FT596 as a Monotherapy and in Combination With Anti-CD20 Monoclonal Antibodies
- Interventional
- Recruiting
- NCT04245722
Contact Information
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
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.
Gender
All
Age Group
18 Years and up
Accepting Healthy Volunteers?
No
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
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