Clinical Trials /

FT596 With Rituximab as Relapse Prevention After Autologous HSCT for NHL

NCT04555811

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.

Related Conditions:
  • Diffuse Large B-Cell Lymphoma
  • Double-Hit Lymphoma
  • High Grade B-Cell Lymphoma, Not Otherwise Specified
  • Triple-Hit Lymphoma
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

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

DrugSynonymsArms
FT596FT596 + Rituximab Dose Level 1: 9x10^7 cells/dose
RituximabRituxanFT596 + 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 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

NameTypeDescriptionInterventions
FT596 + Rituximab Dose Level 1: 9x10^7 cells/doseExperimentalUp to three sequential FT596 dose levels are planned for Day 30 (±1 day) 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
FT596 + Rituximab Dose Level 2: 3x10^8 cells/doseExperimentalUp to three sequential FT596 dose levels are planned for Day 30 (±1 day) 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
FT596 + Rituximab Dose Level 3: 9x10^8 cells/doseExperimentalUp to three sequential FT596 dose levels are planned for Day 30 (±1 day) 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

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

          -  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) 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.
      
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

September 28, 2020