Symptoms and General Pathology

All Conditions

Recurrence

Antineoplastic Agents

All Drugs and Chemicals

Antirheumatic Agents

Paclitaxel

Albumin-Bound Paclitaxel

Cyclophosphamide

Fludarabine

Fludarabine phosphate

Tubulin Modulators

Antimitotic Agents

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

TCR-T cells will be infused to patients with advanced solid tumors after non-myeloablative lymphocyte-depleting preparative regimen.

patients will be administration of TCR-T cells

TCR-T cells

Part of the non-myeloablative lymphocyte-depleting preparative regime

Cyclophosphamide Capsules

Albumin-bound paclitaxel

Following cell infusion, the patient will be administration high-dose IL-2.

IL-2

Meifang Li

Zhiyong He

New York Esophageal Squamous Cell Carcinoma 1 (NY-ESO-1) is a Cancer-Testis Antigen (CTA) which is expressed in various tumors. After selected the high affinity TCR gene to NY-ESO-1, the researchers insert genes into the cell that expressing a kind of protein that targeting NY-ESO-1. Then the engineered cells are re-infused in the patients with tumors for curing the tumor patient or prolonging life.

This is a single-center, open-label, Phase I clinical study of TCR-T cells for the treatment of the recurrent/metastatic solid tumors patients who had failed standard therapy.

TCR-T cells are expanded from peripheral blood, and after ex vivo modification, and extensive expansion, are reinfused to patients after non-myeloablative lymphocyte-depleting preparative regimen.

The primary purpose of this study is to evaluate the safety and tolerability of TCR-T cells in patients with recurrent/metastatic solid tumors.

The second purpose of this study is to preliminarily explore the effectiveness of TCR-T cells in patients with recurrent/metastatic solid tumors.

Eligibility:

Adults aging 18-70 who were failed to standard treatment or have no standard treatment with recurrent/metastatic solid tumors.

TCR-T Cells for the Treatment NY-ESO-1-positive Advanced Solid Tumors

A Single-arm, Open-label, Dose-finding Clinical Study of TCR-T Cells in Patients With HLA-A2-expressing and NY-ESO-1-positive Recurrent or Metastatic Solid Tumors

Dose Limiting Toxicity (DLT) is defined as patients with the adverse event (AE) or laboratory abnormality recognized by Investigators, and should be possibly related to TCR-T cells therapy

The severity and incidence of various adverse events and serious adverse events

Objective response rate (ORR) is defined as the proportion of patients in whom a complete response (CR) or partial response (PR) (per Response Evaluation Criteria in Solid Tumors \[RECIST 1.1\]) is observed as best overall response

PFS is defined as time from start of treatment to the first documentation of disease progression or death, whichever occurs first

OS defined as the time from start of treatment to the date of death due to any cause

Fujian Cancer Hospital

Neoplasms

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

This study uses the "3+3" dose escalation method. The initial dose is Dose1, the maximum dose that patients can tolerate is determined as the phase II recommended dose (RPIID), and at least 6 patients are receiving RPIID treatment . If patients develop intolerance in Dose 1 (≥3 subjects with DLT), then the subsequent enrolled patients will receive Dose-1 infusion.

T cells genetically engineered with a TCR targeting HPV16 E6 (E6 TCR) that display specific reactivity against HLA-A2+, HPV-16+ target cells

TC-E202 cells

Following cell infusion, the patient receives high-dose bolus IL-2, which is dosed to individual patient tolerance. IL-2 improves the survival of TC-E202 cells after infusion.

Part of the non-myeloablative lymphocyte-depleting preparative regimen.

XiaoHua Wu, doctor

Jian Zhang, doctor

Wang Miaomiao

Background:

Cervical cancer is the most common gynecologic malignant tumor. The occurrence and progression of cervical carcinoma is firmly relevant to HPV (Human papilloma virus) infection. Cancer cells infected by HPV expressing an HPV protein called E6. E6 is the main factors of HPV 16 carcinogenesis. In TCR-T therapy, researchers take the blood of a certain patient, select T cells and insert genes into the cell that expressing a kind of protein that targeting HPV E6. The genetically engineered cells are called E6 TCR-T cells. The engineered cells are re-infused in the patients with cervical carcinoma.

Objective:

To evaluate the safety and efficacy of TCR-T cells in the treatment of cervical carcinoma.

Eligibility:

Adults aging 18-70 with relapsed/refractory to standard treatment or metastatic cervical carcinoma.

Design:

Patients will have many screening tests, including imaging procedures, heart and lung tests, and lab tests.

Patients will have leukapheresis. Blood will be removed through a needle in the arm. A machine separates the white blood cells. The rest of the blood is returned through a needle in the other arm.

Engineered T cells will be re-infused into the patients will stay in hospital and be evaluated.

Background:

Cervical cancer is the most common gynecologic malignant tumor. The occurrence and progression of cervical carcinoma is firmly relevant to HPV (Human papilloma virus) infection.

Cancer cells infected by HPV expressing an HPV protein called E6. E6 is the main factors of HPV 16 carcinogenesis. T cells genetically engineered with a TCR targeting HPV-16 E6 (E6 TCR) display specific reactivity against HLA-A2+, HPV-16+ target cells.

T cell receptor (TCR) gene engineered T cells infusion can induce objective tumor responses in certain malignancies including HPV-16+ cancer.

Objective:

Phase I: Determine the safety and tolerability of TC-E202 inHPV16 positive patients with relapsed/refractory to standard treatment or metastatic cervical carcinoma and determine the Recommended Phase II Dose (RPIID).

Primary endpoints: safety and tolerability. The evaluation of safety and tolerability will be based on the following endpoints: 1) Whether DLT occurs or MTD is achieved; 2) The incidence of various adverse events and serious adverse events and their relationship with TCR-T, IL-2, lymphodepletion chemotherapy and leukapheresis.

Secondary endpoints: efficacy. Objective response rate (ORR), duration of response (DOR), progression-free survival (PFS), and overall survival (OS) were assessed based on RECIST 1.1 and iRECIST.

Eligibility:

Adults aging 18-70 with relapsed/refractory to standard treatment or metastatic cervical carcinoma.

Eligible patients were HLA-A\*02 and had metastatic HPV16-positive cervical cancer. Patients had received or declined previous systemic therapy, with more than 4 weeks elapsed since previous systemic treatment. Patients had an Eastern Cooperative Oncology Group performance score of 0 or 1 and adequate hematologic, hepatic, and renal function.

Design:

This is a Phase I/II clinical trial to evaluate the efficacy and safety of TC-E202.

Dose escalation will proceed according to 3+3 procedure. All patients will receive a lymphocyte-depleting preparative regimen of cyclophosphamide and fludarabine followed by an infusion of E6 TCR (TC-E202) cells. Cell infusion will be followed by IL-2 administration.

All patents will be evaluated based on ORR according to RECIST v1.1\&iRECIST. Phase I clinical trials establish a Drug Safety Review Committee (SRC), and the SRC will hold regular and irregular meetings to evaluate the safety data of the subjects, the clinical pharmacology, along with associated clinical efficacy, to decide escalating dose and RPIID. In addition, the SRC will decide whether to explore higher or lower doses than planned doses based on specific data.

HPV16 E6 TCR T Cells for Cervical Carcinoma

A Phase I/II Clinical Trail of TC-E202 Targeting HPV16 E6 for Relapsed/Refractory to Standard Treatment or Metastatic Cervical Carcinoma

Dose Limiting Toxicity (DLT) is defined as patients with the adverse event (AE) or laboratory abnormality recognized by SRC, and should be possibly related to TC-E202 cell therapy, and should be unrelated to the disease itself, disease progression, concomitant diseases or concomitant medication.

The MTD is the highest dose at which ≤1 of 6 patients experienced a dose limiting toxicity (DLT) or the highest dose level studied if DLTs are not observed at any of the dose levels.

The efficacy of TC-E202 will be assessed by the objective response rate (ORR) is evaluated according to RECIST 1.1 and iRECIST. ORR is described as patients assessed with partial response (PR) and complete response (CR).

The type, incidence and severity of adverse events include abnormal laboratory examination results with clinical significance after treatment, abnormal physical examination and blood examination results, bone marrow examination results, etc. Clinical and laboratory adverse events will be classified according to the National Cancer Institute general terminology standard for adverse events (NCI CTCAE) version 5.0.

The efficacy of TC-E202 will be assessed by duration of response (DOR). The DOR refers to the length of time from the first appearance of a treatment response to the first occurrence of progressive disease or recurrence.

The efficacy of TC-E202 will be assessed by progression free survival (PFS). The PFS refers to the time from treatment to progressive disease or death for any reason.

The efficacy of TC-E202 will be assessed by overall survival (OS). The OS refers to the time from treatment to death.

Blood samples were collected to measure persistence of infused TC-E202 using polymerase chain reaction of a vector specific sequence in deoxyribonucleic acid (DNA) extracted from peripheral blood mononuclear cell (PBMC).

Blood samples were collected to measure persistence of infused TC-E202 using polymerase chain reaction of a vector specific sequence in DNA extracted from PBMC.

The pharmacodynamics of TC-E202 will be assessed by Anti-PD-1 single chain antibody content.

Fudan University

TCRCure Biopharma Ltd.

TIL cells (2.5×10\^9-5×10\^10) will be infused i.v. to patients with advanced solid tumors after non-myeloablative lymphocyte-depleting preparative regimen.

On day 0 patients will be intravenous infusion of TILs

Tumor Infiltrating Lymphocytes

Part of the non-myeloablative lymphocyte-depleting preparative regimen

Following cell infusion, the patient receives high-dose bolus IL-2, which is dosed to individual patient tolerance.

meifang Li

zhiyong He

This study is to investigate the safety and efficacy of tumor infiltrating lymphocyte (TILs) therapy in patients with Advanced malignant solid tumors. TILs are expanded from tumor resections or biopsies, and after ex vivo stimulation, activation and extensive expansion, are reinfused to patients after non-myeloablative lymphocyte-depleting preparative regimen.

This is a single-center, open-label, Phase I clinical study of TILs for the treatment of the recurrent/metastatic solid tumors patients who had failed standard therapy.

TILs are expanded from tumor resections or biopsies, and after ex vivo stimulation, activation and extensive expansion, are reinfused to patients after non-myeloablative lymphocyte-depleting preparative regimen.

The primary purpose of this study is to evaluate the safety and tolerability of TILs in patients with recurrent/metastatic solid tumors.

The second purpose of this study is to preliminarily explore the effectiveness of TILs in patients with recurrent/metastatic solid tumors.

Eligibility:

Adults aging 18-75 who were failed to standard treatment or have no standard treatment with recurrent/metastatic solid tumors.

TIL Cells for the Treatment of the Advanced Solid Tumors Patients

A Single-center, Open-label Clinical Study of TIL Cells for the Treatment of the Recurrent/Metastatic Solid Tumors Patients Who Had Failed Standard Therapy

Dose Limiting Toxicity (DLT) is defined as patients with the adverse event (AE) or laboratory abnormality recognized by Investigators, and should be possibly related to TILs therapy.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
TCR-T Cells for the Treatment NY-ESO-1-positive Advanced Solid Tumors	NCT05648994	Solid Tumors	TCR-T cells Fludarabine Cyclophosphamid... Albumin-bound p... IL-2	18 Years - 70 Years	Fujian Cancer Hospital
TCR-T Cells for the Treatment NY-ESO-1-positive Advanced Solid Tumors	NCT05648994	Solid Tumors	TCR-T cells Fludarabine Cyclophosphamid... Albumin-bound p... IL-2	18 Years - 70 Years	Fujian Cancer Hospital
HPV16 E6 TCR T Cells for Cervical Carcinoma	NCT05357027	Cervical Carcin...	TC-E202 cells IL-2 Fludarabine Cyclophosphamid...	18 Years - 70 Years	TCRCure Biopharma Ltd.
TIL Cells for the Treatment of the Advanced Solid Tumors Patients	NCT05649618	Solid Tumor	Tumor Infiltrat... Fludarabine Cyclophosphamid... IL-2	18 Years - 75 Years	Fujian Cancer Hospital

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