FT596 With Rituximab as Relapse Prevention After Autologous HSCT for NHL

  • STATUS
    Recruiting
  • End date
    Oct 22, 2025
  • participants needed
    50
  • sponsor
    Masonic Cancer Center, University of Minnesota
Updated on 22 March 2022
remission
rituximab
b-cell lymphoma

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.

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.

Details
Condition NHL, Non Hodgkin Lymphoma, Diffuse Large B Cell Lymphoma, High-grade B-cell Lymphoma
Treatment Rituximab, FT596
Clinical Study IdentifierNCT04555811
SponsorMasonic Cancer Center, University of Minnesota
Last Modified on22 March 2022

Eligibility

Yes No Not Sure

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
No requirement for systemic immunosuppressive therapy (> 5mg prednisone daily) during the FT596 dosing period
platelet>20,000 without transfusion support within previous 7 days). There are
no CBC parameters for Day 7 dosing
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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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