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) (ACTION)

  • End date
    Dec 15, 2037
  • participants needed
  • sponsor
    Tessa Therapeutics
Updated on 14 October 2022


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.


Upon successful leukapheresis to produce CD30.CAR-T cells, patients will enter the treatment phase of the study. Treatments will include 4 cycles of nivolumab and CD30.CAR-T infusion (preceded by lymphodepletion chemotherapy). Patients will then enter the post-treatment follow-up phase of the study, whereby patients will undergo either autologous stem cell transplant or continue to receive up to 6 additional treatment cycles of nivolumab. Patients will be followed for response assessments and safety monitoring until end of study (EOS); approximately 3 years after leukapheresis. Long-term follow-up will continue with additional safety monitoring and survival for up to 15 years after Leukapheresis.

Condition Classical Hodgkin Lymphoma, Hodgkin Disease Refractory, Hodgkin Disease Recurrent
Treatment Fludarabine, Nivolumab, Bendamustine, Autologous CD30.CAR-T
Clinical Study IdentifierNCT05352828
SponsorTessa Therapeutics
Last Modified on14 October 2022


Yes No Not Sure

Inclusion Criteria

Signed ICF
Male or female patients who are 12 years of age and above
Relapsed or refractory CD30+ cHL following failure of a standard frontline chemotherapy
At least 1 lesion, which must be fluordeoxyglucose positron emission tomography (FDG-PET) avid and measurable by PET-CT scan
Adequate laboratory parameters including hematologic, renal, hepatic, and coagulation function
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)
Anticipated life expectancy > 12 weeks
No active infections including COVID 19 at Screening

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
Unresolved > Grade 1 non-hematologic toxicity associated with any prior treatments
Previous history of known or suspected autoimmune disease within the past 5 years
Active interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected drug-related pulmonary toxicity
Evidence of human immunodeficiency virus (HIV) infection
Evidence of active viral infection with hepatitis B virus (HBV)
Evidence of active viral infection with hepatitis C virus (HCV)
Active second malignancy or history of another malignancy within the last 3 years
History of hypersensitivity reactions to murine protein-containing products or other product excipients
Any allergic or adverse reaction to nivolumab, fludarabine, or bendamustine that precludes treatment with these agents
History of a significant irAE from prior immune checkpoint inhibitor therapy
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