PBCAR0191 for Blood Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called PBCAR0191, targeting blood cancers such as B-ALL (a type of leukemia) and B-cell NHL (a type of lymphoma). The goal is to evaluate the safety and effectiveness of azer-cel, a type of CAR T-cell therapy that modifies immune cells to fight cancer. Participants will receive varying doses to determine the optimal and safest amount. This trial may suit individuals with specific aggressive blood cancers who have already tried two or more treatments without success. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new therapy.
Will I have to stop taking my current medications?
The trial protocol does not specify if you need to stop taking your current medications. However, it mentions that participants should not have received certain cancer treatments or live vaccines within specific time frames before starting the trial. It's best to discuss your current medications with the trial team to get a clear answer.
Is there any evidence suggesting that this treatment is likely to be safe for humans?
Research has shown that azer-cel, also known as PBCAR0191, has been tested for safety in people with certain blood cancers. Early results suggest it is generally well-tolerated. Some patients have experienced side effects, but these are often manageable. For instance, studies found that adjusting the dose can help manage risks, highlighting the importance of careful dosing.
While more information is needed to fully understand its safety, these early studies provide valuable insights. As this treatment remains in the early testing stages, scientists are primarily focused on finding the right dose and checking for any serious side effects. Interested individuals should consult a doctor to understand how these findings might apply to them.12345Why do researchers think this study treatment might be promising?
Researchers are excited about PBCAR0191 for blood cancer because it utilizes a cutting-edge approach called CAR T-cell therapy. Unlike standard treatments like chemotherapy or radiation, CAR T-cell therapy involves genetically modifying a patient's own T-cells to better recognize and attack cancer cells. This personalized method not only offers a targeted attack on cancer but has also shown promise in cases where traditional therapies have failed. Furthermore, the different dosing levels being tested could lead to a more effective and customizable treatment plan, maximizing patient outcomes while minimizing side effects.
What evidence suggests that PBCAR0191 might be an effective treatment for blood cancer?
Research has shown that PBCAR0191, also known as azer-cel, holds promise for treating certain blood cancers. This trial evaluates various dose levels of azer-cel, each as a separate treatment arm, to determine the most effective and safe dosage. Studies have found that azer-cel can lead to high response rates in patients with relapsed or hard-to-treat diffuse large B-cell lymphoma (DLBCL), a type of non-Hodgkin lymphoma. In some cases, azer-cel has even resulted in complete responses, meaning the cancer becomes undetectable after treatment. This treatment uses CAR T-cells, specially modified immune cells that seek out and destroy cancer cells. Early findings suggest that the right dose of azer-cel can be given safely and may have strong cancer-fighting effects.12345
Who Is on the Research Team?
John Byon, MD, PhD
Principal Investigator
Imugene Limited
Are You a Good Fit for This Trial?
Adults with aggressive CD19+ B-cell Non-Hodgkin's Lymphoma (NHL) or relapsed/refractory B-cell Acute Lymphoblastic Leukemia (ALL), who have tried at least two prior treatments, can join this trial. They should not have severe heart, lung, kidney, liver issues or active infections and must be HIV negative. Those with a history of CNS disease need to show clear recovery.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Lymphodepletion
Participants receive lymphodepletion treatment prior to azer-cel administration
Treatment
Participants receive intravenous infusion of azer-cel on Day 0 and Day 5
Follow-up
Participants are monitored for safety and effectiveness after treatment
Long-term follow-up
Participants are followed in a separate long-term follow-up study for up to 15 years
What Are the Treatments Tested in This Trial?
Interventions
- Cyclophosphamide
- Fludarabine
- PBCAR0191
Find a Clinic Near You
Who Is Running the Clinical Trial?
Imugene Limited
Lead Sponsor
Precision BioSciences, Inc.
Lead Sponsor