CAR T Cell Therapy for Large B-Cell Lymphoma
(ALPHA2 Trial)
Trial Summary
Do I need to stop my current medications to join the trial?
The trial protocol does not specify if you need to stop taking your current medications. However, you must not have had systemic anti-cancer therapy within 2 weeks before receiving ALLO-647.
Will I have to stop taking my current medications?
The trial requires that you stop any systemic anti-cancer therapy at least 2 weeks before receiving ALLO-647. The protocol does not specify about other medications, so it's best to discuss with the trial team.
What data supports the idea that CAR T Cell Therapy for Large B-Cell Lymphoma is an effective treatment?
The available research shows that CAR T Cell Therapy is an effective treatment for Large B-Cell Lymphoma. In a study comparing CAR T Cell Therapy to another treatment called alloHCT, patients who received CAR T Cell Therapy had a longer median survival time of 475 days compared to 285 days for those who received alloHCT. Additionally, after receiving the treatment, 68% of CAR T Cell patients were still alive after 12 months, compared to 54% of alloHCT patients. This suggests that CAR T Cell Therapy may be a better option for patients with this type of lymphoma.12345
What data supports the effectiveness of the treatment ALLO-501A for large B-cell lymphoma?
Research shows that CD19-directed CAR T-cell therapy, like ALLO-501A, is a standard treatment for relapsed or refractory large B-cell lymphoma, with outcomes not inferior to other treatments like allogeneic transplantation. Patients receiving CAR T-cell therapy had a median overall survival of 475 days, suggesting it is a viable option for this condition.12345
What safety data is available for CAR T Cell Therapy in treating large B-cell lymphoma?
CAR T Cell Therapy, specifically targeting CD19, has been evaluated for safety in various studies. The therapy is associated with some adverse events, including cytokine release syndrome (33-69%), neurotoxicity (8-33%), and B-cell aplasia (54%). However, the therapy has shown a good safety profile in some trials, with no serious adverse events directly attributed to the treatment and no dose-limiting toxicities reported. The risk of graft-versus-host disease is low, especially with off-the-shelf CAR T-cell therapies. Infectious complications are a concern, and optimal antimicrobial prophylaxis strategies are still being studied.678910
Is CAR T-cell therapy safe for humans?
CAR T-cell therapy, including treatments like ALLO-501A, has been studied for safety in various conditions like acute lymphoblastic leukemia (ALL) and non-Hodgkin lymphoma (NHL). Common side effects include cytokine release syndrome (a reaction causing fever and low blood pressure) and neurotoxicity (nerve damage), but serious adverse events are rare. Overall, it is considered safe with manageable side effects.678910
Is the treatment ALLO-501A a promising treatment for large B-cell lymphoma?
How is the treatment ALLO-501A different from other treatments for large B-cell lymphoma?
ALLO-501A is a type of CAR T-cell therapy that uses specially modified immune cells to target and destroy cancer cells, specifically those with the CD19 marker. Unlike traditional treatments, it involves using donor-derived (allogeneic) T-cells, which can be more readily available than the patient's own cells, potentially offering a quicker treatment option.311121314
What is the purpose of this trial?
This is a single-arm, open label, multicenter Phase 1/2 study evaluating ALLO-501A in adult subjects with R/R LBCL and CLL/SLL. The purpose of the ALPHA2 study is to assess the safety, efficacy, and cell kinetics of ALLO-501A in adults with relapsed or refractory large B-cell lymphoma and assess the safety of ALLO-501A in adults with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) after a lymphodepletion regimen comprising fludarabine, cyclophosphamide, and ALLO-647.
Eligibility Criteria
Adults with relapsed or refractory large B-cell lymphoma who have tried at least two chemotherapy treatments can join. They should be relatively healthy (ECOG status 0 or 1), not have had certain recent treatments like radiation, and must not have active infections or other cancers treated in the last three years.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Lymphodepletion
Participants receive a lymphodepletion regimen comprising fludarabine, cyclophosphamide, and ALLO-647
Treatment
Participants receive ALLO-501A, an anti-CD19 allogeneic CAR T cell therapy
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- ALLO-501A
- Cyclophosphamide
- Fludarabine
Find a Clinic Near You
Who Is Running the Clinical Trial?
Allogene Therapeutics
Lead Sponsor