Colon Cancer Stage IVPhase 1/2NCT03329664
Autologous Killer Cell Therapy in Colon Cancer Patients
A Phase 1/2 study testing Cytokine-induced killer cell and Chemotherapy AND/OR Radiation Therapy in people with Colon Cancer Stage IV, run by Sabz Biomedicals at 1 site in Iran.
Trial summary
This study aims to evaluate the safety and efficacy of activated and expanded autologous cytokine-killer cells in controlling disease recurrence in colon cancer patients with liver metastasis. 20 patients with confirmed stage IV colon carcinoma with metastasis will be assigned into two groups. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Colon Cancer Stage IV
- What is being tested?
- Cytokine-induced killer cell and Chemotherapy AND/OR Radiation Therapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteIran
- Study dates
- 9 Feb 2020to Jan 2022
- Phase
- Phase 1/2
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with histologically confirmed colorectal cancer at stage IV
- ECOG performance status 0-2
- Adequate cardiac/renal/hepatic function
- Adequate bone marrow function (blood cell count)
Who cannot join
- Patients that have received prior chemotherapy or immune cell therapy
- Patients that have previously participated in another clinical trial
- History of positive test result for HIV, HBV, HCV, HTLV-1, syphilis
- Presence of Active infections
- Patients with immunodeficiencies, autoimmunities, or severe allergies
- Receiving immunosuppressive regimens
Trial locations and contacts
1 site in 1 country.
Iran1 site, 1 recruiting
- Recruiting
Gene Therapy Research Center, Digestive Disease Research Institute, Tehran University of Medical Sciences
Tehran
Naser Ahmadbeigi, Phd, 09129155066, ahmadbeigi28@gmail.com
About this study
Official title: Safety and Efficacy of ex Vivo Activated and Expanded Autologous Cytokine-induced Killer Cells for Colon Cancer Patients
This study aims to evaluate the safety and efficacy of activated and expanded autologous cytokine-killer cells in controlling disease recurrence in colon cancer patients with liver metastasis. 20 patients with confirmed stage IV colon carcinoma with metastasis will be assigned into two groups. Patients in both groups will receive the same therapeutic regimen as usual. Patients in one group additionally will be treated with a single infusion of autologous killer cells that had been previously prepared from peripheral blood.
- Conditions
- Colon Cancer Stage IV
- Being tested
- Cytokine-induced killer cell, Chemotherapy AND/OR Radiation Therapy
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cytokine-induced killer cellBiological
Also called CIK
Immune-cell therapy with CIK cells
Chemotherapy AND/OR Radiation TherapyOther
Routine treatments for colon cancer patients according to their stage
| Study group | Role | What they receive |
|---|---|---|
| CIK Intervention plus routine treatment | Experimental | Patients who receive their routine treatment (chemotherapy, radiation therapy) + Cytokine-induced killer cell infusion Receives: Biological: Cytokine-induced killer cell; Other: Chemotherapy AND/OR Radiation Therapy |
| Control | Active comparator | Patients who receive routine treatments only (chemotherapy, radiation therapy) Receives: Other: Chemotherapy AND/OR Radiation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of administering CIK cells plus chemotherapy
Patients will be continually assessed for unexpected adverse events or unexpected early mortality 30 days post infusion
Measured: one month post infusion
Progression-free Survival (PFS)
The time from treatment initiation day to first documented progressive disease or death due to disease.
Measured: 2 years
Time to progression (TTP)
the time from randomization until cancer progression, not including death.
Measured: 2 years
Secondary outcomes (2)
Overall survival (OS)
The length of time that the patients are still alive at a defined period of time after treatment
Measured: 2 years
Patient quality of life
Quality of patients enrolling in the study assessed using EORTC-CR29 questionnaire
Measured: each 3 months for 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2017
- Study start9 Feb 2020
- Primary completionSep 2021 (estimated)
- Study completionJan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon Cancer Stage IVStudies 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 1/2
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sabz Biomedicals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Ministry of Health and Medical Education, Digestive Diseases Research Institute, Tehran University of Medical Sciences, Iran
- Responsible party
- Principal investigator, Naser Ahmadbeigi, Tehran University of Medical Sciences
- Investigators
- Naser Ahmadbeigi, Ph.D, Principal investigator, Cell-based Therapies Research Center, Digestive Disease Research Institute, Tehran University of Medical Sciences, Tehran, Iran
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03329664
- Sponsor's protocol ID
- Autologous Killer cell therapy
- Status last verified
- Mar 2021
- First submitted
- 30 Oct 2017
- Last updated
- 15 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of ex Vivo Activated and Expanded Autologous Cytokine-induced Killer Cells for Colon Cancer Patients
- ClinicalTrials.gov ID
- NCT03329664
- Acronym / sponsor ID
- Autologous Killer cell therapy
- Conditions
- Colon Cancer Stage IV
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Sabz BiomedicalsIndustry (pharma, biotech, devices)
- Collaborators
- Ministry of Health and Medical Education, Digestive Diseases Research Institute, Tehran University of Medical Sciences, Iran
- Study start
- 9 Feb 2020 (actual)
- Primary completion
- Sep 2021 (estimated)
- Study completion
- Jan 2022 (estimated)
- First posted
- 6 Nov 2017 (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.
This study aims to evaluate the safety and efficacy of activated and expanded autologous cytokine-killer cells in controlling disease recurrence in colon cancer patients with liver metastasis. 20 patients with confirmed stage IV colon carcinoma with metastasis will be assigned into two groups. Patients in both groups will receive the same therapeutic regimen as usual. Patients in one group additionally will be treated with a single infusion of autologous killer cells that had been previously prepared from peripheral blood.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CIK Intervention plus routine treatment | Experimental | Biological: Cytokine-induced killer cell, Other: Chemotherapy AND/OR Radiation TherapyPatients who receive their routine treatment (chemotherapy, radiation therapy) + Cytokine-induced killer cell infusion |
| Control | Active comparator | Other: Chemotherapy AND/OR Radiation TherapyPatients who receive routine treatments only (chemotherapy, radiation therapy) |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with histologically confirmed colorectal cancer at stage IV
- ECOG performance status 0-2
- Adequate cardiac/renal/hepatic function
- Adequate bone marrow function (blood cell count)
Key exclusion criteria (6 listed)
- Patients that have received prior chemotherapy or immune cell therapy
- Patients that have previously participated in another clinical trial
- History of positive test result for HIV, HBV, HCV, HTLV-1, syphilis
- Presence of Active infections
- Patients with immunodeficiencies, autoimmunities, or severe allergies
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 |
|---|---|---|
| Cytokine-induced killer cellAlso: CIKImmune-cell therapy with CIK cells | Biological | CIK Intervention plus routine treatment |
| Chemotherapy AND/OR Radiation TherapyRoutine treatments for colon cancer patients according to their stage | Other | CIK Intervention plus routine treatment, Control |
Primary outcome
Safety of administering CIK cells plus chemotherapy
Time frame: one month post infusion
Patients will be continually assessed for unexpected adverse events or unexpected early mortality 30 days post infusion
Progression-free Survival (PFS)
Time frame: 2 years
The time from treatment initiation day to first documented progressive disease or death due to disease.
Time to progression (TTP)
Time frame: 2 years
the time from randomization until cancer progression, not including death.
2 secondary outcomes
Overall survival (OS)
Time frame: 2 years
Patient quality of life
Time frame: each 3 months for 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2021.
Related trials for Colon Cancer Stage IV
Not yet recruitingPhase 2
SAMe in Prevention of Oxaliplatin-associated Liver Injury
Colorectal Cancer, Liver Metastases
RecruitingPhase 3
Pressurized Intraperitoneal Aerosolized Chemotherapy With Mitomycin for the Treatment of Unresectable Appendix or Colorectal Cancer With Peritoneal Metastases, The IMPACT Trial
Metastatic Appendix Carcinoma, Metastatic Colorectal Carcinoma
Not yet recruitingPhase 2
Cemiplimab With Fianlimab for Resectable Non-Metastatic Colon Cancer
Colon Cancer
RecruitingObservational study
Collecting Blood Samples From Patients With and Without Cancer to Evaluate Tests for Early Cancer Detection
Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia
Active, not recruitingPhase 2
CBX-12 for the Treatment of Metastatic Chemotherapy-Refractory Microsatellite Stable Colorectal Cancer
Metastatic Mismatch Repair Proficient Colorectal Carcinoma, Refractory Mismatch Repair Proficient Colorectal Carcinoma
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.
Naser Ahmadbeigi, Ph.D principal investigator
Cell-based Therapies Research Center, Digestive Disease Research Institute, Tehran University of Medical Sciences, Tehran, Iran
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Cytokine-induced killer cell and Chemotherapy AND/OR Radiation Therapy in people with Colon Cancer Stage IV, run by Sabz Biomedicals at 1 site in Iran.
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 4 inclusion and 6 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 15 Mar 2021. 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 Iran. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Naser Ahmadbeigi, Ph.D (+9821-82415103, n-ahmadbeigi@sina.tums.ac.ir), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of administering CIK cells plus chemotherapy (time frame: one month post 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 15 Mar 2021.