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HV-101注射液治疗既往治疗失败的复发或者转移性实体瘤患者的安全性、耐受性和初步有效性的Ⅰ期临床研究
[Translation] A phase I clinical study on the safety, tolerability and preliminary efficacy of HV-101 injection in patients with recurrent or metastatic solid tumors who have failed previous treatments
主要目的:评价HV-101注射液在既往治疗失败的复发或者转移性实体瘤患者中的安全性和耐受性。
次要目的:初步评估HV-101注射液在既往治疗失败的复发或者转移性实体瘤患者中的有效性。
[Translation] Primary objective: To evaluate the safety and tolerability of HV-101 injection in patients with recurrent or metastatic solid tumors who have failed previous treatment.
Secondary objective: To preliminarily evaluate the efficacy of HV-101 injection in patients with recurrent or metastatic solid tumors who have failed previous treatment.
A Phase I/II Clinical Study on the Safety, Tolerability, and Preliminary Efficacy of HV-101 Injection for the Patients With Recurrent or Metastatic Solid Tumors
Background:
Tumor-infiltrating lymphocyte (TIL) therapy is a type of adoptive cellular therapy by harvesting infiltrated lymphocytes from tumors, culturing and amplifying them in vitro and then infusing back to treat patients. TIL therapy has shown strong efficacy for the treatment of solid tumors, and has achieved high objective response rates in multiple cancers.
Objective:
To evaluate the safety and efficacy of HV-101 for the treatment of advanced solid tumors.
Eligibility:
Adults aging 18-75 with advanced solid tumors
Design:
Patients will undergo screening tests, including imaging procedures, heart and lung tests, and lab tests.
Freshly resected patient tumors were dissected by the surgeon.
TIL cells were isolated from the patient's tumor tissue in the laboratory, then cultured in vitro, activated and expanded.
HV-101 will be re-infused into the patient.
Tumor Infiltrating Lymphocyte (TIL) Therapy for the Treatment of Advanced Solid Tumors
Background:
Tumor-infiltrating lymphocyte (TIL) therapy is a type of adoptive cellular therapy by harvesting infiltrated lymphocytes from tumors, culturing and amplifying them in vitro and then infusing back to patients.
TIL therapy has shown strong efficacy for the treatment of solid tumors and has achieved high objective response rates in multiple cancers, such as melanoma, NSCLC, and cervical cancer.
Objective:
To evaluate the safety and efficacy of TIL for the patients with advanced solid tumor.
Eligibility:
Adults aging 18-75 with advanced solid tumor.
Design:
Patients will undergo screening tests, including imaging procedures, heart and lung tests, and lab tests.
Freshly resected patient tumors were dissected by the surgeon.
TIL cells were isolated from the patient's tumor tissue, then cultured in vitro, activated and expanded.
At last TIL cells will be re-infused into the patients.
100 Clinical Results associated with Hervor Therapeutics
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100 Translational Medicine associated with Hervor Therapeutics