CD30 Targeted CAR-T in Treating CD30-Expressing Lymphomas

NCT03383965 | Unknown Phase 1

• 1 other identifier: CD30-targeting CAR-T
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Hodgkin Lymphoma; Anaplastic Large Cell Lymphoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Measure the anti-tumor effect of ICAR30 T cells

  3 years

• Measure the survival time of ICAR30 T cells in vivo

  5 years

Study Arms (1)

ICAR30 T cells

EXPERIMENTAL

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

Biological: ICAR30 T cells

Interventions

ICAR30 T cells BIOLOGICAL

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.

Also known as: Biological drug

ICAR30 T cells

Eligibility Criteria

• Age: 2 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Immune Cell, Inc.: lead
• Weifang People's Hospital: collaborator

Study Sites (1)

Weifang People's Hospital

Weifang, Shandong, 261000, China

RECRUITING

MeSH Terms

Conditions

Hodgkin Disease; Lymphoma, Large-Cell, Anaplastic

Interventions

Biological Products

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Lymphoma, T-Cell; Lymphoma, Non-Hodgkin

Intervention Hierarchy (Ancestors)

Complex Mixtures

Central Study Contacts

Xiulian Sun, MD.,Ph.D

CONTACT

(+86) 010-62420689; xiuliansun@ymcell.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Masking Details: None (Open Label)
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 6, 2017
• First Posted: December 27, 2017
• Study Start: March 1, 2017
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2025
• Last Updated: December 27, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)