Early Clinical Study of JY306 Universal NK Cell Injection in the Treatment of Adult Relapsed or Refractory CD70+ Malignant Hematologic Tumors

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 or Refractory CD70+ Malignant Hematological Tumors.

Study Overview

• Status: Not yet recruiting
• Conditions: Relapsed or Refractory Hematological Malignancies
• Intervention / Treatment: Biological: JY306 universal NK cell injection

• Study Type: Interventional
• Enrollment (Estimated): 18
• Phase: Early Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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;

Exclusion Criteria:

• 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;
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: JY306 universal NK cell injection	Biological: JY306 universal NK cell injection; "3+3" dose escalation trial

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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	From enrollment to one year after infusion

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital with Nanjing Medical University

Study record dates

Study Major Dates

• Study Start (Estimated): February 15, 2025
• Primary Completion (Estimated): March 1, 2026
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: February 16, 2025
• First Submitted That Met QC Criteria: February 16, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 16, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Hematologic Diseases; Hematologic Neoplasms
• Other Study ID Numbers: 2024-SR-1013

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No