NCT07117175

A Clinical Study to Evaluate the Safety and Efficacy of Anti-human CD 7 CAR-NK Cell Injection in Subjects With Relapsed and Refractory CD7-positive Hematological Malignancy

• Status: Not Yet Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 18 (estimated)
• Sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This study is a single-arm, open-label, dose-escalation clinical trial to explore the safety, tolerability, pharmacokinetics and pharmacodynamics characteristics of the drug; The efficacy of the study drug in subjects with relapsed/refractory CD7-positive hematological malignancies, and the expression of B cells, T cells, and NK cell subtypes in peripheral blood were preliminarily observed. At the same time, explporing the distribution of anti-human CD7 CAR-NK cells in tumor tissues after administration of anti-human CD7 CAR-NK cell injection, and evaluating the immunogenicity of anti-human CD7 CAR-NK cell injection . To evaluate the correlation between the proportion of CD7-positive tumor cells and the safety and efficacy of anti-human CD7 CAR-NK cell injection and the evaluation. To explore the pharmacokinetics (PK) and pharmacodynamics(PD) characteristics of bone marrow in Chinese medicine.

Detailed description

"This study employed a dose escalation approach combining accelerated titration for the first dose group and the standard '3+3' rule for subsequent dose groups, aiming to minimize patient exposure to ineffective doses while reducing potential risks as much as possible. The study comprised three dose groups for single administration, with doses set at 1×10\^7 CAR-NK cells/kg, 2×10\^7 CAR-NK cells/kg, and 5×10\^7 CAR-NK cells/kg. For the 1×10\^7 CAR-NK cells/kg dose group, an accelerated titration method was applied: after obtaining informed consent, one eligible subject meeting the inclusion/exclusion criteria was enrolled into this group. A safety assessment was conducted 14-28 days after the first cell infusion. If no dose-limiting toxicity (DLT) occurred, the subject could proceed to the next dose group upon agreement between the investigator and sponsor. If DLT occurred in one subject, after evaluation by the investigator and sponsor, two additional subjects were enrolled into the same dose group for a 28-day observation period. If DLT events occurred in ≤1 of these three subjects, the study could advance to the next dose group; if DLT events occurred in \>1 subject, the decision to continue was made through joint discussion between the investigator and sponsor. Dose escalation to the 2×10\^7 CAR-NK cells/kg dose group followed the standard '3+3' rule. This group initially enrolled three subjects. If no DLT occurred in all three subjects, the study could proceed to the 5×10\^7 CAR-NK cells/kg dose group upon agreement between the investigator and sponsor. If one DLT occurred in this group, three additional subjects were enrolled for further observation of the same dose level. If the total number of DLT events among these six subjects was ≤1, the study could advance to the 5×10\^7 CAR-NK cells/kg dose group with agreement. If more than one subject experienced DLT in this group, enrollment for this dose level was terminated, and the dose was reduced to complete enrollment of remaining subjects, as decided by the investigator and sponsor. Dose escalation to the 5×10\^7 CAR-NK cells/kg dose group also adhered to the standard '3+3' rule. This group first enrolled three subjects. After cell infusion, a 28-day safety assessment was completed. If no DLT occurred in all three subjects, the decision to continue dose escalation was made through joint discussion between the investigator and sponsor. If no further escalation was decided, the remaining subjects were enrolled in this dose group. If one DLT occurred among the first three subjects, three additional subjects were enrolled for further observation. If DLT events occurred in \>1 of these six subjects, enrollment for this dose group was terminated, and the dose level was reduced to complete enrollment of remaining subjects. If no maximum tolerated dose (MTD) was observed at the maximum dose of 5×10\^7 CAR-NK cells/kg, the decision to add additional dose groups was made through joint discussion between the investigator and sponsor, with the new group still following the standard '3+3' rule. During the study, dose groups could be adjusted based on the tolerability, pharmacokinetics, pharmacodynamics, and efficacy of anti-human CD7 CAR-NK cells in patients, combined with prior CAR-NK treatment experience, as determined by the investigator and sponsor. This could involve adding or reducing groups or adjusting dose levels. If special safety or efficacy issues arose during dose escalation, the clinical study could be terminated after joint discussion between the investigator and sponsor.

Conditions

• Immunology
• Hematologic Malignancies
• CAR-NK

Interventions

Type	Name	Description
DRUG	Anti-human CD7 CAR-NK cell injection	Administer anti-human CD7 CAR-NK cell injection on D0

Timeline

• Start date: 2025-09-01
• Primary completion: 2027-12-15
• Completion: 2028-01-30
• First posted: 2025-08-12
• Last updated: 2025-08-12

Locations

1 site across 1 country: China