Active, not recruiting
Phase 1
Phase 1 Study of Autologous CD30.CAR-T in Relapsed or Refractory CD30 Positive Non-Hodgkin Lymphoma
Condition(s) studied
Anaplastic Large Cell LymphomaPeripheral T Cell LymphomaExtranodal NK/T-cell LymphomaDiffuse Large B Cell LymphomaPrimary Mediastinal Large B-Cell Lymphoma (PMBCL)
Investigational drug(s) / intervention(s)
CD30.CAR-T: Bendamustine and Fludarabine (3 days)
Dose level 1: 2 x 108 cell/m2 CD30.CAR-T (Day 0)
Dose level 2: 4 x 108 cell/m2 CD30.CAR-T (Day 0)
Dose level 3: 6 x 108 cell/m2 CD30.CAR-T (Day 0)
Study summary
This is a phase 1 study to evaluate safety and dose-limiting toxicity of autologous CD30.CAR-T in subjects with relapsed or refractory CD30+ Non-Hodgkin Lymphoma
Eligibility
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
Primary outcome measure(s)
- To evaluate safety and dose limiting toxicities (DLT) of autologous CD30.CAR-T and establish the recommended Phase dose — Day 0 to 28 for DLT
Incidence of DLTs and occurrence of study related adverse events
Trial sites (4)
| Facility | City | Region | Status |
| City of Hope |
Duarte |
California |
|
| Sarah Cannon Research Institute |
Nashville |
Tennessee |
|
| Baylor College of Medicine |
Houston |
Texas |
|
| The University of Texas MD Anderson Cancer Centre |
Houston |
Texas |
|
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