Actively Recruiting

Phase 1
Phase 2
Age: 16Years - 80Years
All Genders
NCT02259556

CD30-directed Chimeric Antigen Receptor T (CART30) Therapy in Relapsed and Refractory CD30 Positive Lymphomas

Led by Chinese PLA General Hospital · Updated on 2016-01-28

30

Participants Needed

1

Research Sites

782 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Chimeric antigen receptor-modified T cells (CART) holds great promise for treatment of tumors. In this trial, CD30 positive Hodgkin's lymphoma and Non-Hodgkin's lymphoma will be treated by CD30-specific CART cells (CART30).

CONDITIONS

Official Title

CD30-directed Chimeric Antigen Receptor T (CART30) Therapy in Relapsed and Refractory CD30 Positive Lymphomas

Who Can Participate

Age: 16Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male and female subjects with CD30+ Hodgkin lymphoma and Non-Hodgkin lymphoma relapsing after autologous stem-cell transplantation, or refractory to 2 multidrug regimens and/or anti-CD30 antibody treatment
  • Newly diagnosed CD30+ Hodgkin lymphoma and Non-Hodgkin lymphoma patients unable to receive or complete standard chemotherapy
  • Karnofsky or Lansky score greater than 60%
  • Expected survival greater than 12 weeks
  • Creatinine less than 2.5 mg/dl
  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) less than 3 times normal
  • Bilirubin less than 2.5 mg/dl
  • Pulse oximetry above 90% on room air
  • Adequate pulmonary function with FEV1, FVC, and DLCO at least 50% of expected corrected for hemoglobin
  • Available autologous T cells with 10% or more CD30 CAR expression determined by flow cytometry
  • Patients or legal guardians must sign informed consent acknowledging understanding of this research study and its possible benefits and side effects
Not Eligible

You will not qualify if you...

  • Active infection such as hepatitis B or C
  • Received anti-CD30 antibody-based therapy within the past 6 weeks
  • Current use of systemic corticosteroids
  • Pregnant or lactating
  • Confirmed tumor in pulmonary or archenteric tissues

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Chinese PLA General Hospital

Beijing, Beijing Municipality, China, 100853

Actively Recruiting

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Research Team

W

Weidong Han, Ph.D

CONTACT

Q

Quanshun Wang, Ph.D

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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