Safety and Efficacy of Cellular Drugs, Objective Response Rate of Subjects, EtcEarly Phase 1NCT06572956
Clinical Study on the Safety and Efficacy of CAR-T/CAR-NK Cells in the Treatment of Recurrent Refractory or Unresectable Solid Tumors
A Early Phase 1 study testing CAR-T/CAR-NK cell injection in people with Safety and Efficacy of Cellular Drugs, Objective Response Rate of Subjects, Etc, run by The Second Hospital of Shandong University at 1 site in China.
Trial summary
To investigate the safety and efficacy of CAR-T/CAR-NK cells in patients with recurrent or unresectable solid tumors, including pancreatic cancer, prostate cancer, breast cancer, glioma, etc Read more about this study
- Who is it for?
- Ages 15 to 80 years
- Conditions the study is for
- Safety and Efficacy of Cellular Drugs, Objective Response Rate of Subjects, Etc
- What is being tested?
- CAR-T/CAR-NK cell injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 21 Mar 2024to 1 Mar 2025
- 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 15 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Recurrent or unresectable solid tumors (including pancreatic, prostate, breast, glioma, etc.).
- Age over 15 and under 80.
- KPS≥50 or ECOG score ≤2 and expected survival greater than 3 months.
- No systemic therapy (except systemic immune checkpoint suppression or activation therapy) for at least 2 weeks or at least 5 drug half-lives (whichever is shorter) prior to apheresis.
- The absolute number of neutrophils was > 1.0x109 /L.
- Absolute number of platelets > 50x109 /L.
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- Absolute number of lymphocytes ≥ 0.2x109 /L.
- ALT/AST < 3 times normal value.
- Total bilirubin < 1.5mg/dl.
- Creatinine < 2.5mg/dl, or creatinine clearance ≥60 mL/min/1.73 m2.
- The ejection fraction of heart ≥ 45%, echocardiography examination centerless fluid, electrocardiogram normal
- Blood oxygen saturation ≥92% under normal environment.
- Women of childbearing age who had a negative urine pregnancy test before dosing began and agreed to take effective contraception during the trial until the last follow-up visit.
- Volunteer to participate in this experiment and sign the informed consent.
Who cannot join
- 1) Those who are expected to survive less than 3 months. 2) Patients whose disease progression was so rapid that a complete treatment cycle could not be ensured at the time of enrollment as determined by the investigator.
- 3) Patients with primary tumors other than melanoma skin cancer (unless cured for more than 3 years).
- 4) Patients with infections including fungal, bacterial, viral or other uncontrolled infections or those requiring level 4 isolation.
- 5) HIV, HBV, HCV positive patients. 6) Patients with central nervous system diseases including stroke, epilepsy, dementia or autoimmune central nervous system diseases.
- 7) Myocardial infection, cardiac angiography or stenting, active angina pectoris or other significant clinical symptoms, or cardiogenic asthma or cardiovascular plasma cell infiltration in the 12 months prior to enrollment.
- 8) Those who are receiving anticoagulation therapy or have severe coagulation dysfunction.
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- 9) The drug treatment that the patient is receiving will affect the safety and efficacy study of this project according to the judgment of the investigator.
- 10) Patients with allergy or history of allergy to the biologics used in this project.
- 11) Pregnant or lactating women. 12) Systematic use of systemic or systemic steroid drugs within 2 weeks prior to treatment (except those who have recently or currently used inhaled steroids).
- 13) The efficiency of T cell transduction by replication-deficient lentivirus was less than 30%, or the ability to expand in response to CD3 / CD28 costimulatory signals was insufficient (<5 times).
- 14) Those who have other uncontrolled diseases that the researchers consider unsuitable for enrollment.
- 15) Any situation that the investigator believes may increase the risk to the subject or interfere with the test results.
- 16) Patients who are also participating in other clinical studies.
Trial locations and contacts
1 site in 1 country.
About this study
To investigate the safety and efficacy of CAR-T/CAR-NK cells in patients with recurrent or unresectable solid tumors, including pancreatic cancer, prostate cancer, breast cancer, glioma, etc
Read the detailed description
To investigate the safety and efficacy of CAR-T/CAR-NK cells in patients with recurrent or unresectable solid tumors, including pancreatic cancer, prostate cancer, breast cancer, glioma, etc.
The study was divided into five stages: screening period, single harvest period, pretreatment chemotherapy period, treatment period, observation and follow-up period after treatment.
Subjects were pretreated with FC regimen before transfusion, and the subjects who met the infusion conditions were given CAR-T/CAR-NK cell infusion 1 ~ 2 days after the completion of eluent chemotherapy. The CAR-T/CAR-NK dose is calculated according to the patient's body weight, and the total number of cells transfused is about 1-2x106 /kg. Single intravenous infusion.
The efficacy was evaluated according to the evaluation criteria for solid tumors (RECIST1.1 selection).
- Being tested
- CAR-T/CAR-NK cell injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAR-T/CAR-NK cell injectionBiological
One to two days after completion of eluvial chemotherapy, CAR-T/CAR-NK cells were transfused in subjects assessed by the investigators as eligible for infusion. The CAR-T/CAR-NK dose is calculated according to the patient's body weight, and the total number of cells transfused is about 1-2x106 /kg. Single intravenous infusion.
| Study group | Role | What they receive |
|---|---|---|
| recurrent or unresectable solid tumors | Experimental | One to two days after completion of eluvial chemotherapy, CAR-T/CAR-NK cells were transfused in subjects assessed by the investigators as eligible for infusion. The CAR-T/CAR-NK dose is calculated according to the patient's body weight, and the total number of cells transfused is about 1-2x106 /kg. Single intravenous infusion. Receives: Biological: CAR-T/CAR-NK cell injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR
Proportion of patients with PR or CR.
Measured: 2024.11
PFS
The time from the start of a randomized clinical trial until tumorigenesis (any aspect) progresses or death from any cause.
Measured: 2024.11
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2024
- Study start21 Mar 2024
- Primary completion1 Mar 2025 (estimated)
- Study completion1 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Safety and Efficacy of Cellular Drugs, Objective Response Rate of Subjects, EtcStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Second Hospital of Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06572956
- Sponsor's protocol ID
- 2024 car-t/nk solid tumors
- Status last verified
- Aug 2024
- First submitted
- 13 Aug 2024
- Last updated
- 27 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on the Safety and Efficacy of CAR-T/CAR-NK Cells in the Treatment of Recurrent Refractory or Unresectable Solid Tumors
- ClinicalTrials.gov ID
- NCT06572956
- Acronym / sponsor ID
- 2024 car-t/nk solid tumors
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- The Second Hospital of Shandong UniversityUniversity, hospital or other
- Study start
- 21 Mar 2024 (actual)
- Primary completion
- 1 Mar 2025 (estimated)
- Study completion
- 1 Mar 2025 (estimated)
- First posted
- 27 Aug 2024 (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.
To investigate the safety and efficacy of CAR-T/CAR-NK cells in patients with recurrent or unresectable solid tumors, including pancreatic cancer, prostate cancer, breast cancer, glioma, etc
Detailed description
To investigate the safety and efficacy of CAR-T/CAR-NK cells in patients with recurrent or unresectable solid tumors, including pancreatic cancer, prostate cancer, breast cancer, glioma, etc.
The study was divided into five stages: screening period, single harvest period, pretreatment chemotherapy period, treatment period, observation and follow-up period after treatment.
Subjects were pretreated with FC regimen before transfusion, and the subjects who met the infusion conditions were given CAR-T/CAR-NK cell infusion 1 ~ 2 days after the completion of eluent chemotherapy. The CAR-T/CAR-NK dose is calculated according to the patient's body weight, and the total number of cells transfused is about 1-2x106 /kg. Single intravenous infusion.
The efficacy was evaluated according to the evaluation criteria for solid tumors (RECIST1.1 selection).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| recurrent or unresectable solid tumors | Experimental | Biological: CAR-T/CAR-NK cell injectionOne to two days after completion of eluvial chemotherapy, CAR-T/CAR-NK cells were transfused in subjects assessed by the investigators as eligible for infusion. The CAR-T/CAR-NK dose is calculated according to the patient's body weight, and the total number of cells transfused is about 1-2x106 /kg. Single intravenous infusion. |
Who may qualify
- Ages
- 15 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (14 listed)
- Recurrent or unresectable solid tumors (including pancreatic, prostate, breast, glioma, etc.).
- Age over 15 and under 80.
- KPS≥50 or ECOG score ≤2 and expected survival greater than 3 months.
- No systemic therapy (except systemic immune checkpoint suppression or activation therapy) for at least 2 weeks or at least 5 drug half-lives (whichever is shorter) prior to apheresis.
- The absolute number of neutrophils was > 1.0x109 /L.
Key exclusion criteria (13 listed)
- 1) Those who are expected to survive less than 3 months. 2) Patients whose disease progression was so rapid that a complete treatment cycle could not be ensured at the time of enrollment as determined by the investigator.
- 3) Patients with primary tumors other than melanoma skin cancer (unless cured for more than 3 years).
- 4) Patients with infections including fungal, bacterial, viral or other uncontrolled infections or those requiring level 4 isolation.
- 5) HIV, HBV, HCV positive patients. 6) Patients with central nervous system diseases including stroke, epilepsy, dementia or autoimmune central nervous system diseases.
- 7) Myocardial infection, cardiac angiography or stenting, active angina pectoris or other significant clinical symptoms, or cardiogenic asthma or cardiovascular plasma cell infiltration in the 12 months prior to enrollment.
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 |
|---|---|---|
| CAR-T/CAR-NK cell injectionOne to two days after completion of eluvial chemotherapy, CAR-T/CAR-NK cells were transfused in subjects assessed by the investigators as eligible for infusion. The CAR-T/CAR-NK dose is calculated according to the patient's body weight, and the total number of cells transfused is about 1-2x106 /kg. Single intravenous infusion. | Biological | recurrent or unresectable solid tumors |
Primary outcome
ORR
Time frame: 2024.11
Proportion of patients with PR or CR.
PFS
Time frame: 2024.11
The time from the start of a randomized clinical trial until tumorigenesis (any aspect) progresses or death from any cause.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2024.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing CAR-T/CAR-NK cell injection in people with Safety and Efficacy of Cellular Drugs, Objective Response Rate of Subjects, Etc, run by The Second Hospital of Shandong 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 14 inclusion and 13 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 27 Aug 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?
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR (time frame: 2024.11). 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?
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 27 Aug 2024.