For Healthcare Professionals

Autologous CD30.CAR-T in Combination With Nivolumab in cHL Patients After Failure of Frontline Therapy


About the study

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 take part

You may be eligible to participate in the study if you meet the following criteria:


Inclusion Criteria:

  1. Signed ICF
  2. Male or female patients who are 12 years of age and above
  3. Relapsed or refractory CD30+ cHL following failure of a standard frontline chemotherapy
  4. At least 1 lesion, which must be fluordeoxyglucose positron emission tomography (FDG-PET) avid and measurable by PET-CT scan
  5. Adequate laboratory parameters including hematologic, renal, hepatic, and coagulation function
  6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1, or equivalent either Karnofsky performance status (for patients ≥ 16 years of age) or Lansky performance status (for patients < 16 years of age)
  7. Anticipated life expectancy > 12 weeks
  8. No active infections including COVID 19 at Screening


Exclusion Criteria:

  1. Evidence of lymphomatous involvement of the central nervous system (CNS)
  2. 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
  3. Symptomatic cardiovascular disease: Class III or IV according to the New York Heart Association (NYHA) Functional Classification
  4. Active uncontrolled bleeding or a known bleeding diathesis
  5. Inadequate pulmonary function defined as oxygen saturation by pulse oximetry < 90% on room air
  6. Echocardiogram (ECHO) or Multi-gated Acquisition (MUGA) scan with left ventricular ejection fraction (LVEF) < 45%
  7. Prior receipt of salvage therapy, for relapsed or refractory cHL, including allogeneic or ASCT
  8. Prior receipt of investigational CD30.CAR-T cells
  9. Receiving any investigational agents or any tumor vaccines
  10. Receiving any live/attenuated vaccines
  11. Ongoing treatment with immunosuppressive drugs or chronic systemic corticosteroids
  12. Unresolved > Grade 1 non-hematologic toxicity associated with any prior treatments
  13. Previous history of known or suspected autoimmune disease within the past 5 years
  14. Active interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected drug-related pulmonary toxicity
  15. Evidence of human immunodeficiency virus (HIV) infection
  16. Evidence of active viral infection with hepatitis B virus (HBV)
  17. Evidence of active viral infection with hepatitis C virus (HCV)
  18. Active second malignancy or history of another malignancy within the last 3 years
  19. History of hypersensitivity reactions to murine protein-containing products or other product excipients
  20. Any allergic or adverse reaction to nivolumab, fludarabine, or bendamustine that precludes treatment with these agents
  21. History of a significant irAE from prior immune checkpoint inhibitor therapy

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Study Locations

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How to Apply

Contact the study center to learn if this study is a good match for you.

Study’s details


Classical Hodgkin Lymphoma,Hodgkin Disease Refractory,Hodgkin Disease Recurrent

Age (in years)



Phase 1

Participants needed


Est. Completion Date

Dec 15, 2037

Treatment type



Tessa Therapeutics identifier


Study number


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