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

Last updated: January 26, 2016
Sponsor: Chinese PLA General Hospital
Overall Status: Active - Recruiting

Phase

1/2

Condition

Non-hodgkin's Lymphoma

Lymphoproliferative Disorders

Leukemia

Treatment

N/A

Clinical Study ID

NCT02259556
CHN-PLAGH-BT-011
  • Ages 16-80
  • All Genders

Study Summary

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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Male and female subjects with CD30+ Hodgkin lymphoma and Non-Hodgkin lymphomarelapsing after autologous stem-cell transplantation (ASCT), or refractory to 2multidrug regimens and/or anti-CD30 antibody treatment.

  • Newly diagnosed CD30+ Hodgkin lymphoma and Non-Hodgkin lymphoma patients who areunable to receive or complete standard chemotherapy.

  • Karnofsky or Lansky score greater than 60%.

  • Expected survival>12 weeks.

  • Creatinine<2.5mg/dl.

  • ALT (alanine aminotransferase)/AST (aspartate aminotransferase)<3 fold normal.

  • Bilirubin<2.5mg/dl.

  • Pulse oximetry of >90% on room air.

  • Adequate pulmonary function with FEV1, FVC and DLCO greater than or equal to 50% ofexpected corrected for hemoglobin.

  • Available autologous T cells with 10% or more expression of CD30 CAR determined byflow-cytometry.

  • Patients or legal guardians must sign an informed consent indicating that they areaware this is a research study and have been told of its possible benefits and toxicside effects. Patients or their guardians will be given a copy of the consent form.

Exclusion

Exclusion Criteria:

  • Active infection such as hepatitis B or C.

  • Receive anti-CD30 antibody-based therapy within recent 6 weeks.

  • Current use of systemic corticosteroids.

  • Pregnant or lactating.

  • Confirmed tumor in pulmonary and archenteric tissues.

Study Design

Total Participants: 30
Study Start date:
October 01, 2014
Estimated Completion Date:
October 31, 2029

Study Description

When patients enroll on this trial, autologous CART-33 cells were generated from the mononuclear cells of 50 to 90 ml of the patient's peripheral blood (PB). During the term of cell preparation of CART30, patients will receive a conditioning regimen including cyclophosphamide and fludarabine. One day after completing conditioning regimen, the patient will be given infusions of CART30 cells into the vein in escalating doses over a period of 3 to 5 consecutive days.

Extra blood will be drawn to measure the persistence of CART30 in vivo.

Connect with a study center

  • Chinese PLA General Hospital

    Beijing, Beijing 100853
    China

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.