NCT05447234

Brief Summary

To observe and determine the safety, tolerability, cellular pharmacokinetics and efficacy of TCRx T cells in patients with advanced or recurrent gastric/gastroesophageal junction cancer after failure of first chemotherapy.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P75+ for early_phase_1 gastric-cancer

Timeline
22mo left

Started Mar 2023

Longer than P75 for early_phase_1 gastric-cancer

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress64%
Mar 2023Mar 2028

First Submitted

Initial submission to the registry

July 3, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 7, 2022

Completed
8 months until next milestone

Study Start

First participant enrolled

March 1, 2023

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2026

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2028

Expected
Last Updated

February 16, 2023

Status Verified

July 1, 2022

Enrollment Period

3 years

First QC Date

July 3, 2022

Last Update Submit

February 14, 2023

Conditions

Gastric CancerGastroesophageal-junction Cancer

Keywords

T Cell ReceptorGastric CancerGastroesophageal-junction Cancer

Outcome Measures

Primary Outcomes (2)

  • tumor volume

    RECIST 1.1

    about 2 years

  • Overall Survival

    The time from randomization to death due to any reason.

    about 2 years

Secondary Outcomes (1)

  • AEs

    about 2 years

Study Arms (1)

TCRX-T

EXPERIMENTAL

① 1x10\^7/m2 ; * 3x10\^7/m2； * 1x10\^8/m2； * 3x10\^8/m2； * 1x10\^9/m2。

Biological: Tcrx T cell

Interventions

Tcrx T cellBIOLOGICAL

Sequential IV infusion

TCRX-T

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18-70 years old;
  • Histologically confirmed advanced/locally advanced or metastatic gastric cancer at the stomach or gastroesophageal junction, progressed after first-line chemotherapy, or recurrence after gastric/gastroesophageal junction surgery combined with neoadjuvant/adjuvant chemotherapy
  • Expected survival time ≥ 3 months
  • Eastern Cooperative Oncology Group (ECOG) score 0-2
  • According to the Response Evaluation Criteria for Solid Tumors (RECIST 1.1), at least one one-dimensional, measurable tumor (short-axis diameter greater than 1 cm)
  • Normal bone marrow hematopoietic function: (leukocytes≥4000 cells/㎕, neutrophils≥1500 cells/㎕, platelet counts≥100000 cells/㎕)
  • Normal liver and kidney function: serum bilirubin \<1.5mg/dl, AST (SGOT) and ALT (SGPT) \<2.5UNL, alkaline phosphatase \<5UNL; serum creatinine \<1.5mg/dl;
  • Men and women must take appropriate contraceptive measures.

You may not qualify if:

  • Patients with previous non-gastric/gastroesophageal junction malignant tumor
  • History of severe acute allergy
  • There is an uncontrolled infection
  • History or clinical evidence of central nervous system (CNS) metastasis or leptomeningeal carcinomatosis
  • History of cerebrovascular accident within the past 6 months, including transient ischemic attack (TIA), pulmonary embolism or untreated deep vein thrombosis (DVT)
  • History of one or more of the following cardiovascular diseases within the past 6 months: cardiac angioplasty or stenting, myocardial infarction, unstable angina, coronary artery bypass grafting, symptomatic peripheral vascular disease , NYHA type III or IV congestive heart failure
  • Poor control of hypertension
  • QT interval \>480ms
  • Evidence of active bleeding or bleeding tendency
  • Clinically significant gastrointestinal abnormalities, such as bleeding, obstruction, and high risk of perforation
  • Grade 3 or 4 diarrhea
  • Any serious and/or unstable previous medical, psychiatric, or other circumstances that may affect subject safety, provide informed consent, or comply with research procedures
  • Unable or unwilling to stop using illicit drugs for at least 14 days or drug half-life (whichever is longer) before and during the first study drug administration
  • Treated with any of the following anticancer therapies: radiotherapy, tumor embolization or chemotherapy, immunotherapy, biological therapy within 14 days before the first dose; neoadjuvant chemotherapy or adjuvant chemotherapy must be at least 6 months before the start of the study Finish
  • Any persistent toxicity greater than grade 1 and/or worsening in severity from prior anticancer therapy, except for alopecia
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: ① 1x10\^7/m2 * 3x10\^7/m2； * 1x10\^8/m2； * 3x10\^8/m2； * 1x10\^9/m2。
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 3, 2022

First Posted

July 7, 2022

Study Start

March 1, 2023

Primary Completion

March 1, 2026

Study Completion (Estimated)

March 1, 2028

Last Updated

February 16, 2023

Record last verified: 2022-07