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

Primary Purpose

Hodgkin's Lymphoma, Non-Hodgkin's Lymphoma

Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
CART30
Sponsored by
Chinese PLA General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hodgkin's Lymphoma

Eligibility Criteria

16 Years - 80 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Chinese PLA General HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

anti-CD30 CAR T cells

Arm Description

Patients receive CART30 cell infusions with an escalation dose.

Outcomes

Primary Outcome Measures

Occurrence of related adverse events

Secondary Outcome Measures

Anti-tumor response to CART30 cell infusions
Evaluated mainly by computed tomography scanning

Full Information

First Posted
October 5, 2014
Last Updated
January 26, 2016
Sponsor
Chinese PLA General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02259556
Brief Title
CD30-directed Chimeric Antigen Receptor T (CART30) Therapy in Relapsed and Refractory CD30 Positive Lymphomas
Acronym
CART30
Official Title
CD30-directed Chimeric Antigen Receptor T (CART30) Therapy in Relapsed and Refractory CD30 Positive Lymphomas
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Recruiting
Study Start Date
October 2014 (undefined)
Primary Completion Date
October 2018 (Anticipated)
Study Completion Date
October 2029 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese PLA General Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hodgkin's Lymphoma, Non-Hodgkin's 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
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
anti-CD30 CAR T cells
Arm Type
Experimental
Arm Description
Patients receive CART30 cell infusions with an escalation dose.
Intervention Type
Biological
Intervention Name(s)
CART30
Other Intervention Name(s)
anti-CD30 CAR T cells
Intervention Description
Cells will be infused 1 day after the completion of conditioning regimen.
Primary Outcome Measure Information:
Title
Occurrence of related adverse events
Time Frame
untill week 24
Secondary Outcome Measure Information:
Title
Anti-tumor response to CART30 cell infusions
Description
Evaluated mainly by computed tomography scanning
Time Frame
Up to 24 weeks
Other Pre-specified Outcome Measures:
Title
in vivo existence of CART30
Description
Measure mainly by the changes of CAR molecule levels in blood
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Weidong Han, Ph.D
Phone
86-10-66937463
Email
hanwdrsw@sina.com
First Name & Middle Initial & Last Name or Official Title & Degree
Quanshun Wang, Ph.D
Phone
86-10-66939486
Email
wqs63@sohu.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Weidong Han, Ph.D
Organizational Affiliation
Chinese PLA General Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Chinese PLA General Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100853
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Weidong Han, Ph.D
Phone
86-10-66937463
Email
hanwdrsw@sina.com
First Name & Middle Initial & Last Name & Degree
Quanshun Wang, Ph.D
Phone
86-10-66939486
Email
wqs63@sohu.com

12. IPD Sharing Statement

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

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