CAR-T Cell Immunotherapy for EphA2 Positive Malignant Glioma Patients

NCT02575261 | Withdrawn Phase 1 DMC

• 1 other identifier: CAR-T for malignant glioma
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the safety and effectiveness of CAR-T cell immunotherapy in treating with EphA2 positive malignant glioma patients.

Conditions

EphA2 Positive Malignant Glioma; CAR-T Cell Immunotherapy

Keywords

CAR-T cell immunotherapy; EphA2; malignant glioma

Outcome Measures

Primary Outcomes (1)

• The effectiveness of CAR-T cell immunotherapy

  After CAR-T cell infusion,we will detect the persistence of CAR-T cells by flow-cytometric analysis.And we will observe if this CAR T cells can significantly inhibite the tumor growth by discovering the change of tumor volume.

  24 weeks

Secondary Outcomes (1)

• The safety of CAR-T cell immunotherapy (adverse events)

  6 weeks

Other Outcomes (2)

• Clinical response

  24 weeks

• Progress free disease (PFS)

  1 year

Study Arms (2)

Experimental:CAR-T cell immunotherapy

EXPERIMENTAL

Enrolled patients will receive CAR-T cell immunotherapy with a novel specific Chimeric antigen receptor aiming at EphA2 antigen by infusion.

Biological: CAR-T cell immunotherapy

No Intervention

NO INTERVENTION

Interventions

CAR-T cell immunotherapy BIOLOGICAL

This CAR-T cell immunotherapy with a novel specific Chimeric antigen receptor aiming at EphA2 antigen.

Experimental:CAR-T cell immunotherapy

Eligibility Criteria

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

You may qualify if:

• the primary EphA2 positive patients, the best are malignant glioma patients.
• the recurrent EphA2 positive patients, the best are malignant glioma patients.
• Patients must have evidence of adequate bone marrow reserve, hepatic and renal function as evidenced by the following laboratory parameters:
• Absolute neutrophil count greater than 1500/mm3. Platelet count greater than 100,000/mm3. Hemoglobin greater than 10g/dl (patients may receive transfusions to meet this parameter).
• Total bilirubin \< 1.5 times upper limits of normal. Serum creatinine less than or equal to 1.6 mg/ml or the creatinine clearance must be greater than 70 ml/min/1.73m(2).
• Seronegative for HIV antibody.
• Seronegative for active hepatitis B, and seronegative for hepatitis C antibody.
• Patients must be willing to practice birth control during and for four months following treatment.NOTE:women of child-bearing age must have evidence of negative pregnancy test.
• Patients must be willing to sign an informed consent.

You may not qualify if:

• the patients with multiple kinds of cancars are excluded.
• Patients with uncontrolled hypertension (\> 160/95), unstable coronary disease evidenced by uncontrolled arrhythmias, unstable angina, decompensated congestive heart failure (\> New York Heart Association Class II), or myocardial infarction within 6 months of study will be excluded.
• Patients with any of the follo wing pulmonary function abnormalities will be excluded: FEV(forced expiratory volume), \< 30% predicted; DLCO (diffusing capacity of lung for carbon monoxide) \< 30% predicted (post-bronchodilator); Oxygen Saturation less than 90% on room air.
• Patients with severe liver and kidney dysfunction or consciousness disorders will be excluded.
• Pregnant and/or lactating women will be excluded.
• Patients with active infections, including HIV, will be excluded, due to unknown effects of the vaccine on lymphoid precursors.
• Patients with any type of primary immunodeficiencies will be excluded from the study.
• Patients requiring corticosteroids (other than inhaled) will be excluded.
• Patients with history of T cell tumors will be excluded.
• Patients who are participating or participated any other clinical trials in latest 30 days will be excluded.

Sponsors & Collaborators

• Fuda Cancer Hospital, Guangzhou: lead

Study Sites (1)

Central laboratory in Fuda cancer hospital

Guangzhou, Guangdong, 510000, China

Location

MeSH Terms

Conditions

Glioma

Interventions

Immunotherapy, Adoptive

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Adoptive Transfer; Immunization, Passive; Immunization; Immunotherapy; Immunomodulation; Biological Therapy; Therapeutics; Immunologic Techniques; Investigative Techniques

Study Officials

• Lizhi Niu, PhD

  Fuda Cancer Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2015
• First Posted: October 14, 2015
• Study Start: September 1, 2015
• Primary Completion: August 15, 2016
• Study Completion: August 15, 2016
• Last Updated: July 16, 2020

Record last verified: 2020-07

Locations

CN (1)