Advanced Breast CancerPhase 1NCT06724835
Treating Nectin-4-positive Advanced Breast Cancer with XKDCT293 (Nectin-4-CAR-T)
A Phase 1 study testing XKDCT293 and CAR-T cell in people with Advanced Breast Cancer, run by Shenzhen Celconta Life Science Co., Ltd. at 1 site in China.
Trial summary
A single-center, single-arm, dose-escalation exploratory clinical trial of the safety, efficacy, and pharmacokinetics of XKDCT 293 (Nectin-4-CAR-T) in Nectin-4-positive advanced breast cancer Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Breast Cancer
- What is being tested?
- XKDCT293 and CAR-T cell
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteChina
- Study dates
- 11 Mar 2024to Mar 2026
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ·You must meet all of the following conditions to be eligible for the group：
- Understand and voluntarily sign the informed consent form;
- Age at screening ranged from 18 to 75 years (including the cutoff value), regardless of gender;
- Locally advanced or metastatic breast cancer that is unresectable as confirmed by histology or cytology, including triple-negative breast cancer, Her-2-positive, and HR-positive breast cancer;
- Histological or cytological tumor specimens were confirmed by immunohistochemistry to have moderate to high expression of nectin-4 (expression intensity ≥2+ and tumor cell positive rate ≥50%);
- Patients who have received standard systemic treatment for breast cancer recommended by the Breast Cancer Diagnosis and Treatment Guidelines (2022 Edition) and have had imaging or other objective evidence of disease progression after receiving standard treatment; or patients with refractory breast cancer who cannot tolerate standard treatment or have contraindications to standard treatment, and who have at least one measurable lesion (according to RECIST version 1.1, the long diameter of the measurable lesion on spiral CT scan is ≥10mm or the short diameter of the enlarged lymph node is ≥15mm, see Appendix 1 for RECIST version 1.1); Note: Treatment failure is defined as disease progression during treatment or recurrence after treatment.
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- Definition of intolerance : the occurrence of grade ≥ IV hematological toxicity, grade ≥ III non-hematological toxicity, or grade ≥ III damage to major organs such as heart, liver, and kidney during treatment (refer to NCI-CTCAE v5.0 standards), or a comprehensive assessment by the investigator.
- The expected survival time at enrollment was greater than 12 weeks;
- During screening, laboratory tests must meet the following requirements:
- White blood cell count ≥3.0×10^9 /L;
- Neutrophil count ≥1.5×10^9 /L;
- Lymphocyte count ≥ 0.5 × 10^9 /L;
- Hemoglobin ≥90 g/L;
- Platelet count ≥75×10^9 /L;
- Serum total bilirubin ≤2.0× upper limit of normal (ULN);
- Aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤2.5× ULN; For patients with liver metastases or primary liver tumor lesions, aspartate aminotransferase and alanine aminotransferase should be ≤5×ULN; for patients with a history of Gilbert syndrome/suspected Gilbert syndrome, total bilirubin (TBIL) should be ≤3×ULN;
- Creatinine <1.5×ULN and endogenous creatinine clearance ≥50 mL/min (creatinine clearance Cockcroft-Gault method: creatinine clearance for men = [(140-age)×body weight (kg)]/[0.818×creatinine (umol/L)]; creatinine clearance for women = [(140-age)×body weight (kg)×0.85]/[0.818×creatinine (umol/L)]).
- Good lung function, with basic finger saturation ≥ 95% in indoor air environment;
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;
- Female subjects of childbearing age must undergo a serum pregnancy study with negative results at screening and before purging, and be willing to use medically approved highly effective contraceptive methods during the study and for at least 1 year after the last study treatment. Male subjects whose partners are female subjects of childbearing age should undergo surgical sterilization or agree to use effective contraceptive methods during the study and for at least 1 year after the last study treatment, and are prohibited from donating sperm within 1 year.
- Venous access can be established, and peripheral blood mononuclear cell collection can be performed at the investigator's discretion.
Who cannot join
- ·Anyone who has any of the following conditions cannot be selected as a subject：
- Pregnant or breastfeeding women;
- Those who have a history of allergy to any component of the cell product ;
- Suffering from other malignant tumors, except for the following: cured non-melanoma skin cancer, cervical carcinoma in situ, localized prostate cancer, superficial bladder cancer, and other malignant tumors with a disease-free survival period of more than 5 years;
- Hepatitis B surface antigen (HBsAg) positive; Hepatitis B core antibody (HBcAb) positive, and HBV DNA copy number positive; Hepatitis C antibody (HCV-Ab) positive; Anti-Treponema pallidum antibody (TP-Ab) positive; Human immunodeficiency virus antibody (HIV-Ab) positive; Those who meet any of the following conditions;
- Previous anti-tumor treatment or clinical trial participation:
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- Previously received CAR-T therapy or other gene-edited cell therapy;
- Participated in other clinical studies within 28 days before reinfusion;
- Received local radiotherapy within 7 days or at least 5 half-lives (whichever is longer) before apheresis or small molecule chemotherapy drugs;
- Daily use of systemic glucocorticoids ≥ 15 mg within 7 days before apheresis, excluding inhaled corticosteroids;
- Previously received Nectin-4 targeted therapy;
- Live vaccine or live attenuated vaccine received within 4 weeks before single collection;
- Surgery has been performed within 2 weeks before apheresis and the researchers believe that it may affect the patient's safety;
- The investigators judged that there were comorbidities that required the use of systemic corticosteroids or other immunosuppressive drugs during the study;
- Those who are known to have life-threatening hypersensitivity reactions or other intolerances to cyclophosphamide or fludarabine or severe allergic constitutions; those who have hypersensitivity constitutions, are allergic to human serum albumin, DMSO, etc.; those who are allergic to commonly used first aid and anesthetic drugs;
- Suffering from any unstable circulatory system disease within 180 days prior to screening, including but not limited to unstable angina, myocardial infarction, heart failure [New York Heart Association (NYHA) grade ≥ III], severe arrhythmia requiring medication, or cardiac angioplasty, coronary artery stenting, or heart bypass surgery within 180 days prior to screening;
- Uncontrolled diabetes (glycosylated hemoglobin>8%), uncontrolled hypertension (systolic blood pressure/diastolic blood pressure>160mmHg/100mmHg while taking medication);
- Patients with active infection or uncontrollable infection requiring systemic treatment;
- The presence or history of central nervous system disease, such as epilepsy, cerebral ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease involving the CNS;
- Active autoimmune diseases (including but not limited to systemic lupus erythematosus, Sjögren's syndrome, rheumatoid arthritis, psoriasis, multiple sclerosis, inflammatory bowel disease, Hashimoto's thyroiditis, etc., except for hypothyroidism that can be controlled only by hormone replacement therapy);
- Bleeding and thrombotic tendency: clinically significant bleeding symptoms or clear bleeding tendency, such as bleeding gastric ulcer, within 90 days before screening; hereditary or acquired bleeding and thrombotic tendency (such as hemophilia, coagulation disorder, hypersplenism, etc.); currently receiving thrombolytic or anticoagulant therapy; arterial/venous thrombotic events within 180 days before screening, such as cerebrovascular disease (including cerebral hemorrhage, cerebral infarction, etc.), deep vein thrombosis and pulmonary embolism, etc.;
- Acute toxicity caused by previous treatment has not recovered to grade 1 or below (except hematological toxicity, alopecia, and events judged to be tolerable by the investigator);
- Those who have a history of psychotropic drug abuse and are unable to quit, or those with a history of mental disorders;
- The researcher believes that the patient is not suitable for this clinical study (e.g., poor compliance, drug abuse, etc.).
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
AnYang Tumor Hospital
Anyang, Henan, 455000
Baozhong Li, 13937238883, libaozhong99@126.com
About this study
Official title: A Single-center, Single-arm, Dose-escalation Exploratory Clinical Trial of the Safety, Efficacy, and Pharmacokinetics of XKDCT293 (Nectin-4-CAR-T) in Nectin-4-positive Advanced Breast Cancer
A single-center, single-arm, dose-escalation exploratory clinical trial of the safety, efficacy, and pharmacokinetics of XKDCT 293 (Nectin-4-CAR-T) in Nectin-4-positive advanced breast cancer
Read the detailed description
This study is a prospective, single-arm, open-label, single-dose dose-finding study to evaluate the safety, tolerability, pharmacokinetics, and anti-tumor efficacy characteristics of XKDCT 293 (Nectin-4-CAR-T) cell preparation in subjects with Nectin-4-positive advanced breast cancer.
The study will enroll subjects with pathologically confirmed advanced breast cancer, positive Nectin-4 expression, who have previously received standard treatment, failed treatment or cannot tolerate it. Imaging examinations show evaluable tumor lesions.
The study included screening period, PBMC collection, baseline, lymphocyte pre-depletion chemotherapy , rest evaluation, cell transfusion, hospitalization observation period, routine follow-up period, and long-term follow-up period.
The study set up three dose groups, and adopted the classic 3+3 experimental design for dose escalation.
Main purpose:
(1)the safety and tolerability of XKDCT 293 in the treatment of nectin-4-positive advanced breast cancer
Secondary Purpose:
- the cellular metabolic kinetics and pharmacodynamics of XKDCT 293 in the treatment of nectin-4 -positive advanced breast cancer ;
- To preliminarily evaluate the efficacy of XKDCT 293 cell preparations in patients with advanced Nectin-4-positive breast cancer.
- Conditions
- Advanced Breast Cancer
- Being tested
- XKDCT293, CAR-T cell
- Keywords
- Nectin-4 positive advanced breast cancer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XKDCT293Drug
Autologous targeted Nectin4 chimeric antigen receptor T cell injection
CAR-T cellOther
Nectin-4-CAR-T
| Study group | Role | What they receive |
|---|---|---|
| Autologous targeted Nectin4 chimeric antigen receptor T cell injection | Experimental | Autologous targeted Nectin4 chimeric antigen receptor T cell injection Receives: Drug: XKDCT293; Other: CAR-T cell |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose limiting toxicity (DLT)
Dose limiting toxicity (DLT) in the dose escalation phase
Measured: 28 days of single infusion
Incidence of Treatment Related adverse events (AEs)
Incidence of Treatment Related AEs, AEs of special interest and serious adverse events (SAEs)
Measured: 1 year
Maximum tolerated dose (MTD)
Maximum tolerated dose (MTD) in the dose escalation phase
Measured: 28 days of single infusion
Secondary outcomes (2)
Cellular metabolic kinetics indicators
C max of the number of copies of CAR in peripheral blood of XKDCT293 , the time to reach the maximum concentration T max , the area under the curve for 28 days/90 days AUC 28d /AUC 90d and other related PK parameters and the correlation between cytokines and efficacy
Measured: 1 year
objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS), and overall survival (OS)
To evaluate the objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS), and overall survival (OS)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2024
- Study start11 Mar 2024
- Primary completionMar 2026 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Breast CancerStudies 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
- Model description
- Model Description
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenzhen Celconta Life Science Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06724835
- Sponsor's protocol ID
- 2023YP31H01
- Status last verified
- Mar 2024
- First submitted
- 5 Dec 2024
- Last updated
- 9 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Single-arm, Dose-escalation Exploratory Clinical Trial of the Safety, Efficacy, and Pharmacokinetics of XKDCT293 (Nectin-4-CAR-T) in Nectin-4-positive Advanced Breast Cancer
- ClinicalTrials.gov ID
- NCT06724835
- Acronym / sponsor ID
- 2023YP31H01
- Conditions
- Advanced Breast Cancer
- Keywords
- Nectin-4 positive advanced breast cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Shenzhen Celconta Life Science Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 11 Mar 2024 (actual)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 9 Dec 2024 (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.
A single-center, single-arm, dose-escalation exploratory clinical trial of the safety, efficacy, and pharmacokinetics of XKDCT 293 (Nectin-4-CAR-T) in Nectin-4-positive advanced breast cancer
Detailed description
This study is a prospective, single-arm, open-label, single-dose dose-finding study to evaluate the safety, tolerability, pharmacokinetics, and anti-tumor efficacy characteristics of XKDCT 293 (Nectin-4-CAR-T) cell preparation in subjects with Nectin-4-positive advanced breast cancer.
The study will enroll subjects with pathologically confirmed advanced breast cancer, positive Nectin-4 expression, who have previously received standard treatment, failed treatment or cannot tolerate it. Imaging examinations show evaluable tumor lesions.
The study included screening period, PBMC collection, baseline, lymphocyte pre-depletion chemotherapy , rest evaluation, cell transfusion, hospitalization observation period, routine follow-up period, and long-term follow-up period.
The study set up three dose groups, and adopted the classic 3+3 experimental design for dose escalation.
Main purpose:
(1)the safety and tolerability of XKDCT 293 in the treatment of nectin-4-positive advanced breast cancer
Secondary Purpose:
- the cellular metabolic kinetics and pharmacodynamics of XKDCT 293 in the treatment of nectin-4 -positive advanced breast cancer ;
- To preliminarily evaluate the efficacy of XKDCT 293 cell preparations in patients with advanced Nectin-4-positive breast cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Model Description
| Arm | Type | Receives |
|---|---|---|
| Autologous targeted Nectin4 chimeric antigen receptor T cell injection | Experimental | Drug: XKDCT293, Other: CAR-T cellAutologous targeted Nectin4 chimeric antigen receptor T cell injection |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- ·You must meet all of the following conditions to be eligible for the group：
- Understand and voluntarily sign the informed consent form;
- Age at screening ranged from 18 to 75 years (including the cutoff value), regardless of gender;
- Locally advanced or metastatic breast cancer that is unresectable as confirmed by histology or cytology, including triple-negative breast cancer, Her-2-positive, and HR-positive breast cancer;
- Histological or cytological tumor specimens were confirmed by immunohistochemistry to have moderate to high expression of nectin-4 (expression intensity ≥2+ and tumor cell positive rate ≥50%);
Key exclusion criteria (24 listed)
- ·Anyone who has any of the following conditions cannot be selected as a subject：
- Pregnant or breastfeeding women;
- Those who have a history of allergy to any component of the cell product ;
- Suffering from other malignant tumors, except for the following: cured non-melanoma skin cancer, cervical carcinoma in situ, localized prostate cancer, superficial bladder cancer, and other malignant tumors with a disease-free survival period of more than 5 years;
- Hepatitis B surface antigen (HBsAg) positive; Hepatitis B core antibody (HBcAb) positive, and HBV DNA copy number positive; Hepatitis C antibody (HCV-Ab) positive; Anti-Treponema pallidum antibody (TP-Ab) positive; Human immunodeficiency virus antibody (HIV-Ab) positive; Those who meet any of the following conditions;
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 |
|---|---|---|
| XKDCT293Autologous targeted Nectin4 chimeric antigen receptor T cell injection | Drug | Autologous targeted Nectin4 chimeric antigen receptor T cell injection |
| CAR-T cellNectin-4-CAR-T | Other | Autologous targeted Nectin4 chimeric antigen receptor T cell injection |
Primary outcome
Dose limiting toxicity (DLT)
Time frame: 28 days of single infusion
Dose limiting toxicity (DLT) in the dose escalation phase
Incidence of Treatment Related adverse events (AEs)
Time frame: 1 year
Incidence of Treatment Related AEs, AEs of special interest and serious adverse events (SAEs)
Maximum tolerated dose (MTD)
Time frame: 28 days of single infusion
Maximum tolerated dose (MTD) in the dose escalation phase
2 secondary outcomes
Cellular metabolic kinetics indicators
Time frame: 1 year
objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS), and overall survival (OS)
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2024.
- Individual participant dataSharing planned: No
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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.
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 XKDCT293 and CAR-T cell in people with Advanced Breast Cancer, run by Shenzhen Celconta Life Science Co., Ltd. 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 21 inclusion and 24 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: status not confirmed, as of the sponsor's last update on 9 Dec 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Baozhong Li (13937238883, libaozhong99@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose limiting toxicity (DLT) (time frame: 28 days of single infusion). 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 9 Dec 2024.