Autologous CD30.CAR-T in Combination With Nivolumab in cHL Patients After Failure of Frontline Therapy (NCT05352828)
Phase 1b Study Evaluating the Safety and Efficacy of Autologous CD30.CAR-T in Combination With PD-1 Checkpoint Inhibitor (Nivolumab) in Relapsed or Refractory Classical Hodgkin Lymphoma Patients After Failure of Frontline Therapy (ACTION)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (8 items) and avoid the listed exclusions (22 items).
Location: City of Hope National Medical Center — Duarte, California
Age range: 12 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- Evidence of lymphomatous involvement of the central nervous system (CNS)
- Presence of clinically relevant or active seizure disorder, stroke, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with central nervous system (CNS) involvement
- Symptomatic cardiovascular disease: Class III or IV according to the New York Heart Association (NYHA) Functional Classification
- Active uncontrolled bleeding or a known bleeding diathesis
- Inadequate pulmonary function defined as oxygen saturation by pulse oximetry \< 90% on room air
- Echocardiogram (ECHO) or Multi-gated Acquisition (MUGA) scan with left ventricular ejection fraction (LVEF) \< 45%
- Prior receipt of salvage therapy, for relapsed or refractory cHL, including allogeneic or ASCT
- Prior receipt of investigational CD30.CAR-T cells
- Receiving any investigational agents or any tumor vaccines
- Receiving any live/attenuated vaccines
- Ongoing treatment with immunosuppressive drugs or chronic systemic corticosteroids
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (5 Sites)
- City of Hope National Medical Center — Duarte, California
- University of Miami — Miami, Florida
- UNC Lineberger Comprehensive Cancer Center — Chapel Hill, North Carolina
- Baylor College of Medicine — Houston, Texas
- MD Anderson Cancer Center — Houston, Texas
📞 Contact the Study Coordinator
Phone: (800) 826-4673
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Classical Hodgkin Lymphoma
- Fitness-adapted, Pembrolizumab-based Therapy for Untreated Classical Hodgkin Lymphoma Patients 60 Years of Age and Above — New Brunswick, New Jersey
- CD30 CAR T-cells Post AutoHSCT for Poor-risk Hodgkin Lymphoma — Valhalla, New York
- Study of Pembrolizumab With Bendamustine in Hodgkin Lymphoma — Toronto, Ontario
- Itacitinib + Everolimus in Hodgkin Lymphoma — Philadelphia, Pennsylvania
- Ibrutinib and Nivolumab in Treating Patients With Relapsed or Refractory Classical Hodgkin Lymphoma — Atlanta, Georgia
Explore by condition: All Classical Hodgkin Lymphoma clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.