Antineoplastic Agents

All Drugs and Chemicals

Immune Checkpoint Inhibitors

Pembrolizumab

Immunomodulating Agents

Nivolumab

3+3 Dose escalation of agenT-797 will be administered as a single intravenous (IV) infusion.

Single prespecified dose of agenT-797 administered by IV infusion in combination with approved ICIs administered in accordance with manufacturer instructions and institutional guidelines as per standard of care

agenT-797 is an off-the-shelf cell therapy consisting of ≥ 95% allogeneic human unmodified iNKT cells isolated from 1 healthy donor mononuclear cell apheresis unit and expanded ex vivo.

agenT-797

Approved ICIs

Medical Director

This is a Phase 1, open-label study to explore the safety, tolerability, and preliminary clinical activity of agenT-797, an unmodified, allogeneic iNKT cell therapy, in participants with relapsed/refractory (r/r) solid tumors, as well as define the recommended phase II dose in solid tumors. This Phase 1 study will also explore the safety, tolerability, and preliminary clinical activity of agenT-797 in combination with approved immune checkpoint inhibitors (ICIs), including pembrolizumab and nivolumab, in participants with r/r solid tumors.

A Study Investigating agenT-797 in Participants With Relapsed/Refractory Solid Tumors

A Phase 1, Open-Label Study of the Safety, Tolerability and Preliminary Clinical Activity of Allogeneic Invariant Natural Killer T (iNKT) Cells (agenT-797) as a Single Agent and in Combination With Approved Immune Checkpoint Inhibitors in Patients With Relapsed/ Refractory Solid Tumors

This will be determined according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI CTCAE v5.0).

This will be determined according to the NCI CTCAE v5.0.

This will be measured as a length of time, through collection of peripheral blood mononuclear cells and analysis by flow cytometry.

For solid tumors, this will be determined per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 guidelines and for prostate cancer (not evaluable per RECIST 1.1), Prostate Cancer Working Group 3 (PCWG3) will be used.

For solid tumors, this will be determined per RECIST 1.1 guidelines and for prostate cancer (not evaluable per RECIST 1.1), PCWG3 will be used.

MiNK Therapeutics

Neoplasms

All Conditions

Digestive System Diseases

Carcinoma

Carcinoma, Hepatocellular

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Liver Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

the iNKT cells will be intravenous infused every two weeks as a course of treatment for up to six courses , the reinfusion dose is determined according to the patient's body surface area, which was about 108\~109cells/m2.

iNKT Cells

Intravenous infusion, according to the drug instructions.

PD-1

Oral administration, according to the drug instructions.

Regorafenib

Jun Lu, MD.

Songtao Liu, MD.

The goal of this clinical trial is to explore the efficacy and safety of autologous iNKT cells in patients with progressed hepatocellular carcinoma (HCC) after treatment with PD-1 antibody. The main question it aims to answer are:

* the efficacy of autologous iNKT cells in patients with progressed HCC after treatment with PD-1 antibody.
* the safety of autologous iNKT cells in patients with progressed HCC after treatment with PD-1 antibody.

Participants will be randomized 1:1 to receive Regorafenib + PD-1 + iNKT cells (RPI group) or the treatment of Regorafenib + PD-1 (RP group).

Researchers will compare RPI group and RP group to see whether the iNKT cells can achieve a better therapeutic effect on HCC patients with PD-1 resistance.

Single center, randomized, open trial in Barcelona Clinic Liver Cancer（BCLC）C stage patients with progressed HCC after anti-angiogenic targeted drugs combined with PD-1 monoclonal antibody therapy to explore the efficacy and safety of autologous iNKT cells.

This study includes screening period, treatment period and follow-up period (until the subjects withdrew their informed consent or received other anti-tumor therapy or participated in other clinical trials or the researchers judged that it is not in the best interests of patients to continue to participate in the study) after treatment.

The patients will be randomized 1:1 using a random number table to receive Regorafenib + PD-1 + iNKT cells (RPI group) or the treatment of Regorafenib + PD-1 (RP group).

1. iNKT Cells：Intravenous infusion. The cells will be infused every two weeks as a course of treatment for up to six courses.
2. PD-1：Intravenous infusion, according to the drug instructions.
3. Regorafenib：Oral administration, according to the drug instructions. All target and non-target lesions will be assessed by chest, abdomen, and pelvis CT or MRI at baseline and every 8 weeks until radiological progression (according to mRECIST/iRECIST).

Safety and side-effect profiles will be assessed based on the nature, frequency, and severity of adverse events, according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 5.0.

Block randomization was performed by the independent masked statistician. Two independent masked radiologist who are blinded to patients' clinical information will review the imaging examinations.

Adoptive Autologous iNKT Cells for the Treatment of Progressed Hepatocellular Carcinoma Continuing on PD-1 Inhibitor Therapy

An Open Label, Randomized, Controlled, Clinical Trial of Adoptive Autologous Invariant Natural Killer T Cells for the Treatment of Progressed Hepatocellular Carcinoma Continuing on PD-1 Inhibitor Therapy

The time from enrollment to disease progression according to the modified RECIST (mRECIST) guideline in trial immunotherapeutics, or death from any cause, whichever occurred first；the time from enrollment to confirmed disease progression (iCPD) according to the iRECIST

including complete response (CR), partial response (PR), and disease stabilization (SD), evaluated by imaging according to iRECIST for target lesions and assessed by MRI/CT.

complete response (CR) and partial response (PR) evaluated by imaging according to mRECIST/iRECIST for target lesions and assessed by MRI/CT.

Time from the date of enrollment to the date of death from any cause.

The proportion of subjects who were still alive from the date of enrollment to 1 year later

The time from the first tumor remission (CR or PR according to mRECIST/iRECIST) to the first recording of disease progression (PD according to mRECIST criteria or iCPD according to iRECIST) or death from any cause (whichever occurs first).

Time from the date of enrollment to the date of first disease progression (PD) according to mRECIST or iCPD according to iRECIST).

EORTC QLQ-C30: European Organization for Research on Treatment of Cancer Quality of Life Questionnare-Core 30.

The totally 30 items spread out over five functional scales (15 items), three symptom scales (7 items), a global health status/QoL scale (2 items), and six single items. 1-28 item ranges 1: not at all, 2: a little, 3: quite a lit, 4: very much; 29-30 item ranges 1-7 from very poor to excellent. Raw score (RS) is an average of all items in each area. Standardized score is in the range of 0-100 by formula SS=\[1-(RS-1)/n\] x100 (function) or SS=\[（RS-1）/n\]x100 (symptom or overall health) respectively. A high scale score represents a higher/healthy response level.

Time to deterioration was defined as a decrease from baseline of 10 points or more on the EORTC QLQ-C30 maintained for two consecutive assessments.

Beijing Gene Key Life Technology Co., Ltd.

Beijing YouAn Hospital

Chief physician

Antirheumatic Agents

Analgesics

Cyclophosphamide

Chlorotrianisene

Interleukin-2

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

Analgesics, Non-Narcotic

TACE combined with autologous iNKT cells infusion will be applied for patients in experimental group. TACE will be performed at 0th and 4th week. 5×10\^8-10\^9/m2 iNKT cells will be infused to patients at 1st, 3rd, 5th, 7th, 8th and 12th week.

TACE will be conducted at 0th week and 4th week.

5×10\^8-10\^9/m2 iNKT cells will be infused to patients at 1st, 3rd, 5th, 7th, 8th and 12th week.

iNKT cells

CTX will be administered intravenously at a dose of 750mg/m2 2 days before the first iNKT cells infusion.

IL-2 will be given at a dose of 25,000 IU/kg/day for 5-14 days after iNKT cells infusion.

Human recombinated Interleukin-2

TACE will be conducted to all patients at 0th week and 4th week.

TACE

Jun Lu, Director

Jia Guo, Clinician

Xuli Bao, Clinician

Hepatocellular carcinoma (HCC) is a common disease with high mortality. More than 80% patients are first diagnosed with late-stage and unresectable, their effective drugs and treatments are very limited. invariant Natural Killer T (iNKT) cell exhibit antitumor activity against malignant tumors through producing high levels of cytokines. iNKT cells are abundant in the liver, but defect in liver cancer development. iNKT cells can express homing receptors licensing them specifically to migrate liver, then play key antitumor immunity. We already did a phase I study of autologous infusion of iNKT cells in the treatment of patients with advanced HCC. Safety and feasibility of iNKT infusion was proved. The purpose of this study is to verify the effectiveness of iNKT cells infusion combined with transcatheter arterial chemoembolization (TACE) in treatment of advanced HCC.

Patients with advanced HCC will be enrolled and divided into two groups. Patients in experimental group will be treated with TACE combined with iNKT cells infusion. TACE will be performed at 0th and 4th week. iNKT cells will be infused at 1st, 3rd, 5th, 7th, 8th and 12th week. Patients in control group will be treated with TACE at 0th and 4th week. Adverse events（AEs）, overall survival (OS) time and recurrence-free survival (RFS) time, change of immune cells will be monitored.

Study of Adoptive Transfer of iNKT Cells Combined With TACE to Treat Advanced HCC

Study of Adoptive Transfer of Invariant Natural Killer T Cells Combined With Transcatheter Arterial Chemoembolization (TACE) to Treat Advanced Hepatocellular Carcinoma (HCC): Phase II Clinical Trial

OS is the duration from the date of enrollment to the date of death due to any causes.

PFS is the duration from the date of enrolled into clinical trial to the date of first documentation of tumor progression.

DCR is the proportion of patients who had a response rate including complete remission (CR), partial remission (PR) and disease stabilization (SD) evaluated by imaging according to the irRC standard.

Frequencies of immune cells such as iNKT cells, natural killer cells (NK) , regulatory T cells (Treg), myeloid-derived suppressor cells (MDSC), et al will be analyzed by flow cytometry before and after iNKT infusion.

The severities of AEs will be divided into 5 levels according to the National Cancer Institute (NCI) Common Terminology Standard for Adverse Events (CTCAE) version 4.03.

AFP is the best-defined tumor marker for HCC, and it is widely used in clinical settings as an adjuvant diagnostic and prognostic indicator.

Director of Hepatology and Cancer Biotherapy Ward

Tegafur

Antimetabolites

Autologous in vitro expanded iNKT cells in conjunction with IL-2 and along with lymphodepleting chemotherapy (Tegafur) will be administered to patients with advanced HCC.

Three different dosing schedules will be evaluated. Three patients will be evaluated on each dosing schedule.

The following dose levels will be evaluated:

Loading Dose 1: 3x10\^7/m2 Loading Dose 2: 6x10\^7/m2 Loading Dose 3: 9x10\^7/m2 The doses are calculated according to the actual number of iNKT cells.

IL-2 will be given at a dose of 25,000 IU/kg/day for 5-14 days.

IL-2

Tegafur will be given at a dose of 40\~60 mg bis in die (BID) 2 weeks.

This study enrolls patients who have relapsed/advanced hepatocellular carcinoma (HCC, BCLC stage C). The HCC tumor relapsed or metastasized through the body after standard treatment or the patients cannot receive standard treatment under current conditions. This research study uses special immune system cells called iNKT cells, a new experimental treatment.

The purpose of this study is to find the biggest dose of iNKT cells that is safe and tolerance, to see how long they last in the body, to learn the immunoresponse in the body, to learn the side effects are and to see if the iNKT cells will help people with relapsed/advanced hepatocellular carcinoma (HCC).

Adoptive Transfer of iNKT Cells for Treating Patients With Relapsed/Advanced HCC

A Study of Adoptive Invariant Nature Killer T Cell Therapy for Relapsed/Advanced Hepatocellular Carcinoma (HCC)

PFS is the time that passes from the date that patient enrolled in the clinical trial and the date on which HCC progresses or the date on which the patient dies. HCC progression was evaluated by imaging according to the irRC standard.

Defined as signs/symptoms, laboratory toxicities, and clinical events that are possibly, likely, or definitely related to study treatment Adverse events assessed according to NCI-CTCAE v4.0 criteria 2.

To assess the biological activity of infused in vitro expanded autologous iNKT cells in conjunction with IL-2.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study Investigating agenT-797 in Participants With Relapsed/Refractory Solid Tumors	NCT05108623	Tumor, Solid	agenT-797 Approved ICIs	18 Years -	MiNK Therapeutics
A Study Investigating agenT-797 in Participants With Relapsed/Refractory Solid Tumors	NCT05108623	Tumor, Solid	agenT-797 Approved ICIs	18 Years -	MiNK Therapeutics
Adoptive Autologous iNKT Cells for the Treatment of Progressed Hepatocellular Carcinoma Continuing on PD-1 Inhibitor Therapy	NCT05962450	Hepatocellular ...	iNKT Cells PD-1 Regorafenib	18 Years - 75 Years	Beijing YouAn Hospital
Adoptive Autologous iNKT Cells for the Treatment of Progressed Hepatocellular Carcinoma Continuing on PD-1 Inhibitor Therapy	NCT05962450	Hepatocellular ...	iNKT Cells PD-1 Regorafenib	18 Years - 75 Years	Beijing YouAn Hospital
Study of Adoptive Transfer of iNKT Cells Combined With TACE to Treat Advanced HCC	NCT04011033	Hepatocellular ...	iNKT cells Cyclophosphamid... Human recombina... TACE	18 Years - 80 Years	Beijing YouAn Hospital
Adoptive Transfer of iNKT Cells for Treating Patients With Relapsed/Advanced HCC	NCT03175679	Hepatocellular ...	iNKT cells IL-2 Tegafur	18 Years - 80 Years	Beijing YouAn Hospital
Study of Adoptive Transfer of iNKT Cells Combined With TACE to Treat Advanced HCC	NCT04011033	Hepatocellular ...	iNKT cells Cyclophosphamid... Human recombina... TACE	18 Years - 80 Years	Beijing YouAn Hospital

Spots Global Cancer Trial Database for inkt cells

Every month we try and update this database with for inkt cells cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for inkt cells

Every month we try and update this database with for inkt cells cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for inkt cells cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.