Axicabtagene Ciloleucel for Non-Hodgkin Lymphoma
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a treatment called Axicabtagene Ciloleucel, a type of CAR T-cell therapy, to determine its safety for people with Large B Cell Lymphoma (LBCL) who are likely to experience a relapse. The trial aims to assess whether this treatment can benefit those at high risk who have already tried one other treatment for LBCL. Suitable candidates have aggressive forms of B cell lymphoma and at least one measurable tumor on a scan. 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 requires a washout period (time without taking certain medications) of at least 2 weeks or 5 half-lives, whichever is shorter, since any prior systemic therapy before starting the study. This means you may need to stop some medications before participating.
Is there any evidence suggesting that Axicabtagene Ciloleucel is likely to be safe for humans?
Research has shown that Axicabtagene Ciloleucel has been tested for safety in patients with non-Hodgkin lymphoma. In earlier studies, some patients experienced cytokine release syndrome (CRS), a reaction that can be serious or life-threatening. This occurred in about 90% of patients who received the treatment. However, the FDA has already approved this treatment for certain types of lymphoma, indicating that its safety is well understood.
As this trial is in an early stage, the main goal is to ensure the treatment's safety for a new group of patients. Researchers will closely monitor any side effects. Participants will receive careful monitoring to ensure their safety.12345Why do researchers think this study treatment might be promising?
Axicabtagene Ciloleucel (Axi-Cel) is unique because it uses CAR T-cell therapy to target non-Hodgkin lymphoma, specifically high-risk relapsed/refractory large B-cell lymphoma (LBCL). Unlike traditional treatments like chemotherapy and radiation, which attack both cancerous and healthy cells, Axi-Cel reprograms a patient's own immune cells to recognize and destroy cancer cells more precisely. This targeted approach not only promises fewer side effects but also offers hope for patients who haven't responded well to standard therapies. Researchers are particularly excited about its potential to provide long-term remission with just one dose.
What evidence suggests that Axicabtagene Ciloleucel might be an effective treatment for Non-Hodgkin Lymphoma?
Research shows that axicabtagene ciloleucel (Axi-Cel) can effectively treat large B-cell lymphoma (LBCL). One study found that patients with LBCL, which returned early or didn't respond to other treatments, lived longer with Axi-Cel compared to other options. Another study on patients with non-Hodgkin lymphoma, a type of LBCL, reported positive results with Axi-Cel, indicating it helps manage the disease. Real-world data supports these findings, showing improvement in patients who didn't respond well to previous treatments. This trial will evaluate Axi-Cel in two phases: a Safety Run-in phase and a Phase 1b, to further assess its efficacy for those at high risk of the disease returning.23567
Who Is on the Research Team?
Saurabh Dahiya, MD
Principal Investigator
Stanford University
Are You a Good Fit for This Trial?
Adults over 18 with high-risk Large B Cell Lymphoma who've had one prior treatment can join. They must have normal organ function, not be pregnant or breastfeeding, agree to use birth control, and cannot have a history of certain cancers or severe reactions to Axi-Cel. Those with central nervous system lymphoma, previous CAR-T therapy, or conditions affecting study participation are excluded.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Safety Run-in
First three patients (maximum of 6) will receive 0.5 x 10^6/kg CART cells (25% standard dose) as reinfusion product between days 7 through 14 if CRS/ICANS has resolved to a grade 1 or less.
Phase 1b Treatment
Up to 20 evaluable subjects will receive the target dose of AxiCel infusion to evaluate efficacy of Axi-Cel-2 in adults with high risk relapsed/refractory LBCL.
Follow-up
Participants are monitored for safety and effectiveness after treatment, with a focus on dose limiting toxicity (DLT) for 28 days after the infusion of Axi-Cel-2.
What Are the Treatments Tested in This Trial?
Interventions
- Axicabtagene Ciloleucel
Axicabtagene Ciloleucel is already approved in United States, European Union for the following indications:
- Large B-cell lymphoma that is refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line chemoimmunotherapy
- Relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy
- Relapsed or refractory follicular lymphoma after two or more lines of systemic therapy
- Diffuse large B-cell lymphoma (DLBCL) and high-grade B-cell lymphoma (HGBL) that relapses within 12 months from completion of, or is refractory to, first-line chemoimmunotherapy
- Relapsed or refractory DLBCL and primary mediastinal large B-cell lymphoma, after two or more lines of systemic therapy
- Relapsed or refractory follicular lymphoma after three or more lines of systemic therapy
Find a Clinic Near You
Who Is Running the Clinical Trial?
Stanford University
Lead Sponsor
Kite Pharma
Collaborator