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FT596 With Rituximab as Relapse Prevention After Autologous HSCT for NHL

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ClinicalTrials.gov Identifier: NCT04555811
Recruitment Status : Recruiting
First Posted : September 21, 2020
Last Update Posted : December 11, 2020
Sponsor:
Information provided by (Responsible Party):
Masonic Cancer Center, University of Minnesota

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
NHL Non Hodgkin Lymphoma Diffuse Large B Cell Lymphoma High-grade B-cell Lymphoma Drug: FT596 Drug: Rituximab Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description:

Patients are enrolled in cohorts of 3 starting at Dose Level 1. There are three dose escalating doses of FT596. A minimum of 28 days will separate each cohort. For Dose Level 1 a minimum of 28 days will separate each patient to assess for dose limiting toxicity (DLT). In subsequent cohorts, the 1st and 2nd patient will be separated by at least 28 days and at least 14 days will separate the 2nd and 3rd patient.

Each new cohort of three patients will be sequentially assigned to the most appropriate dose based on the updated toxicity probabilities under the continuous reassessment method (CRM), and the MTD will be identified when the total sample size of 18 is exhausted or 6 patients are sequentially enrolled at the same dose.

Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: FATE FT596 With Rituximab as Relapse Prevention in High Risk Patients After Autologous Hematopoietic Stem Cell Transplantation for Non-Hodgkin Lymphoma
Actual Study Start Date : September 22, 2020
Estimated Primary Completion Date : October 2025
Estimated Study Completion Date : October 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
Drug Information available for: Rituximab

Arm Intervention/treatment
Experimental: FT596 + Rituximab Dose Level 1: 9x10^7 cells/dose
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).
Drug: FT596
FT596 is given 2-3 days after rituximab; however, it may be delayed for up to 7 days until all rituximab infusion related toxicities resolve to ≤Grade 1.

Drug: Rituximab
Rituximab 375 mg/m^2 is administered as an IV infusion per institutional standard of care and package insert on 2-3 days (48 to 72 hours) prior to the FT596 infusion
Other Name: Rituxan

Experimental: FT596 + Rituximab Dose Level 2: 3x10^8 cells/dose
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).
Drug: FT596
FT596 is given 2-3 days after rituximab; however, it may be delayed for up to 7 days until all rituximab infusion related toxicities resolve to ≤Grade 1.

Drug: Rituximab
Rituximab 375 mg/m^2 is administered as an IV infusion per institutional standard of care and package insert on 2-3 days (48 to 72 hours) prior to the FT596 infusion
Other Name: Rituxan

Experimental: FT596 + Rituximab Dose Level 3: 9x10^8 cells/dose
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).
Drug: FT596
FT596 is given 2-3 days after rituximab; however, it may be delayed for up to 7 days until all rituximab infusion related toxicities resolve to ≤Grade 1.

Drug: Rituximab
Rituximab 375 mg/m^2 is administered as an IV infusion per institutional standard of care and package insert on 2-3 days (48 to 72 hours) prior to the FT596 infusion
Other Name: Rituxan




Primary Outcome Measures :
  1. Number of participants experiencing dose limiting toxicity events [ Time Frame: 28 Days Post FT596 infusion ]
    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 :
  1. Number of participants experiencing adverse events [ Time Frame: 1 year post FT596 infusion ]
    Number of participants experiencing adverse events related to FT596 post auto-HSCT in combination with rituximab

  2. Number of participants with relapse/progression [ Time Frame: 1 year post auto HSCT ]
    Number of participants experiencing progression or relapse at 12 months post auto HSCT

  3. Number of non-relapse mortality incidents at 100 days post HSCT [ Time Frame: 100 days post HSCT ]
    Number of participants experiencing non-relapse mortality at 100 days post auto-HSCT.

  4. Number of non-relapse mortality incidents at one year post HSCT [ Time Frame: one year post auto-HSCT ]
    Number of participants experiencing non-relapse mortality at one year post auto-HSCT.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04555811


Contacts
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Contact: Cancer Center Clinical Trials Office 612-676-4200 ccinfo@umn.edu

Locations
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United States, Minnesota
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55401
Principal Investigator: Dr.Veronika Bachanova, MD, PhD         
United States, Missouri
Washington University School of Medicine - Siteman Cancer Center Not yet recruiting
Saint Louis, Missouri, United States, 63110
Contact: Todd Fehniger, MD, PhD         
Principal Investigator: Todd A Fehniger, MD, PhD         
Sponsors and Collaborators
Masonic Cancer Center, University of Minnesota
Investigators
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Principal Investigator: Dr.Veronika Bachanova, MD, PhD Masonic Cancer Center, University of Minnesota
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Responsible Party: Masonic Cancer Center, University of Minnesota
ClinicalTrials.gov Identifier: NCT04555811    
Other Study ID Numbers: 2019LS230
First Posted: September 21, 2020    Key Record Dates
Last Update Posted: December 11, 2020
Last Verified: December 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Masonic Cancer Center, University of Minnesota:
auto HSCT
Stem cell transplantation
Lymphoma
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Rituximab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents