- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03356782
Safety and Efficacy Evaluation of 4th Generation Safety-engineered CAR T Cells Targeting Sarcomas
June 10, 2020 updated by: Lung-Ji Chang, Shenzhen Geno-Immune Medical Institute
The aim of this clinical trial is to assess the feasibility, safety and efficacy of CAR T cells immunotherapy in patients who have sarcoma that is relapsed or late staged.
Another goal of the study is to assess the safety and efficacy of the therapy that combines CAR T cells and IgT cells to treat sarcoma.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
Patients with late staged and/or recurrent sarcoma have poor prognosis despite complex multimodal therapy.
Therefore, novel curative approaches are needed.This study will combine two different ways to fight sarcoma: antibodies and CAR-T cells.
Several immune checkpoint antibodies have been examined on various tumors with good outcomes.
Sarcoma is known to express increased levels of surface antigens that can be targeted by CAR-T cells.
Thus, in this study, the 4SCAR-IgT cells targeting sarcoma surface antigens will be infused in dose escalation cohorts.This study will assess the feasibility, safety, efficacy and side effects of CAR T cells immunotherapy in patients who have sarcoma that is relapsed or late staged.
Study Type
Interventional
Enrollment (Anticipated)
20
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Guangdong
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Shenzhen, Guangdong, China, 518000
- Recruiting
- Shenzhen Geno-Immune Medical Institute
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 year to 75 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Stage Ⅲ,Ⅳ sarcoma patients or recurrent sarcoma patients;
- Age: ≥ 18 and ≤65 years of age at the time of enrollment;
- At least 4 weeks since any chemotherapy or radiotherapy and at least 1 week since immunosuppressive therapy such as using steroid hormone before enrollment;
- Side effects of chemotherapy have been well managed;
- Malignant cells are target antigen positive(higher than ++) confirmed by IHC, quantitative PCR or sequencing;
- Karnofsky /jansky score of 50% or greater;
- Expected survival > 6 weeks;
- ANC≥ 1×10^6/L,PLT ≥ 1×10^8/L;
- Pulse oximetry of≥90% on room air;
- Adequate hepatic function,defined as aspartate aminotransferase(AST)< 5 times upper limit of normal(ULN),serum bilirubin < 3 times ULN;
- Adequate renal function,defined as serum creatinine less than 2 times ULN,if serum creatinine more than 1.5 times ULN,creatinine clearance rate test is needed;
- Patients must have autologous transduced T cells at levels greater than 15%;
- Sign an informed consent and assent.
Exclusion Criteria:
- The disease is progresseing rapidly;
- The patient is receiving therapy of other new drugs;
- Evidence of tumor potentially causing airway obstruction;
- Epilepsy history or other CNS diseases;
- Patients who need immunosuppressive drugs because of GVAD;
- History of long QT syndrome or severe heart diseases;
- Uncontrolled active infection;
- Active hepatitis B virus,hepatitis C virus and HIV infection;
- Receiving systemic corticosteroid 2 weeks before enrollment except for inhaled steroids;
- Previous treatment with any gene therapy;
- Creatinine>2.5mg/dl or ALT/AST>3 times normal or bilirubin>2.0 mg/dl;
- Patients who have other uncontrolled diseases would preclude participation as outlined;
- Pregnant or lactating women;
- Patients previously experienced toxicity from cyclophosphamide;
- Patients who have CNS sarcoma;
- In condition that may bring risks to subjects or interference to clinical trials.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Sarcoma-specific CAR-T cells
Peripheral blood mononuclear cells (PBMCs) of patients who have CD133, GD2, Muc1, CD117 or other marker positive sarcoma will be obtained through apheresis, and T cells will be activated and modified to sarcoma-specific CAR-T cells.
|
1 infusion, for 1x10^6~1x10^7 cells/kg via IV
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety of CART cells in patients using CTCAE version 4.0 standard to evaluate the level of adverse events
Time Frame: 3 months
|
Physiological parameter (measuring cytokine response)
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Persistence and proliferation of CART cells in patients
Time Frame: 3 months
|
The expansion and functional persistence of CART cells in the peripheral blood of patients will be measured by qPCR on Day 7, 14, 21, 28, 60 and 90 after infusion.
|
3 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Anti-tumor effects
Time Frame: 1 year
|
Objective response, such as complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD) will be assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria.
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 1, 2017
Primary Completion (Anticipated)
November 30, 2023
Study Completion (Anticipated)
December 31, 2023
Study Registration Dates
First Submitted
November 24, 2017
First Submitted That Met QC Criteria
November 24, 2017
First Posted (Actual)
November 29, 2017
Study Record Updates
Last Update Posted (Actual)
June 11, 2020
Last Update Submitted That Met QC Criteria
June 10, 2020
Last Verified
June 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GIMI-IRB-17016
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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