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Advanced Gastrointestinal TumorsPhase 1NCT06197178

A Study of LCAR-G08 in Subjects With Advanced Gastrointestinal Tumors Expressing Guanylyl Cyclase C (GCC)

A Phase 1 study testing LCAR-G08 cells in people with Advanced Gastrointestinal Tumors, run by Peking University at 2 sites in China.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This is a phase 1, single-arm, open-label, dose escalation and expansion study of LCAR-G08 in adult subjects with advanced gastrointestinal tumors expressing guanylyl cyclase C (GCC). Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Advanced Gastrointestinal Tumors
What is being tested?
LCAR-G08 cells
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
17 participants
Where
2 sitesChina
Study dates
28 Dec 2023to 22 Oct 2025
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Voluntary agreement to provide written informed consent.
  • Histologically confirmed metastatic colorectal cancers and other advanced gastrointestinal cancers (esophageal cancer, gastric cancer, pancreatic cancer, and small bowel cancer).
  • Aged 18 to 70 years, either sex.
  • GCC immunohistochemistry (IHC) staining is positive.
  • At least one measurable tumor lesion according to RECIST v1.1.
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
  • Expected survival ≥ 3 months.
  • Clinical laboratory values meet screening visit criteria.

Who cannot join

  • Previous CAR-T cell, T cell receptor-engineered (TCR) T cell, or therapeutic tumor vaccination treatment within the past 6 months; and the corresponding CAR-T, TCR-T cells can still be detected.
  • Ever received any treatment targeting GCC.
  • Prior antitumor therapy with insufficient washout period.
  • Brain metastases.
  • Pregnant or lactating women.
  • Hepatitis C virus (HCV) antibody-positive or human immunodeficiency virus (HIV) antibody-positive, active syphilis, Epstein-Barr virus (EBV) infected.
Show all 9Show fewer
  • Severe underlying disease.
  • Presence of other serious pre-existing medical conditions that may limit patient participation in the study.Any condition that, in the investigator's judgment, will make the subject unsuitable for participation in this study.
  • Any condition that, in the investigator's judgment, will make the subject unsuitable for participation in this study.

Trial locations and contacts

2 sites in 1 country.

China2 sites

  • Beijing Cancer Hospital & Institute

    Beijing, Beijing Municipality, 100142

  • Beijing GoBroad Hospital

    Beijing, Beijing Municipality, 102200

Other trials in China

About this study

Official title: A Phase 1, Open-Label Study Evaluating the Safety, Tolerability and Efficacy of (LCAR)-G08, a Chimeric Antigen Receptor (CAR)-T Cell Therapy Targeting Guanylyl Cyclase C (GCC) in Subjects With Advanced Gastrointestinal Tumors

This is a phase 1, single-arm, open-label, dose escalation and expansion study of LCAR-G08 in adult subjects with advanced gastrointestinal tumors expressing guanylyl cyclase C (GCC).

Read the detailed description

This is a phase 1, single-arm, open-label, dose escalation and expansion study to evaluate the safety, tolerability, pharmacokinetics, and anti-tumor efficacy profiles of the cell-based LCAR- G08 in subjects with guanylyl cyclase C (GCC)-positive advanced gastrointestinal tumors. Subjects who meet the eligibility criteria will receive LCAR-G08 infusion. The study will include the following sequential phases: screening, pre-treatment (cell product preparation; lymphodepleting chemotherapy), treatment and follow up.

Being tested
LCAR-G08 cells
Keywords
Advanced Gastrointestinal Tumors

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LCAR-G08 cellsBiological

    Prior to infusion of the LCAR-G08, subjects will receive a conditioning premedication regimen consisting of cyclophosphamide and fludarabine.

Study groups in NCT06197178
Study groupRoleWhat they receive
Chimeric Antigen Receptor T cell LCAR-G08 CellsExperimentalEach subject will receive LCAR-G08 Cells
Receives: Biological: LCAR-G08 cells

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dose-limiting toxicity (DLT) rate

    Dose-limiting toxicity (DLT) refers to a drug-related toxicity during treatment with the drug, the severity of which is clinically unacceptable, limiting the further escalation of drug dose.

    Measured: Minimum 2 years after LCAR-G08 infusion (Day 1)

  2. Incidence, severity, and type of treatment-emergent adverse events (TEAEs)

    An adverse event refers to any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product (investigational or non-investigational), which does not necessarily have a causal relationship with the treatment.

    Measured: Minimum 2 years after LCAR-G08 infusion (Day 1)

  3. Recommended Phase 2 Dose (RP2D) regimen finding

    RP2D established through accelerated titration design (ATD) and Bayesian Optimal Interval (BOIN) design.

    Measured: Minimum 2 years after LCAR-G08 infusion (Day 1)

  4. Maximum concentration (Cmax)

    The maximum observed concentration of CAR positive T cells or transgene CAR copy number after LCAR-G08 infusion.

    Measured: Minimum 2 years after LCAR-G08 infusion (Day 1)

  5. Time to Cmax (Tmax)

    The time it takes to reach the maximum concentration or time to Cmax after LCAR-G08 infusion.

    Measured: Minimum 2 years after LCAR-G08 infusion (Day 1)

  6. Time to the last observed concentration

    The time it takes to reach the last observed concentration after LCAR-G08 infusion.

    Measured: Minimum 2 years after LCAR-G08 infusion (Day 1)

  7. Area Under the Curve (AUC) last

    The total exposure of the drug experienced by the subject in a clinical study from LCAR-G08 infusion to time to the last observed concentration.

    Measured: Minimum 2 years after LCAR-G08 infusion (Day 1)

Secondary outcomes (7)

  1. Objective Response Rate (ORR) after administration

    Objective Response Rate (ORR) is defined as the proportion of subjects who achieve complete response (CR) or partial response (PR) after treatment via LCAR-G08 cell infusion, and the objective tumor response rate will be calculated for patients with measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 only.

    Measured: Minimum 2 years after LCAR-G08 infusion (Day 1)

  2. Disease Control Rate (DCR) after administration

    Disease Control Rate (DCR) is defined as the proportion of patients with complete response, partial response and stable disease.

    Measured: Minimum 2 years after LCAR-G08 infusion (Day 1)

  3. Duration of Remission (DoR) after administration

    Duration of Remission (DoR) is defined as the time from the first documentation of remission (PR or better) to the first documented disease progression evidence (according to RECIST 1.1) of the responders (who achieve PR or better response).se).

    Measured: Minimum 2 years after LCAR-G08 infusion (Day 1)

  4. Time to Response (TTR) after administration

    Time to Response (TTR) is defined as the time from the date of first infusion of LCAR-G08 to the date of the first response evaluation of the subject who has met all criteria for PR or better.

    Measured: Minimum 2 years after LCAR-G08 infusion (Day 1)

  5. Progression-free Survival (PFS) after administration

    Progression-free Survival (PFS) is defined as the time from the date of first infusion of the LCAR-G08 to the first documented disease progression (according to RECIST 1.1) or death (due to any cause), whichever occurs first.

    Measured: Minimum 2 years after LCAR-G08 infusion (Day 1)

  6. Overall Survival (OS) after administration

    Overall Survival (OS) is defined as the time from the date of first infusion of LCAR-G08 to death of the subject.

    Measured: Minimum 2 years after LCAR-G08 infusion (Day 1)

  7. Incidence of anti-LCAR-G08 antibody and positive sample titer

    Venous blood samples will be collected to measure LCAR-G08 positive cell concentrations and the transgenic level of LCAR-G08, at the time points when anti-LCAR-G08 antibody serum samples are evaluated.

    Measured: Minimum 2 years after LCAR-G08 infusion (Day 1)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jan 2024
  2. Study start28 Dec 2023
  3. Primary completion22 Oct 2025
  4. Study completion22 Oct 2025

Why it stopped: achieved the proof of concept

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Model Description
Masking
None (open label)
Enrolment
17 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06197178
Sponsor's protocol ID
LB2301-0001
Status last verified
Dec 2024
First submitted
20 Nov 2023
Last updated
6 Feb 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing LCAR-G08 cells in people with Advanced Gastrointestinal Tumors, run by Peking University at 2 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 6 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: achieved the proof of concept). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose-limiting toxicity (DLT) rate (time frame: Minimum 2 years after LCAR-G08 infusion (Day 1)). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06197178.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2026.

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