Phase 1 Study of Autologous CD30.CAR-T in Relapsed or Refractory CD30 Positive Non-Hodgkin Lymphoma

Prior treatment

• Ongoing treatment with immunosuppressive drugs including calcineurin inhibitions, TNFalpha, mTOR, etc or chronic systemic corticosteroids (\>10 mg/day prednisone or equivalent for \>48 hours)
• Received prior therapy of:
  • Anti-CD30 Ab based therapy within the previous 8 weeks Previous CD30.CAR-T investigational product Bi-specific CD30 Ab within the previous 8 weeks Allogenic HSCT in the last 180 days Autologous HSCT within 90 days

Other illness

• CNS involvement by malignancy
• Active uncontrolled bleeding or a known bleeding diathesis
• HIV positive
• Active HBV and/or HCV

Lab values

• Inadequate laboratory abnormalities at screening:
  • Hgb ≤ 8.0 g/dL Total bilirubin \> 1.5 x ULN (\>2 x ULN for patients with Gilbert's syndrome) AST and ALT ≥ 5 x ULN CrCL ≤ 45 mL/min (as measured by Cockcroft-Gault equation) ANC ≤ 1000/uL Platelets ≤75,000/uL PR or INR \>1.5 x ULN aPTT\> 1.5 x ULN

Other

• Inadequate pulmonary function defined as pulse oximetry \< 90% on room air
• Active GVHD requiring immune suppression regardless of grade

• Eligibility is determined priori to leukapheresis. Patients must satisfy the following criteria to be enrolled in this study:
• Signed Informed Consent Form
• Male or female patients who are 18-75 years of age
• Histologically confirmed ALCL, PTCL- NOS, ENKTCL nasal type, DLBCL-NOS and PMBCL
• Relapsed or refractory CD30-positive NHL who have failed all available standards of therapy. Patients may or may not have received an autologous or allogeneic HSCT CD30-positive tumor
• At least 1 measurable lesion according to the Lugano Classification
• ECOG PS of 0 to 1 or equivalent Karnofsky PS Anticipated life expectancy \>12 weeks