Safety and Efficacy of CT0494BCP in Participants With Advanced Gastric/Esophagogastric Junction Adenocarcinoma

NCT07538856 | Not Yet Recruiting

• 1 other identifier: CT0494BCP
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the safety and tolerability of CT0494BCP following infusion in participants with advanced gastric/esophagogastric junction adenocarcinoma (G/GEJA) To evaluate preliminary efficacy of CT0494BCP To evaluate the cellular metabolism kinetics of CT0494BCP The investigational drug in this study is CT0494BCP cells, including CT0494 cells and CT7095 cells. Dose escalation will be performed according to the Bayesian optimal interval (BOIN) design principle (refer to the dose escalation principle in Section 4.1 Study Design Description and the flow chart of BOIN design in Figure 2 for details) and dose expansion. In the dose escalation phase, CT0494 cells were tentatively assigned to 3 escalating doses of 3.0 × 108, 4.5 × 108 and 6.0 × 108, respectively, and CT7095 cells were tentatively assigned to 2 escalating doses of 1.5 × 108 and 3.0 × 108, respectively. If the exploratory dose is not identified as a possible recommended dose (RD), a possible RD may be explored by escalating to a higher dose or tapering to a lower dose at the discretion of the investigator and sponsor in consultation. Dose groups, number of subjects per dose group, and other escalation or de-escalation decisions may be adjusted during the study based on available data.

Conditions

Gastric; Gastric / Gastroesophageal Junction Adenocarcinoma

Keywords

CT0494BCP

Outcome Measures

Primary Outcomes (5)

• To evaluate the safety and tolerability of CT0494BCP following infusion in participants with advanced gastric/esophagogastric junction adenocarcinoma (G/GEJA)

  treatment-related adverse events (TRAE)

  12 months after infusion

• To evaluate the safety and tolerability of CT0494BCP following infusion in participants with advanced gastric/esophagogastric junction adenocarcinoma (G/GEJA)

  • Frequency, type, and severity of adverse events, including treatment-emergent adverse events (TEAE)

  12 months after infusion

• To evaluate the safety and tolerability of CT0494BCP following infusion in participants with advanced gastric/esophagogastric junction adenocarcinoma (G/GEJA)

  serious adverse events (SAE), and adverse events of special interest (AESI)

  To evaluate the safety and tolerability of CT0494BCP following infusion in participants with advanced gastric/esophagogastric junction adenocarcinoma (G/GEJA)

• To evaluate the safety and tolerability of CT0494BCP following infusion in participants with advanced gastric/esophagogastric junction adenocarcinoma (G/GEJA)

  Dose limiting toxicity (DLT)

  28 days after infusion

• To evaluate the safety and tolerability of CT0494BCP following infusion in participants with advanced gastric/esophagogastric junction adenocarcinoma (G/GEJA)

  recommended dose (RD)

  28 days after infusion

Secondary Outcomes (6)

• To evaluate preliminary efficacy of CT0494BCP

  24 months

• To evaluate preliminary efficacy of CT0494BCP

  24 months

• To evaluate preliminary efficacy of CT0494BCP

  24 months

• To evaluate preliminary efficacy of CT0494BCP

  24 months

• To evaluate preliminary efficacy of CT0494BCP

  24 months

Study Arms (6)

Initial Dose (Dose Group 1)

CT0494 Cell Dose 3.0 × 108 CT7095 Cell Dose 1.5 × 108

Drug: Initial Dose (Dose Group 1)

Dose Group 2

CT0494 Cell Dose 4.5 × 108 CT7095 Cell Dose 1.5 × 108

Drug: Dose Group 2

Dose Group 3

CT0494 Cell Dose 6.0×108 CT7095 Cell Dose 1.5×108

Drug: Dose Group 3

Dose Group 4

CT0494 Cell Dose 3.0 × 108 CT7095 Cell Dose 3.0 × 108

Drug: Dose Group 4

Dose Group 5

CT0494 Cell Dose 4.5 × 108 CT7095 Cell Dose 3.0 × 108

Drug: Dose Group 5

Dose Group 6

CT0494 Cell Dose 6.0 × 108 CT7095 Cell Dose 3.0 × 108

Drug: Dose Group 6

Interventions

Initial Dose (Dose Group 1) DRUG

CT0494 Cell Dose 3.0 × 108 CT7095 Cell Dose 1.5 × 108

Initial Dose (Dose Group 1)

Dose Group 2 DRUG

CT0494 Cell Dose 4.5 × 108 CT7095 Cell Dose 1.5 × 108

Dose Group 2

Dose Group 3 DRUG

CT0494 Cell Dose 6.0×108 CT7095 Cell Dose 1.5×108

Dose Group 3

Dose Group 4 DRUG

CT0494 Cell Dose 3.0 × 108 CT7095 Cell Dose 3.0 × 108

Dose Group 4

Dose Group 5 DRUG

CT0494 Cell Dose 4.5 × 108 CT7095 Cell Dose 3.0 × 108

Dose Group 5

Dose Group 6 DRUG

CT0494 Cell Dose 6.0 × 108 CT7095 Cell Dose 3.0 × 108

Dose Group 6

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Gastric/Esophagogastric Junction Adenocarcinoma

You may qualify if:

• Volunteer to participate in the clinical trial; I fully understand and are informed of this trial and sign the informed consent form; Willing to follow and able to complete all trial procedures; Age 18-70 years (inclusive), male or female; Participants with pathologically confirmed advanced gastric/esophagogastric junction adenocarcinoma; Failed at least second-line treatment (if the first-line treatment includes three drugs including taxanes \[or anthracyclines\], platinum and fluoropyrimidines, the participants can also be enrolled into the trial as eligible as assessed by the investigator); Participant's tumor tissue sample is CLDN18.2 positive by immunohistochemistry (IHC) staining (expression intensity ≥ 2 + and% positive tumor cells ≥ 40%); Estimated survival \> 12 weeks; Measurable tumor lesions according to RECIST v1.1; ECOG performance status 0 \~ 1;
• Unless otherwise specified, participants should meet the following criteria before clearing the lymphoma (local laboratory results that do not meet the following criteria are allowed to perform a re-examination within one week; if they still do not meet the criteria, they cannot clear the lymphoma):

You may not qualify if:

• Pregnant or lactating females;
• HIV, Treponema pallidum, HCV serology positive (HCV antibody positive but HCV-RNA negative can be included), Epstein-Barr virus (EBV) DNA (plasma or whole blood) positive, cytomegalovirus (CMV) DNA positive;
• Any uncontrolled active infection, including but not limited to active tuberculosis, HBV infection (including HBsAg positive, or HBcAb positive with HBV DNA above the lower limit of the laboratory test in our center), and other bacterial, viral or fungal infections requiring drug treatment. Participants who use drugs to prevent infection and can continue the trial as judged by the investigator;
• Known HER2-positive (defined as IHC3 +, or IHC2 + with amplification by FISH);
• Clinically significant abnormal thyroid function as judged by the investigator (serum thyroid hormone determination includes at least FT3, FT4 and serum thyroid stimulating hormone TSH), but patients with hypothyroidism whose disease is under stable control as assessed by the investigator can enter the trial;
• Toxic reactions caused by previous treatment have not recovered to CTCAE v6.0 ≤ Grade 1, except for alopecia and other tolerable events as judged by the investigator or laboratory abnormalities allowed in this trial;
• Received anti-tumor treatment for the disease under study within 2 weeks prior to CLL, including but not limited to surgery, systemic chemotherapy (or within 5 half-lives of the drug, whichever is shorter), radiotherapy, intervention, etc., or received anti-PD-(L) 1 monoclonal antibody therapy or CLDN18.2 targeted therapy or other non-marketed clinical trial drugs within 4 weeks prior to CLL (or within 5 half-lives of the drug, whichever is shorter);
• Ongoing use of glucocorticoids within 7 days prior to CLL. Recent or current use of inhaled or topical dermal glucocorticoids and physiologic replacement therapy doses of glucocorticoids were not excluded;
• Vaccination with live attenuated vaccines within 4 weeks prior to CLL or planned during the trial;
• Participants with known active autoimmune disease, including but not limited to psoriasis or rheumatoid arthritis, or other conditions requiring chronic use of immunosuppressive therapy;
• Previous allergies to immunotherapy, tocilizumab, cyclophosphamide, fludarabine or nab-paclitaxel and other related drugs, allergies to components of CT0494BCP such as albumin, DMSO or other severe allergies;
• Previously received any genetic engineering modified cell therapy (including CAR-T, TCR-T cells, etc.);
• Presence of known or suspected central nervous system metastases;
• Central type or extensive lung metastasis, or extensive liver metastasis, or extensive bone metastasis;
• The longest diameter of a single target lesion \> 4 cm before CLL (lymph node lesion is short axis);

Sponsors & Collaborators

• Beijing GoBroad Hospital: lead

Study Sites (1)

BeijingGoBroadH

Beijing, Beijing Municipality, 10000, China

Location

Central Study Contacts

Changsong Qi Changsong Qi

CONTACT

010-50847588; gcc2@gobroadhealthcare.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2026
• First Posted: April 20, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): March 1, 2028
• Last Updated: April 20, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)