Gastrointestinal TumorsPhase 1NCT05981235
Phase 1 Trial of AZD6422 in CLDN18.2+ GI Tumors
A Phase 1 study testing AZD6422 CLDN18.2 CAR-T product in people with Gastrointestinal Tumors, run by Peking University at 1 site in China.
Trial summary
This is a FTiH, Phase 1 IIT to evaluate the safety, feasibility, cellular kinetics (CK), pharmacodynamics (PD), immunogenicity, and preliminary antitumor activity of AZD6422 in adult participants with advanced or metastatic CLDN18.2+ GI tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastrointestinal Tumors
- What is being tested?
- AZD6422 CLDN18.2 CAR-T product
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteChina
- Study dates
- 14 Dec 2023to 25 Jun 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1Capable of giving signed informed consent and keep compliance with the requirements and restrictions listed in the ICF and in this protocol.
- 2Age ≥ 18 years at the time of signing the informed consent. 3At least 1 lesion, that qualifies as a RECIST v1.1 target lesion at baseline. Histologically confirmed diagnosis of unresectable or metastatic GI adenocarcinoma that has failed prior lines systemic treatment or with standard anticancer therapy.
- 4Confirmation of CLDN18.2 expression determined by IHC . 5ECOG PS of 0 to 1. 6 Life expectancy of > 12 weeks. 7Evidence of appropriate organ function, as determined by clinical laboratory values.
- 8Participants of childbearing potential (including woman of childbearing potential and males who have a partner) must take highly effective contraception measure.
Who cannot join
- 1.Prior treatment with any CAR-T cell therapy. 2.History of upper digestive tract bleeding secondary to previous CLDN18.2-targeting therapies; clinically significant unstable or active peptic ulcer disease or upper digestive tract bleeding 3.Cancer-related spinal cord compression, leptomeningeal disease, or brain metastases.
- 4.Receipt of the last dose of anticancer therapy within 5 half-lives or ≤ 21 days prior to apheresis, treatment radiotherapy within 6 weeks (loco-regional palliative radiotherapy within 7 days) prior to apheresis.
- 5.Treatment with any anticoagulant or antiplatelet therapy. 6.History of, or active, bleeding diatheses. 7.Active or chronic infection disease (s). 8.History of another primary malignancy ≤ 3 years before enrolment. 9.Any history of autoimmune neurological conditions. 10.Other active autoimmune or inflammatory disorders. 11.Stroke, intracranial haemorrhage, or seizure within 6 months of apheresis. 12.Active uncontrolled epilepsy. 13.Cardiac disease, including arrhythmias, QT prolongation, cardiomyopathy and unstable ischaemic heart disease.
- 14.Uncontrolled intercurrent illness. 15.Steroids or other immunomodulators of systemic therapeutic dose within 14 days prior to apheresis.
- 16.Prior pegylated G-CSF within 60 days before apheresis. Prior G-CSF/granulocyte-macrophage colony stimulating factor (GM-CSF) within 14 days before apheresis.
- 17.Any prohibited medication. 18.Major surgery within 2 weeks prior to apheresis, or planned surgery within 4 weeks after study intervention.
Show all 12Show fewer
- 19.Any history of life-threatening allergies, hypersensitivity, or severe infusion reaction to monoclonal antibodies or biological therapies, or intolerance to the CAR-T product or its excipients.
- 20.Toxicity from previous anticancer therapy that has not resolved to baseline levels or to ≤ Grade 1 prior to apheresis.
- 21.Female participants who are pregnant or breastfeeding or expect to be pregnant or breastfeeding during the study.
- 22.Judgment by the investigator that the participant should not participate in the study if the participant is unlikely to comply with study procedures, restrictions, and requirements.
- 23.Receipt of live or live attenuated vaccine within 30 days prior to the start of lymphodepletion.
- 24.Participant has any medical or psychiatric condition.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: FTiH, Phase 1 Investigator-Initiated Trial (IIT) to Evaluate the Safety, Feasibility, Cellular Kinetics, and Preliminary Antitumor Activity of AZD6422 in Adult Participants With Advanced or Metastatic CLDN18.2+ GI Tumors
This is a FTiH, Phase 1 IIT to evaluate the safety, feasibility, cellular kinetics (CK), pharmacodynamics (PD), immunogenicity, and preliminary antitumor activity of AZD6422 in adult participants with advanced or metastatic CLDN18.2+ GI tumors.
Read the detailed description
Qualified researchers can request access to anonymized individual patient-level data from sponsor or the collaborator group of companies sponsored clinical trials via the request portal. All requests will be evaluated as per the sponsor disclosure commitment. Yes, indicates that sponsors are accepting requests for IPD, but this does not mean all requests will be shared.
- Conditions
- Gastrointestinal Tumors
- Being tested
- AZD6422 CLDN18.2 CAR-T product
- Keywords
- CLDN18.2+ GI Tumors Solid tumor CAR-T Cell therapy AZD6422
- Medical subject headings
- Digestive System Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD6422 CLDN18.2 CAR-T productBiological
Also called AZD6422
AZD6422 CAR-T product infusion after pre-conditioning
| Study group | Role | What they receive |
|---|---|---|
| AZD6422 | Experimental | It is anti-CLDN18.2 CAR-T cell therapy and the study consists of two parts: dose escalation (part 1) and dose expansion (part 2) Receives: Biological: AZD6422 CLDN18.2 CAR-T product |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment-emergent AEs, AESIs, and SAEs.
Incidence of treatment-emergent AEs, AESIs, and SAEs.
Measured: Within 24 months of the last AZD6422 infusion or the start of a new anticancer treatment
Occurrence of Dose limiting toxicity.
Occurrence of DLTs (Dose limiting toxicity).
Measured: Within 28 days after the first infusion
Changes from baseline in vital signs, laboratory parameters, physical examination, and 12-lead ECG.
Changes from baseline in vital signs, laboratory parameters, physical examination, and 12-lead ECG.
Measured: Within 28 days after the first infusion
Secondary outcomes (4)
ORR
The proportion of participants who have a confirmed CR or confirmed PR as determined by the investigator at local site per RECIST v1.1.
Measured: 24 months post AZD6422 infusion
DoR
The time from first documented confirmed response until date of documented progression of disease per RECIST v1.1 as determined by investigator at local site or death due to any cause.
Measured: 24 months post AZD6422 infusion
DCR
The proportion of participants who have a confirmed CR, confirmed PR, or who have SD per RECIST v1.1 as assessed by the investigator at local site and derived from the raw tumor data for at least 11 weeks after infusion date.
Measured: 24 months post AZD6422 infusion
PFS
Time from infusion date until progression per RECIST v1.1 as assessed by the investigator at local site, or death due to any cause.
Measured: 24 months post AZD6422 infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2023
- Study start14 Dec 2023
- Primary completion25 Jun 2025
- Study completion25 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Responsible party
- Sponsor
- Investigators
- Lin Shen, PHD, Principal investigator, Peking University Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05981235
- Sponsor's protocol ID
- D9540C00001
- Status last verified
- Jul 2023
- First submitted
- 1 Aug 2023
- Last updated
- 31 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from sponsor or the collaborator group of companies sponsored clinical trials via the request portal. All requests will be evaluated as per the sponsor disclosure commitment. Yes, indicates that sponsors are accepting requests for IPD, but this does not mean all requests will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FTiH, Phase 1 Investigator-Initiated Trial (IIT) to Evaluate the Safety, Feasibility, Cellular Kinetics, and Preliminary Antitumor Activity of AZD6422 in Adult Participants With Advanced or Metastatic CLDN18.2+ GI Tumors
- ClinicalTrials.gov ID
- NCT05981235
- Acronym / sponsor ID
- D9540C00001
- Conditions
- Gastrointestinal Tumors
- Keywords
- CLDN18.2+ GI Tumors Solid tumor CAR-T Cell therapy AZD6422
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Collaborators
- AstraZeneca
- Study start
- 14 Dec 2023 (actual)
- Primary completion
- 25 Jun 2025 (actual)
- Study completion
- 25 Jun 2025 (actual)
- First posted
- 8 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a FTiH, Phase 1 IIT to evaluate the safety, feasibility, cellular kinetics (CK), pharmacodynamics (PD), immunogenicity, and preliminary antitumor activity of AZD6422 in adult participants with advanced or metastatic CLDN18.2+ GI tumors.
Detailed description
Qualified researchers can request access to anonymized individual patient-level data from sponsor or the collaborator group of companies sponsored clinical trials via the request portal. All requests will be evaluated as per the sponsor disclosure commitment. Yes, indicates that sponsors are accepting requests for IPD, but this does not mean all requests will be shared.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AZD6422 | Experimental | Biological: AZD6422 CLDN18.2 CAR-T productIt is anti-CLDN18.2 CAR-T cell therapy and the study consists of two parts: dose escalation (part 1) and dose expansion (part 2) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 1Capable of giving signed informed consent and keep compliance with the requirements and restrictions listed in the ICF and in this protocol.
- 2Age ≥ 18 years at the time of signing the informed consent. 3At least 1 lesion, that qualifies as a RECIST v1.1 target lesion at baseline. Histologically confirmed diagnosis of unresectable or metastatic GI adenocarcinoma that has failed prior lines systemic treatment or with standard anticancer therapy.
- 4Confirmation of CLDN18.2 expression determined by IHC . 5ECOG PS of 0 to 1. 6 Life expectancy of > 12 weeks. 7Evidence of appropriate organ function, as determined by clinical laboratory values.
- 8Participants of childbearing potential (including woman of childbearing potential and males who have a partner) must take highly effective contraception measure.
Key exclusion criteria (12 listed)
- 1.Prior treatment with any CAR-T cell therapy. 2.History of upper digestive tract bleeding secondary to previous CLDN18.2-targeting therapies; clinically significant unstable or active peptic ulcer disease or upper digestive tract bleeding 3.Cancer-related spinal cord compression, leptomeningeal disease, or brain metastases.
- 4.Receipt of the last dose of anticancer therapy within 5 half-lives or ≤ 21 days prior to apheresis, treatment radiotherapy within 6 weeks (loco-regional palliative radiotherapy within 7 days) prior to apheresis.
- 5.Treatment with any anticoagulant or antiplatelet therapy. 6.History of, or active, bleeding diatheses. 7.Active or chronic infection disease (s). 8.History of another primary malignancy ≤ 3 years before enrolment. 9.Any history of autoimmune neurological conditions. 10.Other active autoimmune or inflammatory disorders. 11.Stroke, intracranial haemorrhage, or seizure within 6 months of apheresis. 12.Active uncontrolled epilepsy. 13.Cardiac disease, including arrhythmias, QT prolongation, cardiomyopathy and unstable ischaemic heart disease.
- 14.Uncontrolled intercurrent illness. 15.Steroids or other immunomodulators of systemic therapeutic dose within 14 days prior to apheresis.
- 16.Prior pegylated G-CSF within 60 days before apheresis. Prior G-CSF/granulocyte-macrophage colony stimulating factor (GM-CSF) within 14 days before apheresis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AZD6422 CLDN18.2 CAR-T productAlso: AZD6422AZD6422 CAR-T product infusion after pre-conditioning | Biological | AZD6422 |
Primary outcome
Incidence of treatment-emergent AEs, AESIs, and SAEs.
Time frame: Within 24 months of the last AZD6422 infusion or the start of a new anticancer treatment
Incidence of treatment-emergent AEs, AESIs, and SAEs.
Occurrence of Dose limiting toxicity.
Time frame: Within 28 days after the first infusion
Occurrence of DLTs (Dose limiting toxicity).
Changes from baseline in vital signs, laboratory parameters, physical examination, and 12-lead ECG.
Time frame: Within 28 days after the first infusion
Changes from baseline in vital signs, laboratory parameters, physical examination, and 12-lead ECG.
4 secondary outcomes
ORR
Time frame: 24 months post AZD6422 infusion
DoR
Time frame: 24 months post AZD6422 infusion
DCR
Time frame: 24 months post AZD6422 infusion
PFS
Time frame: 24 months post AZD6422 infusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2025.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from sponsor or the collaborator group of companies sponsored clinical trials via the request portal. All requests will be evaluated as per the sponsor disclosure commitment. Yes, indicates that sponsors are accepting requests for IPD, but this does not mean all requests will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lin Shen, PHD principal investigator
Peking University Cancer Hospital & Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AZD6422 CLDN18.2 CAR-T product in people with Gastrointestinal Tumors, run by Peking 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 4 inclusion and 12 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: finished, as of the sponsor's last update on 31 Jul 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incidence of treatment-emergent AEs, AESIs, and SAEs. (time frame: Within 24 months of the last AZD6422 infusion or the start of a new anticancer treatment). 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?
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 31 Jul 2025.