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Efficacy and Safety Evaluation of Percutaneous Ommaya Capsule Injection of Autologous Bi-dimensional Specific T Cells in the Treatment of Glioma and in Combination With Pemetrexed in the Treatment of Brain/Meningeal Metastases

Primary Purpose

Glioma, Brain Metastases

Status

Recruiting

Phase

Early Phase 1

Locations

China

Study Type

Interventional

Intervention

Autologous progenitor expansion -T

pemetrexed

About this trial

This is an interventional treatment trial for Glioma

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Clear diagnosis of glioma; The pathological diagnosis of the primary lesion is clear, and the intracranial lesion can be diagnosed as intracranial metastasis by clinical, cerebrospinal fluid and imaging diagnosis according to the standards of the European Society of Neuro-Oncology - European Society of Medical Oncology (EANo-ESMO).
Patients with glioma and solid tumor with brain metastasis who have relapsed after surgery, whole brain radiotherapy or chemotherapy, or who are intolerant and not suitable for surgery or radiotherapy, and who are determined by clinicians to no longer benefit from systemic chemotherapy;
Surgical indications for Ommaya capsule implantation;
Age ≥18 years old and ≤80 years old, regardless of gender;
ECOG score for general physical condition is 0 ~ 2;
The expected survival time is at least 1 month;
WBC≥3.0×109/L, Hb≥90g/L, PLT≥75×109/L at baseline upon enrollment;
Liver and kidney function are basically normal A) Liver: total bilirubin ≤2.0 mg/dL (34.2umol/L), AST and ALT≤ 2.5 times the upper limit of normal value, AST and ALT≤ 5 times the upper limit of normal value in patients with liver metastasis.
B) Kidney: creatinine ≤2.5 mg/dL (221umol/L), creatinine clearance ≥60 mL/min;
Understand and sign informed consent to participate in clinical study voluntarily.

Exclusion Criteria:

Patients with primary brain tumors other than glioma;
Patients with systemic metastasis, poor general condition, and expected survival time less than 1 month;
People allergic to pemetrexed;
Severe coagulation disorder;
Severe active infection and other serious complications;
Patients with active viral hepatitis;
There are urgent intracranial symptoms (cerebral hernia, etc.), systemic diseases affecting treatment, and basic diseases affecting patients' cognitive function (such as cerebrovascular diseases, Alzheimer's disease, etc.);
Pregnant or lactating women;
Within 4 weeks prior to enrollment, translumbar administration was performed;
Other factors considered by researchers are not suitable candidates.

Sites / Locations

Fudan University Pudong Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Treatment of glioma

Treatment of brain metastases

Arm Description

For patients with glioma, after the patient's general condition was stable, contraindications were excluded and RAK cells were injected into Ommaya sac.

For patients with brain/meninges metastasis, Ommaya capsule was placed subcutaneously after puncture under local anesthesia. Two days after surgery, chemotherapy was started when the intracranial pressure was stable and the condition was stable, and the conjunctivitis was eliminated. Intracapsular injection of autoimmune cells was started in the second week after chemotherapy.

Outcomes

Primary Outcome Measures

Clinical response rate

The percentage of patients with CR and PR in the total number of patients in the same period

Secondary Outcome Measures

Overall survival (OS)

Frome the starting date of the enrollment until the date of the first documented disease progression or the date of the death from any cause,whichever comes first

Safty(adverse events)

Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

Full Information

NCT ID

NCT05459441

First Posted

June 24, 2022

Last Updated

July 12, 2022

Sponsor

Shanghai Pudong Hospital

1. Study Identification

Unique Protocol Identification Number

NCT05459441

Brief Title

Efficacy and Safety Evaluation of Percutaneous Ommaya Capsule Injection of Autologous Bi-dimensional Specific T Cells in the Treatment of Glioma and in Combination With Pemetrexed in the Treatment of Brain/Meningeal Metastases

Official Title

Study Type

Interventional

2. Study Status

Record Verification Date

February 2022

Overall Recruitment Status

Recruiting

Study Start Date

January 1, 2022 (Actual)

Primary Completion Date

June 30, 2023 (Anticipated)

Study Completion Date

December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Shanghai Pudong Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

Cerebral metastases are common intracranial tumor, its incidence increased year by year, in recent years, although the whole brain radiation therapy, surgical resection, stereotactic radiosurgery treatment, targeted drugs, and other comprehensive treatment in patients with symptoms of mitigation and the extension of survival has played a positive role, but due to individual differences, treatment in patients with poor compliance were a lot of factors, Further treatment of brain metastases after conventional treatment requires the assistance and cooperation of clinical multi-disciplines. To evaluate the efficacy and safety of percutaneous Ommaya capsule injection of autologous bi-dimensional specific T cells in the treatment of glioma and combined with pemetrexed in the treatment of brain/meningeal metastasis. Using translational research techniques and means, to find molecular indicators related to clinical prognosis and outcome, establish the clinical use standard of this holistic treatment technology, and popularize it in multi-centers.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Glioma, Brain Metastases

7. Study Design

Primary Purpose

Treatment

Study Phase

Early Phase 1

Interventional Study Model

Single Group Assignment

Model Description

Single center prospective clinical study

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Treatment of glioma

Arm Type

Experimental

Arm Description

For patients with glioma, after the patient's general condition was stable, contraindications were excluded and RAK cells were injected into Ommaya sac.

Arm Title

Treatment of brain metastases

Arm Type

Experimental

Arm Description

Intervention Type

Biological

Intervention Name(s)

Autologous progenitor expansion -T

Intervention Description

After the completion of RAK cell culture, RAK cells were slowly injected into the tumor cavity through Ommaya capsule for no less than 10 minutes, each time about 1.0-4.0 108/4 mL, once a week,3 times as a course of treatment. Il-2 (500,000 units/capsule) was injected into the tumor cavity through Ommaya reservoir every other day after the injection of RAK cells In other words, the day of RAK cell injection was the first day, and the third and fifth days were respectively injected. Then, about LML of sac fluid was pumped back before each injection to observe the growth of RAK cells in the tumor cavity. Il-2 was dissolved with LML normal saline, and the fluid storage sac was pressed 3-5 times after injection to make the sac fluid and IL-2 fully mixed.

Intervention Type

Drug

Intervention Name(s)

pemetrexed

Intervention Description

For patients with brain metastasis from solid tumor that met the inclusion conditions, the Ommaya capsule was placed 2 days later, and the maximum tolerated dose of pemetrexed intrathecal chemotherapy was injected intravaginally at 10mg according to the general situation of the patients and the results of the previous study.

Primary Outcome Measure Information:

Title

Clinical response rate

Description

The percentage of patients with CR and PR in the total number of patients in the same period

Time Frame

24 months

Secondary Outcome Measure Information:

Title

Overall survival (OS)

Description

Frome the starting date of the enrollment until the date of the first documented disease progression or the date of the death from any cause,whichever comes first

Time Frame

24 months

Title

Safty(adverse events)

Description

Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Clear diagnosis of glioma; The pathological diagnosis of the primary lesion is clear, and the intracranial lesion can be diagnosed as intracranial metastasis by clinical, cerebrospinal fluid and imaging diagnosis according to the standards of the European Society of Neuro-Oncology - European Society of Medical Oncology (EANo-ESMO). Patients with glioma and solid tumor with brain metastasis who have relapsed after surgery, whole brain radiotherapy or chemotherapy, or who are intolerant and not suitable for surgery or radiotherapy, and who are determined by clinicians to no longer benefit from systemic chemotherapy; Surgical indications for Ommaya capsule implantation; Age ≥18 years old and ≤80 years old, regardless of gender; ECOG score for general physical condition is 0 ~ 2; The expected survival time is at least 1 month; WBC≥3.0×109/L, Hb≥90g/L, PLT≥75×109/L at baseline upon enrollment; Liver and kidney function are basically normal A) Liver: total bilirubin ≤2.0 mg/dL (34.2umol/L), AST and ALT≤ 2.5 times the upper limit of normal value, AST and ALT≤ 5 times the upper limit of normal value in patients with liver metastasis. B) Kidney: creatinine ≤2.5 mg/dL (221umol/L), creatinine clearance ≥60 mL/min; Understand and sign informed consent to participate in clinical study voluntarily. Exclusion Criteria: Patients with primary brain tumors other than glioma; Patients with systemic metastasis, poor general condition, and expected survival time less than 1 month; People allergic to pemetrexed; Severe coagulation disorder; Severe active infection and other serious complications; Patients with active viral hepatitis; There are urgent intracranial symptoms (cerebral hernia, etc.), systemic diseases affecting treatment, and basic diseases affecting patients' cognitive function (such as cerebrovascular diseases, Alzheimer's disease, etc.); Pregnant or lactating women; Within 4 weeks prior to enrollment, translumbar administration was performed; Other factors considered by researchers are not suitable candidates.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jun Ren, MD,PhD

Phone

021-68035321

jun.ren@duke.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jun Ren, MD,PhD

Organizational Affiliation

Fudan University Pudong Medical Center

Official's Role

Study Chair

Facility Information:

Facility Name

Fudan University Pudong Medical Center

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

201399

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jun Ren, MD,PhD

Phone

021-68035322

jun.ren@duke.edu

12. IPD Sharing Statement

Plan to Share IPD

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