: Progression-free survival (PFS) [ Time Frame: Up to 15 years ]
  5. Overall survival (OS) [ Time Frame: Up to 15 years ]
  6. Determination of the pharmacokinetics of FT819 cells in peripheral blood. [ Time Frame: Study Days 1, 2, 3, 4, 5, 6, 8, 11, 15, 18, 22, 25, and 29 ]
    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

  7. For B-ALL Only: Investigator-assessed relapse-free survival (RFS) [ Time Frame: Up to 15 years ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04629729


Contacts
Layout table for location contacts
Contact: Rebecca Reynolds 858-875-1800 clinical@fatetherapeutics.com
Contact: Jamuna Thimmarayappa 858-875-1800 clinical@fatetherapeutics.com

Locations
Layout table for location information
United States, Alabama
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35294
United States, Iowa
University of Iowa Recruiting
Iowa City, Iowa, United States, 52242
United States, Kansas
The University of Kansas Medical Center Recruiting
Westwood, Kansas, United States, 66205
United States, New Jersey
Hackensack University Medical Center Recruiting
Hackensack, New Jersey, United States, 07601
United States, New York
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10021
United States, Oregon
Oregon Health & Sciences University Recruiting
Portland, Oregon, United States, 97239
United States, Texas
MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
United States, Wisconsin
University of Wisconsin-Madison Recruiting
Madison, Wisconsin, United States, 53705
Sponsors and Collaborators
Fate Therapeutics
Investigators
Layout table for investigator information
Study Director: Clinical Development Fate Therapeutics
Additional Information:
Layout table for additonal information
Responsible Party: Fate Therapeutics
ClinicalTrials.gov Identifier: NCT04629729    
Other Study ID Numbers: FT819-101
First Posted: November 16, 2020    Key Record Dates
Last Update Posted: July 29, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Fate Therapeutics:
Lymphoma
Leukemia
BCL
CLL
B-ALL
CAR-T
cellular therapy
Additional relevant MeSH terms:
Layout table for MeSH terms
Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphocytic, Chronic, B-Cell
Lymphoma, B-Cell
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, Lymphoid
Leukemia, B-Cell
Lymphoma, Non-Hodgkin
Cyclophosphamide
Fludarabine
Interleukin-2
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents