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Study Summary
This trial is testing a new drug, FT819, as a possible treatment for various types of blood cancers. The study will have two parts: a dose-escalation stage, to find the best dose of the drug, and an expansion stage, to test the drug in more people.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I do not have non-cancerous brain conditions like stroke or epilepsy.I have been diagnosed with B-Cell Lymphoma.I haven't taken any cancer therapy or investigational drugs recently.I have been diagnosed with chronic lymphocytic leukemia.I haven't received a live vaccine in the last 6 weeks.I have received an organ transplant from another person.My condition did not improve after two different treatments.I am currently on or might need drugs that weaken my immune system.I have tested positive for Hepatitis B.I am 18 years old or older.I have a serious heart condition.I can sign and understand the consent form.I am willing to follow the study's procedures and timeline.I have been diagnosed with Precursor B-cell Acute Lymphocytic Leukemia.My cancer returned or didn't respond after 2+ standard treatments. If my cancer is Ph+, I also couldn't tolerate or didn't respond to a specific drug therapy.I have been diagnosed with B-ALL through specific tests.I have been diagnosed with a type of B-cell blood cancer.My lymphoma is confirmed to express CD19.My body weight is less than 50 kg.My organs are not functioning properly.I need continuous treatment for GvHD after a stem cell or CAR-T transplant.My cancer has spread to my brain or spinal cord.My condition did not improve after 2 different cancer treatments.I have Chronic Lymphocytic Leukemia.I am following the birth control requirements outlined in the study.I am not pregnant or breastfeeding.My daily activity is limited due to my health condition.
- Group 1: FT819 Step Fractionated Monotherapy in Combination with IL-2, B-ALL
- Group 2: FT819 Step Fractionated Monotherapy in Combination with IL-2, B-Cell Lymphoma
- Group 3: FT819 Step Fractionated Monotherapy in Combination with IL-2, CLL
- Group 4: FT819 Single-Dose in Combination with IL-2, B-Cell Lymphoma
- Group 5: FT819 Step Fractionated Monotherapy, B-Cell Lymphoma
- Group 6: FT819 Single-Dose Monotherapy, CLL
- Group 7: FT819 Single-Dose in Combination with IL-2, CLL
- Group 8: FT819 Step Fractionated Monotherapy, CLL
- Group 9: FT819 Single-Dose Monotherapy, B-ALL
- Group 10: FT819 Single-Dose in Combination with IL-2, B-ALL
- Group 11: FT819 Step Fractionated Monotherapy, B-ALL
- Group 12: FT819 Single-Dose Monotherapy, B-Cell Lymphoma
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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.
Frequently Asked Questions
What is the patient participation rate in this particular clinical experiment?
"Affirmative. The clinical trial, first posted on July 26th 2021, is actively recruiting according to data hosted on clinicaltrials.gov. There are 8 different sites that need to recruit a total of 297 patients for the study."
How many places can individuals access this research initiative?
"At present, there are 8 sites servicing this medical trial. These locations span from Westwood to Madison and Birmingham as well as several other locales. To minimize travel difficulties when enrolling, it is prudent to select the closest site available."
Are there currently opportunities for individuals to join this research endeavor?
"Affirmative. The clinical trial registry indicates that this medical investigation, which was first made public on July 26th 2021, is presently recruiting participants. There needs to be 297 individuals recruited from 8 distinct study locations."
What additional investigations have been conducted on the usage of FT819?
"FT819's first clinical trial was conducted at the City of Hope Comprehensive Cancer Centre in 1997. Since then, 1326 trials have been concluded and 901 active recruitments are being held across the United States, primarily centered around Westwood, Kansas."
What ailment is FT819 the most commonly prescribed for?
"FT819 has been approved to treat multiple sclerosis, as well as acute myelocytic leukemia and retinoblastoma. Additionally, it is useful for treating histiocytic lymphomas."
Has the FDA given its endorsement to FT819?
"The safety of FT819 was evaluated at a 1 on our scale due to this being an early-stage trial, meaning there is only limited evidence available regarding its effectiveness and security."
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