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AzTrials

Gastric CancerPhase 1NCT06134960

NKG2D/CLDN18.21 CAR-T(KD-496) in the Treatment of Advanced NKG2DL+/CLDN18.2+ Solid Tumor

A Phase 1 study testing KD-496 in people with Gastric Cancer and Pancreatic Cancer, run by Peking 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
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Trial summary

This is a Phase 1, single-arm, single-center, open-label study to evaluate the safety and effectiveness of NKG2D/CLDN18.2-based CAR-T cells infusion in the treatment of advanced NKG2DL+/CLDN18.2+ solid tumors. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Gastric Cancer, Pancreatic Cancer, Solid Tumor
What is being tested?
KD-496
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteChina
Study dates
16 Nov 2024to 15 Nov 2027
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

  • Subjects fully understand the study and voluntarily sign informed consent；
  • Age 18 to 75 years old (including 75 years old), male and female；
  • Patients diagnosed with advanced solid tumors by histopathology or cytology and failed at least 2 prior lines treatment; preferentially enrolled in gastric cancer, pancreatic cancer, etc. Standard treatment recommendations refer to the latest version of the National Comprehensive Cancer Network (NCCN) guidelines or the Chinese Society of Clinical Oncology (CSCO) guidelines；
  • Immunohistochemistry confirmed that NKG2DL/CLDN18.2 was positive (the sum of NKG2DL and CLDN18.2 positive scores ≥5 according to the principle of positive comprehensive score 0~12 points).Tissue specimens for IHC testing must be obtained within 1 year prior to registration for screening or, if not available, new tissue samples must be obtained from a recently obtained surgery or diagnostic biopsy；
  • Subjects must have measurable lesions as defined by the RECIST v1.1 standard;
  • ECOG physical status score 0 to 1;
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  • Estimated life expectancy ≥ 3 months;
  • Subjects must have adequate peripheral venous access for peripheral blood mononuclear cell (PBMC) collection;
  • Subjects must meet the following conditions prior to screening precondition. If any of the laboratory tests are abnormal, they can be reviewed within 1 week. If the following conditions are still not met, the screening fails:
  • 1)Absolute neutrophil count ≥1.5×10^9/L, platelets ≥90×10^9/L, hemoglobin ≥90 g/L (no blood transfusion or erythropoietin within 14 days) 2)Coagulation parameters: INR≤1.5 times upper limit of normal (ULN), APTT≤1.5 ULN; 3)Liver function: total bilirubin ≤1.5 ULN; Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 ULN; 4)Renal function: creatinine ≤1.5 ULN or creatinine clearance ≥60ml/min (Cockcroft and Gault formula); 5)Lung function: SaO2≥92%; 6)Cardiac function: Cardiac ejection fraction (LVEF) ≥50% detected by echocardiography or MUGA 1 month before enrollment; 10.Male and female participants of reproductive age agreed to use an approved contraceptive method (e.g., contraceptive pill, barrier device, IUD) for the duration of the study until at least 12 months after the last dose of infusion and two consecutive PCR tests found no CAR T cells.

Who cannot join

  • Serologically positive for HIV or treponema pallidum, or active hepatitis B (HBV DNA ≥500 IU/mL) or hepatitis C (anti-HCV positive with HCV RNA above the lower limit of assay detection)
  • Any active infection that can't be controlled
  • Patients have autoimmune diseases, have undergone organ transplantation or allogeneic hematopoietic stem cell transplantation, and require long-term systemic glucocorticoid (local use allowed) or other immunosuppressive therapy;
  • History of severe heart disease, including poorly controlled hypertension (SBP >160mmHg and/or DBP >90mmHg), and any of the following conditions that have occurred in the past 6 months: prolonged QT interval syndrome, ECG shows QTc interval >470mSEC, congestive heart failure (New York Heart Association grade ≥ III), cardiac angioplasty and stenting, myocardial infarction, unstable angina, severe arrhythmia, or other heart disease assessed by the investigator as unsuitable for enrollment;
  • Brain metastases with clinical symptoms, except for patients who are stable and asymptomatic lasting at least 14 days after radiotherapy or surgery;
  • Other central nervous system disorders assessed by the investigator to affect the trial: such as seizures, cerebral ischemia/bleeding, dementia, cerebellar diseases, or diseases affecting the central nervous system;
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  • Complicated with hematologic malignancies or other primary malignant solid tumors, except for the following cases: 1) patients with cervical cancer or breast cancer in situ with no evidence of disease for more than 3 years after radical treatment; 2) Patients who have successfully received definitive in situ tumor resection without evidence of disease for ≥5 years;
  • Patients with unstable or active peptic ulcer or gastrointestinal bleeding;
  • Received chemotherapy, molecular targeted therapy, interventional therapy, or other antitumor therapy within 3 weeks before apheresis;
  • Patients have received treatment with genetically modified T cells (including CAR-T, TCR-T) or other immune cell therapy previously;
  • Female subjects who are pregnant or breastfeeding;
  • Patients with AEs induced by previous anti-tumor treatment that have not recovered to Common Terminology Criteria for Adverse Events (CTCAE) ≤1, except for alopecia;
  • Received any live vaccine within 2 weeks prior to enrollment;
  • Patients are allergic to precondition drugs (including not limited to fludarabine, cyclophosphamide), allergic to KD-496 injection ingredients (dimethyl sulfoxide, human blood albumin), or have a history of severe allergies (such as anaphylactic shock);
  • Other conditions that investigators considered unsuitable for inclusion;

Trial locations and contacts

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

Lin Shen, Professor contact

13911219511

doctorshenlin@sina.cn

Changsong Qi, Professor contact

13811394004

xiwangpku@126.com

China1 site, 1 recruiting

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100142

    Shen Lin, Professor, 010-88196561, doctorshenlin@sina.cn

    Shen Lin, professor

    Recruiting

Other trials in China

About this study

Official title: A Single-center, Open-label, Single-arm Clinical Study of the Safety and Efficacy of KD-496 CAR-T Therapy in Advanced NKG2DL+/CLDN18.2+ Solid Tumors

This is a Phase 1, single-arm, single-center, open-label study to evaluate the safety and effectiveness of NKG2D/CLDN18.2-based CAR-T cells infusion in the treatment of advanced NKG2DL+/CLDN18.2+ solid tumors.

Being tested
KD-496
Medical subject headings
Stomach Neoplasms, Pancreatic Neoplasms

What participants receive

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

  • KD-496Biological

    Autologous genetically modified anti-NKG2DL/CLDN18.2 CAR transduced T cells

Study groups in NCT06134960
Study groupRoleWhat they receive
KD-496 cell infusionExperimentalNot described
Receives: Biological: KD-496

What is being measured

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

  1. Incidence of Treatment Related adverse events (AEs)

    Incidence of Treatment Related AEs, AEs of special interest and serious adverse events (SAEs)

    Measured: 3 months after infusion

  2. Dose-limiting toxicity (DLT) rate

    A drug-related toxicity during treatment with the drug, the severity of which is clinically unacceptable, limiting the further escalation of drug dose.

    Measured: 1 month after single infusion

Secondary outcomes (4)

  1. Objective response rate(ORR)

    objective tumor response rate will be calculated for patients with measurable disease per RECIST 1.1

    Measured: Up to 1 year after infusion

  2. Duration of Response

    Duration of time from first response to progression of disease as determined by investigator

    Measured: Up to 18 months

  3. Disease Control Rate

    Percentage of patients evaluated as CR and PR determined by investigator

    Measured: Up to 18 months

  4. CAR positive T cells in patients

    The time of CAR-T cell reach the peak and turn back to baseline

    Measured: Up to 6 months after infusin

Timeline

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

  1. First posted18 Nov 2023
  2. Study start16 Nov 2024
  3. Primary completion30 Jun 2027 (estimated)
  4. Study completion15 Nov 2027 (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
12 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06134960
Sponsor's protocol ID
KD-496-01
Status last verified
Sep 2026
First submitted
13 Nov 2023
Last updated
14 Sep 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 KD-496 in people with Gastric Cancer and Pancreatic Cancer, 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 10 inclusion and 15 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 14 Sep 2026. 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 Lin Shen, Professor (13911219511, doctorshenlin@sina.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Treatment Related adverse events (AEs) (time frame: 3 months after infusion). The study lists 2 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 NCT06134960.

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 14 Sep 2026.

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