Clinical trial NCT02259556: CD30-directed Chimeric Antigen Receptor T (CART30) Therapy in Relapsed and Refractory CD30 Positive Lymphomas
Official title: CD30-directed Chimeric Antigen Receptor T (CART30) Therapy in Relapsed and Refractory CD30 Positive Lymphomas
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Hodgkin's Lymphoma
Non-Hodgkin's Lymphoma
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2014-10-08
Enrollment: 30
Sex: ALL
Minimum age (years): 16
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Occurrence of related adverse events
timeFrame: untill week 24
Secondary outcomes:
measure: Anti-tumor response to CART30 cell infusions
timeFrame: Up to 24 weeks
Other outcomes:
measure: in vivo existence of CART30
timeFrame: 1 year
Locations:
city: Beijing
country: China
facility: Chinese PLA General Hospital
state: Beijing
Study officials:
affiliation: Chinese PLA General Hospital
name: Weidong Han, Ph.D
role: STUDY_CHAIR
References: