NCT02274584

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.

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Mar 2014

Typical duration for phase_1

Geographic Reach
2 countries

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

October 22, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 24, 2014

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

October 24, 2014

Status Verified

October 1, 2014

Enrollment Period

2.6 years

First QC Date

October 22, 2014

Last Update Submit

October 22, 2014

Conditions

Lymphomas

Keywords

Hodgkin's lymphomaAnaplastic large cell lymphomaCD30 positive lymphomaPeripheral T/Natural Killer (NK) cell lymphoma

Outcome Measures

Primary Outcomes (1)

  • 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.

    2 years.

Secondary Outcomes (3)

  • Survival time of Anti-CD30 CAR T cells in vivo.

    2 years.

  • Response rates to the 4th generation CAR T cells.

    2 years.

  • Survival time of the patients.

    2 years.

Study Arms (1)

CAR T cells

EXPERIMENTAL

Autologous 4th generation anti-CD30 CAR T cells

Genetic: Anti-CD30 CAR T cells

Interventions

Anti-CD30 CAR T cellsGENETIC

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

CAR T cells

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Florida

Gainesville, Florida, 32610, United States

RECRUITING

Peking University Cancer Hospital

Beijing, Beijing Municipality, 100142, China

RECRUITING

MeSH Terms

Conditions

LymphomaHodgkin DiseaseLymphoma, Large-Cell, Anaplastic

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLymphoma, T-CellLymphoma, Non-Hodgkin

Study Officials

  • Jun Zhu, MD

    Peking University Cancer Hospital & Institute

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jun Zhu, MD

CONTACT

+861088196596zj@bjcancer.org

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

October 22, 2014

First Posted

October 24, 2014

Study Start

March 1, 2014

Primary Completion

October 1, 2016

Study Completion

October 1, 2017

Last Updated

October 24, 2014

Record last verified: 2014-10

Locations

US(1)CN(1)