Phase 2 Study Evaluating Autologous CD30.CAR-T Cells in Patients With Relapsed/Refractory Hodgkin Lymphoma (CHARIOT)

Prior treatment

• On-going treatment with immunosuppressive drugs or chronic systemic corticosteroids
• Having received:
  • Anti-CD30 antibody-based therapy within 4 weeks prior to CD30.CAR-T infusion
  • Prior investigational CD30.CAR-T
  • CD30 bispecific agent within 8 weeks prior to CD30.CAR-T infusion
  • Autologous HSCT within 90 days or allogeneic HSCT within 180 days prior to CD30.CAR-T infusion
• Currently receiving any investigational agents within 4 weeks prior to study enrollment; or received any tumor vaccines within 6 weeks prior to CD30.CAR-T infusion
• Unresolved \> Grade 1 non-hematologic toxicity associated with any prior treatments

Other illness

• 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
• Active uncontrolled bleeding or a known bleeding diathesis
• Active acute or chronic graft versus host disease (GVHD) requiring immune suppression regardless of grade
• Evidence of human immunodeficiency virus (HIV) infection
• Seropositive for and with evidence of active viral infection with hepatitis B virus (HBV) or hepatitis C virus (HCV)
• History of hypersensitivity reactions to murine protein-containing products or other product excipients
• Symptomatic cardiovascular disease: Class III or IV according to the New York Heart Association (NYHA) Functional Classification
• Active second malignancy or history of another malignancy within the last 3 years
• Any other serious, life-threatening, or unstable preexisting medical conditions

Lab values

• ECHO or MUGA with LVEF \< 45%

Other

• Evidence of lymphomatous involvement of central nervous system (CNS)
• Inadequate pulmonary function defined as pulse oximetry \< 90% on room air
• Women who are pregnant or intending to become pregnant; women who are breastfeeding; persons with procreative potential not using and not willing to use 2 highly effective methods of contraception

• Eligibility is determined prior to blood collection . Patients must satisfy the following criteria to be enrolled in the study:
• Signed Informed Consent Form
• Male or female patients who are 12 - 75 years of age
• Histologically confirmed classical Hodgkin Lymphoma
• Relapsed or refractory cHL that has failed at least 3 prior lines of therapy, including:
  • chemotherapy
  • BV and/or
  • PD-1 inhibitor Patients may have previously received an autologous and/or allogeneic stem cell transplant
• CD30-positive tumor
• At least 1 measurable lesion according to The Lugano Classification
• Laboratory parameters: Hematological, renal and hepatic functions, and coagulation parameters
  • Hgb ≥ 8.0 g/dL
  • Total bilirubin ≤ 1.5 × ULN
  • AST and ALT ≤ 5 × the ULN
  • CrCl \> 45 mL/min
  • ANC \>1,000/µL
  • Platelets \>75,000/µL
  • PT or INR ≤ 1.5 × ULN; PTT or aPTT ≤ 1.5 × ULN
• ECOG PS of 0 to 1 or equivalent \[either Karnofsky PS (for patients ≥ 16 year of age) or Lansky PS (for patients \< 16 years of age)\]
• Anticipated life expectancy \> 12 weeks