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Advanced Solid TumorPhase 1NCT06084286

Dual-targeting CLDN18.2 and PD-L1 CAR-T for Patients with CLDN18.2-positive Advanced Solid Tumors

A Phase 1 study testing Dual-targeting CLDN18.2 and PD-L1 CAR-T cells in people with Advanced Solid Tumor, run by Sichuan University at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

Claudin18.2(CLDN18.2) is a kind of integrin membrane protein in the tight junction between epithelium and endothelium, which is highly expressed in many solid tumors, especially in gastric cancer and pancreatic cancer. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Advanced Solid Tumor
What is being tested?
Dual-targeting CLDN18.2 and PD-L1 CAR-T cells
Could I receive a placebo?
No, everyone receives an active treatment
How many people
29 participants
Where
1 siteChina
Study dates
1 Jan 2024to 30 Oct 2026
Phase
Phase 1
Are there results?
Not yet: the study is under way

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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female, Age 18-75 years old;
  • Patients with pathologically/histologically confirmed diagnosis of solid tumors (such as advanced gastric adenocarcinoma or gastroesophageal junction adenocarcinoma and pancreatic adenocarcinoma) have received at least once systemic standard treatment and disease progressed; or refused/ cannot tolerate the subsequential standard treatment after the first line treatment;
  • Must have CLDN18.2-positive tumor expression ≥10% as determined by the CLDN18.2 IHC assay;
  • Estimated life expectancy > 3 months (according to investigator's judgement);
  • At least 1 measurable lesion per RECIST 1.1;
  • The Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
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  • Sufficient venous access for leukapheresis collection and no other contraindications to leukapheresis;
  • Patients should have reasonable CBC counts, renal and hepatic functions;
  • No other serious diseases (autoimmune diseases or any immune deficiency disease);
  • Women of childbearing age must undergo a serum pregnancy test with negative results before screening and infusion and be willing to use effective and reliable method of contraception for at least 12-months after T-cell infusion;
  • Men must be willing to use effective and reliable method of contraception and are not allowed to donate sperm for at least 12-months after T-cell infusion;
  • Voluntarily participate in the research, understand and sign the informed consent.

Who cannot join

  • Pregnant or lactating women;
  • Patient with hepatitis B or C active period, HIV infection ≥ the upper limit of the normal level;
  • Any uncontrolled active infection;
  • Patients who have clinically significant thyroid dysfunction;
  • Patients who have received prior cellular therapy such as CAR T, TCR, tumor-infiltrating lymphocytes;
  • Patients who are allergic to immunotherapy or any associated drugs, such as cytokines and the preconditioning regimen (cyclophosphamide, fludarabine);
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  • Patients with untreated central nervous system (CNS) metastatic disease, leptomeningeal disease, or cord compression;
  • Patients have clinical significant cardiac conditions that researchers believe that participating in this clinical trial may endanger the health of the patients;
  • Unstable pulmonary embolism, deep venous embolism or other major arterial/venous thromboembolic events occurred within 6 months before enrollment;
  • Patients with active autoimmune diseases, history of autoimmune diseases or other diseases in need of immunosuppressive therapy;
  • Patients with major surgery or injury less than 4 weeks prior to leukapheresis or plan to have major surgery during the research period;
  • Patients with second malignancies in addition to targeted malignancies within 5 years before screening;
  • Patients with unstable/active ulcer or digestive tract bleeding;
  • Patient suffering from diseases that affect the signing of written informed consent or compliance with research procedures; or are unwilling or unable to comply with research requirements;
  • Patients who have a history or a tendency for digestive tract bleeding;
  • Patients who are inappropriate to participate in this research as considered by PI.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Yao Zeng contact

(+86)15982172735

yao_zeng@stu.scu.edu.cn

Dan Li, PhD. contact

(+86)13880025826

lidan@wchscu.cn

China1 site, 1 recruiting

  • West China Hospital, Sichuan University

    Chengdu, Sichuan, 610041

    Yao Zeng, (+86)15982172735, yao_zeng@stu.scu.edu.cn

    Dan Li, PhD, (+86)13880025826, lidan@wchscu.cn

    Recruiting

Other trials in China

About this study

Official title: A Phase I, Open-label, Single-arm, Dose-escalation and Expansion Study of Specific Dual-targeting CLDN18.2 and PD-L1 CAR-T for Patients with CLDN18.2-positive Advanced Solid Tumors

Claudin18.2(CLDN18.2) is a kind of integrin membrane protein in the tight junction between epithelium and endothelium, which is highly expressed in many solid tumors, especially in gastric cancer and pancreatic cancer. The CLDN18.2/PD-L1 dual-targeting CAR-T will be investigated in patients with CLDN18.2-positive advance solid tumors.

Read the detailed description

In this study, the CLDN18.2/PD-L1 dual-targeting CAR-T cells will be injected intravenously to patients with CLDN18.2-positive advanced solid tumors, such as gastric adenocarcinoma or gastroesophageal junction adenocarcinoma and pancreatic adenocarcinoma, who had nearly no response to standard treatment. The safety and effectiveness will be evaluated. The safety evaluation standard refers to the standard of CTCAE 5.0. The evaluation standard of effectiveness refers to the evaluation standard of solid tumor curative effect RECIST 1.1 to evaluate the curative effect.

There are two phases of this study. The first is dose escalation phase, and 9 patients with CLDN18.2-positive advanced solid tumors are planned to be enrolled. The second is dose expansion phase. The curative effect has been observed in the first phase, and after the DLT observation period of the related dose group finished, the PI will decide whether to conduct the dose expansion research finally. It is planned to enroll 20 patients in dose expansion phase.

Being tested
Dual-targeting CLDN18.2 and PD-L1 CAR-T cells
Keywords
CAR-T cell therapy, Solid Tumors, CLDN18.2-positive

What participants receive

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

  • Dual-targeting CLDN18.2 and PD-L1 CAR-T cellsBiological

    The trial consists of a traditional '3 + 3' pattern dose-escalation phase and a dose-expansion phase.

Study groups in NCT06084286
Study groupRoleWhat they receive
CAR-T cell therapyExperimentalDual-targeting CLDN18.2 and PD-L1 CAR-T cells
Receives: Biological: Dual-targeting CLDN18.2 and PD-L1 CAR-T cells

What is being measured

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

  1. Adverse Events (AEs)

    Safety evaluation. AEs will be recorded and evaluated by CTCAE 5.0.

    Measured: 28 days

  2. Dose-limiting toxicity (DLT)

    Tolerability evaluation. DLT will be assessed by CTCAE 5.0.

    Measured: 28 days

  3. Recommended phase II dose (RP2D)

    Efficacy dose.

    Measured: Approximately 18 months

Secondary outcomes (8)

  1. Objective Remission Rate (ORR)

    Include CR (complete response) and PR (partial response).

    Measured: 3 months

  2. Progression-Free Survival (PFS)

    The time from CAR-T administration to disease progression or death.

    Measured: Approximately 18 months

  3. Duration of Control Rate (DCR)

    The number of cases in which response (PR + CR) and stable disease (SD) are achieved from the start of cell infusion/the total number of evaluable cases (%).

    Measured: Approximately 18 months

  4. Duration of Response (DOR)

    It refers to the time from the first evaluation of CR or PR to the first evaluation of PD (Progressive Disease) or death from any reason.

    Measured: Approximately 18 months

  5. Overall-Survival (OS)

    It defined as the time from randomization to death from any cause, is a direct measure of clinical benefit to a patient. Patients alive or lost to follow-up are censored.

    Measured: Approximately 18 months

  6. CAR-T cell numbers

    Monitoring CAR-T cell numbers in blood to determine the persistence of CAR-T.

    Measured: 12 months

  7. Anti-CAR antibody production

    Immunogenicity

    Measured: 12 months

  8. CAR-T cell phenotype

    Immunophenotyping

    Measured: 12 months

Timeline

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

  1. First posted16 Oct 2023
  2. Study start1 Jan 2024
  3. Primary completion30 Oct 2026 (estimated)
  4. Study completion30 Oct 2026 (estimated)

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
Masking
None (open label)
Enrolment
29 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06084286
Sponsor's protocol ID
MCART-007
Status last verified
Nov 2024
First submitted
3 Oct 2023
Last updated
19 Nov 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Cheema PK, Burkes RL. Overall survival should be the primary endpoint in clinical trials for advanced non-small-cell lung cancer. Curr Oncol. 2013 Apr;20(2):e150-60. doi: 10.3747/co.20.1226.

    PubMed 23559882

  • Wagner DL, Fritsche E, Pulsipher MA, Ahmed N, Hamieh M, Hegde M, Ruella M, Savoldo B, Shah NN, Turtle CJ, Wayne AS, Abou-El-Enein M. Immunogenicity of CAR T cells in cancer therapy. Nat Rev Clin Oncol. 2021 Jun;18(6):379-393. doi: 10.1038/s41571-021-00476-2. Epub 2021 Feb 25.

    PubMed 33633361

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Dual-targeting CLDN18.2 and PD-L1 CAR-T cells in people with Advanced Solid Tumor, run by Sichuan University at 1 site 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 12 inclusion and 16 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: looking for participants now, as of the sponsor's last update on 19 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

This study is still under way. Results are not available in the source record yet.

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

Contact Yao Zeng ((+86)15982172735, yao_zeng@stu.scu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adverse Events (AEs) (time frame: 28 days). The study lists 3 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 NCT06084286, which also lists 2 linked publications.

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 19 Nov 2024.

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