Relapsed or Refractory Hematological MalignanciesEarly Phase 1NCT06837389
Early Clinical Study of JY306 Universal NK Cell Injection in the Treatment of Adult Relapsed or Refractory CD70+ Malignant Hematologic Tumors
A Early Phase 1 study testing JY306 universal NK cell injection in people with Relapsed or Refractory Hematological Malignancies, run by The First Affiliated Hospital with Nanjing Medical University.
Trial summary
1. Primary objectives of study:To valuate the tolerability and safety of JY306 in patients with relapsed or refractory CD70 + malignant hematological tumors. 2. Secondary objectives of study:To conduct a preliminary Evaluation of the Efficacy, Pharmacokinetics, and Pharmacodynamics of JY306 in Patients with Relapsed… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Relapsed or Refractory Hematological Malignancies
- What is being tested?
- JY306 universal NK cell injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- No sites listed yet
- Study dates
- 15 Feb 2025to 1 Mar 2027
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Relapsed or refractory malignant hematological tumors judged by clinical diagnosis;
- The tumor cells were confirmed positive for CD70 by flow cytometry (FCM) or immunohistochemistry, and the positivity rate was >80%;
- Age 18-75 years (inclusive);
- The expected survival period from the signing date of the informed consent is more than 3 months;
- KPS≥80 points;
- The function of vital organs needs to meet the following conditions: 1) EF >50%, and there is no obvious abnormality in ECG; 2)SpO2≥90%; 3) Cr≤2.5ULN;4) ALT and AST≤5ULN, TBil≤3ULN;
- Subjects with pregnancy plans must agree to use contraception prior to enrollment in the study and after six months of study duration; If the subject is pregnant or suspects pregnancy, the investigator should be notified immediately;
- The subject or guardian understands and signs the informed consent form;
Who cannot join
- Have a New York Heart Association (NYHA) classification ≥III heart failure or myocardial infarction, cardiac angioplasty or stenting, unstable angina, or other clinically prominent heart disease within one year prior to signing the informed consent form, Or QTc interval >480ms (QTc interval is calculated by Fridericia formula) during screening;
- Those who have active GvHD, or need to use immunosuppressants;
- Have been diagnosed with malignant tumors other than primary tumors within 5 years prior to screening, except for adequately treated carcinoma in situ of the cervix, basal cell or squamous epithelial cell skin cancer, localized prostate cancer after radical resection, and ductal carcinoma in situ of the breast after radical resection;
- There are active infections or uncontrollable infections that require systemic treatment (excluding mild urinary and genital tract infections and upper respiratory tract infections) within 7 days prior to screening;
- History of autoimmune diseases (such as rheumatoid arthritis, systemic lupus erythematosus, Crohn's disease) requiring systemic immunosuppressive/systemic disease-modifying drugs within the past 2 years;
- At screening, those with positive hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HbcAb), and peripheral blood hepatitis B virus (HBV) DNA levels above the lower limit of detection; those with positive hepatitis C virus (HCV) antibody and positive peripheral blood HCV RNA; those with positive human immunodeficiency virus (HIV) antibody; those with positive cytomegalovirus (CMV) DNA; those with positive Epstein-Barr virus (EBV) DNA; and those with positive Treponema pallidum particle agglutination (TPPA) test for syphilis should all be excluded;
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- Subjects who have participated in other clinical trials within 4 weeks prior to signing the informed consent form, or for whom the date of signing the informed consent form is still within 5 half-lives of the last dose of the drug from the previous clinical trial (whichever is longer).
- Have a history of severe allergy to biological products;
- Unstable systemic diseases judged by the investigator: including but not limited to severe hepatic, renal or metabolic diseases requiring drug treatment;
- Pregnant or lactating women, and female subjects who plan to become pregnant within 2 years after cell infusion or male subjects whose partners plan to become pregnant within 2 years after cell infusion;
- According to the judgment of the investigator conditions that may increase the subject's risk or interfere with the trial results.
About this study
- Primary objectives of study:To valuate the tolerability and safety of JY306 in patients with relapsed or refractory CD70 + malignant hematological tumors.
- Secondary objectives of study:To conduct a preliminary Evaluation of the Efficacy, Pharmacokinetics, and Pharmacodynamics of JY306 in Patients with Relapsed or Refractory CD70+ Malignant Hematological Tumors.
- Being tested
- JY306 universal NK cell injection
- Medical subject headings
- Recurrence, Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JY306 universal NK cell injectionBiological
"3+3" dose escalation trial
| Study group | Role | What they receive |
|---|---|---|
| JY306 universal NK cell injection | Experimental | Not described Receives: Biological: JY306 universal NK cell injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
The occurrence frequency, number of cases, incidence rate and severity of adverse events and adverse reactions occurring after infusion and before withdrawal or the safety follow-up period
Measured: From enrollment to one year after infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2025
- Study start15 Feb 2025 (estimated)
- Primary completion1 Mar 2026 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed or Refractory Hematological MalignanciesStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing Medical UniversityThe sponsor's other registered studies.
- 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
- 18 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06837389
- Sponsor's protocol ID
- 2024-SR-1013
- Status last verified
- Feb 2025
- First submitted
- 16 Feb 2025
- Last updated
- 20 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Clinical Study of JY306 Universal NK Cell Injection in the Treatment of Adult Relapsed or Refractory CD70+ Malignant Hematologic Tumors
- ClinicalTrials.gov ID
- NCT06837389
- Acronym / sponsor ID
- 2024-SR-1013
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 15 Feb 2025 (estimated)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 20 Feb 2025 (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.
- Primary objectives of study:To valuate the tolerability and safety of JY306 in patients with relapsed or refractory CD70 + malignant hematological tumors.
- Secondary objectives of study:To conduct a preliminary Evaluation of the Efficacy, Pharmacokinetics, and Pharmacodynamics of JY306 in Patients with Relapsed or Refractory CD70+ Malignant Hematological Tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| JY306 universal NK cell injection | Experimental | Biological: JY306 universal NK cell injection |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Relapsed or refractory malignant hematological tumors judged by clinical diagnosis;
- The tumor cells were confirmed positive for CD70 by flow cytometry (FCM) or immunohistochemistry, and the positivity rate was >80%;
- Age 18-75 years (inclusive);
- The expected survival period from the signing date of the informed consent is more than 3 months;
- KPS≥80 points;
Key exclusion criteria (11 listed)
- Have a New York Heart Association (NYHA) classification ≥III heart failure or myocardial infarction, cardiac angioplasty or stenting, unstable angina, or other clinically prominent heart disease within one year prior to signing the informed consent form, Or QTc interval >480ms (QTc interval is calculated by Fridericia formula) during screening;
- Those who have active GvHD, or need to use immunosuppressants;
- Have been diagnosed with malignant tumors other than primary tumors within 5 years prior to screening, except for adequately treated carcinoma in situ of the cervix, basal cell or squamous epithelial cell skin cancer, localized prostate cancer after radical resection, and ductal carcinoma in situ of the breast after radical resection;
- There are active infections or uncontrollable infections that require systemic treatment (excluding mild urinary and genital tract infections and upper respiratory tract infections) within 7 days prior to screening;
- History of autoimmune diseases (such as rheumatoid arthritis, systemic lupus erythematosus, Crohn's disease) requiring systemic immunosuppressive/systemic disease-modifying drugs within the past 2 years;
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 |
|---|---|---|
| JY306 universal NK cell injection"3+3" dose escalation trial | Biological | JY306 universal NK cell injection |
Primary outcome
The occurrence frequency, number of cases, incidence rate and severity of adverse events and adverse reactions occurring after infusion and before withdrawal or the safety follow-up period
Time frame: From enrollment to one year after infusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing JY306 universal NK cell injection in people with Relapsed or Refractory Hematological Malignancies, run by The First Affiliated Hospital with Nanjing Medical University.
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: opening soon, as of the sponsor's last update on 20 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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?
The occurrence frequency, number of cases, incidence rate and severity of adverse events and adverse reactions occurring after infusion and before withdrawal or the safety follow-up period (time frame: From enrollment to one year after infusion). 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 20 Feb 2025.