FT596 With Rituximab as Relapse Prevention After Autologous HSCT for NHL

NCT ID: NCT04555811

Last Updated: 2024-07-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-22
• Study Completion Date: 2023-11-30

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.

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.

Conditions

NHL; Non Hodgkin Lymphoma; Diffuse Large B Cell Lymphoma; High-grade B-cell Lymphoma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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).

Group Type: EXPERIMENTAL

FT596

Intervention Type: DRUG

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.

Rituximab

Intervention Type: DRUG

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

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).

Group Type: EXPERIMENTAL

FT596

Intervention Type: DRUG

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.

Rituximab

Intervention Type: DRUG

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

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).

Group Type: EXPERIMENTAL

FT596

Intervention Type: DRUG

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.

Rituximab

Intervention Type: DRUG

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

Interventions

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.

Intervention Type: 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

Intervention Type: DRUG

Other Intervention Names

Rituxan

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Masonic Cancer Center, University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dr.Veronika Bachanova, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Masonic Cancer Center, University of Minnesota

Locations

University of Minnesota

Minneapolis, Minnesota, United States

Washington University School of Medicine - Siteman Cancer Center

St Louis, Missouri, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

P01CA111412

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2019LS230

Identifier Type: -

Identifier Source: org_study_id