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MT2019-40: A Phase I, Open-Label, Multicenter Study of FT596 as a Monotherapy and in Combination with Rituximab or Obinutuzumab in Subjects with Relapsed/Refractory B-cell Lymphoma and Chronic Lymphocytic Leukemia

Recruiting

This study is designed to determine the recommended Phase II dose (RP2D), as well as evaluate the safety and efficacy for FT596 as monotherapy and in combination with rituximab or obinutuzumab in patients with relapsed/refractory B-cell Lymphoma and Chronic Lymphocytic Leukemia.

I'm interested

All
18 Years and over
This study is NOT accepting healthy volunteers
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

Drug: FT596, Drug: Cyclophosphamide, Drug: Fludarabine, Drug: Rituximab, Drug: Obinutuzumab

Lymphoma, B-Cell, Chronic Lymphocytic Leukemia

Lymphoma, Leukemia, Clinics and Surgery Center (CSC)

Veronika Bachanova - bach0173@umn.edu
Veronika Bachanova, MD
Phase 1
STUDY00008387
NCT04245722
See this study on ClinicalTrials.gov

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