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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03383965
Other study ID # CD30-targeting CAR-T
Secondary ID
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
Health authority
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;

Study Design


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
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