NKG2D/CLDN18.21 CAR-T(KD-496) in the Treatment of Advanced NKG2DL+/CLDN18.2+ Solid Tumor
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorPeking University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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；
Disqualifiers
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;
Trial design
Design model
Single group
Treatments tested in this trial
KD-496
Biological/VaccineAutologous genetically modified anti-NKG2DL/CLDN18.2 CAR transduced T cells
Treatment groups
12 Participants
are divided into 1 treatment groupGroup A: KD-496 cell infusionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Incidence of Treatment Related adverse events (AEs)
Incidence of Treatment Related AEs, AEs of special interest and serious adverse events (SAEs)
Time frame
3 months after infusion2
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.
Time frame
1 month after single infusionSecondary outcomes
1
Objective response rate(ORR)
objective tumor response rate will be calculated for patients with measurable disease per RECIST 1.1
Time frame
Up to 1 year after infusion2
Duration of Response
Duration of time from first response to progression of disease as determined by investigator
Time frame
Up to 18 months3
Disease Control Rate
Percentage of patients evaluated as CR and PR determined by investigator
Time frame
Up to 18 months4
CAR positive T cells in patients
The time of CAR-T cell reach the peak and turn back to baseline
Time frame
Up to 6 months after infusinSponsors and contacts
Click on the lead sponsor to view all of their trials.
Peking University
Lead sponsor
KAEDI
Collaborator
Source ClinicalTrials.gov