Loncastuximab Tesirine for Non-Hodgkin's Lymphoma
What You Need to Know Before You Apply
What is the purpose of this trial?
To learn if loncastuximab tesirine (called "lonca" in this informed consent form) can help to control large B-cell lymphoma that is relapsed or refractory after receiving CAR T-cell therapy. The safety and possible effects of the study therapy will also be studied.
Will I have to stop taking my current medications?
The trial protocol does not specify if you need to stop taking your current medications. It's best to discuss your specific medications with the study team to get a clear answer.
What safety data exists for CAR T-cell therapy, including Loncastuximab Tesirine, in humans?
CAR T-cell therapy, including treatments like Loncastuximab Tesirine, has shown promise in treating certain cancers but comes with potential safety concerns. Common side effects include cytokine release syndrome (a severe immune reaction) and neurological issues, which can be serious but are manageable with proper medical care. Other risks include infections, cardiac effects, and nonrelapse mortality, which require careful monitoring and management by healthcare professionals.12345
How is loncastuximab tesirine different from other drugs for non-Hodgkin's lymphoma?
Loncastuximab tesirine is unique because it is an antibody-drug conjugate that specifically targets CD19, a protein found on B-cells, and delivers a powerful cancer-killing agent directly to these cells. This targeted approach can be more effective and potentially have fewer side effects compared to traditional chemotherapy, which affects both cancerous and healthy cells.678910
What data supports the effectiveness of the drug Loncastuximab Tesirine for treating Non-Hodgkin's Lymphoma?
Research shows that Loncastuximab Tesirine, a drug targeting CD19 on cancer cells, has been effective in treating relapsed or refractory diffuse large B-cell lymphoma, a type of Non-Hodgkin's Lymphoma. In clinical trials, it showed an overall response rate of about 48%, with some patients achieving complete remission, and it was approved by the FDA for this use due to its demonstrated safety and effectiveness.67101112
Who Is on the Research Team?
Paolo Strati
Principal Investigator
M.D. Anderson Cancer Center
Are You a Good Fit for This Trial?
Adults with certain types of large B-cell lymphoma that didn't respond well to CAR T-cell therapy can join this trial. They should have partially responded to the previous treatment, be in good physical condition, and not have had any other cancer treatments since. People with heart issues, blood clots, severe allergies to study drugs, or active infections can't participate. Women who could get pregnant must test negative for pregnancy and agree to use birth control.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Loncastuximab Tesirine (lonca) by vein as consolidation therapy
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- CAR T-cell Therapy
- Loncastuximab Tesirine
CAR T-cell Therapy is already approved in United States, European Union for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
M.D. Anderson Cancer Center
Lead Sponsor