Your session is about to expire
← Back to Search
CAR T-cell Therapy
FT596 + Rituximab for Lymphoma Relapse Prevention
Phase 1
Waitlist Available
Led By Dr.Veronika Bachanova, MD, PhD
Research Sponsored by Masonic Cancer Center, University of Minnesota
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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
No requirement for systemic immunosuppressive therapy (> 5mg prednisone daily) during the FT596 dosing period.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year post ft596 infusion
Awards & highlights
Study Summary
This trial is testing a new drug to see if it can help prevent lymphoma from coming back after a stem cell transplant.
Who is the study for?
This trial is for adults over 18 with diffuse large B cell lymphoma or high-grade B-cell lymphoma, who've had or are planning an autologous stem cell transplant. Participants must agree to long-term follow-up and contraception, have no severe ongoing health issues, no active infections, and meet specific organ function criteria post-transplant.Check my eligibility
What is being tested?
The study tests the safety of a new therapy called FT596 in combination with Rituximab to prevent relapse after an autologous hematopoietic stem cell transplant in patients with certain types of aggressive B-cell lymphomas.See study design
What are the potential side effects?
While not explicitly listed here, potential side effects may include reactions related to immune system activation such as fever and fatigue, infusion-related reactions from Rituximab like chills or body aches, and possible impacts on blood counts or organ functions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
You do not have an ongoing and uncontrollable infection.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year post auto hsct
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year post auto hsct
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of participants experiencing dose limiting toxicity events
Secondary outcome measures
Number of non-relapse mortality incidents at 100 days post HSCT
Number of non-relapse mortality incidents at one year post HSCT
Number of participants experiencing adverse events
+1 moreTrial Design
3Treatment groups
Experimental Treatment
Group I: FT596 + Rituximab Dose Level 3: 9x10^8 cells/doseExperimental Treatment2 Interventions
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 II: FT596 + Rituximab Dose Level 2: 3x10^8 cells/doseExperimental Treatment2 Interventions
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 III: FT596 + Rituximab Dose Level 1: 9x10^7 cells/doseExperimental Treatment2 Interventions
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).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Rituximab
1999
Completed Phase 4
~1880
Find a Location
Who is running the clinical trial?
Masonic Cancer Center, University of MinnesotaLead Sponsor
275 Previous Clinical Trials
14,807 Total Patients Enrolled
Dr.Veronika Bachanova, MD, PhDPrincipal InvestigatorMasonic Cancer Center, University of Minnesota
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have not participated in any experimental treatment within 28 days before starting FT596 or planned to do so within the first 100 days after transplant.You cannot receive rituximab treatment.You do not have an ongoing and uncontrollable infection.You are scheduled to receive radiation treatment after a transplant before Day +100.
Research Study Groups:
This trial has the following groups:- Group 1: FT596 + Rituximab Dose Level 1: 9x10^7 cells/dose
- Group 2: FT596 + Rituximab Dose Level 2: 3x10^8 cells/dose
- Group 3: FT596 + Rituximab Dose Level 3: 9x10^8 cells/dose
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Share this study with friends
Copy Link
Messenger