Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Rare Diseases

Small Cell Lung Carcinoma

Lung Neoplasms

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Small Cell Lung Cancer

Antineoplastic Agents

All Drugs and Chemicals

Carboplatin

Etoposide

Cisplatin

Immunomodulating Agents

Etoposide phosphate

phlebotomation 50ml 1-7 days before chemotherapy for culture of R-CIK cells chemotherapeutic regimen EP or EC as follows: VP-16 100mg/m2 D1-3 plus cisplatin 75mg/m2 D1 or VP-16 100mg/m2 D1-3 plus carboplatin AUC=5 D1 R-CIK cells were transfused back to the patients 2-7 days after the end of chemotherapy, and the amount of R-CIK cells returned each time was about 5×109 three weeks each cycle efficacy evaluated every two cycles patients with the efficay is CR, PR or SD after 4-6 cycles enter the sintilimab maintenance therapy for one year or until the progression of disease, or occurrence of intolerable adverse events.

the dose of sintilimab is fixed dose of 200mg every three weeks

the patients with CR, PR or SD after the chemotherapy plus R-CIK will receive sintilimab maintenance therapy. The dose of sintilimab is fixed at 200mg every three weeks.

sintilimab maintenance

Quanli Gao, Dr.

Quanli Gao, M.D

Lingdi Zhao, M.D.

Jing Ding, Master

Small cell lung cancer is a highly aggressive malignancy. Currently, there is no effective regimen for patients after the progression offirst-line chemotherapy. The prognosis of patients with extensive disease is very poor, and the improved therapeutic efficacy is urgently needed. Most patients with small cell lung cancer have a long history of smoking, and the tumor mutation burden is relatively high, which provides potential for immunological checkpoint inhibitors represented by PD-1 antibodies. A number of studies have shown that chemotherapy combined with adoptive cellular immunotherapy could prolong the survival of patients. This study is a clinical study to explore the efficacy and safety of maintenance therapy with sintilimab after 4-6 cycles of first-line chemotherapy combined with adoptive cellular immunotherapy in patients with advanced small cell lung cancer.

Study of Sintlimab Maintenance Therapy in Patients With Extensive Small Cell Lung Cancer

Clinical Study of Sequential Sequential Sintilimab Maintenance Therapy in Patients With Extensive Small Cell Lung Cancer After Chemotherapy Combined With Adoptive Cellular Immunotherapy

the period from the day of enrollment to the date of death

the period from the day of enrollment to the date of confirmed progression or death depending on which one occurs first.

from the date of first dose of sintilimab to the date of confirmed progression following

the rate of adverse events during the maintenance therapy of sintilimab

Henan Cancer Hospital

Blood and Lymph Conditions

Immune System Diseases

Infections

Symptoms and General Pathology

Lymphoma

Lymphoma, T-Cell

Lymphoma, T-Cell, Peripheral

Mycoses

Mycosis Fungoides

Lymphoma, T-Cell, Cutaneous

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Communicable Diseases

Bacterial Infections

Bacterial Infections and Mycoses

Lymphoma, Non-Hodgkin

Lymphosarcoma

Peripheral T-cell Lymphoma

Antirheumatic Agents

Cyclophosphamide

Fludarabine

Fludarabine phosphate

MT-101 preceded by conditioning (lymphodepleting) chemotherapy

MT-101

IV administration of fludarabine and cyclophosphamide

MT-101 + Conditioning (Lymphodepleting) Chemotherapy

Michele Gerber, MD, MPH

This is a Phase 1/2 study to test the safety, tolerability, and efficacy of the investigational agent MT-101 in patients with T cell Lymphoma. MT-101 is made with myeloid cells collected from the patient's blood. The myeloid cells are modified and later infused back into their veins. The modified myeloid cells recognize the tumor cells and are designed to target and kill them.

The research study is divided into two parts. The first part will be to determine the safety and tolerability of the study drug product. During this part of the study, there will be 4 groups of study patients. The first group of patients will receive a low dose of cells, the second group will receive the low dose of cells and lymphodepleting chemotherapy to reduce the number of T cells in the blood, the third group will receive a higher dose of cells, and the fourth group will receive the higher dose of cells and lymphodepleting chemotherapy to reduce the number of T cells in the blood. In the second part of the study, cells with or without chemotherapy will be administered based on results of Part 1 and the safety, tolerability, and efficacy of MT-101 will be assessed. All patient groups will receive 6 doses of drug product over 3 weeks.

A Study of MT-101 in Subjects With CD5+ Relapsed/Refractory TCL

A Phase 1/2, Open-Label, First-in-human, Multiple Ascending Dose Multicenter Study of MT-101 in Subjects With CD5+ Relapsed/Refractory T Cell Lymphoma

DOR is the time interval between the date of first assessment of PR or CR to the date of the follow-on first documentation of progressive disease or death, whichever occurs earlier.

PFS is defined as the time from the date of the first administration of MT-101 to the date of first documentation of progressive disease or death, whichever occurs earlier.

OS is defined as the time from date of the first administration of MT-101 to the date of death.

Safety and tolerability of the drug will be determined based on observed adverse events (AEs), including all potential dose limiting toxicities.

The ORR is defined as the number (%) of subjects achieving a best overall response of complete response (CR) or partial response (PR)

Myeloid Therapeutics

Wounds and Injuries

Behaviors and Mental Disorders

Neoplasm Metastasis

Hyperthermia

Fever

Neoplasms, Second Primary

Pelvic Neoplasms

Neoplastic Processes

Body Temperature Changes

Stress Disorders, Traumatic

Heat Stress Disorders

Antibodies

Pembrolizumab

Immunoglobulins

Immunologic Factors

Hyperthermia for 40 minutes, with maximum temperature setted on 42℃ ± 0.5℃ as upper limit, twice a week for a total of 10 times.

Thermotron RF-8

Mononuclear cells were collected from 50ml peripheral blood , and cultured cytokine-induced killer cells for 15-20 days. Cells were infused back to the patients in 3 times via intravenous infusion .Patients will received at least 2 cycles of CIK Immunotherapy . If the evaluation of the treatment is complete response, partial response or stable disease, additional cycles were eligible.

Adoptive cellular Immunotherapy

Patients will receive pembrolizumab 100mg every three weeks and assess the clinical outcome every 2 dosage of anti-PD-1 antibody treatment.

Anti-PD-1 antibody

Patients will receive standard chemotherapy until disease progression, unacceptable toxicity or patient refusal.

Chemotherapy

It is a non-randomized pilot study.The allocation will be determined by patients or their immediate family members who were cooperative with physician's interpretations on the disease progression and updated information of cutting of edge treatment, the financial affordability, availability of treatment plans, possible tolerance or risks etc.The purpose of this study is to investigate the clinical efficacy and toxicity of autologous cellular immunotherapy combined with hyperthermia in abdominal and pelvic malignancies or metastases patients. Furthermore, to characterize response to different regimens,the investigators intent to explore the predictive and prognostic biomarker, as well as the changes in immune repertoire.

Hyperthermia Combined With Immunotherapy in the Treatment of Abdominal and Pelvic Malignancies or Metastases

A Prospective Study of Hyperthermia Combined With Autologous Adoptive Cellular Immunotherapy in the Treatment of Abdominal and Pelvic Malignancies or Metastases

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

Proportion of patients with reduction in tumor burden of a predefined amount

From starting date of the enrollment until the date of first documented disease progression or date of death from any cause, whichever comes first.

To assess and compare the PRO-CTCAE by patients in each groups

Capital Medical University

Director,Capital Medical University (CMU)Cancer Center

Digestive System Diseases

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Bevacizumab

Ten patients with CRC stage UICC IV under routine first line FOLFOX 6/Bevacizumab therapy are planned to receive a singular treatment with an autologous T cell product at a dose of 5x10\^7 (first three or six patients) or 5x10\^8 (last four or seven patients) cells.

autologous reactivated T cells against p53

re-activated T cells

Alexis Ulrich, MD Prof. Dr.

The study "Phase I trial of Adoptive T cell Therapy with Activated P53 specific T cells for Treatment of Advanced Colorectal Cancer" is an open label, single arm trial.

Most patients with colorectal carcinoma (CRC) accumulate high numbers of endogenous tumor antigen specific cytotoxic and helper memory T cells in their blood. Upon appropriate reactivation, tumor antigen specific T cells can recognize and eliminate autologous tumor cells. This can be achieved ex vivo by their stimulation with antigen pulsed autologous dendritic cells in the absence of regulatory T cells. Upon adoptive transfer, specifically reactivated T cells from cancer patients can efficiently reject autologous human tumors in vivo.

A major target antigen of anti tumor effector T cells in CRC patients is p53, which is overexpressed in many colorectal cancers. Within this clinical trial, high numbers of endogenous tumor specific T cells will be harvested by leukapheresis from the blood of CRC patients harbouring p53-reactive T cells. Isolated T cells will be depleted from regulatory T cells and specifically reactivated for three days ex vivo with three synthetic long peptides containing the most immunogenic regions of p53 using autologous dendritic cells as antigen presenting cells. Activated T cells will be re-infused into the patients.

Ten patients with CRC stage UICC IV under routine first line FOLFOX 6/Bevacizumab therapy are planned to receive a singular treatment with an autologous T cell product at a dose of 5x10\^7 (first three or six patients) or 5x10\^8 (last four or seven patients) cells.

Patient treatment and follow-up will be performed at the National Center for Tumor Diseases (NCT) and at the Department of General, Visceral and Transplantation Surgery, University of Heidelberg. Leukapheresis will take place at the DRK-Blutspendedienst Baden-Württemberg-Hessen in Mannheim and generation of therapeutic cells will be performed at the GMP Unit Cellular Therapy of the DKFZ. Analysis of blood samples with respect to special immune parameters is carried out at the Immune Monitoring Laboratory, Department of Translational Immunology at the NCT, Heidelberg.

The primary objective of this study is to evaluate the safety and tolerability of an adoptive transfer of ex vivo reactivated p53 specific T cells obtained from peripheral blood.

Trial of Adoptive T Cell Therapy With Activated P53 Specific T Cells for Treatment of Advanced Colorectal Cancer

Phase I Trial of Adoptive T Cell Therapy With Activated P53 Specific T Cells for Treatment of Advanced Colorectal Cancer

The primary endpoint is the Dose Limiting Toxicity (DLT), defined as: any adverse event (AE) ≥ Grade 3 according to the Common Terminology Criteria for Adverse Events (CTCAE version 4.03), that is judged by the investigator as definitely, probably or possibly related to the investigational medicinal product (IMP) or to the combination of the IMP and the treatment with FOLFOX 6/Bevacizumab.

The response of a patient to the p53 peptide mix or to each of the single p53 peptides

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study of Sintlimab Maintenance Therapy in Patients With Extensive Small Cell Lung Cancer	NCT03983759	Small Cell Lung... Extensive Disea... Adoptive Cellul... Chemotherapy Maintenance	sintilimab main...	18 Years - 70 Years	Henan Cancer Hospital
A Study of MT-101 in Subjects With CD5+ Relapsed/Refractory TCL	NCT05138458	Lymphoma, T-Cel... Lymphoma, T-Cel... Mycosis Fungoid... Adoptive Cellul... Cell Therapy	MT-101 MT-101 + Condit...	18 Years -	Myeloid Therapeutics
Hyperthermia Combined With Immunotherapy in the Treatment of Abdominal and Pelvic Malignancies or Metastases	NCT03757858	Cancer Abdominal Cance... Pelvic Cancer Metastatic Canc... Peritoneal Meta... Liver Metastase...	Thermotron RF-8 Adoptive cellul... Anti-PD-1 antib... Chemotherapy	18 Years -	Capital Medical University
Trial of Adoptive T Cell Therapy With Activated P53 Specific T Cells for Treatment of Advanced Colorectal Cancer	NCT02577588	Colorectal Carc...	re-activated T ...	18 Years -	National Center for Tumor Diseases, Heidelberg
A Study of MT-101 in Subjects With CD5+ Relapsed/Refractory TCL	NCT05138458	Lymphoma, T-Cel... Lymphoma, T-Cel... Mycosis Fungoid... Adoptive Cellul... Cell Therapy	MT-101 MT-101 + Condit...	18 Years -	Myeloid Therapeutics

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