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CAR T-Cell Therapy for Leukemia
Study Summary
This trial will test if a new manufacturing process is safe and effective to produce cells to treat B-ALL.
Timeline
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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- My brain-related disease is responding to treatment.I currently have an infection that is not under control.My brain condition is getting worse despite treatment, or I have brain lesions that could make treatment risky.I am HIV positive.I had a poor response to previous B cell therapy.I am on medication for my seizure disorder.I am currently receiving treatment for graft-versus-host disease.My leukemia cells test positive for CD19.I have relapsed or refractory ALL or LBL.I can do most of my daily activities by myself.I had severe brain side effects from previous CAR T cell therapy.My organs are working well.I am 29 years old or younger.My cancer shows CD19 expression in tests after receiving CD19-targeted therapy.I am not on steroids or immunosuppressants that could affect cell therapy, except for necessary treatments or inhaled steroids.
- Group 1: Dose Escalation Arm
- Group 2: Dose Expansion Arms
- 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
To date, how many people have signed up to be a part of this research project?
"That is correct. The information on clinicaltrials.gov does show that this particular trial is looking for participants at the moment. This trial was first posted on 9/20/2022 and was last updated on 10/5/2022. They are searching for a total of 89 patients from 1 site."
Are there any current vacancies for this experimental treatment program?
"Presently, this clinical trial is seeking enrolment from patients. All information regarding the study was first posted on September 20th, 2022 with the most recent edit taking place on October 5th, 2022."
Will this research project be considering any volunteers who are not yet seventy years old?
"The age range for participants in this clinical trial is 0 to 29 years old. Out of all the 477 similar studies, this one focuses on a younger patient demographic. There are 1229 trials for patients over 65 years old."
What benefits are researchers hoping to achieve from this clinical trial?
"The primary outcome of this study is the safety of huCART19 administration, which will be assessed over a period of approximately 5 years. Secondary outcomes include remission rate (defined as the overall remission rate among treated subjects at Day 28 post-huCART19 infusion), manufacturing feasibility (defined as the percentage of manufactured products that meet release criteria for vector transduction efficiency, T cell product purity, viability, and sterility), and event-free survival (defined as 1-year Event-Free Survival in subjects with relapsed/refractory B-ALL [Cohort A] and in subjects with poor response to"
How do I sign up for the research study?
"This study is seeking to enroll 89 young patients, aged 0-29, who have b-lymphocytes and meet the following additional inclusion criteria: Signed informed consent, relapsed or refractory ALL or Lly, poor response to prior B cell directed engineered cell therapy, CNS3 disease responsive to therapy , CD19 tumor expression in bone marrow, peripheral blood, cerebrospinal fluid (CSF), or tumor tissue by flow cytometry , age 0-29 years old , adequate organ function , adequate performance status defined as Lansky or Karnofsky performance score ≥50. Subjects of reproductive potential must agree to use acceptable birth"
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