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CAR T-Cell Therapy for Leukemia and Lymphoma
Study Summary
This trial is testing the safety and effects of giving CD19/CD22-CAR T cells to children and young adults with B-cell cancer.
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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- My condition is rapidly worsening, which may prevent me from completing the treatment.I have had previous treatments for my condition.I have previously undergone CAR therapy or similar treatments.My B cell ALL or lymphoma has not responded to at least two treatments.I have no other curative treatment options and cannot undergo or have chosen not to undergo a stem cell transplant.I am between 3 and 39 years old.My organs and bone marrow are working well.I have active brain lymphoma or disease, eligible for targeted brain radiation.I have another cancer type, but it's not cervical cancer in situ.My cancer can be measured or seen on tests.My cancer cells show high levels of CD19.I am eligible even if I have brain or spinal cord disease.My ALL has come back or didn't respond to treatment, and it's only in my testicles.I do not have any uncontrolled illnesses causing symptoms.I do not have HIV, HBV, or HCV infections.I can do most of my daily activities on my own.I have had a stem cell transplant from a donor.
- Group 1: Dose escalation
- Group 2: Dose expansion
- 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
How many participants are currently admitted to this medical experiment?
"Affirmative. The clinicaltrials.gov website reveals that this trial, first posted on March 26th 2018, is actively searching for participants. 87 individuals must be recruited from a sole facility."
Are there openings in this research program at the present time?
"That is accurate. According to clinicaltrials.gov, this medical research was initially listed on March 26th 2018 and the latest update was made on November 5th 2022. At the moment, 87 patients need to be recruited from a single site for this trial."
Is eligibility for this experiment restricted to those under 35 years old?
"This trial is enrolling individuals who are between 3 and 39 years old."
What is the current regulatory status of CD19/CD22 chimeric antigen receptor T-cell therapy?
"Due to the limited amount of data related to this treatment, our team has assigned a score of 1 for CD19/CD22 CAR T-Cells in terms of safety. This is because it's currently at its first stage trial phase and there are only minimal studies that have assessed efficacy."
What other research has been done involving CD19/CD22 Chimeric Antigen Receptor T-Cell therapies?
"As of present, 889 studies exploring CD19/CD22 CAR T-Cells are being conducted internationally. Of those trials, 161 have reached the Phase 3 stage. The majority of these clinical trials are located in Philadelphia, Pennsylvania but there are over 28 thousand sites conducting research with this treatment modality."
What conditions are CD19/CD22 CAR T-Cells commonly utilized to treat?
"CD19/CD22 CAR T-Cells is normally employed to treat multiple sclerosis, but it can be an effective treatment for various other illnesses including mixed-cell type lymphoma, leukemia, myelocytic, acute and retinoblastoma."
Do I meet the requirements to take part in this clinical exploration?
"This medical study is seeking out 87 individuals aged 3 to 39 with diffuse lymphoma. To be qualified, these patients must have evidence of disease through flow cytometry, immunohistochemistry or PCR analysis; CD19 expression on more than 15% malignant cells via histology or 90% by flow cytometry (the method will depend on tissue available); Karnofsky/Lansky score over 50%; leukocyte and platelet count exceeding 750/mcL* and 50,000 mcL*, respectively; a B cell ALL diagnosis that has been unresponsive to standard chemotherapy regimens plus salvage therapy for which there are no other cur"
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