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Refractory Metastatic Colorectal CancerEarly Phase 1NCT05248048

NKG2D CAR-T Cells to Treat Patients With Previously Treated Liver Metastatic Colorectal Cancer

A Early Phase 1 study testing CAR-T infusion in people with Refractory Metastatic Colorectal Cancer, run by The Third Affiliated Hospital of Guangzhou Medical University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Evaluate the clinical safety and feasibility of NKG2D CAR-T administrated by hepatic artery transfusion for patients with previously treated liver metastatic colorectal cancer. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Refractory Metastatic Colorectal Cancer
What is being tested?
CAR-T infusion
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
9 participants
Where
1 siteChina
Study dates
13 Sep 2021to Oct 2022
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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Prior to performing any study protocol-related procedures other than routine care, a voluntarily signed and dated subject informed Consent Form (ICF) must be obtained in accordance with regulatory and institutional guidelines.
  • Aged 18-75 years.
  • There is definite histological evidence of adenocarcinoma of the colon or rectum.
  • The Eastern Cooperative Oncology Group (ECOG) performance Status (PS) score was 0-1 (see Appendix 1).
  • Liver metastasis was confirmed by PET-CT, CT, MR, and/or intraoperative exploration (histological diagnosis is not required).
  • According to the response evaluation criteria in solid Tumors (RECIST) (Version 1.1), patients have at least one target lesion with a measurable diameter line (CT scan of tumor lesion length >= 10 mm, The short diameter of CT scan of lymph node lesions >= 15 mm, and the scanning layer thickness is no more than 5 mm).
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  • Failure of treatment after previous standard chemotherapy for metastatic colorectal cancer (including disease progression and unacceptable adverse reactions):
  • (1)Chemotherapy regimens must include fluorouracil (5-fluorouracil/capecitabine /S-1), oxaliplatin and irinotecan (2)Patients receiving oxaliplatin in adjuvant therapy should develop disease progression during adjuvant therapy or within 6 months after completion of adjuvant therapy; (3)patients may have previously received bevacizumab and/or cetuximab and/or rigfinil and/or furoquitinib.
  • 8. The primary tumor of the colon or rectum has been surgically removed, or the liver metastases are considered to be irretrievable after the evaluation of a multidisciplinary colorectal cancer team consisting of at least two gastrointestinal surgeons, one hepatobiliary surgeon, one oncologist, one interventional surgeon, and one radiologist.
  • 9. The following laboratory test values obtained during the root screening period (reaching the standard and stable before participating in the study) have appropriate organ functions: Neutrophil count >= 1.5 x 109/L, platelet count >= 75 x 10^9/L, serum total bilirubin <= upper normal limits UNL), aspartate aminotransferase <= 2 x UNL, alanine aminotransferase <= 2 x UNL, serum creatinine <= 1.5 x UNL.
  • 10. Negative urine or serum pregnancy tests in women of reproductive age within 7 days prior to treatment.

Who cannot join

  • The presence or co-existence of other active malignancies (other than those that have been curable for more than 5 years and have received curative treatment or carcinoma in situ that can be cured with adequate treatment).
  • Subjects have central nervous system metastasis or previous brain metastases.
  • Had received hepatic arterial infusion chemotherapy, hepatic arterial embolization chemotherapy or hepatic radiotherapy within 3 months.
  • Received liver surgery (except biopsy for liver metastasis) and liver interventional ablation within the previous 3 months.
  • CT angiography showed severe arterial embolism or hepatic arterial variation.
  • Partial prothrombin time (APTT) or prothrombin time (PT) exceeded 1.5 x ULN (based on the normal value in the clinical trial research center), or patients with evidence or history of bleeding tendency within 2 months prior to enrollment, regardless of severity.
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  • Active infection less than 7 days after completion of systemic antibiotic therapy.
  • Major surgery or severe trauma, such as laparotomy, thoracotomy, laparoscopic viscerectomy, etc. within 4 weeks prior to enrollment (surgical incisions should be completely healed before randomization).
  • Active coronary artery disease, severe/unstable angina or newly diagnosed angina or myocardial infarction within 12 months prior to enrollment.
  • Thrombosis or embolism events, such as cerebrovascular accident (including transient ischemic attack), pulmonary embolism, and deep vein thrombosis, occurred within 12 months prior to enrollment.
  • The New York Heart Association (NYHA) has grade II congestive Heart failure or higher (see Appendix 2).
  • 12. Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS), active hepatitis (hepatitis B, defined as HBV-DNA >= 500 IU/ mL; Hepatitis C, defined as hcV-RNA higher than the lower limit of the assay) or co-infection with hepatitis B and c.
  • 13. Presence of any active, known or suspected autoimmune disease. Subjects who are in a stable state and do not require systemic immunosuppressive therapy, such as type I diabetes, hypothyroidism requiring only hormone replacement therapy, and skin conditions that do not require systemic therapy (e.g., vitiligo, psoriasis, and hair loss) are allowed to be enrolled.
  • 14. Presence of interstitial lung disease, non-infectious pneumonia or uncontrolled systemic disease (e.g., diabetes, hypertension, pulmonary fibrosis and acute pneumonia).
  • 15. Common Terminology Criteria for Adverse Events (CTCAE) (version 5.0) grade 2 or above toxicity (except anaemia, hair loss, skin pigmentation) arising from any prior treatment that has not subsided.
  • 16. Programmed death-1 within 3 months Pd-1) or its ligand (PD-L1) antibody, anti-cytotoxic T-lymphocyte associated protein 4 (CTLA-4) antibody, or other drugs/antibodies that act on T cell co-stimulation or checkpoint pathways.
  • 17. Positive pregnancy test before first use in women who are pregnant or breast-feeding or who are at risk of pregnancy.
  • 18. The investigator considers that the subject has any clinical or laboratory abnormalities or compliance issues that make it inappropriate to participate in this clinical study.
  • 19. There are serious psychological or mental abnormalities. 20. Participated in clinical trials of other drugs within 4 weeks.

Trial locations and contacts

1 site in 1 country.

Xuehu Xu, MD contact

13609020099 ext. 0086

maxtiger@126.com

Nanqi Huang contact

13560316181

China1 site, 1 recruiting

  • The Third Affiliated Hospital of Guangzhou Medical University

    Guangzhou, Guangdong

    Recruiting

Other trials in China

About this study

Official title: Hepatic Artery Transfusion of NKG2D CAR-T Cells to Treat Patients With Previously Treated Liver Metastatic Colorectal Cancer: a Prospective, Multicenter Clinical Trial

Evaluate the clinical safety and feasibility of NKG2D CAR-T administrated by hepatic artery transfusion for patients with previously treated liver metastatic colorectal cancer.

Read the detailed description

Evaluate the clinical safety and feasibility of NKG2D CAR-T administrated by hepatic artery transfusion for patients with previously treated liver metastatic colorectal cancer. Evaluate the maximum tolerated dose (MTD), dose limiting toxicities (DLT), and toxicity spectrum of NKG2D CAR-T treatment administrated by hepatic artery transfusion. Secondary Objectives: Evaluate the efficacy of NKG2D CAR-T administrated by hepatic artery transfusion for patients with previously treated liver metastatic colorectal cancer, including PSF, DCR, SD >= 8 weeks, ORR, OS, and DOR.

Being tested
CAR-T infusion
Keywords
Refractory Metastatic Colorectal Cancer, NKG2D, CAR-NK
Medical subject headings
Colorectal Neoplasms

What participants receive

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

  • CAR-T infusionBiological

    Also called Natural killer group 2 member D (NKG2D) ligand-targeting chimeric antigen receptor (CAR) natural killer (NK) cells

    NKG2D CAR-NK Cell Therapy in Patients With Refractory Metastatic Colorectal Cancer

Study groups in NCT05248048
Study groupRoleWhat they receive
NKG2D CAR-NKExperimentalCAR-T infusion
Receives: Biological: CAR-T infusion

What is being measured

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

  1. Dose-Limiting Toxicity#DLT#

    Safety

    Measured: 28 days

  2. Maximal Tolerable Dose#MTD#

    tolerability evaluation

    Measured: 28 days

Secondary outcomes (2)

  1. Antitumor efficacy-Objective response rate (ORR)

    The number of cases in which tumor size is reduced to partial response (PR) or complete response (CR) / the total number of evaluable cases (%).

    Measured: 52 weeks

  2. Antitumor efficacy-Overall survival (OS)

    The period from the first study treatment to any cause of death

    Measured: 52 weeks

Timeline

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

  1. First posted21 Feb 2022
  2. Study start13 Sep 2021
  3. Primary completionOct 2022 (estimated)
  4. Study completionOct 2022 (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
Early Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential
Masking
None (open label)
Enrolment
9 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05248048
Sponsor's protocol ID
CART-002
Status last verified
Feb 2022
First submitted
8 Feb 2022
Last updated
21 Feb 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing CAR-T infusion in people with Refractory Metastatic Colorectal Cancer, run by The Third Affiliated Hospital of Guangzhou Medical 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 11 inclusion and 19 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 21 Feb 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 Xuehu Xu, MD (13609020099 ext. 0086, maxtiger@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). 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 NCT05248048.

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 Feb 2022.

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