A Phase I Study of NK042 Cell Injection in Advanced Solid Tumors

NCT ID: NCT06773091

Last Updated: 2025-02-11

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 76 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-07
• Study Completion Date: 2026-12-31

Brief Summary

This is a single-arm, open-label, multi-center phase 1 clinical study designed to evaluate the safety and preliminary efficacy of NK042 cell injection in patients with advanced solid tumors.

Detailed Description

This study is divided into two phases: Phase Ia and Phase Ib.

Dose-Escalation and Expansion:

• Phase Ia: This dose-escalation phase involves both single-dose and multiple-dose administrations of NK042 in patients with advanced solid tumors.
• Phase Ib: This multiple-dose cohort-expansion phase will focus on solid tumor indications that demonstrated preliminary efficacy in Phase Ia.

Conditions

Advanced Solid Tumors

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

NK042 - cellular therapy

Phase Ia (Dose Escalation): Determines maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) using single- and multiple-dose escalation with a "3+3" design.

Phase Ib (Cohort Expansion): Evaluates safety, tolerability, and efficacy in solid tumor indications that demonstrated preliminary efficacy in Phase Ia.

Participants undergo lymphodepletion prior to the first infusion of NK042.

Group Type: EXPERIMENTAL

NK042

Intervention Type: BIOLOGICAL

NK042 is an allogeneic, off-the-shelf cellular therapy derived from healthy donors and enriched with NKR+ NK cells.

Fludarabine (FLU)

Intervention Type: DRUG

Fludarabine (FLU) is administered as a lymphodepletion regimen prior to NK042 infusion.

Cyclophosphamide (CTX)

Intervention Type: DRUG

Cyclophosphamide (CTX) is administered as a lymphodepletion regimen prior to NK042 infusion.

Interventions

NK042

NK042 is an allogeneic, off-the-shelf cellular therapy derived from healthy donors and enriched with NKR+ NK cells.

Intervention Type: BIOLOGICAL

Fludarabine (FLU)

Fludarabine (FLU) is administered as a lymphodepletion regimen prior to NK042 infusion.

Intervention Type: DRUG

Cyclophosphamide (CTX)

Cyclophosphamide (CTX) is administered as a lymphodepletion regimen prior to NK042 infusion.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Voluntary signing of a written informed consent form.

2. Age between 18 and 70 years.

3. Histologically or cytologically confirmed locally advanced or metastatic solid tumor patients who are not amenable to surgical resection, with no standard treatment options, or who have relapsed or progressed after standard treatment, or are resistant or intolerant to standard treatment.

4. At least one assessable tumor lesion according to Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1).

5. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1.

6. Expected survival ≥12 weeks.

7. Must have adequate bone marrow, liver, and renal function.

Exclusion Criteria

1. Insufficient washout period for prior anti-tumor treatments before the first dose, including chemotherapy, targeted therapy, antibody therapy, and radiotherapy.

2. Participation in another clinical trial and use of investigational drugs within 28 days before the first dose.

3. Requirement for anticoagulation therapy.

4. Symptomatic brain parenchymal metastases with less than 4 weeks of stability after treatment.

5. Active pulmonary diseases, including but not limited to interstitial lung disease, pneumonitis.

6. Uncontrolled active infections.

7. Uncontrollable massive pleural effusion, ascites, or pericardial effusion.

8. Previous receipt of other cellular therapies.

9. Planned concurrent participation in other anti-tumor treatments during the study.

10. Pregnant or breastfeeding women.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai NK Cell Technology Co., LTD

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lin Shen, MD

Role: PRINCIPAL_INVESTIGATOR

Peking University Cancer Hospital & Institute

Locations

Peking University Cancer Hospital

Beijing, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Wei Song, MD

Role: CONTACT

wei.song@nk-celltech.com

+86 15900324279

Facility Contacts

Changsong Qi, MD

Role: primary

xiwangpku@126.com

+8613811394004

Lin Shen, MD

Role: backup

Other Identifiers

NK042-I-ST-01

Identifier Type: -

Identifier Source: org_study_id