BGT007H Cells for the Treatment of Recurrent/Refractory Gastrointestinal Tumors

November 22, 2023 updated by: BioSyngen Pte Ltd

Clinical Study on the Safety and Preliminary Efficacy of BGT007H Cell Therapy in Patients With Recurrent/Refractory Gastrointestinal Tumors

This study is an exploratory single-arm, open, modified "3+3" dose escalation study with BGT007H injection. Approximately 11 to 14 subjects with recurrent/refractory gastrointestinal tumors will be enrolled to evaluate the safety of BGT007H injection.

Four dose levels were designed for this study: 1.0×10^8cells, 3.0×10^8cells, 1.0×10^9cells, and 3.0×10^9cells. The primary objective of this study was to evaluate the safety, tolerability and pharmacokinetic profile of BGT007H cell therapy in patients with recurrent/refractory digestive tract tumors, to determine the maximum tolerated dose or the best effective dose, and to initially evaluate the effectiveness of BGT007H cell products.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Main research objectives:

Evaluation of the safety and tolerability of BGT007H cell therapy in patients with recurrent/refractory gastrointestinal tumors

Secondary research objectives:

  1. Evaluate the pharmacokinetic (PK) characteristics of BGT007H cells after reinfusion;
  2. Evaluation of the initial effectiveness of BGT007H cell therapy in patients with recurrent/refractory gastrointestinal tumors

Exploratory Purpose

  1. Exploring the correlation between the proliferation and survival of BGT007H cells in vivo and their therapeutic effects;
  2. Exploring the correlation between target expression levels and efficacy

Study Type

Interventional

Enrollment (Estimated)

14

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Henan
      • Zhengzhou, Henan, China
        • Recruiting
        • The First Affiliated Hospital of Zhengzhou University
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 1. Resources sign written informed consent;
  • 2, age ≥18, male and female can;
  • 3. Expected survival ≥3 months;
  • 4. The Eastern Cancer Collaboration (ECOG) physical status score was 0-1;
  • 5. Biopsy specimen or pathological wax section test (within 3 years before accepting the signed informed consent) : positive target test;
  • 6. According to RECISTv1.1 solid tumor evaluation criteria, there is at least one measurable lesion;
  • 7. Patients with advanced gastrointestinal tumors (esophageal cancer, gastric cancer, pancreatic cancer or colorectal cancer, etc.) who have been diagnosed by histology/cytology as having failed the standard of second-line or above treatment or are not suitable for/refuse to accept the standard treatment or cannot tolerate the standard treatment; The definition of intolerance: according to CTCAE V5.0, the occurrence of ≥Ⅳ hematological toxicity or ≥Ⅲ non-hematological toxicity or ≥Ⅱ damage to the heart, liver, kidney and other important organs during treatment; Treatment failure is defined as disease progression (PD) during treatment or recurrence after the end of treatment (including postoperative recurrence);
  • 8, can establish monopexy or venous blood collection venous access, and there are no other contraindications for blood cell separation;
  • 9, with adequate organ and bone marrow function;
  • 10. During the study period and for 6 months after the end of dosing, fertile subjects (both male and female) must use effective medical contraception. For female subjects of reproductive age, a pregnancy test should be performed within 72 hours before the first dose, and the result is negative.

Exclusion Criteria:

  • 1. Active central nervous system metastasis (except stable after treatment);
  • 2, HIV positive, HBsAg positive simultaneously detected HBV DNA copy number positive (quantitative detection ≥1000cps/ml), HCV antibody positive and HCV RNA positive;
  • 3, mental or mental illness can not cooperate with treatment and efficacy evaluation;
  • 4. Subjects with severe autoimmune diseases and long-term use of immunosuppressants;
  • 5. Active or uncontrollable infection requiring systemic treatment within 14 days prior to enrollment;
  • 6. Any unstable systemic disease (including but not limited to: Active infections (except local infections); Unstable angina pectoris Cerebral ischemia or cerebrovascular accident (within 6 months prior to screening) Myocardial infarction (within 6 months prior to screening) Congestive heart failure (New York Heart Association [NYHA] classification ≥Ⅲ; Severe arrhythmias requiring medical treatment; Have heart disease that requires treatment or uncontrolled hypertension after treatment (blood pressure > 160mmHg/100mmHg);
  • 7, combined with lung, brain, kidney and other important organ dysfunction;
  • 8. The subject has undergone major surgery or severe trauma within 4 weeks prior to receiving cell therapy, or is expected to undergo major surgery during the study period;
  • 9. Received any systemic chemotherapy, immunotherapy or small molecule targeted therapy within 1-2 weeks or 5 half-lives (whichever is shorter) before anapheresis;
  • 10. The subject currently has or has had other malignant tumors that cannot be cured within 3 years, except cervical cancer or basal cell carcinoma of the skin, and other malignant tumors with a disease-free survival of more than 5 years;
  • 11, received chimeric antigen receptor modified T cells (including CAR-T, CTT-T) treatment within half a year;
  • 12. Combined graft-versus-host disease (GVHD)
  • 13. Subjects who were receiving systemic steroid therapy prior to screening and who were determined by the investigator to require long-term use of systemic steroid therapy during treatment (except for inhalation or topical use); And subjects treated with systemic steroids within 72 hours prior to cell transfusion (except for inhalation or topical use);
  • 14. Severe allergy or history of allergy;
  • 15. Subjects requiring anticoagulation therapy;
  • 16, pregnant or breastfeeding women, or six months within the pregnancy plan (unisex;
  • 17. Researchers believe that there are other reasons for not being included in the treatment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: BGT007H injection
Intravenous infusion
Biological: First dose
1.0×10^8cells,Intravenous infusion，1 subject is planned to be enrolled
Biological: Second dose
3.0×10^8cells,Intravenous infusion，3 subject is planned to be enrolled
Biological: The third dose
1.0×10^9cells,Intravenous infusion，3 subject is planned to be enrolled
Biological: The fourth dose
3.0×10^9cells,Intravenous infusion，3 subject is planned to be enrolled

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dose-Limiting Toxicity (DLT)
Time Frame: From the infusion (Day 0) to Day 28
Incidence of adverse events defined as Dose-Limiting Toxicity (DLT).
From the infusion (Day 0) to Day 28
Maximum tolerated dose
Time Frame: From the infusion (Day 0) to Day 28
The maximum CAR-T dose that can be tolerated in the study.
From the infusion (Day 0) to Day 28
AE, SAE, AESI, CRS, ICANS, TEAE
Time Frame: The day of leukapheresis to 12 months after infusion
The incidence of adverse events (AE), serious adverse events (SAE), adverse events of special interest (AESI), cytokine release syndrome (CRS) immune cell associated neurotoxicity syndrome (ICANS) and treatment-emergent adverse events (TEAE).
The day of leukapheresis to 12 months after infusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

BioSyngen Pte Ltd

Collaborators

The First Affiliated Hospital of Zhengzhou University

Investigators

  • Principal Investigator: Yi Zhang, The First Affiliated Hospital of Zhengzhou University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 9, 2023

Primary Completion (Estimated)

July 19, 2025

Study Completion (Estimated)

July 19, 2027

Study Registration Dates

First Submitted

November 22, 2023

First Submitted That Met QC Criteria

November 22, 2023

First Posted (Actual)

December 1, 2023

Study Record Updates

Last Update Posted (Actual)

December 1, 2023

Last Update Submitted That Met QC Criteria

November 22, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BR-BGT-003

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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