CD30 Targeted CAR-T in Treating CD30-Expressing Lymphomas

Immune Cell, Inc.

Status and phase: Enrolling; Phase 1

Conditions: Hodgkin Lymphoma; Anaplastic Large Cell Lymphoma

Treatments: Biological: ICAR30 T cells

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03383965

CD30-targeting CAR-T

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 2 to 80 years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

ICAR30 T cells

Experimental group

Description:

anti-CD30 CAR-T cells. Patients receive ICAR30 T cells infusion.

Treatment:

Biological: ICAR30 T cells