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Colorectal CancerPhase 1NCT06043466

A Clinical Trial Targeting CEA Chimeric Antigen Receptor T (CAR-T) for CEA Positive Advanced Malignant Solid Tumors

A Phase 1 study testing CEA-targeted CAR-T cells in people with Colorectal Cancer and Esophagus Cancer, run by Chongqing Precision Biotech Co., Ltd at 2 sites 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
Search all trials

Trial summary

This is a single-arm, open, dose-increasing phase I clinical study to explore the safety, tolerability and pharmacokinetic characteristics of the drug C-13-60 cells, and preliminarily observe the efficacy of the drug in CEA positive late malignant solid tumors, and explore the applicable dose regimen for phase II… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
CEA-targeted CAR-T cells
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
2 sitesChina
Study dates
11 Aug 2023to 31 Dec 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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥18 years old, male or female;
  • Patients with advanced malignant solid tumors confirmed by histology or pathology, including colorectal cancer, esophageal cancer, gastric cancer, pancreatic cancer, non-small cell lung cancer, breast cancer, and cholangiocarcinoma;
  • Progression or intolerance occurs after receiving systematic standard therapy according to guidelines,(systemic therapy including but not limited to systemic chemotherapy, molecular targeting, etc.) and is not suitable for surgery or local therapy (including ablative therapy, interventional therapy, and radiation therapy), among which colorectal cancer needs to receive at least third-line therapy failure or intolerance or inapplicability. Esophageal, gastric, non-small cell lung, breast, and cholangiocarcinoma require at least second-line treatment failure or intolerance or inadequacy, and pancreatic cancer require at least first-line treatment failure or intolerance or inadequacy:
  • Advanced colorectal cancer: progression or intolerance or inadequacy after third-line standard therapy including cetuximab ± Irinotecan/regorafenib /fruquintinib/trifluridine；
  • Advanced or metastatic esophageal cancer/esophagogastric junction cancer: patients with esophageal cancer who progress or are intolerant or inapplicable after second-line therapy including PD-1 MAB /PD-L1 mab; Patients with esophagogastric junction cancer progressed or were intolerant or inapplicable after second-line therapy including taxane or irinotecan or PD-1 /PD-L1 monoclonal antibody; For HER-2 positive patients, trastuzumab containing system therapy should fail or be intolerable or not applicable;
  • Advanced/metastatic gastric cancer: the combination of PD-1 MAB /PD-L1 MAB and chemotherapy has been developed or is not tolerated or suitable; For HER-2 positive patients, systemic treatment containing trastuzumab should fail or be intolerable or inapplicable.
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  • Patients with advanced, metastatic, or recurrent non-small cell lung cancer who have received systemic treatment progression or intolerance, including: Patients with positive driver genes (EGFR, ALK, ROS1, BRAF, NTRK, MET, RET) should receive targeted therapy failure or drug resistance (squamous cell carcinoma does not require driver gene testing). In addition, patients with EGFR-positive driver gene who are resistant to first-line EGFR-Tkis and who are positive for EGFR T790M mutations need to be treated with third-generation EGFR-TKI (such as Osimertinib, almonertinib, or furmonertinib) after failure or resistance. For patients with positive ALK fusion and drug resistance after first-line crizotinib treatment, second-line treatment with ceritinib or alectinib should fail or be resistant; Patients with PD-L1 expression (PD-L1 TPS≥1%) should undergo immune checkpoint inhibitor treatment failure or intolerance; In patients with negative driver genes, the disease progresses or becomes intolerable after chemotherapy with platinum-containing regiments-such as Camrelizumab, Pembrolizumab, Tislelizumab, Sintilimab or Atezolizumab combined with pemetrexed
  • Advanced, metastatic breast cancer: HER-2 positive patients need to have received anti-HER-2 therapy, hormone receptor positive patients need to receive endocrine therapy and other standard treatments have failed or are intolerable or not applicable, and rescue chemotherapy for those who have failed/are intolerable or triple-negative breast cancer (including: Gemcitabine + cisplatin/carboplatin, albumin paclitaxel/other taxoid drugs + cisplatin/carboplatin) fail or are not tolerated or suitable;
  • Locally advanced or metastatic pancreatic cancer: advanced or intolerant or inappropriate after at least first-line treatment, including: Gemcitabine + albumin-bound paclitaxel/cisplatin/erlotinib/capecitabine/tegafur/Nimotuzumab, or FOLFIRINOX (oxaliplatin + irinotecan +LV+5-FU), or mFOLFIRINOX (oxaliplatin + irinotecan + calcium folinate +5-FU);
  • Advanced cholangiocarcinoma: progression or intolerance or inapplicability after at least second-line therapy (mFOLFOX); Remarks: Chemotherapy failure is defined as disease progression or intolerable toxicity during treatment or within 3 months after the last dose; If patients cannot receive the above treatment for economic reasons, those whose benefits outweigh the risks of inclusion in the study can be enrolled.
  • Subjects with positive CEA (IHC score 3+) in tumor tissue samples (paraffin sections or fresh tissue specimens or puncture biopsy samples) within 3 months before screening; If the immunohistochemical results of the tumor samples are more than 3 months from the time of screening, the patient needs to re-biopsy; If the tumor specimens are not available or the amount is too small for immunohistochemical detection of CEA, the CEA positive can be confirmed by re-staining of previous tissue specimens, and the peripheral blood serum CEA≥2.0×ULN can be included in the group.
  • Have at least one evaluable target lesion according to RECIST 1.1 criteria;
  • Colorectal cancer, esophageal cancer, non-small cell lung cancer, breast cancer, stomach cancer, cholangiocarcinoma ECOG 0 ~ 1 score, pancreatic cancer ECOG 0 ~ 2 score;
  • Expected survival time is more than 12 weeks;
  • No serious mental disorders;
  • Unless otherwise stated, the subject's vital organ functions shall meet the following conditions:
  • Blood routine: white blood cells > 3.5×109/L, neutrophils > 1.8×109/L, lymphocytes \> 0.5 ×109/L, platelet > 80×109/L, hemoglobin > 90g/L;
  • Cardiac function: Echocardiography indicated cardiac ejection fraction ≥50%, and no obvious abnormality was found in electrocardiogram;
  • Renal function: serum creatinine ≤2.0×ULN;
  • Liver function: ALT and AST≤3.0×ULN (patients with liver tumor infiltration can be relaxed to ≤5.0 ×ULN);
  • Total bilirubin ≤2.0×ULN (Gilbert syndrome ≤3.0×ULN; The patients with liver tumor infiltration can be enlarged to ≤5.0×ULN);
  • Blood oxygen saturation in non-oxygen state \> 92%.
  • Have the criteria for simple or intravenous blood collection, and no other contraindications for cell collection;
  • The subject agrees to use a reliable and effective method of contraception (excluding safe period contraception) for 1 year from signing the informed consent to receiving the C-13-60 cell infusion. Including but not limited to: abstinence, can inhibit ovulation implantable progesterone contraceptive; Intrauterine device (IUD); Intrauterine hormone release system; Spousal vasectomy; Combined hormonal contraceptives (oral, vaginal, and transdermal) that inhibit ovulation; Progesterone contraceptives (oral or injectable) that inhibit ovulation; Male subjects who have sex with fertile women must consent to the use of a barrier method of contraception (e.g., condom plus spermicidal foam/gel/film/emulsion/suppository). At the same time, the subject should promise not to donate eggs (egg cells, oocytes) or sperm for assisted reproduction within 1 year after the cell infusion.
  • The patient or his/her guardian agrees to participate in the clinical trial and signs the ICF, indicating that he/she understands the purpose and procedure of the clinical trial and is willing to participate in the study.

Who cannot join

  • People who have received CAR-T therapy or other gene-modified cell therapy;
  • Patients with BMS with clinical symptoms or lesions located in key parts of the brain at the time of screening, patients with BMS without clinical symptoms or lesions located in non-critical parts of the brain should be evaluated by researchers or specialists to gain more than the risk.
  • Received any of the following medications or treatments before screening:
  • Received other investigational drugs or treatments that are not on the market within 4 weeks prior to screening;
  • Received live attenuated vaccine within 4 weeks prior to screening;
  • Received radioactive iodine-125 particle implantation within 8 weeks prior to screening;
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  • Received the following drugs or treatments before apheresis:
  • received the equivalent of \&gt within 2 weeks prior to apheresis; 10mg/ day of prednisone for systemic steroids, except inhaled steroids;
  • Received anti-PD-1 / PD-L1 monoclonal antibody treatment within 4 weeks before apheresis; Received chemotherapy, targeted therapy, or other investigational agents within 2 weeks of preapheresis or at least 5 drug half-lives (whichever is shorter);
  • There is an active or uncontrolled infection that requires systemic treatment within 1 week prior to screening;
  • Subjects with intestinal obstruction, active gastrointestinal bleeding, history of massive gastrointestinal bleeding within 3 months, severe gastroduodenal ulcer, severe ulcerative colitis and other severe intestinal inflammation;
  • History of severe respiratory disease;
  • There are a large number of serous effusions that cannot be controlled by treatment (such as pleural effusions, abdominal effusions and pericardial effusions);
  • Have any of the following heart conditions:
  • New York Heart Association (NYHA) Stage III or IV congestive heart failure;
  • Had myocardial infarction or coronary artery bypass grafting (CABG) within ≤6 months before enrollment;
  • A history of clinically significant ventricular arrhythmia, or unexplained syncope (other than those caused by vasovagal or dehydration);
  • History of severe non-ischemic cardiomyopathy.
  • Known to have active or uncontrolled autoimmune diseases that require treatment with immunosuppressants, including biologics, such as Crohns disease, rheumatoid arthritis, systemic lupus erythematosus, systemic vasculitis, etc.;
  • Hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) positive and peripheral blood hepatitis B virus (HBV) DNA test greater than the normal range; Hepatitis C virus (HCV) antibody positive and peripheral blood hepatitis C virus (HCV) RNA detection greater than the normal range; Human immunodeficiency virus (HIV) antibody positive; Syphilis positive; Cytomegalovirus (CMV) DNA test positive;
  • At the time of screening, subjects had venous embolism events (e.g., pulmonary embolism) and required anticoagulant therapy;
  • Other uncured malignant tumors within the past 3 years or at the same time, except cervical carcinoma in situ and skin basal cell carcinoma;
  • Women who are pregnant or nursing, and male or female subjects who plan to have a child within 1 year after receiving C-13-60 cell transfusion;
  • Circumstances deemed unsuitable for participation in the study by other researchers.

Trial locations and contacts

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

Ying Yuan, M.D contact

13858193601

yuanying1999@tom.com

Weijia Fang, M.D contact

13758211655

weijiafang@zju.edu.cn

China2 sites, 2 recruiting

  • The First Affiliated Hospital of Zhejiang University School of Medicine

    Hangzhou, Zhejiang

    Weijia Fang, MD, 13758211655, weijiafang@zju.edu.cn

    Recruiting

  • The Second Affiliated Hospital of Zhejiang University School of Medicine

    Hangzhou, Zhejiang

    Ying Y, MD, 13858193601, yuanying1999@tom.com

    Recruiting

Other trials in China

About this study

Official title: Phase I Clinical Study of Chimeric Antigen Receptor T Cells (C-13-60) in the Treatment of Carcinoembryonic Antigen (CEA) Positive Advanced Malignant Solid Tumors

This is a single-arm, open, dose-increasing phase I clinical study to explore the safety, tolerability and pharmacokinetic characteristics of the drug C-13-60 cells, and preliminarily observe the efficacy of the drug in CEA positive late malignant solid tumors, and explore the applicable dose regimen for phase II clinical trials.

Read the detailed description

According to the sequence principle of low and high dose of C-13-60 cell reinfusion, the dose escalation experiment was carried out successively. Three subjects in each dose group were enrolled first. If DLT did not appear, the decision of whether to enter the next dose group was made according to Safety review committee (SRC) resolution. If there was one case of DLT, then 3 subjects were enrolled one by one, and DLT observation was completed for 28 days after each subject's infusion. If no DLT was found, the next infusion was continued. If DLT was found, the subsequent enrollment of the dose group was terminated, and the experiment was terminated or the dose was reduced according to the dose increasing principle. If > 1 case of DLT occurs, the trial is terminated or the dose is reduced.According to the evaluation of the researchers, the subjects who met the conditions of antisepsis received antisepsis chemotherapy 1-5 to -3 days before the transfusion of C-13-60 cells；

Being tested
CEA-targeted CAR-T cells
Keywords
CAR-T, CEA, CEA-positive advanced/metastatic solid tumors
Medical subject headings
Colorectal Neoplasms, Esophageal Neoplasms, Stomach Neoplasms, Pancreatic Neoplasms, Carcinoma, Non-Small-Cell Lung, Breast Neoplasms, Bile Duct Neoplasms

What participants receive

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

  • CEA-targeted CAR-T cellsBiological

    Administration method: intravenous infusion； Subjects will receive conditioning therapy by Fludarabine and Cyclophosphamide before cell infusion.

Study groups in NCT06043466
Study groupRoleWhat they receive
Intravenous of CEA-targeted CAR-TExperimentalInfusion of CEA-targeted CAR-T cells by dose of 2-10x10^6 cells/kg
Receives: Biological: CEA-targeted CAR-T cells

What is being measured

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

  1. To determine the dose range and DLT of C-13-60 cells for CEA positive advanced malignant solid tumors [Safety and Tolerability]

    The incidence of adverse events (TEAE) after treatment; Incidence of treatment-related adverse events; Adverse evens of Special Interest (AESI);

    Measured: 1 month

  2. To obtain the maximum tolerable dose of C-13-60 cells [Safety and Tolerability]

    Incidence and number of dose-limiting toxicity (DLT) cases，Dose-limiting toxicity after CAR-T cell infusion

    Measured: 1month

Secondary outcomes (5)

  1. Disease control rate (DCR) within 3 months after infusion of C-13-60 cell preparation[Effectiveness]

    Disease control rate: The proportion of subjects who achieved complete response (CR), partial response (PR), stable disease (SD) after CAR-T infusion accounted for all treated subjects (Assessed based on RECIST criteria)，the minimum value is 0%，maximum value is 100%, and higher scores mean a better outcome.

    Measured: 3 months

  2. Area under the curve (AUCS) of C-13-60 cell [Cell dynamics]

    AUCS is defined as the area under the curve in 90 days

    Measured: 3 months

  3. Maximum concentration (CMAX) of C-13-60 cell [Cell dynamics]

    CMAX is defined as the highest concentration of CEA CAR-T cells expanded in peripheral blood

    Measured: 3 months

  4. Maximum time (TMAX) of C-13-60 cell[Cell dynamics]

    TMAX is defined as the time to reach the highest concentration

    Measured: 3 months

  5. The content of CEA in peripheral blood after infusion of C-13-60 cell [Cell dynamics]

    The concentration of serum CEA in peripheral blood was detected by ELISA at the visit points specified in the research protocol

    Measured: 3 months

Timeline

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

  1. First posted21 Sep 2023
  2. Study start11 Aug 2023
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 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
Sequential
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06043466
Sponsor's protocol ID
PB06
Status last verified
Sep 2023
First submitted
5 Sep 2023
Last updated
21 Sep 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing CEA-targeted CAR-T cells in people with Colorectal Cancer and Esophagus Cancer, run by Chongqing Precision Biotech Co., Ltd at 2 sites 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 25 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: looking for participants now, as of the sponsor's last update on 21 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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 Ying Yuan, M.D (13858193601, yuanying1999@tom.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To determine the dose range and DLT of C-13-60 cells for CEA positive advanced malignant solid tumors [Safety and Tolerability] (time frame: 1 month). 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 NCT06043466.

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 21 Sep 2023.

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