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

Chinese PLA General Hospital (301 Hospital)

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Hodgkin's Lymphoma; Non-Hodgkin's Lymphoma

Treatments: Biological: CART30

Study type: Interventional

Funder types: Other

Identifiers

NCT02259556

CHN-PLAGH-BT-011

Details and patient eligibility

About

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).

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 16 to 80 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

anti-CD30 CAR T cells

Experimental group

Description:

Patients receive CART30 cell infusions with an escalation dose.

Treatment:

Biological: CART30