BGT007H cell therapy for treating recurrent gastrointestinal tumors

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

This study is testing a new cell therapy called BGT007H to see if it is safe and effective for people with recurrent gastrointestinal tumors.

Quick facts

• Phase: Early Phase 1
• Study type: Interventional
• Enrollment: 14 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: BioSyngen Pte Ltd (Industry-sponsored)
• Drugs / interventions: CAR-T, chimeric antigen receptor, chemotherapy, immunotherapy
• Locations: 1 site (Zhengzhou, Henan)
• Trial ID: NCT06152757 on ClinicalTrials.gov

What this trial studies

This exploratory study evaluates the safety and tolerability of BGT007H cell therapy in patients with recurrent or refractory gastrointestinal tumors. It is a single-arm, open-label, modified '3+3' dose escalation study involving approximately 11 to 14 subjects. Participants will receive varying doses of BGT007H cells to determine the maximum tolerated dose and assess initial effectiveness. The study also aims to explore the pharmacokinetic profile of the therapy and its correlation with therapeutic effects.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with advanced gastrointestinal tumors who have failed standard treatments or are not suitable for them.

Not a fit: Patients with gastrointestinal tumors who have not yet undergone second-line treatment or have not been diagnosed with recurrent or refractory disease may not benefit from this study.

Why it matters

Potential benefit: If successful, this therapy could provide a new treatment option for patients with difficult-to-treat gastrointestinal tumors.

How similar studies have performed: While this approach is exploratory, similar cell therapies have shown promise in treating various cancers, indicating potential for success.

Eligibility criteria

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.

Where this trial is running

Zhengzhou, Henan

• The First Affiliated Hospital of Zhengzhou University — Zhengzhou, Henan, China (Recruiting)

Study contacts

• Principal investigator: Yi Zhang — The First Affiliated Hospital of Zhengzhou University
• Study coordinator: Xinfeng Chen

Conditions Gastrointestinal Tumors