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

January 26, 2016 updated by: Han weidong, Chinese PLA General Hospital
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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Quanshun Wang, Ph.D
  • Phone Number: 86-10-66939486
  • Email: wqs63@sohu.com

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100853
        • Recruiting
        • Chinese PLA General Hospital
        • Contact:
        • Contact:
          • Quanshun Wang, Ph.D
          • Phone Number: 86-10-66939486
          • Email: wqs63@sohu.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 80 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male and female subjects with CD30+ Hodgkin lymphoma and Non-Hodgkin lymphoma relapsing after autologous stem-cell transplantation (ASCT), or refractory to 2 multidrug regimens and/or anti-CD30 antibody treatment.
  • Newly diagnosed CD30+ Hodgkin lymphoma and Non-Hodgkin lymphoma patients who are unable 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% of expected corrected for hemoglobin.
  • Available autologous T cells with 10% or more expression of CD30 CAR determined by flow-cytometry.
  • Patients or legal guardians must sign an informed consent indicating that they are aware this is a research study and have been told of its possible benefits and toxic side effects. Patients or their guardians will be given a copy of the consent form.

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: anti-CD30 CAR T cells
Patients receive CART30 cell infusions with an escalation dose.
Biological: CART30
Cells will be infused 1 day after the completion of conditioning regimen.
Other Names:
  • anti-CD30 CAR T cells

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Occurrence of related adverse events
Time Frame: untill week 24
untill week 24

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anti-tumor response to CART30 cell infusions
Time Frame: Up to 24 weeks
Evaluated mainly by computed tomography scanning
Up to 24 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
in vivo existence of CART30
Time Frame: 1 year
Measure mainly by the changes of CAR molecule levels in blood
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese PLA General Hospital

Investigators

  • Study Chair: Weidong Han, Ph.D, Chinese PLA General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Anticipated)

October 1, 2018

Study Completion (Anticipated)

October 1, 2029

Study Registration Dates

First Submitted

October 5, 2014

First Submitted That Met QC Criteria

October 7, 2014

First Posted (Estimate)

October 8, 2014

Study Record Updates

Last Update Posted (Estimate)

January 28, 2016

Last Update Submitted That Met QC Criteria

January 26, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHN-PLAGH-BT-011

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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