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Dual CAR T Cell Therapy for Acute Lymphoblastic Leukemia
Study Summary
This trial will test two new treatments for childhood leukemia to see if they're safe and effective.
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?
Media Library
- I do not have any ongoing infections that aren't responding to treatment.My leukemia cells test positive for CD19 or CD22.My leukemia has returned or is not responding to treatment.I am currently receiving treatment for Graft Vs. Host Disease.I am HIV positive.I can do most activities but may need help.I am 29 years old or younger.My organs are working well.My previous cell therapy targeting B cells didn't work well.My cancer shows CD19 or CD22 presence in tests after my last treatment.I am not on steroids or immunosuppressants that could affect cell therapy, except for necessary treatments or inhaled steroids.My brain condition is getting worse despite treatment, or I have brain lesions that could make treatment risky.My brain-related disease responds to treatment.
- Group 1: Dose Finding Arm
- Group 2: Expansion Arm
- 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 extent of individual participation in this clinical research?
"Affirmative, the information hosted on clinicaltrials.gov reveals that this research is actively trying to recruit candidates. It was posted on January 25th 2023 and last updated the same day. A total of 93 patients must be enrolled from a single site."
Is there a recruitment period open for participants of this study?
"Affirmative. According to the clinicaltrials.gov record, this medical study is actively seeking patients since it was first posted on January 25th 2023 and updated on the same day. 93 participants must be acquired from a single site for the trial to commence."
What effects are investigators trying to ascertain from this research?
"The principal objective of this year-long trial is to examine the safety profile of CART22-65s and huCART19 co-administration. Auxiliary goals include assessing the persistence of CAR T cell therapy through PCR or flow cytometry, evaluating anti-tumor responses via negative minimal residual disease (MRD) at day 28, as well as measuring relapse free survival in both CAR naive and exposed participants with poor response to prior B cell directed engineered cell therapy."
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