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CAR T-cell Therapy

FT596 for Chronic Lymphocytic Leukemia

Phase 1

Waitlist Available

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 from baseline tumor assessment up to approximately 2 years after last dose of ft596

Awards & highlights

Study Summary

This trial is testing a new drug, FT596, to see if it can help people with B-cell lymphoma or chronic lymphocytic leukemia who have relapsed or haven't responded to other treatments.

Eligible Conditions

Chronic Lymphocytic Leukemia
B-Cell Lymphoma

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline tumor assessment up to approximately 2 years after last dose of ft596

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from baseline tumor assessment up to approximately 2 years after last dose of ft596

This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline tumor assessment up to approximately 2 years after last dose of ft596 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of dose-limiting toxicities within each dose level cohort

Incidence, nature, and severity of adverse events (AEs) of FT596 as monotherapy and in combination with rituximab or obinutuzumab in r/r B-cell lymphomas and r/r chronic lymphocytic leukemia, with severity determined according to NCI CTCAE, v5.0

Nature of dose-limiting toxicities within each dose level cohort

Secondary outcome measures

Investigator-assessed duration of complete response (DoCR)

Investigator-assessed duration of objective response (DOR)

Investigator-assessed objective-response rate (ORR)

+3 more

Trial Design

5Treatment groups

Experimental Treatment

Group I: FT596 in Combination with Rituximab, LymphomaExperimental Treatment5 Interventions

FT596 in combination with Rituximab in adult subjects with r/r B-cell Lymphoma

Group II: FT596 in Combination with Obinutuzumab, LymphomaExperimental Treatment5 Interventions

FT596 in combination with Obinutuzumab in adult subjects with r/r B-cell Lymphoma

Group III: FT596 in Combination with Obinutuzumab, CLLExperimental Treatment5 Interventions

FT596 in combination with Obinutuzumab in adult subjects with r/r CLL

Group IV: FT596 Monotherapy, LymphomaExperimental Treatment4 Interventions

FT596 monotherapy in adult subjects with r/r B-cell Lymphoma

Group V: FT596 Monotherapy, CLLExperimental Treatment4 Interventions

FT596 monotherapy in adult subjects with r/r CLL

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Fludarabine

2012

Completed Phase 3

~1100

Obinutuzumab

2015

Completed Phase 3

~3250

Cyclophosphamide

1995

Completed Phase 3

~3770

Rituximab

1999

Completed Phase 4

~1880

Bendamustine

2015

Completed Phase 3

~2950

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Fate TherapeuticsLead Sponsor

21 Previous Clinical Trials

1,703 Total Patients Enrolled

Rebecca Elstrom, MDStudy DirectorFate Therapeutics

7 Previous Clinical Trials

996 Total Patients Enrolled

Fate Trial DisclosureStudy DirectorFate Therapeutics

10 Previous Clinical Trials

768 Total Patients Enrolled

Media Library

FT596 (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04245722 — Phase 1

Chronic Lymphocytic Leukemia Research Study Groups: FT596 in Combination with Obinutuzumab, Lymphoma, FT596 in Combination with Rituximab, Lymphoma, FT596 in Combination with Obinutuzumab, CLL, FT596 Monotherapy, Lymphoma, FT596 Monotherapy, CLL

Chronic Lymphocytic Leukemia Clinical Trial 2023: FT596 Highlights & Side Effects. Trial Name: NCT04245722 — Phase 1

FT596 (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04245722 — Phase 1

Frequently Asked Questions

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

Has the regulatory body acknowledged FT596 as a viable therapeutic option?

"Due to the limited supporting evidence, FT596 receives a score of 1 for safety. This is because this particular trial is part of Phase 1 clinical trials and does not have ample data on its efficacy yet."

Answered by AI

Does this research endeavor still accept enrollees?

"The study is actively recruiting, with the original listing posted on March 19th 2020 and updated most recently on June 21st 2022."

Answered by AI

What other investigations have been undertaken using FT596?

"The initial research on FT596 dates back to 1993, when it was conducted at the National Institutes of Health Clinical Center in Rockville. Since then, 1878 studies have been completed and 1241 trials are active presently; many of them being performed in Houston, Texas."

Answered by AI

What is the common therapeutic application of FT596?

"FT596 has been successfully trialled to help combat lung cancers, multiple sclerosis, and b-cell lymphomas."

Answered by AI

Are there any institutional hubs conducting this research in North America?

"As of now, 9 medical centres are accommodating patients for this trial. These sites can be found in Houston, Saint Louis and Chicago as well as 6 other locations. To reduce commuting time, it is recommended that you choose the closest participating site to your home."

Answered by AI

How many participants have been recruited for this trial thus far?

"Fate Therapeutics must enlist 552 eligible patients in order to conduct the trial, which is being administered by MD Anderson Cancer Center and Washington University School of Medicine."

Answered by AI

Recent research and studies

Cell Stem CellJournal

Human Ipsc-derived Natural Killer Cells Engineered with Chimeric Antigen Receptors Enhance Anti-tumor Activity

Li, Ye, David L. Hermanson, Branden S. Moriarity, and Dan S. Kaufman. 2018. “Human Ipsc-derived Natural Killer Cells Engineered with Chimeric Antigen Receptors Enhance Anti-tumor Activity”. Cell Stem Cell. Elsevier BV. doi:10.1016/j.stem.2018.06.002.

clinicaltrials.govStudy

FT596 as a Monotherapy and in Combination With Anti-CD20 Monoclonal Antibodies

2020. "FT596 as a Monotherapy and in Combination With Anti-CD20 Monoclonal Antibodies". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04245722.