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

Phase 1

Recruiting

• Conditions: Non-Hodgkin's Lymphoma; Hodgkin's Lymphoma
• Interventions: Biological: CART30

• Registration Number: NCT02259556
• Lead Sponsor: Chinese PLA General Hospital

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.

Study Timeline

• Study Start: 2014-10
• Study First Submitted: 2014-10-05
• Study First Submitted QC: 2014-10-07
• Study First Posted: 2014-10-08
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-26
• Last Update Posted: 2016-01-28
• Primary Completion: 2018-10
• Study Completion: 2029-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
anti-CD30 CAR T cells	CART30	Patients receive CART30 cell infusions with an escalation dose.

Primary Outcome Measures

Name	Time	Method
Occurrence of related adverse events	untill week 24

Secondary Outcome Measures

Name	Time	Method
Anti-tumor response to CART30 cell infusions	Up to 24 weeks	Evaluated mainly by computed tomography scanning

Trial Locations

Locations (1)

Chinese PLA General Hospital; 🇨🇳 Beijing, Beijing, China