CD30-directed Chimeric Antigen Receptor T (CART30) Therapy in Relapsed and Refractory CD30 Positive Lymphomas
CART30
1 other identifier
interventional
30
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Oct 2014
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2014
CompletedFirst Submitted
Initial submission to the registry
October 5, 2014
CompletedFirst Posted
Study publicly available on registry
October 8, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2029
ExpectedJanuary 28, 2016
January 1, 2016
4 years
October 5, 2014
January 26, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Occurrence of related adverse events
untill week 24
Secondary Outcomes (1)
Anti-tumor response to CART30 cell infusions
Up to 24 weeks
Other Outcomes (1)
in vivo existence of CART30
1 year
Study Arms (1)
anti-CD30 CAR T cells
EXPERIMENTALPatients receive CART30 cell infusions with an escalation dose.
Interventions
Cells will be infused 1 day after the completion of conditioning regimen.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Chinese PLA General Hospital
Beijing, Beijing Municipality, 100853, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Weidong Han, Ph.D
Chinese PLA General Hospital
Central Study Contacts
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 5, 2014
First Posted
October 8, 2014
Study Start
October 1, 2014
Primary Completion
October 1, 2018
Study Completion (Estimated)
October 1, 2029
Last Updated
January 28, 2016
Record last verified: 2016-01