Recruiting
Phase 1
Phase 2

CAR T Cells

Sponsor:

Peking University

Code:

NCT02274584

Conditions

Lymphomas

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Anti-CD30 CAR T cells

Study Details

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.

Conditions

Lymphomas

Study ID

NCT02274584

Start date

Mar, 2014

Status verified date

Oct, 2014

Completion date

Oct, 2017

Anticipated

Primary completion date

Oct, 2016

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: CAR T cells

Autologous 4th generation anti-CD30 CAR T cells

Interventions

Anti-CD30 CAR T cells

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

Primary outcome measure

  • Number of patients with adverse events. [ Time Frame: 2 years. ]

Central Contacts and Locations

Central contacts

Jun Zhu, MD

+861088196596zj@bjcancer.org

Locations

University of Florida

Recruiting

Gainesville, Florida, United States, 32610

Contacts

Lung-Ji Chang, PhD

352-273-8949lchang@mgm.ufl.edu

Principal Investigator:

Lung-Ji Chang, PhD

More Information

Sponsor

Peking University

Last update posted

Oct 24, 2014

Last verified

Oct, 2014

Keywords

  • Hodgkin's lymphoma
  • Anaplastic large cell lymphoma
  • CD30 positive lymphoma
  • Peripheral T/Natural Killer (NK) cell lymphoma

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Peking University on 2014-10-24.