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Refractory Metastatic Colorectal CancerPhase 1NCT05213195

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

A Phase 1 study testing NKG2D CAR-NK in people with Refractory Metastatic Colorectal Cancer, run by Zhejiang 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 The sponsor has not verified this record for over two years, so it may be out of date.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

NKG2D CAR-NK Cell Therapy in Patients With Refractory Metastatic Colorectal Cancer Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Refractory Metastatic Colorectal Cancer
What is being tested?
NKG2D CAR-NK
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
38 participants
Where
1 siteChina
Study dates
10 Dec 2021to 30 Jun 2025
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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Aged between 18 and 70 years (including boundary values), both male and female.
  • Patients with advanced colorectal cancer with abdominal metastasis who had previously failed standard therapy and no other feasible and effective treatment was available.
  • The expected survival period of the subject is ≥12 weeks.
  • Subjects should have at least one target lesion that can be assessed stably by CT or MRI according to RECIST V.1.1.
  • The target lesions had measurable diameter lines (tumor lesions with CT scan length ≥10 mm, lymph node lesions with CT scan short diameter ≥10 mm 15 mm, scanning layer thickness is no more than 5 mm). Or by laparoscopy, at least one of them had PCI scores Accurate, assessable target lesions.
  • 5. ECOG physical status score is 0 ~ 1.
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  • 6. Subject has adequate organ and bone marrow function. Laboratory screening must meet the following criteria for all laboratory tests Results should be within the stable range described below and without continuous supportive treatment.
  • Blood test: WBC≥ 1.5×109/L; Platelet count PLT ≥60×109/L; Hemoglobin content Hb 8.0 g/dL or higher; Lymphocyte LYM≥0.4×109/L;
  • Blood biochemistry: serum creatinine ≤1.5 ×ULN, if serum creatinine > 1.5 ×ULN, creatinine clearance rate > 50mL/min (calculated according to the Cockcroft-Gault formula); Serum total bilirubin ≤1.5×ULN, ALT≤2 ×ULN, AST≤ 2 ×ULN (liver metastasis or liver cancer patients) ALT≤5 x ULN, AST≤5 x ULN).
  • Amylase and lipase ≤ 1.5 × ULN;
  • Routine urine examination: urinary protein < 2+.
  • 7. Left ventricular ejection fraction (LVEF) > 45% by color doppler echocardiography within one month
  • 8. Fertility status: Female patients of reproductive age or male patients with sexual partners of female patients of reproductive age are willing to sign informed consent,Use effective contraception from the beginning to 6 months after the last cell infusion (women of childbearing age include premenopausal women and postmenopausal women)
  • Women within 2 years).
  • 9. Subject must sign and date written informed consent.
  • 10. Subjects must be willing and able to comply with scheduled treatment regimens, laboratory tests, follow-up visits, and other study requirements

Who cannot join

  • Pregnant and lactating women.
  • Known history of human immunodeficiency virus (HIV) infection; Acute or chronic active hepatitis B (HBsAg positive);
  • Acute or chronic active hepatitis C (positive for HCV antibody). Syphilis antibody positive; Epstein-barr virus DNA quantification
  • 500 copies; Cytomegalovirus (CMV) infection (IgM positive).
  • 3. Severe infection that is in the active stage or clinically poorly controlled.
  • 4. Existing heart disease requiring treatment or hypertension determined to be poorly controlled by the investigator (defined as standardized blood pressure reduction)
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  • Systolic blood pressure ≥140 mmHg and/or diastolic blood pressure > 90 mmHg after treatment).
  • 5. Presence of any of the following cardiac clinical symptoms or diseases:
  • Unstable angina pectoris;
  • Myocardial infarction occurred within 1 year;
  • Resting state ecg QTc > 450ms(male) or QTc > 470ms (female);
  • Abnormalities of clinical significance (such as heart rate, conduction, morphological characteristics, etc.) detected by resting ecg examination
  • Complete left bundle branch block or grade 3 heart block or grade 2 heart block or PR interval >
  • 250 ms;
  • There are factors that increase the risk of prolonged QTc and abnormal heart rate, such as heart failure, hypokalemia, and congenital long QT
  • Family history of long QT syndrome or sudden unexplained death of a direct family member under 40 years of age, or prolonged period of time
  • Phase iii concomitant medication.
  • 6. Abnormal coagulation function (INR > 1.5× ULN), bleeding tendency or receiving thrombolytic or conventional anticoagulant therapy (e.g
  • Warfarin or heparin) in patients requiring long-term antiplatelet therapy (aspirin > 300mg/day; Clopidogrel,
  • Dose > 75mg/day).
  • 7. Subjects requiring systemic treatment with corticosteroids or other immunosuppressive agents during the treatment period.
  • 8. Blood oxygen saturation ≤95% (pulse oxygen test) before treatment.
  • 9. Received systemic steroids equivalent to > 15mg/ day of prednisone, excluding inhaled steroids, within 4 weeks prior to treatment.
  • 10. New arrhythmias, including but not limited to arrhythmias that could not be controlled by drugs, occurred in subjects prior to pretreatment with clear shower
  • Often, low blood pressure requiring compression, bacterial, fungal, or viral infections requiring intravenous antibiotics. Use the test
  • Subjects who received antibiotics to prevent infection were judged by the investigator to be eligible for further study.
  • 11. Known past or present hepatic encephalopathy requiring treatment; Patients who currently have or have a history of central nervous system disorders, such as epilepsy
  • Seizures, cerebral ischemia/hemorrhage, dementia, cerebellar disease or any autoimmune disease associated with central nervous system involvement
  • Disease; Central nervous system metastasis or meningeal metastasis with clinical symptoms, or other evidence of the patient's central nervous system
  • General or meningeal metastases were not controlled and were deemed unsuitable for inclusion by the investigator.
  • 12. Patients with prior or concurrent malignancy, except for: Adequately treated basal cell or squamous cell carcinoma (adequate wound healing required prior to enrollment); Carcinoma in situ of cervical or breast cancer, treated curatively, with no signs of recurrence for at least 3 years prior to the study; The primary malignancy has been completely resected with complete remission for ≥5 years.
  • 13. Prior NK or CAR-NK immunotherapy.
  • 14. Received anti-PD-1 /PD-L1 monoclonal antibody treatment within 4 weeks prior to treatment.
  • 15. Subjects who have previously received other gene therapies.
  • 16. Subjects with severe mental disorders.
  • 17. Participated in other clinical studies in the past 1 month.
  • 18. The investigator assessed subjects' inability or unwillingness to comply with study protocol requirements.
  • 19. Subjects withdraw from the study for various reasons and cannot participate in the study again.

Trial locations and contacts

1 site in 1 country.

Weijia Fang, MD contact

13758211655

weijiafang@zju.edu.cn

zheng hong contact

18050102049

China1 site, 1 recruiting

  • The First Affiliated Hospital, Zhejiang University

    Hangzhou, Zhejiang

    Weijia Fang, MD

    Recruiting

Other trials in China

About this study

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

Read the detailed description

NKG2D CAR-NK Cell Therapy in Patients With Refractory Metastatic Colorectal Cancer Will be intra-peritoneal infusion in Stage 1 and combined with intra-venous infusion in Stage 2. While in Stage 3, the investigators will expand to other cancer type at certain situation.

Being tested
NKG2D CAR-NK
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.

  • NKG2D CAR-NKDrug

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

    NKG2D CAR-NK infusion through peritoneal in stage 1 and later combined with intra venous in stage 2.

Study groups in NCT05213195
Study groupRoleWhat they receive
NKG2D CAR-NKExperimentalNKG2D CAR-NK Cell Therapy in Patients With Refractory Metastatic Colorectal Cancer Will be intra-peritoneal infusion in Stage 1 and combined with intra-venous infusion in Stage 2. While in Stage 3, the investigators will expand to other cancer type at certain situation
Receives: Drug: NKG2D CAR-NK

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 (3)

  1. Antitumor efficacy-Duration of response (DOR)

    The period from the first evaluation of complete response ( CR) or partial response (PR) to the first evaluation of progressive disease (PD)or death of any cause.

    Measured: 52 weeks

  2. 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

  3. 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 posted28 Jan 2022
  2. Study start10 Dec 2021
  3. Primary completion31 Dec 2024 (estimated)
  4. Study completion30 Jun 2025 (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
38 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05213195
Sponsor's protocol ID
CARNK-002
Status last verified
Feb 2024
First submitted
25 Dec 2021
Last updated
12 Feb 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing NKG2D CAR-NK in people with Refractory Metastatic Colorectal Cancer, run by Zhejiang 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 16 inclusion and 38 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 12 Feb 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 Weijia Fang, MD (13758211655, weijiafang@zju.edu.cn), 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 NCT05213195.

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 12 Feb 2024.

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