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

This is an interventional treatment trial for Anaplastic Large Cell Lymphoma focused on measuring CD30, r/r NHL, DLBCL, ALCL, ENKTCL, PMBCL, PTCL, adult Read More

Inclusion Criteria:

Eligibility is determined priori to leukapheresis. Patients must satisfy the following criteria to be enrolled in this study:

1. Signed Informed Consent Form
2. Male or female patients who are 18-75 years of age
3. Histologically confirmed ALCL, PTCL- NOS, ENKTCL nasal type, DLBCL-NOS and PMBCL
4. 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
5. At least 1 measurable lesion according to the Lugano Classification
6. ECOG PS of 0 to 1 or equivalent Karnofsky PS Anticipated life expectancy >12 weeks

Exclusion Criteria:

1. CNS involvement by malignancy

2. 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

3. Active uncontrolled bleeding or a known bleeding diathesis
4. Inadequate pulmonary function defined as pulse oximetry < 90% on room air
5. Ongoing treatment with immunosuppressive drugs including calcineurin inhibitions, TNFalpha, mTOR, etc or chronic systemic corticosteroids (>10 mg/day prednisone or equivalent for >48 hours)

6. 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

7. Active GVHD requiring immune suppression regardless of grade
8. HIV positive
9. Active HBV and/or HCV