CD30-directed Chimeric Antigen Receptor T (CART30) Therap... | NCT02259556

Studies
CD30-directed Chimeric Antigen Receptor T (CART30) Therapy in Relapsed and Refractory CD30 Positive Lymphomas

NCT02259556

Sponsor

Chinese PLA General Hospital

Status

Recruiting

Last Update Posted

Jan 28, 2016Estimated

Enrollment

30Estimated

Phase

Phase 1Phase 2

Conditions

Hodgkin's Lymphoma
Non-Hodgkin's Lymphoma

Interventions

CART30

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2016

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2014

Primary Completion Date

Oct 2018Estimated

Completion Date

Oct 2029Estimated

First Submitted Date

Oct 5, 2014

First Submission Date that Met QC Criteria

Oct 7, 2014

First Posted Date

Oct 8, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 26, 2016

Last Update Posted Date

Jan 28, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Chimeric antigen receptor-modified T cells (CART) holds great promise for treatment of tumors. In this trial, CD30 positive Hodgkin's lymphoma and Non-Hodgkin's lymphoma will be treated by CD30-specific CART cells (CART30).

Detailed Description

When patients enroll on this trial, autologous CART-33 cells were generated from the mononuclear cells of 50 to 90 ml of the patient's peripheral blood (PB). During the term of cell preparation of CART30, patients will receive a conditioning regimen including cyclophosphamide and fludarabine. One day after completing conditioning regimen, the patient will be given infusions of CART30 cells into the vein in escalating doses over a period of 3 to 5 consecutive days.

Extra blood will be drawn to measure the persistence of CART30 in vivo.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
anti-CD30 CAR T cells	Experimental	Patients receive CART30 cell infusions with an escalation dose.	Biological: CART30

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CART30	Biological	Cells will be infused 1 day after the completion of conditioning regimen.	anti-CD30 CAR T cells

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Occurrence of related adverse events		untill week 24

Secondary Outcomes

Measure	Description	Time Frame
Anti-tumor response to CART30 cell infusions	Evaluated mainly by computed tomography scanning	Up to 24 weeks

Other Outcomes

Measure	Description	Time Frame
in vivo existence of CART30	Measure mainly by the changes of CAR molecule levels in blood	1 year

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male and female subjects with CD30+ Hodgkin lymphoma and Non-Hodgkin lymphoma relapsing after autologous stem-cell transplantation (ASCT), or refractory to 2 multidrug regimens and/or anti-CD30 antibody treatment.
Newly diagnosed CD30+ Hodgkin lymphoma and Non-Hodgkin lymphoma patients who are unable to receive or complete standard chemotherapy.
Karnofsky or Lansky score greater than 60%.
Expected survival>12 weeks.
Creatinine<2.5mg/dl.
ALT (alanine aminotransferase)/AST (aspartate aminotransferase)<3 fold normal.
Bilirubin<2.5mg/dl.
Pulse oximetry of >90% on room air.
Adequate pulmonary function with FEV1, FVC and DLCO greater than or equal to 50% of expected corrected for hemoglobin.
Available autologous T cells with 10% or more expression of CD30 CAR determined by flow-cytometry.
Patients or legal guardians must sign an informed consent indicating that they are aware this is a research study and have been told of its possible benefits and toxic side effects. Patients or their guardians will be given a copy of the consent form.

Exclusion Criteria:

Active infection such as hepatitis B or C.
Receive anti-CD30 antibody-based therapy within recent 6 weeks.
Current use of systemic corticosteroids.
Pregnant or lactating.
Confirmed tumor in pulmonary and archenteric tissues.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

80 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Weidong Han, Ph.D	Contact	86-10-66937463		hanwdrsw@sina.com
Quanshun Wang, Ph.D	Contact	86-10-66939486		wqs63@sohu.com

Overall Officials

Name	Affiliation	Role
Weidong Han, Ph.D	Chinese PLA General Hospital	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Chinese PLA General Hospital	Recruiting	Beijing	Beijing Municipality	100853	China

Condition Browse Module

MeSH Terms

ID	Term
D006689	Hodgkin Disease
D008228	Lymphoma, Non-Hodgkin

Ancestor Terms

ID	Term
D008223	Lymphoma
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D008232	Lymphoproliferative Disorders

Browse Leaves

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Browse Branches

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