CAR T-Cell TherapyEarly Phase 1NCT05277987
An Evaluation Trial About Anti-claudin18.2 the Specificity of Chimeric Antigen Receptor T Cells in the Advanced Gastric / Esophagogastric Junction Adenocarcinoma and Pancreatic Cancer Subjects
A Early Phase 1 study testing HEC-016(0.5×10^6 CAR-T Cells), HEC-016(0.5×10^6.5 CAR-T Cells) and HEC-016(0.5×10^7 CAR-T Cells) in people with CAR T-Cell Therapy, run by Shenzhen Fifth People's Hospital at 1 site in China.
Trial summary
An Evaluation Trial About Anti-claudin18.2 the Specificity of Chimeric Antigen Receptor T Cells in the Advanced Gastric / Esophagogastric Junction Adenocarcinoma and Pancreatic Cancer Subjects. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- CAR T-Cell Therapy
- What is being tested?
- HEC-016(0.5×10^6 CAR-T Cells), HEC-016(0.5×10^6.5 CAR-T Cells) and HEC-016(0.5×10^7 CAR-T Cells)
- 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
- Mar 2022to Mar 2025
- Phase
- Early 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 ≤ age ≤ 70, regardless of gender;
- Subjects with pathologically confirmed advanced gastric / esophagogastric junction adenocarcinoma who failed or did not tolerate at least second-line treatment; Or patients with advanced pancreatic cancer confirmed by pathology, and at least first-line treatment failed or intolerance.
- The immunohistochemical (IHC) staining of tumor tissue samples of the subjects was positive for claudin 18.2 (positive was defined as the positive expression of claudin 18.2 in ≥ 1% of tumor cells detected by IHC in the laboratory; the subjects with adenocarcinoma at the junction of stomach / esophagus and stomach needed HER2 to be negative);
- ECOG score: 0 ~ 2 points
- Expected survival time ≥ 12 weeks;
- According to the solid tumor efficacy evaluation standard (RECIST) v1.1Measurable lesions;
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- The functional level of important organs must meet the following requirements (not treated with blood products or hematopoietic growth factors, such as granulocyte colony stimulating factor, erythropoietin, etc. within 2 weeks before screening):
- Neutrophil absolute value (ANC) ≥ 1.0 × 10^9/L
- Lymphocyte absolute value (ALC) ≥ 0.3 × 10^9/L
- Platelet (PLT) ≥ 50 × 10^9/L
- Hemoglobin (Hgb) ≥ 70 g / L
- International normalized ratio (INR) and activated partial thromboplastin time (APTT) < 1.5 ULN
- Serum total bilirubin (TBIL) ≤ 1.5 × ULN (TBIL ≤ 3 for Gilbert syndrome subjects) × ULN）； ALT and AST ≤ 2.5 × ALT and AST ≤ 5, if there is liver metastasis × ULN）
- Creatinine clearance calculated according to Cockcroft Gault formula ≥ 50 ml / min
- Subjects whose urine routine shows urinary protein ≥ + + should receive 24-hour quantitative detection of urinary protein, and the test result is < 1.0 G
- Blood oxygen saturation ≥ 95% in non oxygen absorption state
- Female subjects with fertility: non lactation, blood pregnancy test during screening period must be negative for pregnancy, and they agree to take efficient contraceptive measures during treatment and within 6 months after the last infusion of study treatment; Male subjects who were not sterilized: agreed to take effective contraceptive measures during treatment and within 6 months after the last infusion of study treatment;
- The subjects volunteered to participate in the study and signed a written informed consent by themselves or their guardian.
Who cannot join
- Previous treatment history in any of the following situations:
- Subjects who had received other chemotherapy (except pretreatment chemotherapy and bridging therapy specified in the protocol), small molecule targeted therapy, immunoantitumor therapy (Immune checkpoint inhibitor, etc.), radiotherapy and major surgery within 4 weeks before the first infusion;
- Within 4 weeks before the first infusion, received anti-tumor traditional Chinese medicine (with anti-tumor indications approved by nmpa);
- Those who receive live vaccine (including attenuated live vaccine) within 4 weeks before the first infusion and / or plan to receive live vaccine after enrollment;
- Participated in any intervention clinical trial within 4 weeks before the first infusion (except for the overall survival follow-up subjects participating in a study);
- Previously received any cellular immunotherapy (including but not limited to car-t, CIK, NK cell therapy, etc.);
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- Those who have previously received any targeted therapy for claudin 18.2;
- Patients with a history of organ transplantation or allogeneic bone marrow transplantation;
- Not recovered from the adverse reactions of previous anti-tumor treatment (i.e. recovered to ≤ level 1 or baseline level according to CTCAE V5.0);
- Central nervous system metastases currently in need of treatment or uncontrolled central nervous system metastases; Or central nervous system metastasis is confirmed, but it is not stable after anti-tumor treatment for more than 4 weeks (definition of central nervous system metastasis stability: no new neurological defect caused by central nervous system metastasis is found, no new lesions are found in central nervous system imaging examination, and corticosteroid / steroid treatment is not required); Spinal cord compression, cancerous meningitis or leptomeningeal disease;
- In the first 5 years before the first infusion, other malignant tumors except gastric or esophagogastric junction adenocarcinoma or pancreatic cancer were combined. Excluding: tumors with negligible risk of metastasis or death (e.g. expected 5-year OS > 90%) and expected to be curable after treatment (e.g. cervical carcinoma in situ, skin basal cell carcinoma or squamous cell carcinoma, localized prostate cancer treated with radical surgery, breast ductal carcinoma in situ treated with radical surgery), Or any other tumor that has been cured (no evidence of disease recurrence within 5 years);
- Subjects who had thrombosis or embolism events within 12 months before the first infusion, such as cerebrovascular accident (including transient ischemic attack, except lacunar infarction), deep venous thrombosis, pulmonary embolism, etc., or who were receiving thrombolytic or anticoagulant therapy such as warfarin, heparin or other similar drugs
- Massive pleural / ascitic fluid or pericardial effusion with clinical symptoms or requiring symptomatic treatment (puncture or drainage once a month or more frequently);
- The investigator assessed that there is a high risk of unexplained anemia or gastrointestinal bleeding and perforation; Or those who have gastrointestinal bleeding in recent 3 months, including a history of hematemesis, bloody stool or black stool within 3 months; Fecal occult blood (+) and above; Those with occult blood (+) or "positive", "weak positive" or "fecal occult blood transferrin positive" or "fecal occult blood hemoglobin positive" and the primary focus of gastric tumor has not been surgically removed need gastroscopy, and gastrointestinal bleeding may occur according to the judgment of the researcher
- Any past or current active autoimmune disease or history of autoimmune disease, including but not limited to Crohn's disease, ulcerative colitis, systemic lupus erythematosus, sarcoidosis, Wegener syndrome (granulomatosis of polyangitis), immune hypophysitis, autoimmune hepatitis, systemic sclerosis (scleroderma, etc.) Hashimoto's thyroiditis (see below for exceptions), autoimmune vasculitis, autoimmune neuropathy (Guillain Barre syndrome), etc. Except for the following cases: type I diabetes, hormone replacement therapy, hypothyroidism (including hypothyroidism caused by autoimmune thyroid disease), psoriasis or vitiligo without systemic treatment;
- Those who have a history of psychotropic substance abuse and can not quit or have mental disorders;
- Researchers believe that those who have other serious acute or chronic diseases and are not suitable to participate in the clinical trial.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shenzhen Luohu Hospital
Shenzhen, Guangdong, 518000
TAO LIU, PHD, 13682481027, 13682481027@163.com
Meiling Zhou, Master, 13068724206, 754793494@qq.com
About this study
Official title: A Single Arm, Open Lable and Single Site Early Phase I Clinical Trial to Evaluate the Safety, Cell Kinetics and Initial Efficacy About Anti-claudin18.2 the Specificity of Chimeric Antigen Receptor T Cells in the Advanced Gastric / Esophagogastric Junction Adenocarcinoma and Pancreatic Cancer Subjects
An Evaluation Trial About Anti-claudin18.2 the Specificity of Chimeric Antigen Receptor T Cells in the Advanced Gastric / Esophagogastric Junction Adenocarcinoma and Pancreatic Cancer Subjects. To evaluate the tolerability and safety of different doses of HEC-016 CAR-T cell injections in patients with advanced gastric / esophagogastric junction adenocarcinoma and pancreatic cancer, to observe dose limiting toxicity (DLT), to determine the maximum tolerated dose (MTD) and to recommend the regimen for subsequent clinical trials.
Read the detailed description
Single Site, single arm and open label design are adopted. The dose increment is based on the traditional "3 + 3" method, and the initial dose is set to 0.5 × 10^6 car-t cells / kg, and 3 ~ 6 subjects are expected to be included in each dose group. DLT was observed within 28 days after infusion. One suject of each dose group was enrolled first, and there was no DLT within 14 days before entering the next subject. If the subject had DLT within 14 days, the investigator can evaluate whether the dose group continued to be enrolled and the time interval of the next subject. After completing the safety observation of 3 subjects who meet the DLT evaluation and analysis set in each dose group, they can be increased to the next dose when there is no DLT; If one subject in the first three cases has DLT, another three subjects need to be selected into the dose group (but the researcher can also decide whether to continue to be selected into the dose group according to the actual situation of the subjects). In the process of dose increase, if DLT occurs in ≥ 2 / 3 or ≥ 2 / 6 subjects in a dose group, the dose increase stops.
- Conditions
- CAR T-Cell Therapy
- Being tested
- HEC-016(0.5×10^6 CAR-T Cells), HEC-016(0.5×10^6.5 CAR-T Cells), HEC-016(0.5×10^7 CAR-T Cells)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HEC-016(0.5×10^6 CAR-T Cells)Drug
The initial dose is set to 0.5 × 10^6 car-t cells / kg, and 3 ~ 6 subjects are expected to be included in the dose group. DLT was observed within 28 days after cell infusion.
HEC-016(0.5×10^6.5 CAR-T Cells)Drug
The Second dose is set 0.5 × 10^6.5 car-t cells / kg, and 3 ~ 6 subjects are expected to be included in the dose group.
HEC-016(0.5×10^7 CAR-T Cells)Drug
The Third dose is set 0.5 × 10^7 car-t cells / kg, and 3 ~ 6 subjects are expected to be included in the dose group.
| Study group | Role | What they receive |
|---|---|---|
| HEC-016 | Experimental | Anti-claudin18.2 the Specificity of Chimeric Antigen Receptor T Cells Receives: Drug: HEC-016(0.5×10^6 CAR-T Cells); Drug: HEC-016(0.5×10^6.5 CAR-T Cells); Drug: HEC-016(0.5×10^7 CAR-T Cells) |
What is being measured
The primary outcome is the main question the study is designed to answer.
DLT
Dose limiting toxicity
Measured: Within 28 days after the first infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2022
- Study startMar 2022 (estimated)
- Primary completionMar 2025 (estimated)
- Study completionMar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CAR T-Cell TherapyStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenzhen Fifth People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, LiuTao, Shenzhen Fifth People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05277987
- Sponsor's protocol ID
- HEC-016-GC/PC-101
- Status last verified
- Mar 2022
- First submitted
- 3 Mar 2022
- Last updated
- 14 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Arm, Open Lable and Single Site Early Phase I Clinical Trial to Evaluate the Safety, Cell Kinetics and Initial Efficacy About Anti-claudin18.2 the Specificity of Chimeric Antigen Receptor T Cells in the Advanced Gastric / Esophagogastric Junction Adenocarcinoma and Pancreatic Cancer Subjects
- ClinicalTrials.gov ID
- NCT05277987
- Acronym / sponsor ID
- HEC-016-GC/PC-101
- Conditions
- CAR T-Cell Therapy
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Shenzhen Fifth People's HospitalUniversity, hospital or other
- Study start
- Mar 2022 (estimated)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 14 Mar 2022 (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.
An Evaluation Trial About Anti-claudin18.2 the Specificity of Chimeric Antigen Receptor T Cells in the Advanced Gastric / Esophagogastric Junction Adenocarcinoma and Pancreatic Cancer Subjects. To evaluate the tolerability and safety of different doses of HEC-016 CAR-T cell injections in patients with advanced gastric / esophagogastric junction adenocarcinoma and pancreatic cancer, to observe dose limiting toxicity (DLT), to determine the maximum tolerated dose (MTD) and to recommend the regimen for subsequent clinical trials.
Detailed description
Single Site, single arm and open label design are adopted. The dose increment is based on the traditional "3 + 3" method, and the initial dose is set to 0.5 × 10^6 car-t cells / kg, and 3 ~ 6 subjects are expected to be included in each dose group. DLT was observed within 28 days after infusion. One suject of each dose group was enrolled first, and there was no DLT within 14 days before entering the next subject. If the subject had DLT within 14 days, the investigator can evaluate whether the dose group continued to be enrolled and the time interval of the next subject. After completing the safety observation of 3 subjects who meet the DLT evaluation and analysis set in each dose group, they can be increased to the next dose when there is no DLT; If one subject in the first three cases has DLT, another three subjects need to be selected into the dose group (but the researcher can also decide whether to continue to be selected into the dose group according to the actual situation of the subjects). In the process of dose increase, if DLT occurs in ≥ 2 / 3 or ≥ 2 / 6 subjects in a dose group, the dose increase stops.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HEC-016 | Experimental | Drug: HEC-016(0.5×10^6 CAR-T Cells), Drug: HEC-016(0.5×10^6.5 CAR-T Cells), Drug: HEC-016(0.5×10^7 CAR-T Cells)Anti-claudin18.2 the Specificity of Chimeric Antigen Receptor T Cells |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- 18 ≤ age ≤ 70, regardless of gender;
- Subjects with pathologically confirmed advanced gastric / esophagogastric junction adenocarcinoma who failed or did not tolerate at least second-line treatment; Or patients with advanced pancreatic cancer confirmed by pathology, and at least first-line treatment failed or intolerance.
- The immunohistochemical (IHC) staining of tumor tissue samples of the subjects was positive for claudin 18.2 (positive was defined as the positive expression of claudin 18.2 in ≥ 1% of tumor cells detected by IHC in the laboratory; the subjects with adenocarcinoma at the junction of stomach / esophagus and stomach needed HER2 to be negative);
- ECOG score: 0 ~ 2 points
- Expected survival time ≥ 12 weeks;
Key exclusion criteria (17 listed)
- Previous treatment history in any of the following situations:
- Not recovered from the adverse reactions of previous anti-tumor treatment (i.e. recovered to ≤ level 1 or baseline level according to CTCAE V5.0);
- Central nervous system metastases currently in need of treatment or uncontrolled central nervous system metastases; Or central nervous system metastasis is confirmed, but it is not stable after anti-tumor treatment for more than 4 weeks (definition of central nervous system metastasis stability: no new neurological defect caused by central nervous system metastasis is found, no new lesions are found in central nervous system imaging examination, and corticosteroid / steroid treatment is not required); Spinal cord compression, cancerous meningitis or leptomeningeal disease;
- In the first 5 years before the first infusion, other malignant tumors except gastric or esophagogastric junction adenocarcinoma or pancreatic cancer were combined. Excluding: tumors with negligible risk of metastasis or death (e.g. expected 5-year OS > 90%) and expected to be curable after treatment (e.g. cervical carcinoma in situ, skin basal cell carcinoma or squamous cell carcinoma, localized prostate cancer treated with radical surgery, breast ductal carcinoma in situ treated with radical surgery), Or any other tumor that has been cured (no evidence of disease recurrence within 5 years);
- Subjects who had thrombosis or embolism events within 12 months before the first infusion, such as cerebrovascular accident (including transient ischemic attack, except lacunar infarction), deep venous thrombosis, pulmonary embolism, etc., or who were receiving thrombolytic or anticoagulant therapy such as warfarin, heparin or other similar drugs
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 |
|---|---|---|
| HEC-016(0.5×10^6 CAR-T Cells)The initial dose is set to 0.5 × 10^6 car-t cells / kg, and 3 ~ 6 subjects are expected to be included in the dose group. DLT was observed within 28 days after cell infusion. | Drug | HEC-016 |
| HEC-016(0.5×10^6.5 CAR-T Cells)The Second dose is set 0.5 × 10^6.5 car-t cells / kg, and 3 ~ 6 subjects are expected to be included in the dose group. | Drug | HEC-016 |
| HEC-016(0.5×10^7 CAR-T Cells)The Third dose is set 0.5 × 10^7 car-t cells / kg, and 3 ~ 6 subjects are expected to be included in the dose group. | Drug | HEC-016 |
Primary outcome
DLT
Time frame: Within 28 days after the first infusion
Dose limiting toxicity
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2022.
- Individual participant dataSharing planned: Undecided
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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 Early Phase 1 study testing HEC-016(0.5×10^6 CAR-T Cells), HEC-016(0.5×10^6.5 CAR-T Cells) and HEC-016(0.5×10^7 CAR-T Cells) in people with CAR T-Cell Therapy, run by Shenzhen Fifth People's Hospital 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 18 inclusion and 17 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 14 Mar 2022. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 Tao LIU, PHD (13682481027, 13682481027@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DLT (time frame: Within 28 days after the first infusion). 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 14 Mar 2022.