CD30 Targeted CAR-T in Treating CD30-Expressing Lymphomas

December 19, 2017 updated by: Xiulian Sun, Immune Cell, Inc.

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shandong
      • Weifang, Shandong, China, 261000
        • Recruiting
        • Weifang People's Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 80 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: ICAR30 T cells
anti-CD30 CAR-T cells. Patients receive ICAR30 T cells infusion.
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.
Other Names:
  • Biological drug

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measure the safety of ICAR30 T cells
Time Frame: 2 years
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measure the anti-tumor effect of ICAR30 T cells
Time Frame: 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.
3 years
Measure the survival time of ICAR30 T cells in vivo
Time Frame: 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.
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Immune Cell, Inc.

Collaborators

Weifang People's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 1, 2017

Primary Completion (ANTICIPATED)

December 31, 2020

Study Completion (ANTICIPATED)

December 31, 2025

Study Registration Dates

First Submitted

December 6, 2017

First Submitted That Met QC Criteria

December 19, 2017

First Posted (ACTUAL)

December 27, 2017

Study Record Updates

Last Update Posted (ACTUAL)

December 27, 2017

Last Update Submitted That Met QC Criteria

December 19, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CD30-targeting CAR-T

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hodgkin Lymphoma

Clinical Trials on ICAR30 T cells

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Austria

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe