CAR-T + Nivolumab for Hodgkin Lymphoma
(ACTION Trial)
Trial Summary
What is the purpose of this trial?
This is a Phase 1b, multicenter, open-label, single arm study to evaluate the safety and efficacy of the combination therapy, CD30.CAR-T and the programmed cell death protein-1 (PD-1) checkpoint inhibitor, nivolumab, in patients aged 12 years of age and above with relapsed or refractory classical Hodgkin lymphoma (cHL) following failure of standard frontline therapy.
Do I need to stop my current medications for the trial?
The trial protocol does not specify if you need to stop taking your current medications, but it does exclude those on immunosuppressive drugs or chronic systemic corticosteroids.
What data supports the effectiveness of the treatment CAR-T + Nivolumab for Hodgkin Lymphoma?
Research shows that nivolumab, a part of this treatment, has been effective in treating relapsed or difficult-to-treat Hodgkin lymphoma, with a high response rate and durable effects. Additionally, combining similar drugs like brentuximab vedotin with nivolumab has shown impressive results, with many patients experiencing significant improvement.12345
Is the combination of CAR-T and Nivolumab safe for treating Hodgkin Lymphoma?
Nivolumab, used alone, has shown an acceptable safety profile in patients with Hodgkin Lymphoma, with common side effects including fatigue, infections, and cough. Serious side effects occurred in 21% of patients, and there is a risk of immune-related issues like rash and thyroid problems. The safety of combining CAR-T with Nivolumab specifically needs further evaluation.34567
How is the treatment CAR-T + Nivolumab for Hodgkin Lymphoma different from other treatments?
This treatment is unique because it combines CAR-T cell therapy, which uses modified immune cells to target cancer, with Nivolumab, a drug that helps the immune system recognize and attack cancer cells by blocking a protein called PD-1. This combination aims to enhance the immune response against Hodgkin Lymphoma, offering a novel approach compared to traditional chemotherapy or single-agent therapies.3891011
Research Team
Sairah Ahmed, M.D.
Principal Investigator
M.D. Anderson Cancer Center
Helen Heslop, MD
Principal Investigator
Baylor College of Medicine
Eligibility Criteria
This trial is for patients aged 12+ with classical Hodgkin lymphoma (cHL) that didn't respond to standard treatments. They must have at least one lesion visible on PET-CT scans, good organ function, and a performance status indicating they can carry out daily activities with little or no assistance.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Leukapheresis
Leukapheresis to produce CD30.CAR-T cells
Treatment
Participants receive 4 cycles of nivolumab and a single CD30.CAR-T infusion, preceded by lymphodepletion chemotherapy
Post-treatment Follow-up
Participants undergo either autologous stem cell transplant or continue to receive up to 6 additional treatment cycles of nivolumab
Long-term Follow-up
Participants are monitored for response assessments and safety until end of study, with additional safety monitoring and survival follow-up
Treatment Details
Interventions
- Autologous CD30.CAR-T
- Nivolumab
Find a Clinic Near You
Who Is Running the Clinical Trial?
Tessa Therapeutics
Lead Sponsor
Bristol-Myers Squibb
Industry Sponsor
Christopher Boerner
Bristol-Myers Squibb
Chief Executive Officer since 2023
PhD in Business Administration from the Haas School of Business, University of California, Berkeley; BA in Economics and History from Washington University in St. Louis
Deepak L. Bhatt
Bristol-Myers Squibb
Chief Medical Officer since 2024
MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania