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CAR T-Cell Therapy for Leukemia
Study Summary
This trial will test if it is safe to use donor-derived CAR T cells to treat adults with B-cell ALL.
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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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- I have a history of HIV, Hepatitis B, or Hepatitis C.I can take care of myself but may not be able to do heavy physical work.I haven't had a heart attack or other major heart issues in the last year.I have antibodies against my donor's tissue.I do not have any serious infections, or if I do, they are under control.I am on low-dose corticosteroids or other drugs that suppress my immune system.I have active acute lymphoblastic leukemia.I have an autoimmune disease and have used immunosuppressive drugs in the past year.I do not have any brain-related health conditions that could affect my participation.My heart, liver, kidneys, lungs, and brain are functioning well.I have been cancer-free for at least 3 years, except for non-severe types like nonmelanoma skin cancer.I am between 18 and 65 years old.My cancer has come back or didn't fully go away, confirmed twice.I am scheduled for a treatment that reduces T cells, with a washout period if previously treated.My cancer cells have shown CD19 at some point since diagnosis.I can understand and agree to the study's procedures, or I have someone who can consent for me if needed.My donor is a perfect match for me based on specific genetic markers.I have a family member willing to donate cells for my CAR T cell therapy.My leukemia didn't respond to my first chemotherapy or came back, or I have high-risk features.
- Group 1: Dose escalation
- 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
Are persons under 45 years old eligible for participation in this medical experiment?
"The age bracket for this medical trial is between 18 years old and 65. Separately, there are 465 trials specifically designed for minors and 1189 studies tailored towards seniors."
Does the U.S. Food and Drug Administration sanction Allogeneic donor-derived T-cells modified with bivalent lentiviral vector (CD19/CD22-BBz) chimeric antigen receptor (CAR)?
"Our analysis at Power concluded that Allogeneic donor-derived T-cells transduced with bivalent lentiviral vector (CD19/CD22-BBz) chimeric antigen receptor (CAR) is relatively safe, earning it a score of 1. This decision was based on the fact that this trial only in its first phase and there are limited data points to assess safety and efficacy."
What is the intended outcome of this research endeavor?
"The primary endpoint of this trial, assessed over a period of six weeks, is the amount of patients who receive donor CD19/CD22-CAR T cells. Secondary endpoints include progression-free survival post infusion with both donor CD19/CD22 and Orca-T, overall survival following these infusions and cumulative incidence relapse or disease progression as well as nonrelapse mortality after donor CD19/CD22 plus Orca-T transfusion."
Is there still availability for individuals to join this investigation?
"The information accessible on clinicaltrials.gov, which was last updated in August of 2022, affirms that this particular trial is not currently recruiting for participants. Despite this fact there are still 1497 other research projects actively seeking patients."
Is enrollment to this research project open at the moment?
"This medical trial is currently accepting 18 individuals with lymphocytic leukemia, aged between majority and 65. In order to partake in the project, they must fulfil certain criteria: verification of minimal residual disease (MRD) on two occasions at least 2 weeks apart; an HLA-matched related donor willing to undergo unstimulated apheresis for T cell collection followed by GSCF mobilized apheresis for HSC/Treg graft; cardiac ejection fraction over 45%; history of chemotherapy refractory or relapsed ALL, with other high risk features such as CRLF2 rearrangement or hypodiploid kary"
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