CAR T Cells Targeting CD30 Positive Lymphomas (4SCAR30273)

October 22, 2014 updated by: Jun Zhu, Peking University

Safety and Efficacy Evaluation of 4th Generation Safety-engineered CAR T Cells Targeting Relapsed and Refractory CD30 Positive Lymphomas

Currently, a majority of lymphomas cannot be cured by standard chemo-radiotherapy. Cluster of differentiation antigen 30 (CD30) is expressed in many lymphoma subtypes, such as Hodgkin lymphoma (HL) and anaplastic large cell lymphoma (ALCL). CD30 represents a very attractive target for chimeric antigen receptor (CAR)-based immune cell therapy. This study will evaluate a novel 4th generation CD30 CAR engineered with a self-withdrawal mechanism (FKBP-iCasp9) for both efficacy and safety evaluation in lymphoma patients.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

A large number of lymphoma patients exhaust current treatment options and die from the disease. Innovative therapy is urgently needed. Chimeric antigen receptor (CAR)-modified T cells have demonstrated unprecedented successes in treating even late stage cluster of differentiation antigen 19 (CD19) positive B cell malignancies. Besides CD19 lymphomas, many lymphomas are CD30 positive and therefore, CD30-CAR T cells may prove to be effective in treating such patients. We have developed several generations of CD30 CARs. Preclinical studies have demonstrated effective killing of CD30 target cells. In this study, two versions of CD30 CARs, both of which are 4th generation CARs with a self-withdrawal mechanism (FKBP-iCasp9), will be evaluated in CD30 lymphoma patients. The primary goal is safety assessment including cytokine storm response and any other adverse effects. In addition, tumor targeting and disease status after treatment will also be evaluated.

Study Type

Interventional

Enrollment (Anticipated)

20

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 Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100142
        • Recruiting
        • Peking university cancer hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jun Zhu, MD.
  • United States
    • Florida
      • Gainesville, Florida, United States, 32610
        • Recruiting
        • University of Florida
        • Contact:
        • Principal Investigator:
          • Lung-Ji Chang, PhD

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Relapsed or refractory CD30(+) lymphoma patients proved by immuno-histochemistry (IHC) or Flow-cytometry.
  • Not eligible for autologous stem-cell transplantation (ASCT) or relapsed after ASCT.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
  • Age≥18.
  • Pulse oximetry of > 90% on room air.
  • Adequate hepatic function, defined as alanine transaminase (ALT) <3 x upper limit of normal (ULN), aspartate aminotransferase (AST) <3 x ULN; serum bilirubin and alkaline phosphatase <2 x ULN.
  • Adequate renal function, defined as serum creatinine <2.0mg/dl.
  • Adequate heart function with LVEF≥50%
  • Hb≥80g/L
  • Measurable disease can be identified.
  • Life expectancy ≥3 months.
  • Sexually active patients must be willing to utilize one of the more effective birth control methods during the study and for 1 year after the study is concluded. The male partner should use a condom.
  • Patients must sign an informed consent.

Exclusion Criteria:

  • Uncontrolled active infection.
  • Active infection with hepatitis B virus (HBV), hepatitis C virus (HCV).
  • HIV positive
  • Pregnant or lactating.
  • Currently enrolled in another clinical trial.
  • Concurrent use of systemic steroids.

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: CAR T cells
Autologous 4th generation anti-CD30 CAR T cells
Genetic: Anti-CD30 CAR T cells
Autologous 4th generation withdrawal lentiviral-transduced anti-CD30 CAR T cells

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients with adverse events.
Time Frame: 2 years.
Determine the toxicity profile of the 4th generation CAR T cells with Common Toxicity Criteria for Adverse Effects (CTCAE) version 4.0.
2 years.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Response rates to the 4th generation CAR T cells.
Time Frame: 2 years.
Describe the response rates of patients treated with 4th generation CAR T cells, including partial remission (PR), complete remission (CR), stable disease (SD) and progressive disease (PD).
2 years.
Survival time of the patients.
Time Frame: 2 years.
Evaluate the survival time of the patients treated with the 4th generation CAR T cells, including progression free survival (PFS) and overall survival (OS).
2 years.
Survival time of Anti-CD30 CAR T cells in vivo.
Time Frame: 2 years.
Measure the survival of 4th generation CAR T cells transduced with the anti-CD30 lentiviral vector.
2 years.

Collaborators and Investigators

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

Sponsor

Peking University

Collaborators

University of Florida

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

March 1, 2014

Primary Completion (Anticipated)

October 1, 2016

Study Completion (Anticipated)

October 1, 2017

Study Registration Dates

First Submitted

October 22, 2014

First Submitted That Met QC Criteria

October 22, 2014

First Posted (Estimate)

October 24, 2014

Study Record Updates

Last Update Posted (Estimate)

October 24, 2014

Last Update Submitted That Met QC Criteria

October 22, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 30273-4SCAR

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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