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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02259556
Other study ID # CHN-PLAGH-BT-011
Secondary ID
Status Recruiting
Phase Phase 1/Phase 2
First received October 5, 2014
Last updated January 26, 2016
Start date October 2014
Est. completion date October 2029

Study information

Verified date January 2016
Source Chinese PLA General Hospital
Contact Weidong Han, Ph.D
Phone 86-10-66937463
Email hanwdrsw@sina.com
Is FDA regulated No
Health authority China: Ethics Committee
Study type Interventional

Clinical Trial 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).


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date October 2029
Est. primary completion date October 2018
Accepts healthy volunteers No
Gender Both
Age group 16 Years to 80 Years
Eligibility 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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Biological:
CART30
Cells will be infused 1 day after the completion of conditioning regimen.

Locations

Country Name City State
China Chinese PLA General Hospital Beijing Beijing

Sponsors (1)

Lead Sponsor Collaborator
Chinese PLA General Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Other in vivo existence of CART30 Measure mainly by the changes of CAR molecule levels in blood 1 year Yes
Primary Occurrence of related adverse events untill week 24 Yes
Secondary Anti-tumor response to CART30 cell infusions Evaluated mainly by computed tomography scanning Up to 24 weeks No
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