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Active, not recruiting Phase 1

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

NCT04526834 · tracked via the Priya Life Science USA tracker
Phase
Phase 1
Started
2021-09-08
Last updated
2023-04-20

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 →

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

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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)

FacilityCityRegionStatus
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
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04526834 on ClinicalTrials.gov ↗ ← All trials in the USA