Ignite Creation Date:
2025-12-18 @ 8:26 AM
Ignite Modification Date:
2025-12-23 @ 6:58 PM
Study NCT ID:
NCT05868915
Status:
None
Last Update Posted:
2024-03-04 00:00:00
First Post:
2023-05-11 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
HV-101 for Patients With Advanced Solid Tumors
Sponsor:
None
Organization:
Study Overview
Official Title:
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
Status:
None
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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:
1. Patients will undergo screening tests, including imaging procedures, heart and lung tests, and lab tests.
2. Freshly resected patient tumors were dissected by the surgeon.
3. TIL cells were isolated from the patient's tumor tissue in the laboratory, then cultured in vitro, activated and expanded.
4. HV-101 will be re-infused into the patient.
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:
1. Patients will undergo screening tests, including imaging procedures, heart and lung tests, and lab tests.
2. Freshly resected patient tumors were dissected by the surgeon.
3. TIL cells were isolated from the patient's tumor tissue in the laboratory, then cultured in vitro, activated and expanded.
4. HV-101 will be re-infused into the patient.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: