FT819 in Subjects With B-cell Malignancies

Fate Therapeutics

Status and phase: Active, not recruiting; Phase 1

Conditions: Precursor B-Cell Acute Lymphoblastic Leukemia; Lymphoma, B-Cell; Chronic Lymphocytic Leukemia

Treatments: Drug: Bendamustine; Drug: Fludarabine; Drug: FT819; Drug: Cyclophosphamide; Drug: IL-2

Study type: Interventional

Funder types: Industry

Identifiers

NCT04629729

FT819-101

Details and patient eligibility

About

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.

Enrollment: 54 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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54 participants in 12 patient groups

FT819 Single-Dose Monotherapy, B-Cell Lymphoma

Experimental group

Description:

FT819 single-dose monotherapy in adult subjects with r/r B-cell Lymphoma

Treatment:

Drug: Cyclophosphamide

Drug: FT819

Drug: Fludarabine

Drug: Bendamustine

FT819 Single-Dose in Combination with IL-2, B-Cell Lymphoma

Experimental group

Description:

FT819 single-dose in combination with IL-2 in adult subjects with r/r B-cell Lymphoma

Treatment:

Drug: IL-2

Drug: Cyclophosphamide

Drug: FT819

Drug: Fludarabine

Drug: Bendamustine

FT819 Step Fractionated Monotherapy, B-Cell Lymphoma

Experimental group

Description:

FT819 monotherapy administered as step-fractionated dosing in adult subjects with r/r B-cell Lymphoma

Treatment:

Drug: Cyclophosphamide

Drug: FT819

Drug: Fludarabine

Drug: Bendamustine

FT819 Single-Dose Monotherapy, CLL

Experimental group

Description:

FT819 single-dose monotherapy in adult subjects with r/r CLL

Treatment:

Drug: Cyclophosphamide

Drug: FT819

Drug: Fludarabine

Drug: Bendamustine

FT819 Single-Dose in Combination with IL-2, CLL

Experimental group

Description:

FT819 single-dose in combination with IL-2 in adult subjects with r/r CLL

Treatment:

Drug: IL-2

Drug: Cyclophosphamide

Drug: FT819

Drug: Fludarabine

Drug: Bendamustine

FT819 Step Fractionated Monotherapy, CLL

Experimental group

Description:

FT819 monotherapy administered as step-fractionated dosing in adult subjects with r/r CLL

Treatment:

Drug: Cyclophosphamide

Drug: FT819

Drug: Fludarabine

Drug: Bendamustine

FT819 Single-Dose Monotherapy, B-ALL

Experimental group

Description:

FT819 single-dose monotherapy in adult subjects with r/r B-ALL

Treatment:

Drug: Cyclophosphamide

Drug: FT819

Drug: Fludarabine

Drug: Bendamustine

FT819 Single-Dose in Combination with IL-2, B-ALL

Experimental group

Description:

FT819 single-dose in combination with IL-2 in adult subjects with r/r B-ALL

Treatment:

Drug: IL-2

Drug: Cyclophosphamide

Drug: FT819

Drug: Fludarabine

Drug: Bendamustine

FT819 Step Fractionated Monotherapy, B-ALL

Experimental group

Description:

FT819 monotherapy administered as step-fractionated dosing in adult subjects with r/r B-ALL

Treatment:

Drug: Cyclophosphamide

Drug: FT819

Drug: Fludarabine

Drug: Bendamustine

FT819 Step Fractionated Monotherapy in Combination with IL-2, B-Cell Lymphoma

Experimental group

Description:

FT819 monotherapy administered as step-fractionated dosing in combination with IL-2 in adult subjects with r/r B-cell Lymphoma

Treatment:

Drug: IL-2

Drug: Cyclophosphamide

Drug: FT819

Drug: Fludarabine

Drug: Bendamustine

FT819 Step Fractionated Monotherapy in Combination with IL-2, CLL

Experimental group

Description:

FT819 monotherapy administered as step-fractionated dosing in combination with IL-2 in adult subjects with r/r CLL

Treatment:

Drug: IL-2

Drug: Cyclophosphamide

Drug: FT819

Drug: Fludarabine

Drug: Bendamustine

FT819 Step Fractionated Monotherapy in Combination with IL-2, B-ALL

Experimental group

Description:

FT819 monotherapy administered as step-fractionated dosing in combination with IL-2 in adult subjects with r/r B-ALL

Treatment:

Drug: IL-2

Drug: Cyclophosphamide

Drug: FT819

Drug: Fludarabine

Drug: Bendamustine