Personalized Vaccine for Patients With Recurrent Malignant Glioma

• Sponsor: Xuanwu Hospital, Beijing (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04943718
• Collaborator: Beijing Neoantigen Biotechnology Company (Other)
• Enrollment: 10
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 35
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

A single-arm, single-center, open-labeled study will be conducted with an aim to investigate the feasibility, safety, and efficacy of the personalized vaccine for patients with recurrent malignant glioma.

Condition or Disease	Intervention/Treatment	Phase
Malignant Glioma; Recurrent Glioma	Biological: personalized vaccine	Phase 1

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 10 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Personalized Vaccine for Patients With Recurrent Malignant Glioma: a Single-arm, Single-center, Open-labeled Study
• Anticipated Study Start Date: Jul 15, 2021
• Anticipated Primary Completion Date: Jun 13, 2023
• Anticipated Study Completion Date: Jun 13, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: personalized vaccine patients with recurrent malignant gliomas enrolled into this arm will receive the personalized vaccine through sub-cutaneous.	Biological: personalized vaccine; Based on genetic and transcriptional sequencing information, personalized peptide vaccines would be designed and produced; patients would be vaccinated on day 1, 4, 8 ,15, 22 and then on week 12, 20.

Outcome Measures

Primary Outcome Measures

1. incidences of advent events and severe advent events [from initiation of study treatment to 28 weeks post-vaccination]

   would be monitored and measured according to the National Cancer Institute Common Terminology Criteria for Adverse Events (version 4.X.)

Secondary Outcome Measures

1. object response rate (ORR) according to iRANO criteria [from initiation of study treatment to 24 weeks post-vaccination (last shot)]

   ORR including complete response (CR) and partial response (PR) would be assessed and measured based on the conditions proposed by iRANO criteria

2. progression free survival (PFS) [up to 48 weeks post-vaccination(last shot)]

   time interval (measured in weeks) between initiation of study treatment to progression of disease

3. overall survival (OS) [up to 48 weeks post-vaccination(last shot)]

   time interval (measured in weeks) from initiation of study treatment to the death of patients

4. immune response based on the criteria encoded by GRT-C903 and GRT-R904 [Baseline to end of treatment (up to approximately 12 months)]

   humoral and cellular immune responses including generation of specific antibodies, inflammatory factors, immune cells, will be measured as proposed by GRT-C903 and GRT-R904

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• age 18-70;

• signed inform consent;

• patients with recurrent malignant glioma; have received surgery, radiotherapy, chemotherapy;

• patients' tumor tissue should have a high mutation load(>10 TMB); be genetically unstable; at least have 10 neoantigens;

• should be able to provide tumor tissue and peripheral blood for sequencing and flow cytometry analysis;

• at least three months post last operation; one month after the completion of the last anti-drug therapy or radiotherapy;

• have not received any immune therapy;

• at least have one measurable lesion;

• KPS >60;

• estimated survival > 3 months

• patients should have adequate organ and bone marrow function;

Exclusion Criteria:

• female patient is breastfeeding or pregnant;

• known history of allergy to peptides or other stimulating factors (i.e. GM-CSF);

• known history of Graft-Versus-Host Disease (GVHD);

• participation in gene therapy;

• other malignancy;

• systemic disease: i.e., severe infection; HIV;

• other conditions upon investigator's judgement;

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Xuanwu Hospital, Capital Medical University	Beijing	Beijing	China	100054

Sponsors and Collaborators

• Xuanwu Hospital, Beijing
• Beijing Neoantigen Biotechnology Company

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Qingtang Lin, Director, glioma immunotherapy program, Xuanwu Hospital, Beijing
• ClinicalTrials.gov Identifier: NCT04943718
• Other Study ID Numbers: 2019-127
• First Posted: Jun 29, 2021
• Last Update Posted: Jun 29, 2021
• Last Verified: Jun 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Glioma; Recurrence

Study Results

No Results Posted as of Jun 29, 2021