Description:
This is a Phase I multi-center study to evaluate the safety of FT596 when given with
rituximab as relapse prevention in patients who have undergone an autologous hematopoietic
stem cell transplant (auto-HSCT) for diffuse large or high-grade B cell lymphoma.
Title
- Brief Title: FT596 With Rituximab as Relapse Prevention After Autologous HSCT for NHL
- Official Title: FATE FT596 With Rituximab as Relapse Prevention in High Risk Patients After Autologous Hematopoietic Stem Cell Transplantation for Non-Hodgkin Lymphoma
Clinical Trial IDs
- ORG STUDY ID:
2019LS230
- NCT ID:
NCT04555811
Conditions
- NHL
- Non Hodgkin Lymphoma
- Diffuse Large B Cell Lymphoma
- High-grade B-cell Lymphoma
Interventions
| Drug | Synonyms | Arms |
|---|
| FT596 | | FT596 + Rituximab Dose Level 1: 9x10^7 cells/dose |
| Rituximab | Rituxan | FT596 + Rituximab Dose Level 1: 9x10^7 cells/dose |
Purpose
This is a Phase I multi-center study to evaluate the safety of FT596 when given with
rituximab as relapse prevention in patients who have undergone an autologous hematopoietic
stem cell transplant (auto-HSCT) for diffuse large or high-grade B cell lymphoma.
Detailed Description
This study uses a single dose of the investigational product FT596 in the early
post-transplant period. Rituximab or an FDA approved by biosimilar including Rituxan®,
Truxima®, and Ruxience™ is given 48 to 72 hours prior to FT596. The goal of this study is to
1) establish a maximum tolerated dose (MTD) of FT596 when given 30 days after transplant and
2) to confirm the MTD and safety of giving a single dose of FT596 at Day 7 post-transplant
starting at one dose level below the MTD identified at Day 30.
Trial Arms
| Name | Type | Description | Interventions |
|---|
| FT596 + Rituximab Dose Level 1: 9x10^7 cells/dose | Experimental | Up to three sequential FT596 dose levels are planned for Day 30 administration: (Dose Level 1: 9x10^7 cells/dose, Dose Level 2: 3x10^8 cells/dose, Dose Level 3: 9x10^8 cells/dose with a Dose Level -1: 3x10^7 cells/dose tested only if dose limiting toxicity events (DLT) occur at dose level 1).The maximum tolerated dose will be determined by using a modified continual reassessment method (CRM). | |
| FT596 + Rituximab Dose Level 2: 3x10^8 cells/dose | Experimental | Up to three sequential FT596 dose levels are planned for Day 30 administration: (Dose Level 1: 9x10^7 cells/dose, Dose Level 2: 3x10^8 cells/dose, Dose Level 3: 9x10^8 cells/dose with a Dose Level -1: 3x10^7 cells/dose tested only if dose limiting toxicity events (DLT) occur at dose level 1).The maximum tolerated dose will be determined by using a modified continual reassessment method (CRM). | |
| FT596 + Rituximab Dose Level 3: 9x10^8 cells/dose | Experimental | Up to three sequential FT596 dose levels are planned for Day 30 administration: (Dose Level 1: 9x10^7 cells/dose, Dose Level 2: 3x10^8 cells/dose, Dose Level 3: 9x10^8 cells/dose with a Dose Level -1: 3x10^7 cells/dose tested only if dose limiting toxicity events (DLT) occur at dose level 1).The maximum tolerated dose will be determined by using a modified continual reassessment method (CRM). | |
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of diffuse large B cell lymphoma or aggressive (high-grade) B-cell lymphoma
for which an autologous stem cell transplant is planned or recently completed
- High risk for relapse defined as at least one of the below:
- Primary induction failure (no complete or partial remission at any point after
diagnosis
- Initial remission duration < 12 months
- Lack of complete metabolic (PET scan) response after 2-3 cycles of salvage
chemotherapy
- Evidence of c-myc and bcl-2 and/or bcl-6 re-arrangement (double hit or triple hit
lymphoma)
- Age-adjusted IPI 2-3 at relapse
- Age 18 years or older at the time of signing consent.
- Agrees to use adequate contraception (or evidence of sterility) for at least 12 months
after the last dose of rituximab.
- Agrees and signs the separate consent for up to 15 years of follow-up (Long-term
Follow-up study CPRC#2020LS052)
- Provides voluntary written consent prior to the performance of any research related
activities.
Exclusion Criteria:
- Receipt of any investigational therapy within 28 days prior to the first dose of FT596
or planned use of an investigational therapy during the first 100 days after
transplant
- Planned post-transplant irradiation prior to Day +100
- Seropositive for HIV, active Hepatitis B or C infection with detectable viral load by
PCR
- Body weight <50kg
- Known allergy to the following FT596 components: albumin (human) or DMSO
- Unable to receive rituximab
Post-HSCT Reconfirmation of eligibility
- No life-threatening medical issues (i.e. ongoing Grade 4 adverse events) where, in the
opinion of the treating investigator, use of FT596 is not in the patient's best
interest.
- No active uncontrolled infection.
- Adequate organ function post-transplant including:
- alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤5 x ULN
(Grade 2 CTCAE v5)
- total bilirubin ≤1.5 x ULN (Grade 1 CTCAE v5)
- serum creatinine ≤1.5 x ULN (Grade 1 CTCAE v5)
- oxygen saturation ≥93% on room air
- For Day 30 dosing only - CBC requirement consistent with engraftment (ANC>500,
platelet>20,000 without transfusion support within previous 7 days). There are no CBC
parameters for Day 7 dosing.
- No requirement for systemic immunosuppressive therapy (> 5mg prednisone daily) during
the FT596 dosing period.
| Maximum Eligible Age: | N/A |
| Minimum Eligible Age: | 18 Years |
| Eligible Gender: | All |
| Healthy Volunteers: | No |
Primary Outcome Measures
| Measure: | Number of participants experiencing dose limiting toxicity events |
| Time Frame: | 28 Days Post FT596 infusion |
| Safety Issue: | |
| Description: | The component I design (FT596 on day 30) will continue until the MTD is declared or until the first dose is declared to be above MTD. The component I dose limiting toxicity (DLT) is defined as any of the following events within 28 days after the FT596 dosing based on CTCAE v5:Grade 4 hematologic toxicity lasting > 7 days ,Grade 4 non-hematologic toxicity ,Grade ≥3 Infusion Related Reaction, Grade 2 acute GVHD that requires steroid therapy >7 days or progression after 3 days of steroids or has partial response after 14 days of treatment, Grade ≥3 acute GVHD, Grade 4 cytokine release syndrome (CRS), Grade 3 CRS that does not resolve to < Grade 2 in 72 hours, Grade 3 neurotoxicity, Grade 3 organ toxicity involving vital organs, Any Grade 3 non-hematological toxicity that does not resolve to ≤Grade 2 within 72 hours |
Secondary Outcome Measures
| Measure: | Number of participants experiencing adverse events |
| Time Frame: | 1 year post FT596 infusion |
| Safety Issue: | |
| Description: | Number of participants experiencing adverse events related to FT596 post auto-HSCT in combination with rituximab |
| Measure: | Number of participants with relapse/progression |
| Time Frame: | 1 year post auto HSCT |
| Safety Issue: | |
| Description: | Number of participants experiencing progression or relapse at 12 months post auto HSCT |
| Measure: | Number of non-relapse mortality incidents at 100 days post HSCT |
| Time Frame: | 100 days post HSCT |
| Safety Issue: | |
| Description: | Number of participants experiencing non-relapse mortality at 100 days post auto-HSCT. |
| Measure: | Number of non-relapse mortality incidents at one year post HSCT |
| Time Frame: | one year post auto-HSCT |
| Safety Issue: | |
| Description: | Number of participants experiencing non-relapse mortality at one year post auto-HSCT. |
Details
| Phase: | Phase 1 |
| Primary Purpose: | Interventional |
| Overall Status: | Recruiting |
| Lead Sponsor: | Masonic Cancer Center, University of Minnesota |
Trial Keywords
- auto HSCT
- Stem cell transplantation
- Lymphoma
Last Updated
December 11, 2020
