Description:
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.
Title
- Brief Title: FT596 as a Monotherapy and in Combination With Anti-CD20 Monoclonal Antibodies
- Official Title: 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
Clinical Trial IDs
- ORG STUDY ID:
FT596-101
- NCT ID:
NCT04245722
Conditions
- Lymphoma, B-Cell
- Chronic Lymphocytic Leukemia
Interventions
Drug | Synonyms | Arms |
---|
FT596 | | FT596 Monotherapy, CLL |
Cyclophosphamide | | FT596 Monotherapy, CLL |
Fludarabine | | FT596 Monotherapy, CLL |
Rituximab | Rituxan, MabThera | FT596 in Combination with Rituximab, Lymphoma |
Obinutuzumab | Gazyva | FT596 in Combination with Obinutuzumab, CLL |
Purpose
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.
Trial Arms
Name | Type | Description | Interventions |
---|
FT596 Monotherapy, Lymphoma | Experimental | FT596 monotherapy in adult subjects with r/r B-cell Lymphoma | - FT596
- Cyclophosphamide
- Fludarabine
|
FT596 in Combination with Rituximab, Lymphoma | Experimental | FT596 in combination with Rituximab in adult subjects with r/r B-cell Lymphoma | - FT596
- Cyclophosphamide
- Fludarabine
- Rituximab
|
FT596 in Combination with Obinutuzumab, Lymphoma | Experimental | FT596 in combination with Obinutuzumab in adult subjects with r/r B-cell Lymphoma | - FT596
- Cyclophosphamide
- Fludarabine
- Obinutuzumab
|
FT596 Monotherapy, CLL | Experimental | FT596 monotherapy in adult subjects with r/r CLL | - FT596
- Cyclophosphamide
- Fludarabine
|
FT596 in Combination with Obinutuzumab, CLL | Experimental | FT596 in combination with Obinutuzumab in adult subjects with r/r CLL | - FT596
- Cyclophosphamide
- Fludarabine
- Obinutuzumab
|
Eligibility 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
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Incidence of dose-limiting toxicities within each dose level cohort |
Time Frame: | Day 29 |
Safety Issue: | |
Description: | |
Secondary Outcome Measures
Measure: | Investigator-assessed objective-response rate (ORR) |
Time Frame: | From baseline tumor assessment up to approximately 2 years after last dose of FT596 |
Safety Issue: | |
Description: | Proportion of subjects who achieve a partial response (PR) or complete response (CR) per Lugano 2014 classification for lymphomas, a partial remission (PR) or complete remission (CR) per revised iwCLL guidelines for CLL. |
Measure: | Investigator-assessed duration of objective response (DOR) |
Time Frame: | Up to 15 years |
Safety Issue: | |
Description: | Defined as the duration from the first occurrence of a documented objective response (DOR) until the time of disease progression or relapse, or death from any cause, whichever occurs first, per Lugano 2014 classification for lymphomas or revised iwCLL guidelines for CLL. |
Measure: | Investigator-assessed duration of complete response (DoCR) |
Time Frame: | Up to 15 years |
Safety Issue: | |
Description: | Defined as the duration from the first occurrence of a documented complete response (CR) per Lugano 2014 classification for lymphomas or complete remission (CR) per revised iwCLL guidelines for CLL, until the time of disease progression or relapse, or death from any cause, whichever occurs first. |
Measure: | Progression-free survival (PFS) |
Time Frame: | Up to 15 years |
Safety Issue: | |
Description: | Defined as the time from from first dose of lympho-conditioning to progressive disease (PD), or to the day of death for any reason, whichever occurs earlier, based on Lugano 2014 classification for lymphomas or revised iwCLL guidelines for CLL |
Measure: | Overall survival (OS), defined as the time from first dose of lympho-conditioning to death from any cause. |
Time Frame: | Up to 15 years |
Safety Issue: | |
Description: | |
Measure: | The pharmacokinetics of FT596 in peripheral blood will be reported as the relative percentage of product (FT596) DNA versus patient DNA (% chimerism) measured from blood samples at the specified time points |
Time Frame: | Study Days: 1, 2, 4, 8, 11, 15, 18, 22, 29, 43, 57, 71*, 85* (* for 4-Dose Treatment Schedule) |
Safety Issue: | |
Description: | |
Details
Phase: | Phase 1 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Fate Therapeutics |
Trial Keywords
Last Updated
August 10, 2021