Combination Immunotherapy Targeting Sarcomas

STATUS

Recruiting
participants needed

20
sponsor

Shenzhen Geno-Immune Medical Institute

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Updated on 19 February 2024

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renal function

sarcoma

immunosuppression

immunosuppressive agents

steroid hormone

immunosuppressive

kidney function tests

serum bilirubin level

pulse oximetry

creatinine clearance rate

recurrent sarcoma

Summary

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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. Another goal of the study is to assess the safety and efficacy of the therapy that combines multiple CAR T cells followed by sarcoma vaccines.

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 of surface antigens that can be targeted by CAR-T cells. In addition, studies have shown that low dose chemotherapy such as doxorubicin may modulate surface PD-L1 level and enhance immunotherapy effects. This study will combine multiple CAR T cells with low dose chemotherapy to treat sarcoma, and followed by maintenance sarcoma vaccines. The purpose of this clinical trial will assess the feasibility, safety, efficacy and side effects of this combination therapy in patients who have sarcoma that is relapsed or late staged.

Details

Condition	Connective and Soft Tissue Neoplasm, Solid Tumors, Ewing's sarcoma, Osteosarcoma, Osteosarcoma, Sarcoma, Sarcoma, Solid Tumors
Age	1years - 75years
Treatment	Multiple sarcoma-specific CAR-T cells and sarcoma vaccines
Clinical Study Identifier	NCT04433221
Sponsor	Shenzhen Geno-Immune Medical Institute
Last Modified on	19 February 2024

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Eligibility		Yes	No	Not Sure
Inclusion Criteria
	Stage 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 110^6/LPLT 110^8/L
	Pulse oximetry of90% 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 Criteria
	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

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Step 4 Get your study results

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serum bilirubin level

pulse oximetry

creatinine clearance rate

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Combination Immunotherapy Targeting Sarcomas