CD22 CAR T-Cell Therapy for B-Cell Cancers
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called CD22 CAR T-cell therapy for individuals with certain B-cell cancers, such as leukemia and lymphoma, that have returned or are difficult to treat. The goal is to determine if these modified immune cells, created from a patient's own cells, can effectively target cancer cells. The trial includes two main groups: one for those with relapsed or stubborn acute lymphoblastic leukemia (ALL) and another for aggressive B-cell non-Hodgkin lymphoma. Suitable candidates are those who have tried at least two other treatments for these cancers 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 innovative therapy.
Do I need to stop my current medications for the trial?
The trial protocol requires a washout period (time without taking certain medications) of at least 2 weeks or 5 half-lives, whichever is shorter, for most prior systemic therapies before starting the trial. However, some medications like hydroxyurea and certain maintenance chemotherapies have specific guidelines, so it's best to discuss your current medications with the trial team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that CD22 CAR T-cell therapy is generally well-tolerated in people with B-cell cancers. Studies have found that CAR T-cells, which are special immune cells modified in a lab to fight cancer, can be effective with usually manageable side effects.
Trials testing both CD22 and CD19 dual-targeting CAR T-cells demonstrated high effectiveness while maintaining side effects at a tolerable level. This indicates that while some side effects may occur, they are typically not severe enough to outweigh the potential benefits of the treatment.
It is important to note that this trial is in an early phase. Treatments at this stage primarily focus on ensuring safety and identifying any side effects. The current testing of CD22 CAR T-cells indicates that while earlier research has shown promise, their safety and side effects are still under close observation.12345Why do researchers think this study treatment might be promising?
Most treatments for B-cell cancers, like chemotherapy and radiation, work by killing rapidly dividing cells. But CD22 CAR T-cell therapy works differently, targeting the CD22 protein on the surface of cancerous B-cells. This means it offers a more precise attack, potentially leading to fewer side effects compared to traditional treatments. Researchers are excited about this therapy because it uses the body's own immune cells, modified to better recognize and destroy cancer cells, which could lead to more effective and lasting responses for patients with relapsed or refractory B-cell cancers.
What evidence suggests that this trial's treatments could be effective for B-cell cancers?
Research has shown that CD22 CAR T-cell therapy, which participants in this trial may receive, may effectively treat relapsed or hard-to-treat acute lymphoblastic leukemia (r/r ALL). One study found that 74% of patients achieved complete remission, although some later experienced a return of the disease. For aggressive B-cell non-Hodgkin lymphoma (r/r aggressive B-cell NHL), CD22 CAR T-cell therapy is under investigation in this trial. Although still in early stages, the results suggest it could be a promising treatment for these challenging cancers.678910
Who Is on the Research Team?
Matthew Frank, PhD, MD
Principal Investigator
Stanford University
Are You a Good Fit for This Trial?
Adults over 18 with certain B-cell blood cancers that have come back or didn't respond to treatment. They must be able to consent, not pregnant, willing to use birth control, and meet specific health criteria like a minimum number of white blood cells and proper organ function. Can't join if they're pregnant/breastfeeding, have other cancers within 3 years, severe infections needing IV drugs, significant heart issues in the past year or conditions affecting study participation.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Lymphodepletion
Participants undergo lymphodepletion with Fludarabine and Cyclophosphamide prior to CD22 CAR T cell infusion
Treatment
Participants receive CD22 CAR T cell infusion at varying dose levels to determine MTD/RP2D
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- CD22 CAR
- Cyclophosphamide
- Fludarabine
Find a Clinic Near You
Who Is Running the Clinical Trial?
Stanford University
Lead Sponsor
The Leukemia and Lymphoma Society
Collaborator
American Society of Hematology
Collaborator
National Cancer Institute (NCI)
Collaborator