CD30 Targeted CAR-T in Treating CD30-Expressing Lymphomas

Hodgkin Lymphoma Clinical Trial

Official title:

A Clinical Study of CD30 Targeted CAR-T in Treating CD30-Expressing Lymphomas

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03383965
• Other study ID #: CD30-targeting CAR-T
• Status: Recruiting
• Phase: Phase 1
• First received: December 6, 2017
• Last updated: December 19, 2017
• Start date: March 1, 2017
• Est. completion date: December 31, 2025

Study information

• Verified date: March 2017
• Source: Immune Cell, Inc.
• Contact: Xiulian Sun, MD.,Ph.D
• Phone: (+86) 010-62420689
• Email: xiuliansun[@]ymcell.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

CAR-T cells have been validated effective in treating CD19 positive B cell lymphoma. Other lymphomas like Hodgkin's lymphoma and anaplastic large cell lymphoma are CD30 positive. In this study, a newly CD30 targeted CART therapy ICAR30 is designed to specifically kill those CD30 expressing malignancies including Hodgkin's lymphoma and CD30+ anaplastic large cell lymphoma. The subjects will receive several doses of autologous ICAR30 T cells infusion and then the safety, treating effects and lasting period of these cells in vivo will be evaluated.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 80 Years

Eligibility

Inclusion Criteria:

Hodgkin's lymphoma, anaplastic large cell lymphoma and other CD30 positive malignancies, relapsed or refractory:

• Karnofsky or Lansky score >50;

• Expected survival>12 weeks;

• Hgb > 8.0;

• FEV1, FVC and DLCO =50% of expected corrected for hemoglobin;

• LVEF=50%;

• Creatinine<2.5mg/dl;

• Bilirubin<2.5mg/dl;

• ALT (alanine aminotransferase)/AST (aspartate aminotransferase)<3 fold normal;

• Patients must sign an informed consent.

Exclusion Criteria:

• Pregnant or lactating;

• Uncontrolled active infection including hepatitis B or C;

• HIV positive;

• Active clinically significant CNS dysfunction;

• Current use of systemic steroids;

• Heterogenous lymphocyte treatments within recent 6 months;

Related Conditions & MeSH terms

• Anaplastic Large Cell Lymphoma
• Hodgkin Disease
• Hodgkin Lymphoma
• Lymphoma
• Lymphoma, Large-Cell, Anaplastic

Intervention

Biological:
• ICAR30 T cells
T cells were isolated from peripheral blood from patients enrolled. T cells were transduced with lentivirus bearing anti-CD30 antibody scFV and the activation signals of second generation CART designation. The CART cells were infused into the patients by IV with an escalating dosage.

Locations

Country	Name	City	State
China	Weifang People's Hospital	Weifang	Shandong

Sponsors (2)

Lead Sponsor	Collaborator
Immune Cell, Inc.	Weifang People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measure the safety of ICAR30 T cells	To assess the adverse events of ICAR30 T cells infusion in patients with Hodgkin's lymphoma and CD30+ anaplastic large cell lymphoma.	2 years
Secondary	Measure the anti-tumor effect of ICAR30 T cells	To assess the anti-tumor effect of ICAR30 T cells infusion in patients with Hodgkin's lymphoma and CD30+ anaplastic large cell lymphoma.	3 years
Secondary	Measure the survival time of ICAR30 T cells in vivo	To measure the survival time of ICAR30 T cells in vivo, extra blood will be drawn from patients receive ICAR30 T cells infusion in the follow-up time.	5 years