search
Back to results

CAR T Cells Targeting CD30 Positive Lymphomas (4SCAR30273)

Primary Purpose

Lymphomas

Status
Unknown status
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Anti-CD30 CAR T cells
Sponsored by
Peking University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphomas focused on measuring Hodgkin's lymphoma, Anaplastic large cell lymphoma, CD30 positive lymphoma, Peripheral T/Natural Killer (NK) cell lymphoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of FloridaRecruiting
  • Peking University Cancer HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CAR T cells

Arm Description

Autologous 4th generation anti-CD30 CAR T cells

Outcomes

Primary Outcome Measures

Number of patients with adverse events.
Determine the toxicity profile of the 4th generation CAR T cells with Common Toxicity Criteria for Adverse Effects (CTCAE) version 4.0.

Secondary Outcome Measures

Survival time of Anti-CD30 CAR T cells in vivo.
Measure the survival of 4th generation CAR T cells transduced with the anti-CD30 lentiviral vector.
Response rates to the 4th generation CAR T cells.
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).
Survival time of the patients.
Evaluate the survival time of the patients treated with the 4th generation CAR T cells, including progression free survival (PFS) and overall survival (OS).

Full Information

First Posted
October 22, 2014
Last Updated
October 22, 2014
Sponsor
Peking University
Collaborators
University of Florida
search

1. Study Identification

Unique Protocol Identification Number
NCT02274584
Brief Title
CAR T Cells Targeting CD30 Positive Lymphomas (4SCAR30273)
Official Title
Safety and Efficacy Evaluation of 4th Generation Safety-engineered CAR T Cells Targeting Relapsed and Refractory CD30 Positive Lymphomas
Study Type
Interventional

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Unknown status
Study Start Date
March 2014 (undefined)
Primary Completion Date
October 2016 (Anticipated)
Study Completion Date
October 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University
Collaborators
University of Florida

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphomas
Keywords
Hodgkin's lymphoma, Anaplastic large cell lymphoma, CD30 positive lymphoma, Peripheral T/Natural Killer (NK) cell lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CAR T cells
Arm Type
Experimental
Arm Description
Autologous 4th generation anti-CD30 CAR T cells
Intervention Type
Genetic
Intervention Name(s)
Anti-CD30 CAR T cells
Intervention Description
Autologous 4th generation withdrawal lentiviral-transduced anti-CD30 CAR T cells
Primary Outcome Measure Information:
Title
Number of patients with adverse events.
Description
Determine the toxicity profile of the 4th generation CAR T cells with Common Toxicity Criteria for Adverse Effects (CTCAE) version 4.0.
Time Frame
2 years.
Secondary Outcome Measure Information:
Title
Survival time of Anti-CD30 CAR T cells in vivo.
Description
Measure the survival of 4th generation CAR T cells transduced with the anti-CD30 lentiviral vector.
Time Frame
2 years.
Title
Response rates to the 4th generation CAR T cells.
Description
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).
Time Frame
2 years.
Title
Survival time of the patients.
Description
Evaluate the survival time of the patients treated with the 4th generation CAR T cells, including progression free survival (PFS) and overall survival (OS).
Time Frame
2 years.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jun Zhu, MD
Phone
+861088196596
Email
zj@bjcancer.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jun Zhu, MD
Organizational Affiliation
Peking University Cancer Hospital & Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lung-Ji Chang, PhD
Phone
352-273-8949
Email
lchang@mgm.ufl.edu
First Name & Middle Initial & Last Name & Degree
Lung-Ji Chang, PhD
Facility Name
Peking University Cancer Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100142
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jun Zhu, MD.
Phone
+8610-88196596
Email
zhu-jun@bjcancer.org
First Name & Middle Initial & Last Name & Degree
Zhitao Ying, MD.
Phone
+8610-88196109
Email
yingzhitao001@163.com
First Name & Middle Initial & Last Name & Degree
Jun Zhu, MD.

12. IPD Sharing Statement

Learn more about this trial

CAR T Cells Targeting CD30 Positive Lymphomas (4SCAR30273)

We'll reach out to this number within 24 hrs