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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-70
SponsorBeijing GoBroad Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

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);

Trial population

Gastric/Esophagogastric Junction Adenocarcinoma

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Initial Dose (Dose Group 1)

    Drug

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

  • Dose Group 2

    Drug

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

  • Dose Group 3

    Drug

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

  • Dose Group 4

    Drug

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

  • Dose Group 5

    Drug

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

  • Dose Group 6

    Drug

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

Treatment groups

50 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: Initial Dose (Dose Group 1)1 intervention
Group B: Dose Group 21 intervention
Group C: Dose Group 31 intervention
Group D: Dose Group 41 intervention
Group E: Dose Group 51 intervention
Group F: Dose Group 61 intervention

Trial outcomes

Primary outcomes

1

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)

Time frame
12 months after infusion
2

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)

Time frame
12 months after infusion
3

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)

Time frame
To evaluate the safety and tolerability of CT0494BCP following infusion in participants with advanced gastric/esophagogastric junction adenocarcinoma (G/GEJA)
4

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

Dose limiting toxicity (DLT)

Time frame
28 days after infusion

Secondary outcomes

1

To evaluate preliminary efficacy of CT0494BCP

ORR

Time frame
24 months
2

To evaluate preliminary efficacy of CT0494BCP

DOR

Time frame
24 months
3

To evaluate preliminary efficacy of CT0494BCP

DCR

Time frame
24 months
4

To evaluate preliminary efficacy of CT0494BCP

DDC

Time frame
24 months

Other outcomes

Sponsors and contacts

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

This trial is not recruiting at the moment. You can still explore other options: