CAR T Cells Targeting CD30 Positive Lymphomas (4SCAR30273)

NCT ID: NCT02274584

Last Updated: 2014-10-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-03-31
• Study Completion Date: 2017-10-31

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.

Conditions

Lymphomas

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CAR T cells

Autologous 4th generation anti-CD30 CAR T cells

Group Type: EXPERIMENTAL

Anti-CD30 CAR T cells

Intervention Type: GENETIC

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

Interventions

Anti-CD30 CAR T cells

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

Intervention Type: GENETIC

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Florida

OTHER

Sponsor Role: collaborator

Peking University

OTHER

Sponsor Role: lead

Responsible Party

Jun Zhu

Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jun Zhu, MD

Role: PRINCIPAL_INVESTIGATOR

Peking University Cancer Hospital & Institute

Locations

University of Florida

Gainesville, Florida, United States

Site Status: RECRUITING

Peking University Cancer Hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

United States; China

Central Contacts

Jun Zhu, MD

Role: CONTACT

zj@bjcancer.org

+861088196596

Facility Contacts

Lung-Ji Chang, PhD

Role: primary

lchang@mgm.ufl.edu

352-273-8949

Jun Zhu, MD.

Role: primary

zhu-jun@bjcancer.org

+8610-88196596

Zhitao Ying, MD.

Role: backup

yingzhitao001@163.com

+8610-88196109

Other Identifiers

30273-4SCAR

Identifier Type: -

Identifier Source: org_study_id