FT596 as a Monotherapy and in Combination With Anti-CD20 Monoclonal Antibodies

Fate Therapeutics

Status and phase: Terminated; Phase 1

Conditions: Lymphoma, B-Cell; Chronic Lymphocytic Leukemia

Treatments: Drug: FT596; Drug: Fludarabine; Drug: Obinutuzumab; Drug: Cyclophosphamide; Drug: Bendamustine; Drug: Rituximab

Study type: Interventional

Funder types: Industry

Identifiers

NCT04245722

FT596-101

Details and patient eligibility

About

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.

Enrollment: 98 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

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

B-Cell Lymphoma:

• Histologically documented lymphomas expected to express CD19 and CD20
• Relapsed/refractory disease following prior systemic immunochemotherapy regimen

Chronic Lymphocytic Leukemia (CLL):

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

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 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
• Prior allogeneic hematopoietic stem cell transplant (HSCT) or allogeneic CAR-T within 6 months of Day 1, or ongoing requirement for systemic GvHD therapy
• 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
• Known HIV infection
• Known active Hepatitis B (HBV) or 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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98 participants in 5 patient groups

FT596 Monotherapy, Lymphoma

Experimental group

Description:

FT596 monotherapy in adult subjects with r/r B-cell Lymphoma

Treatment:

Drug: Fludarabine

Drug: FT596

Drug: Bendamustine

Drug: Cyclophosphamide

FT596 in Combination with Rituximab, Lymphoma

Experimental group

Description:

FT596 in combination with Rituximab in adult subjects with r/r B-cell Lymphoma

Treatment:

Drug: Fludarabine

Drug: FT596

Drug: Rituximab

Drug: Bendamustine

Drug: Cyclophosphamide

FT596 in Combination with Obinutuzumab, Lymphoma

Experimental group

Description:

FT596 in combination with Obinutuzumab in adult subjects with r/r B-cell Lymphoma

Treatment:

Drug: Fludarabine

Drug: FT596

Drug: Bendamustine

Drug: Cyclophosphamide

Drug: Obinutuzumab

FT596 Monotherapy, CLL

Experimental group

Description:

FT596 monotherapy in adult subjects with r/r CLL

Treatment:

Drug: Fludarabine

Drug: FT596

Drug: Bendamustine

Drug: Cyclophosphamide

FT596 in Combination with Obinutuzumab, CLL

Experimental group

Description:

FT596 in combination with Obinutuzumab in adult subjects with r/r CLL

Treatment:

Drug: Fludarabine

Drug: FT596

Drug: Bendamustine

Drug: Cyclophosphamide

Drug: Obinutuzumab