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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 below
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You do not have an ongoing and uncontrollable infection.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year post auto hsct
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year post auto hsct for reporting.

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 more

Trial 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
271 Previous Clinical Trials
14,622 Total Patients Enrolled
Dr.Veronika Bachanova, MD, PhDPrincipal InvestigatorMasonic Cancer Center, University of Minnesota

Media Library

FT596 (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04555811 — Phase 1
Non-Hodgkin's Lymphoma Research Study Groups: FT596 + Rituximab Dose Level 1: 9x10^7 cells/dose, FT596 + Rituximab Dose Level 2: 3x10^8 cells/dose, FT596 + Rituximab Dose Level 3: 9x10^8 cells/dose
Non-Hodgkin's Lymphoma Clinical Trial 2023: FT596 Highlights & Side Effects. Trial Name: NCT04555811 — Phase 1
FT596 (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04555811 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Have prior investigations included FT596 as a component?

"FT596 was initially investigated in 1993 at the NIH Clinical Center on Rockville Pike. Since then, 804 studies have been completed with an additional 406 currently recruiting new participants; a majority of these are being conducted out of St Louis."

Answered by AI

How many individuals are under observation for this research endeavor?

"Affirmative. The clinicaltrials.gov website displays that this trial is recruiting for participants, which was inaugurated on September 22nd 2020 and updated just recently in January 3rd 2022. A total of 50 individuals from two different sites are needed to complete the study's requirements."

Answered by AI

Is it feasible for patients to participate in this research experiment at the moment?

"Currently, the medical trial listed on clinicaltrials.gov requires participants to join; this experiment was first shared online back in September 2020 and last updated as recently as January 3rd 2022."

Answered by AI

In what manner is FT596 typically employed?

"FT596 is clinically effective for the treatment of diffuse large b-cell lymphoma (DLBCL), certain types of B-Cell Lymphomas, and Polyangiitis."

Answered by AI

Are there any adverse effects associated with FT596?

"Drawing from our team's evaluation, FT596 has been rated a 1 due to the lack of safety and efficacy data that is available as this is just a Phase 1 trial."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
FT596 With Rituximab as Relapse Prevention After Autologous HSCT for NHL
2020. "FT596 With Rituximab as Relapse Prevention After Autologous HSCT for NHL". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04555811.
~1 spots leftby Apr 2025
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