CD30 Targeted CAR-T in Treating CD30-Expressing Lymphomas

Phase 1

Recruiting

• Conditions: Anaplastic Large Cell Lymphoma; Hodgkin Lymphoma
• Interventions: Biological: ICAR30 T cells

• Registration Number: NCT03383965
• Lead Sponsor: Immune Cell, Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2017-03
• Study Start: 2017-03-01
• Study First Submitted: 2017-12-06
• Study First Submitted QC: 2017-12-19
• Last Update Submitted: 2017-12-19
• Study First Posted: 2017-12-27
• Last Update Posted: 2017-12-27
• Primary Completion: 2020-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ICAR30 T cells	ICAR30 T cells	anti-CD30 CAR-T cells. Patients receive ICAR30 T cells infusion.

Primary Outcome Measures

Name	Time	Method
Measure the safety of ICAR30 T cells	2 years	To assess the adverse events of ICAR30 T cells infusion in patients with Hodgkin's lymphoma and CD30+ anaplastic large cell lymphoma.

Secondary Outcome Measures

Name	Time	Method
Measure the anti-tumor effect of ICAR30 T cells	3 years	To assess the anti-tumor effect of ICAR30 T cells infusion in patients with Hodgkin's lymphoma and CD30+ anaplastic large cell lymphoma.
Measure the survival time of ICAR30 T cells in vivo	5 years	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.

Trial Locations

Locations (1)

Weifang People's Hospital; 🇨🇳 Weifang, Shandong, China