FT819 for Blood Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called FT819 (a type of cell therapy), both alone and with another drug, IL-2, for certain blood cancers. It focuses on individuals with specific cancers that have returned or resisted previous treatments, such as B-cell Lymphoma, Chronic Lymphocytic Leukemia (CLL), and Precursor B-cell Acute Lymphoblastic Leukemia (B-ALL). Participants will join different groups to determine the best dose and assess how the treatment affects their cancer type. Those who have tried at least two other treatments for these cancers but still have relapsed or refractory disease might be suitable for this trial. As a Phase 1 trial, this research aims to understand how FT819 works in people, offering participants the chance to be among the first to receive this new treatment.
Will I have to stop taking my current medications?
The trial protocol does not specify if you must stop taking your current medications, but you cannot have received any therapy within 2 weeks before starting the trial. You also cannot be on systemic immunosuppressive therapy or require it during the trial.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that FT819 is generally safe for various types of blood cancer. Early studies, whether using FT819 alone or with IL-2, indicate that patients usually tolerate it well. In B-cell lymphoma, the treatment appears safe, and patients have responded positively. Similarly, early results in B-cell acute lymphoblastic leukemia (B-ALL) suggest it is safe and well-tolerated. Initial data in chronic lymphocytic leukemia (CLL) also suggest a good safety profile. Overall, these studies provide encouraging signs about the safety of FT819 in these blood cancers.12345
Why are researchers excited about this trial's treatments?
Researchers are excited about FT819 for blood cancers because it represents a novel approach using off-the-shelf, genetically engineered T-cells. Unlike traditional treatments like chemotherapy or targeted therapies, FT819 is derived from an innovative line of engineered cells designed to target and destroy cancer cells more precisely. This treatment is unique because it combines FT819 with IL-2, aiming to enhance the immune response against cancer. The step-fractionated dosing allows for a more controlled and potentially safer administration, which is different from conventional single-dose therapies. This cutting-edge strategy could offer a more effective and flexible treatment option for patients with relapsed or refractory blood cancers.
What evidence suggests that this trial's treatments could be effective?
Research shows that FT819 holds promise for treating blood cancers. In this trial, participants with aggressive B-cell lymphoma, chronic lymphocytic leukemia (CLL), and B-cell acute lymphoblastic leukemia (B-ALL) will receive FT819 in various treatment arms. Some arms will administer FT819 as a single-dose monotherapy, while others will use step-fractionated dosing. Additionally, certain arms will combine FT819 with IL-2. Previous studies have shown that FT819 led to complete remission in some patients with B-cell lymphoma, quick responses in CLL, and effectively targeted cancer cells in B-ALL. These results suggest that FT819, especially when combined with IL-2, could be a strong treatment option for these blood cancers.12345
Who Is on the Research Team?
Fate Trial Disclosure
Principal Investigator
Fate Therapeutics
Are You a Good Fit for This Trial?
Adults over 18 with certain B-cell blood cancers (like lymphoma, chronic leukemia, or acute leukemia) that have come back or didn't respond to at least two previous treatments can join. They must be able to consent and follow the study plan, and use birth control as required.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Dose-Escalation
Participants receive FT819 as monotherapy and in combination with IL-2 in a dose-escalation stage
Expansion
Participants are enrolled into indication-specific cohorts for further treatment
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- FT819
Trial Overview
The trial is testing FT819 alone or with IL-2 in patients whose B-cell malignancies have relapsed or are resistant to treatment. It's a Phase I study where they'll first find the right dose and then see how well it works in specific groups of patients.
How Is the Trial Designed?
12
Treatment groups
Experimental Treatment
FT819 monotherapy administered as step-fractionated dosing in adult subjects with r/r CLL
FT819 monotherapy administered as step-fractionated dosing in adult subjects with r/r B-cell Lymphoma
FT819 monotherapy administered as step-fractionated dosing in adult subjects with r/r B-ALL
FT819 monotherapy administered as step-fractionated dosing in combination with IL-2 in adult subjects with r/r CLL
FT819 monotherapy administered as step-fractionated dosing in combination with IL-2 in adult subjects with r/r B-cell Lymphoma
FT819 monotherapy administered as step-fractionated dosing in combination with IL-2 in adult subjects with r/r B-ALL
FT819 single-dose in combination with IL-2 in adult subjects with r/r CLL
FT819 single-dose in combination with IL-2 in adult subjects with r/r B-cell Lymphoma
FT819 single-dose in combination with IL-2 in adult subjects with r/r B-ALL
FT819 single-dose monotherapy in adult subjects with r/r CLL
FT819 single-dose monotherapy in adult subjects with r/r B-cell Lymphoma
FT819 single-dose monotherapy in adult subjects with r/r B-ALL
Find a Clinic Near You
Who Is Running the Clinical Trial?
Fate Therapeutics
Lead Sponsor
Citations
NCT04629729 | FT819 in Subjects With B-cell Malignancies
This is a Phase I dose-finding study of FT819 as monotherapy and in combination with IL-2 in subjects with relapsed/refractory B-cell Lymphoma, ...
FT819-101 Phase I Study
Evidence of anti-tumor activity, including CRs in aggressive lymphoma, in early dose escalation among patients with relapsed/refractory B-cell lymphoma, ...
A Phase I Study of FT819, a First-of-Kind, Off-the-Shelf ...
... B-cell lymphomas (BCL) and pre-B acute lymphoblastic leukemia (B-ALL) have resulted in transformative improvements in clinical outcomes.
4.
fatetherapeutics.com
fatetherapeutics.com/wp-content/uploads/2024/05/ASGCT-2024_FT819-102_VFINAL.pdfFT819-102
Recent clinical data has demonstrated the potential of autologous CD19-directed chimeric antigen receptor (CAR) T-cell therapy to deplete CD19+ B cells and ...
5.
ir.fatetherapeutics.com
ir.fatetherapeutics.com/news-releases/news-release-details/fate-therapeutics-announces-clinical-safety-and-activity-dataFate Therapeutics Announces Clinical Safety and Activity Data ...
Data from the initial dose-escalation cohorts of a single dose of FT819 are indicative of a favorable safety profile and clearly demonstrate ...
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.