Health TrialsbyHealthPanel

NY-ESO-1 TCR-T Cells for NY-ESO-1 Positive Subjects With Advanced Solid Tumors

ConditionAdvanced Solid Tumors
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-70
SponsorTCRCure Biopharma Ltd.

About this trial

New York Esophageal Squamous Cell Carcinoma 1 (NY-ESO-1) is a cancer-testis antigen (CTA) which is expressed in various tumors. 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 NY-ESO-1. The genetically engineered cells are called NY-ESO-1 TCR-T cells. Then the engineered cells are re-infused to the cancer patients to cure the disease or prolong life.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Be able to understand and sign the Informed of Consent Document. Be willing to follow the procedure and protocol of the clinical trial;

Age ≥ 18 years and ≤ 70 years;

Expected survival time > 3 months;

ECOG score 0-1;

Disqualifiers

Under pregnancy or lactation, or positive based on blood pregnancy test;

Severe allergic to related ingredients in the clinical trial;

Received any other investigational treatment within 4 weeks before the first administration or enrolled in another clinical trial the same time;

History of other known malignant tumors within the previous 5 years, including carcinoma in situ of the cervix, basal cell carcinoma of the skin, and carcinoma in situ of the prostate; Except for localized tumors that have been cured;

Trial design

Design model

Single group

Treatments tested in this trial

  • TC-N201 cells

    Biological/Vaccine

    T cells genetically engineered with a TCR targeting NY-ESO-1 (NY-ESO-1 TCR) that displays specific reactivity against HLA-A2+, NY-ESO-1+ target cells.

  • IL-2

    Drug

    Following cell infusion, the patient receives intravenous IL-2. IL-2 improves the survival of TC-N201 cells after infusion.

  • Fludarabine

    Drug

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

  • Cyclophosphamide

    Drug

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

  • Nab-paclitaxel

    Drug

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

Treatment groups

18 Participants
are divided into 1 treatment group
Group A: dose escalationExperimental treatment 5 interventions

Trial outcomes

Primary outcomes

1

Dose Limiting Toxicity or Maximum Tolerated Dose (MTD)

Dose Limiting Toxicity (DLT) is defined as patients with the adverse event (AE) or laboratory abnormality, and should be possibly related to TC-N201 cell therapy, and should be unrelated to the disease itself, disease progression, concomitant diseases or concomitant medication. MTD is defined as the highest dose at which ≤1 of 6 patients experienced a DLT or the highest dose level studied if DLTs are not observed at any of the dose levels.

Time frame
Day 28 after the first TC-N201 infusion
2

Overall response rate

The efficacy of TC-N201 will be assessed by the objective response rate (ORR) evaluated according to RECIST 1.1 and iRECIST. ORR is described as patients assessed with partial response (PR) and complete response (CR).

Time frame
Day 0 - Day 730
3

Treatment-related adverse events as assessed by National Cancer Institute general terminology standard for adverse events (NCI CTCAE) v5.0

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 CTCAE v5.0.

Time frame
Day 0 - Day 730

Secondary outcomes

1

Duration of response

The efficacy of TC-N201 will be assessed by duration of response (DOR). DOR refers to the length of time from the first appearance of a treatment response to the first occurrence of progressive disease or recurrence.

Time frame
Day 0 - Day 730
2

Progression free survival

The efficacy of TC-N201 will be assessed by progression free survival (PFS). PFS refers to the time from treatment to progressive disease or death for any reason.

Time frame
Day 0 - Day 730
3

Overall survival

The efficacy of TC-N201 will be assessed by overall survival (OS). OS refers to the time from treatment to death.

Time frame
Day 0 - Day 730
4

Maximum Persistence (Cmax) of TC-N201

Blood samples were collected to measure persistence of infused TC-N201 using polymerase chain reaction of a vector specific sequence in deoxyribonucleic acid (DNA) extracted from peripheral blood mononuclear cell (PBMC).

Time frame
Day 0 - Day 730

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

TCRCure Biopharma Ltd.

Lead sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Collaborator

Source ClinicalTrials.gov
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