Rondecabtagene Autoleucel for B-Cell Lymphoma
(PiNACLE-H2H Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests the effectiveness of a new treatment, rondecabtagene autoleucel (ronde-cel), for individuals with large B-cell lymphoma that has recurred or not responded to previous treatments. Ronde-cel is a specialized therapy targeting two proteins on cancer cells, potentially providing an alternative to treatments that focus on one protein. The trial compares ronde-cel with other therapies selected by doctors that target a single protein. Suitable candidates for this trial include those whose large B-cell lymphoma has returned or not improved after initial treatments and who have not yet received CD19 CAR T-cell therapy. As a Phase 3 trial, this study is the final step before FDA approval, offering patients access to a potentially groundbreaking treatment.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that rondecabtagene autoleucel, or ronde-cel, produced promising results in earlier studies for treating large B-cell lymphoma. The treatment achieved a 93% overall response rate, with 76% of patients experiencing a complete response, indicating significant patient benefit.
Regarding safety, earlier studies reported that ronde-cel had a good safety profile, with side effects generally manageable and not severe for most patients. Although detailed safety data from these studies aren't included here, the progression to a Phase 3 trial suggests that earlier trials found it to be generally well-tolerated. In Phase 3, treatments typically need to demonstrate sufficient safety for testing on larger groups.
For those considering joining this trial, it is encouraging that ronde-cel has shown good effectiveness and an acceptable safety profile so far. However, discussing any concerns or questions with a healthcare provider remains important.12345Why do researchers think this study treatment might be promising?
Rondecabtagene autoleucel, or Ronde-cel, is unique because it represents a new wave of CAR T-cell therapies specifically tailored for B-cell lymphoma. Unlike traditional treatments like chemotherapy and some existing CAR T-cell therapies, Ronde-cel is engineered to enhance the immune system's ability to target and destroy cancerous B-cells more effectively. Its distinct mechanism of action involves reprogramming a patient’s T-cells to recognize and attack the CD19 protein on cancer cells, which could potentially lead to more sustained remissions. Researchers are excited because this tailored approach aims to improve treatment outcomes and potentially offer a new option for patients who have not responded to standard therapies.
What evidence suggests that ronde-cel might be an effective treatment for B-cell lymphoma?
Research has shown that rondecabtagene autoleucel (ronde-cel), a new type of CAR T-cell therapy, holds promise for treating large B-cell lymphoma. In studies, 93% of patients responded to the treatment, and 76% experienced a complete response, meaning their cancer completely disappeared. Patients also had a median progression-free survival of 18 months, indicating the treatment can prevent the cancer from worsening for a significant period. In this trial, participants will receive either ronde-cel or an investigator's choice of CD19-targeting treatments, such as axicabtagene ciloleucel or lisocabtagene maraleucel. Ronde-cel targets two proteins, CD19 and CD20, on cancer cells, which may help prevent the cancer from returning. These findings suggest that ronde-cel could be a strong option for those with relapsed or hard-to-treat large B-cell lymphoma.12456
Are You a Good Fit for This Trial?
This trial is for people who have certain types of large B-cell lymphoma, including DLBCL and others as classified by WHO or International Consensus. They must not have had CAR T-cell therapy before but should be eligible for it now. Participants need to have relapsed or refractory disease after specific first-line treatments and measurable disease confirmed by PET/CT scans.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Lymphodepletion
Participants receive fludarabine and cyclophosphamide lymphodepletion before CAR T-cell infusion
Treatment
Participants receive a single intravenous infusion of CAR T-cell therapy
Follow-up
Participants are monitored for safety and efficacy
Long-term follow-up
Participants are monitored for long-term safety and efficacy
What Are the Treatments Tested in This Trial?
Interventions
- Ronde-cel
Find a Clinic Near You
Who Is Running the Clinical Trial?
Lyell Immunopharma, Inc.
Lead Sponsor