Safety and EfficacyEarly Phase 1NCT06596057
Safety and Efficacy of CD19 CAR-T/CAR-NK Cells
A Early Phase 1 study testing CAR-T/CAR-NK cells in people with Safety and Efficacy, run by The Second Hospital of Shandong University at 1 site in China.
Trial summary
To investigate the safety and efficacy of CD19 CAR-T/CAR-NK cells in patients with relapsed/refractory B-cell lymphoma and acute B-lymphoblastic leukemia. Read more about this study
- Who is it for?
- Ages 15 to 80 years
- Conditions the study is for
- Safety and Efficacy
- What is being tested?
- CAR-T/CAR-NK cells
- 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
- 10 Feb 2024to Jun 2026
- 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
None listed.
Who cannot join
- Patients with expected survival of less than 3 months.
- Clinical findings (symptoms, signs, imaging, cerebrospinal fluid) of central nervous system leukemia.
- Patients with hyperleukocytoemia (white blood cell count ≥50 x109 /L) or patients whose disease is progressing rapidly at the time of enrollment, as determined by the investigator, to be unable to ensure the completion of a full treatment cycle.
- Patients with skin cancer other than melanoma or other primary tumors (such as cervical cancer, bladder cancer, breast cancer) (unless cured for more than 3 years).
- Patients with infections including fungal, bacterial, viral or other uncontrolled infections or those requiring level 4 isolation.
- Patients who test positive for HIV, HBV, HCV.
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- Patients with central nervous system diseases including stroke, epilepsy, dementia or autoimmune central nervous system diseases.
- Myocardial infection, cardiac angiography or stenting, active angina pectoris or other obvious clinical symptoms, or cardiac asthma or cardiovascular lymphocyte infiltration in the 12 months prior to enrollment.
- Those who are receiving anticoagulation therapy or have severe coagulation dysfunction.
- According to the investigator's judgment, the drug treatment the patient is receiving will affect the safety and efficacy study of this project.
- Patients with allergy or history of allergy to the biologics used in this project.
- Pregnant or lactating women.
- Systematic use of systemic or systemic steroid drugs within 2 weeks prior to treatment (except those who have recently or currently used inhaled steroids).
- The efficiency of T cell transduction by replication-deficient lentivirus is less than 30%, or the ability to expand in response to CD3 / CD28 costimulatory signals is insufficient (<5 times).
- Those who have other uncontrolled diseases that the researchers consider unsuitable for enrollment.
- Any situation that the investigator believes may increase the risk to the subject or interfere with the test results.
- Patients who are also participating in other clinical studies.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Head of Hematology，Vice President and Secretary-General of Shandong Stem Cell Society
To investigate the safety and efficacy of CD19 CAR-T/CAR-NK cells in patients with relapsed/refractory B-cell lymphoma and acute B-lymphoblastic leukemia.
Read the detailed description
Patients who met the exclusion criteria were treated with advanced FC regimen, and subjects who met the infusion criteria assessed by the investigators were given CAR-T/CAR-NK cell infusion 1 to 2 days after completion of eluvial 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 study was divided into five stages: screening period, single harvest period, pretreatment chemotherapy period, treatment period, observation and follow-up period after treatment.
For lymphoma, refer to the 2014 version of Lugano efficacy evaluation criteria
- Conditions
- Safety and Efficacy
- Being tested
- CAR-T/CAR-NK cells
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAR-T/CAR-NK cellsBiological
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 |
|---|---|---|
| experimental group | Experimental | Not described Receives: Biological: CAR-T/CAR-NK cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR
With reference to iRecist1.1, the proportion of patients whose tumor volume shrank to the pre-specified value and maintained the minimum time limit.The time from randomization to tumor progression or death from any cause.
Measured: At least half a year
PFS
In tumor therapy, the proportion of patients whose tumor volume has shrunk to a predetermined value and can be maintained for a certain time. It includes the number of patients with complete response (CR) and partial response (PR) as a proportion of the total number of evaluable cases
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start10 Feb 2024
- Primary completionJun 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Safety and EfficacyStudies 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
- Principal investigator, Linlin Cui, The Second Hospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06596057
- Sponsor's protocol ID
- 2024CAR-T/NK B-nhl/ALL
- Status last verified
- Sep 2024
- First submitted
- 13 Aug 2024
- Last updated
- 19 Sep 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 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Head of Hematology，Vice President and Secretary-General of Shandong Stem Cell Society
- ClinicalTrials.gov ID
- NCT06596057
- Acronym / sponsor ID
- 2024CAR-T/NK B-nhl/ALL
- Conditions
- Safety and Efficacy
- 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
- 10 Feb 2024 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 19 Sep 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 CD19 CAR-T/CAR-NK cells in patients with relapsed/refractory B-cell lymphoma and acute B-lymphoblastic leukemia.
Detailed description
Patients who met the exclusion criteria were treated with advanced FC regimen, and subjects who met the infusion criteria assessed by the investigators were given CAR-T/CAR-NK cell infusion 1 to 2 days after completion of eluvial 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 study was divided into five stages: screening period, single harvest period, pretreatment chemotherapy period, treatment period, observation and follow-up period after treatment.
For lymphoma, refer to the 2014 version of Lugano efficacy evaluation criteria
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Biological: CAR-T/CAR-NK cells |
Who may qualify
- Ages
- 15 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (17 listed)
- Patients with expected survival of less than 3 months.
- Clinical findings (symptoms, signs, imaging, cerebrospinal fluid) of central nervous system leukemia.
- Patients with hyperleukocytoemia (white blood cell count ≥50 x109 /L) or patients whose disease is progressing rapidly at the time of enrollment, as determined by the investigator, to be unable to ensure the completion of a full treatment cycle.
- Patients with skin cancer other than melanoma or other primary tumors (such as cervical cancer, bladder cancer, breast cancer) (unless cured for more than 3 years).
- Patients with infections including fungal, bacterial, viral or other uncontrolled infections or those requiring level 4 isolation.
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 cellsOne 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 | experimental group |
Primary outcome
ORR
Time frame: At least half a year
With reference to iRecist1.1, the proportion of patients whose tumor volume shrank to the pre-specified value and maintained the minimum time limit.The time from randomization to tumor progression or death from any cause.
PFS
Time frame: one year
In tumor therapy, the proportion of patients whose tumor volume has shrunk to a predetermined value and can be maintained for a certain time. It includes the number of patients with complete response (CR) and partial response (PR) as a proportion of the total number of evaluable cases
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
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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.
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 cells in people with Safety and Efficacy, 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 0 inclusion and 17 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 19 Sep 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: At least half a year). 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 19 Sep 2024.