CD147-CART Cells in Patients With Recurrent Malignant Glioma.

NCT04045847 | Unknown Early Phase 1 DMC

• 1 other identifier: Chen Zhinan-2
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single-center, single-arm, open label and dose escalation clinical study of anti-CD147 CART cells in patients with recurrent malignant glioma.

Conditions

Recurrent Glioblastoma; CD147 Positive

Keywords

glioma; CD147; CAR-T

Outcome Measures

Primary Outcomes (1)

• Incidence and type of adverse events induced by CD147-CART

  To assess the safety and tolerability of CD147-CART (anti-CD147 CAR-T cell) for glioma which measured by number and type of adverse events.

  12 weeks

Secondary Outcomes (3)

• DLT and MTD of CD147-CART cell

  12 weeks

• Clinical Activity of CD147-CART cell

  2 years

• CD147-CART detection in Peripheral Blood

  2 years

Study Arms (1)

CD147-CART

EXPERIMENTAL

CD147-CAR modified T cells, intracavity injection, 3+3 design with de-escalation in half step, every 7 days for 3 weeks

Biological: CD147-CART

Interventions

CD147-CART BIOLOGICAL

Three doses of CD147-CART cells were injection to intracavity by Ommaya Reservoir.

Also known as: anti-CD147 chimeric antigen receptor T cells

CD147-CART

Eligibility Criteria

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

You may qualify if:

• Age ≥ 18 year and ≤ 65 years, both male and female;
• Recurrent glioblastoma patients confirmed by histology or cytology, which have received standard care of STUPP protocol (TMZ concurrent chemoradiotherapy and adjuvant chemotherapy protocol) after surgery;
• Cerebral ventricle was not opened after glioma surgery;
• More than 6 months after the first glioma surgery;
• Tumor lesions that can be evaluated or measured according to RANO criteria (Measurable enhancement lesions were defined as enhancement lesions with clear upper boundary of CT or MRI, capable of developing on ≥2 axial films with layer thickness of 5 mm, and the length and diameter of each other were \>10 mm. If the scanning layer thickness is large, the minimum measurable lesion should be \>2 times thick);
• CD147+ was confirmed by histologically diagnosis (IHC staining).
• Adequate PBMC can be obtained according to the requirements of cell preparation, and there are no other contraindications for lymphocyte collection;
• KPS score ≥70;
• Patient with a life expectancy of greater than three months;
• Patients with entirely informed consent and voluntarily sign the informed consent by themselves or their legal representative.

You may not qualify if:

• Patients who have received radiotherapy after recurrence;
• Patients who have received corticosteroids or other immunosuppressive agents in the past 2 weeks;
• Patients who have received live vaccine in the past 4 weeks and/or plan to receive live vaccine after participating in the trial;
• Patients who have received chemotherapy in addition to lymphocyte clearance in the past 2 weeks;
• Patients who have not recover from adverse events caused by previous anti-tumor therapy (≤1 according to CTCAE v5.0) prior to enrollment, except for hair loss；
• Patients who have received gene therapy, cell therapy or immune therapy；
• Patients who have received organ transplantation；
• Patients who cannot able to perform craniocerebral MRI examination;
• Patients with following abnormalities:
• Absolute neutrophil count (ANC)\<1.5×109/L， platelet (PLT)\<80×109/L or hemoglobin(HGB)\<100 g/dL；
• Prothrombin time (PT), activated partial thromboplastin time (APTT) or international normalized ratio (INR) \> 1.5×ULN (upper normal value);
• Total bilirubin(TBIL) \> 2×ULN; ALT, AST or ALP\>3×ULN;
• Serum creatinine (Cr)≥1.5×ULN or glomerular filtration rate (GFR) \< 60mL/min×1.73m2；
• Syphilis test (TRUST) positive, Anti-HIV positive, Anti-HCV positive with HCV-RNA level higher than the lower limit of detection (LOD), or HBcAb positive with HBV-DNA level higher than the LOD;
• Left ventricular ejection fraction (LVEF) \< 50%;

Sponsors & Collaborators

• Xijing Hospital: lead

Study Sites (1)

National Translational Science Center for Molecular Medicine & Department of Cell Biology

Xi'an, Shaanxi, 710032, China

RECRUITING

MeSH Terms

Conditions

Glioblastoma; Glioma

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Zhinan Chen, PhD

CONTACT

029-84774547; znchen@fmmu.edu.cn

Zhou Fei, Dr

CONTACT

029-84775323; feizhou@fmmu.edu.cn

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2019
• First Posted: August 6, 2019
• Study Start: May 30, 2019
• Primary Completion: October 30, 2020
• Study Completion: May 30, 2022
• Last Updated: May 7, 2020

Record last verified: 2019-05

Locations

CN (1)