FT596 With Rituximab as Relapse Prevention After Autologous HSCT for NHL

Part of paid clinical trials in Minneapolis, Minnesota.

Sponsor
Masonic Cancer Center, University of Minnesota
Study ID
NCT04555811
Phase
PHASE1
Status
Completed

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • FT596 — 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 — 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

Study Details

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.

Key Dates

Start date
Sep 22, 2020
Status verified
Jun 2024
Primary completion
Feb 8, 2023
Completion
Nov 30, 2023

Study Design

Enrollment
7 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • 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).
  • 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).
  • 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).

Primary Outcome Measure

Number of Participants Experiencing Dose Limiting Toxicity Events [ Time Frame: 28 Days Post FT596 infusion ]

Locations (2)

FacilityCityStateZIPSite coordinators
University of MinnesotaMinneapolisMinnesota55401-
Washington University School of Medicine - Siteman Cancer CenterSt LouisMissouri63110-

Find similar trials in Minneapolis, MN

By research site
University of Minnesota· Minneapolis, MNWashington University School of Medicine - Siteman Cancer Center· St Louis, MO

Related Studies