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

See if I qualify

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

establish a maximum tolerated dose (MTD) of FT596 when given 30 days after transplant and
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 Identifier	NCT04555811
Sponsor	Masonic Cancer Center, University of Minnesota
Last Modified on	22 March 2022

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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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FT596 With Rituximab as Relapse Prevention After Autologous HSCT for NHL