MelanomaPhase 1/2NCT05117138
Safety and Efficacy of Chimeric Antigen Receptor T Lymphocytes for Patients With Intermediate and Advanced Tumors
A Phase 1/2 study testing AMT-116 CAR-T cells and AMT-253 CAR-T cells in people with Melanoma and Non-small Cell Lung Cancer, run by Beijing Immunochina Medical Science & Technology Co., Ltd. at 1 site in China.
Trial summary
This was a single arm, open-label, single center, cohort study to determine the efficacy and safety of AMT-116 CAR-T cells in patients with moderate or far advanced non-small cell lung carcinoma (NSCLC) and squamous cell cancer of the head and neck (HNSCC)，AMT-253 CAR-T cells in patients with moderate or far advanced… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Melanoma, Non-small Cell Lung Cancer, Head and Neck Squamous Cell Carcinoma
- What is being tested?
- AMT-116 CAR-T cells and AMT-253 CAR-T cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2022to 1 Mar 2024
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-70 years old, both men and women, and the survival period is more than 6 months.
- At least one assessable focus, failure of previous multi-line treatment or stable condition after treatment.
- Patients with melanoma confirmed by histopathology, patients with non-small cell lung cancer(squamous carcinoma) and head and neck squamous cell carcinoma.
- The surgically removed pathological tissue can be used for immunohistochemical detection of target protein (paraffin section should be within 5 years), and the positive expression of target protein in line with pathological diagnosis (immunohistochemical staining + + or + + +).
- Sufficient venous access for blood sampling and venous blood sampling, no contraindications for lymphocyte collection.
- Routine blood examination: white blood cell count (WBC) ≥ 3 × 10^9 / L, lymphocyte count (ly) ≥ 0.8 × 10^9 / L, hemoglobin (HB) ≥ 90g / L, platelet (PLT) ≥ 80 × 10^9/L.
- Liver and kidney function: alanine aminotransferase and aspartate aminotransferase < 3 ULN, total bilirubin (TBIL) < 1.5 ULN, serum creatinine (SCR) < 2 ULN.
- The subjects voluntarily joined the study, signed the informed consent form, had good compliance and cooperated with the follow-up.
Who cannot join
- Active hepatitis B or hepatitis C virus, HIV infection, or other unhealed active infections.
- Patients with second tumor.
- Patients previously treated with car-t cells.
- Requiring long-term use of immunosuppressants for any reason.
- Any serious and uncontrolled systemic autoimmune disease or any unstable systemic disease, including but not limited to systemic lupus erythematosus, rheumatoid arthritis, ulcerative colitis, Crohn's disease and temporal arteritis.
- Subjects with severe heart, lung, liver and kidney dysfunction or severe lung diseases.
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- Current systemic use of steroid cells (except for recent or current use of inhaled steroids).
- Pregnant and lactating subjects.
- Allergic to immunotherapy and related cells.
- Subjects with a history of organ transplantation or waiting for organ transplantation.
- After evaluation, the investigator considered that the subjects were unable or unwilling to comply with the requirements of the study protocol.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Zhengzhou University
Beijing, Beijing Municipality, 450052
Yi Zhang, M.D., yizhang@zzu.edu.cn
Yi Zhang, M.D.
About this study
This was a single arm, open-label, single center, cohort study to determine the efficacy and safety of AMT-116 CAR-T cells in patients with moderate or far advanced non-small cell lung carcinoma (NSCLC) and squamous cell cancer of the head and neck (HNSCC)，AMT-253 CAR-T cells in patients with moderate or far advanced melanoma.
- Being tested
- AMT-116 CAR-T cells, AMT-253 CAR-T cells
- Medical subject headings
- Melanoma, Carcinoma, Non-Small-Cell Lung, Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AMT-116 CAR-T cellsBiological
- Classical "3+3" dose escalation will be applied to 9 subjects with moderate or far advanced non-small cell lung carcinoma (NSCLC) enrolled.
- Classical "3+3" dose escalation will be applied to 9 subjects with moderate or far advanced head and neck Squamous Cell Carcinoma (HNSCC) enrolled.
AMT-253 CAR-T cellsBiological
1.The classic "3 + 3" dose escalation will be applied to 9 selected subjects with moderate or far advanced melanoma by intravenous drip.
2.3 ~ 6 patients with intermediate and advanced melanoma will be injected intratumorally at a dose of ≤ 1 × 10^8 cells.
3.3 ~ 6 patients with operable advanced melanoma will be treated with postoperative adjuvant treatment at a dose of ≤ 1 × 10^8 cells ≤ intravenous drip on Day 1 of each 42 days cycle (8 cycle maximum).
| Study group | Role | What they receive |
|---|---|---|
| NSCLC/HNSCC：AMT-116 CAR-T cells | Experimental | Patients with moderate or far advanced non-small cell lung carcinomav or head and neck Squamous Cell Carcinoma. Receives: Biological: AMT-116 CAR-T cells |
| MEL：AMT-253 CAR-T cells | Experimental | Patients with moderate or far advanced melanoma. Receives: Biological: AMT-253 CAR-T cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events
Measured: 24 weeks
Overall Response Rate (ORR)
Measured: 24 weeks
One year recurrence rate
Measured: 24 weeks
Secondary outcomes (2)
Progression-Free Survival(PFS)
Measured: 24 weeks
Relapse Free Survival(RFS)
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2021
- Study start1 Jan 2022 (estimated)
- Primary completion1 Dec 2023 (estimated)
- Study completion1 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelanomaStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 39 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Immunochina Medical Science & Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05117138
- Sponsor's protocol ID
- MHSW016
- Status last verified
- Sep 2021
- First submitted
- 6 Sep 2021
- Last updated
- 11 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Chimeric Antigen Receptor T Lymphocytes for Patients With Intermediate and Advanced Tumors
- ClinicalTrials.gov ID
- NCT05117138
- Acronym / sponsor ID
- MHSW016
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 39 participants (estimated)
- Lead sponsor
- Beijing Immunochina Medical Science & Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Jan 2022 (estimated)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 1 Mar 2024 (estimated)
- First posted
- 11 Nov 2021 (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 was a single arm, open-label, single center, cohort study to determine the efficacy and safety of AMT-116 CAR-T cells in patients with moderate or far advanced non-small cell lung carcinoma (NSCLC) and squamous cell cancer of the head and neck (HNSCC)，AMT-253 CAR-T cells in patients with moderate or far advanced melanoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NSCLC/HNSCC：AMT-116 CAR-T cells | Experimental | Biological: AMT-116 CAR-T cellsPatients with moderate or far advanced non-small cell lung carcinomav or head and neck Squamous Cell Carcinoma. |
| MEL：AMT-253 CAR-T cells | Experimental | Biological: AMT-253 CAR-T cellsPatients with moderate or far advanced melanoma. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age 18-70 years old, both men and women, and the survival period is more than 6 months.
- At least one assessable focus, failure of previous multi-line treatment or stable condition after treatment.
- Patients with melanoma confirmed by histopathology, patients with non-small cell lung cancer(squamous carcinoma) and head and neck squamous cell carcinoma.
- The surgically removed pathological tissue can be used for immunohistochemical detection of target protein (paraffin section should be within 5 years), and the positive expression of target protein in line with pathological diagnosis (immunohistochemical staining + + or + + +).
- Sufficient venous access for blood sampling and venous blood sampling, no contraindications for lymphocyte collection.
Key exclusion criteria (11 listed)
- Active hepatitis B or hepatitis C virus, HIV infection, or other unhealed active infections.
- Patients with second tumor.
- Patients previously treated with car-t cells.
- Requiring long-term use of immunosuppressants for any reason.
- Any serious and uncontrolled systemic autoimmune disease or any unstable systemic disease, including but not limited to systemic lupus erythematosus, rheumatoid arthritis, ulcerative colitis, Crohn's disease and temporal arteritis.
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 |
|---|---|---|
| AMT-116 CAR-T cells1. Classical "3+3" dose escalation will be applied to 9 subjects with moderate or far advanced non-small cell lung carcinoma (NSCLC) enrolled. 2. Classical "3+3" dose escalation will be applied to 9 subjects with moderate or far advanced head and neck Squamous Cell Carcinoma (HNSCC) enrolled. | Biological | NSCLC/HNSCC：AMT-116 CAR-T cells |
| AMT-253 CAR-T cells1.The classic "3 + 3" dose escalation will be applied to 9 selected subjects with moderate or far advanced melanoma by intravenous drip. 2.3 ~ 6 patients with intermediate and advanced melanoma will be injected intratumorally at a dose of ≤ 1 × 10^8 cells. 3.3 ~ 6 patients with operable advanced melanoma will be treated with postoperative adjuvant treatment at a dose of ≤ 1 × 10^8 cells ≤ intravenous drip on Day 1 of each 42 days cycle (8 cycle maximum). | Biological | MEL：AMT-253 CAR-T cells |
Primary outcome
Incidence of adverse events
Time frame: 24 weeks
Overall Response Rate (ORR)
Time frame: 24 weeks
One year recurrence rate
Time frame: 24 weeks
2 secondary outcomes
Progression-Free Survival(PFS)
Time frame: 24 weeks
Relapse Free Survival(RFS)
Time frame: 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Nov 2021.
- Individual participant dataSharing planned: No
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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 Phase 1/2 study testing AMT-116 CAR-T cells and AMT-253 CAR-T cells in people with Melanoma and Non-small Cell Lung Cancer, run by Beijing Immunochina Medical Science & Technology Co., Ltd. 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 8 inclusion and 11 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 11 Nov 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 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 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events (time frame: 24 weeks). 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 11 Nov 2021.