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

Non-Hodgkin's Lymphoma Clinical Trial

— CART30  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02259556
• Other study ID #: CHN-PLAGH-BT-011
• 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

Related Conditions & MeSH terms

• Hodgkin Disease
• Hodgkin's Lymphoma
• Lymphoma
• Lymphoma, Non-Hodgkin
• Non-Hodgkin's Lymphoma

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