Status:
UNKNOWN
Combination Immunotherapy Targeting Sarcomas
Lead Sponsor:
Shenzhen Geno-Immune Medical Institute
Collaborating Sponsors:
The Seventh Affiliated Hospital of Sun Yat-sen University
Shenzhen Children's Hospital
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 a combination low dose chemotherapy and immunotherapy in patients who have sarcoma that is relapsed or late staged. ...
Detailed Description
Patients with late staged and/or recurrent sarcoma have poor prognosis despite complex multimodal therapy. Therefore, innovative interventions are needed. Sarcoma is known to express increased levels ...
Eligibility Criteria
Inclusion
- Stage Ⅲ，Ⅳ sarcoma patients or recurrent sarcoma patients;
- Age: ≥ 6 months and ≤80 years of age at the time of enrollment;
- At least 2 weeks since the last standard chemotherapy or radiotherapy and immunosuppressive therapy such as steroid hormone before enrollment;
- Side effects of chemotherapy have been well managed;
- Confirmed malignant cell expression of CART target antigens by IHC or flow
- Karnofsky /jansky score of 50% or greater;
- Expected survival \> 8 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 sufficient autologous CART cells at does greater than 0.5x10\^6 cells/kg body weight;
- Sign an informed consent and assent.
Exclusion
- The disease is progressing rapidly;
- The patient is receiving therapy of other new drugs and under evaluation;
- Evidence of tumor potentially causing airway obstruction;
- Epilepsy history or other CNS diseases;
- Patients who need immunosuppressive drugs;
- History of long QT syndrome or severe heart diseases;
- Uncontrolled active infection;
- Active hepatitis B virus, hepatitis C virus or 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 such as obstruction of lung function would preclude participation as outlined;
- Pregnant or lactating women;
- Patients previously experienced toxicity from cyclophosphamide and doxorubicin;
- Patients who have CNS sarcoma;
- In condition that may bring risks to subjects or interference to clinical trials.
Key Trial Info
Start Date :
July 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2023
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04433221
Start Date
July 1 2020
End Date
December 31 2023
Last Update
June 16 2020
Active Locations (2)
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1
Shenzhen Children's Hospital
Shenzhen, Guangdong, China, 518000
2
The Seventh Affilliated Hospital, Sun Yat-Sen University
Shenzhen, Guangdong, China, 518107