← Back to Search

Virus Therapy

FT522 + Rituximab for B-Cell Lymphoma

Phase 1

Recruiting

Research Sponsored by Fate Therapeutics

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 24 months

Awards & highlights

Study Summary

This trial is studying the safety and effectiveness of a new treatment combining FT522 with rituximab for B-cell lymphoma that comes back or doesn’t respond to treatment.

Who is the study for?

This trial is for adults with B-cell lymphoma who've tried at least one treatment including an anti-CD20 antibody, but still need therapy. They must have a type of tumor that shows up on certain scans and can't be pregnant or breastfeeding. Participants should be relatively healthy, not too underweight, and able to use birth control if necessary.Check my eligibility

What is being tested?

The study tests FT522 cells combined with the drug rituximab in people whose B-cell lymphoma has come back or didn't respond to treatment. It's looking for the safest dose that works best (RP2D). Some may get extra chemo drugs like fludarabine or bendamustine before this combo.See study design

What are the potential side effects?

Possible side effects include reactions related to immune system activation such as fever and fatigue, infusion-related reactions from rituximab, and typical chemotherapy side effects like nausea, low blood counts leading to infection risk or bleeding problems.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 24 months 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 with dose limiting toxicities (DLTs)

Severity of DLTs

Secondary outcome measures

Area Under the Plasma-Concentration Time Curve (AUC) of FT522

Duration of Complete Response (DOCR)

Duration of Response (DOR)

+4 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Regimen BExperimental Treatment2 Interventions

Participants receive FT522 in combination with rituximab (or a rituximab biosimilar approved by a local health authority) without chemotherapy.

Group II: Regimen AExperimental Treatment5 Interventions

Participants receive FT522 in combination with rituximab (or a rituximab biosimilar approved by a local health authority) with chemotherapy.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Fludarabine

2012

Completed Phase 3

~1100

Bendamustine

2015

Completed Phase 3

~2950

Rituximab

1999

Completed Phase 4

~1880

Cyclophosphamide

1995

Completed Phase 3

~3770

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Fate TherapeuticsLead Sponsor

21 Previous Clinical Trials

1,479 Total Patients Enrolled

Study DirectorStudy DirectorFate Therapeutics

1,211 Previous Clinical Trials

488,950 Total Patients Enrolled

Frequently Asked Questions

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

What potential safety risks do patients face when taking Regimen A?

"The safety of Regimen A was rated a 1 since it is still in its infancy and has limited data to support efficacy."

Answered by AI

What is the aggregate tally of participants involved in this trial?

"Correct. According to the information on clinicaltrials.gov, this study is still attempting to recruit patients; it was initially posted in November 1st 2023 and last updated October 31st 2023. The trial hopes to enrol 322 participants from a single medical centre."

Answered by AI

Are recruitments for this medical experiment still ongoing?

"Affirmative. Clinicaltrials.gov displays that this clinical trial was originally introduced on November 1st 2023 and has been recently revised as of October 31th 2023. A total of 322 participants are sought for the single location hosting the study."

Answered by AI

What are the ambitions of this clinical experiment?

"The primary outcome that Fate Therapeutics will be measuring in this trial is the severity of DLTs between Day 1 and Day 29 of Cycle 1. Secondary outcomes, such as Cmax of FT522, ORR (Overall Response Rate), and DOR (Duration Of Response) are also being evaluated by the sponsor."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

FT522 With Rituximab in Relapsed/Refractory B-Cell Lymphoma (FT522-101)

2023. "FT522 With Rituximab in Relapsed/Refractory B-Cell Lymphoma (FT522-101)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05950334.