Status:
UNKNOWN
Safety and Efficacy Evaluation of 4th Generation Safety-engineered CAR T Cells Targeting Sarcomas
Lead Sponsor:
Shenzhen Geno-Immune Medical Institute
Conditions:
Sarcoma
Osteoid Sarcoma
Eligibility:
All Genders
1-75 years
Phase:
PHASE1
PHASE2
Brief Summary
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...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2023
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03356782
Start Date
December 1 2017
End Date
December 31 2023
Last Update
June 11 2020
Active Locations (1)
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1
Shenzhen Geno-immune Medical Institute
Shenzhen, Guangdong, China, 518000