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

NCT06773091 | Recruiting Phase 1

• 1 other identifier: NK042-I-ST-01
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

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.

Conditions

Advanced Solid Tumors

Keywords

CAR-NK; Advanced solid tumors; Early-phase clinical trial; Cell Therapy

Outcome Measures

Primary Outcomes (3)

• Incidence of Adverse events (AEs) and Serious Adverse Events (SAEs)

  Number of subjects experiencing adverse events, and the frequency and severity of adverse events. The type, frequency, onset, and severity of treatment-emergent adverse events (TEAEs) will be assessed in accordance with the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE),version 5.0.

  Up to 1 year after first dose of NK042.

• Dose Limiting Toxicities (DLTs)

  Identification of DLTs to determine the maximum tolerated dose (MTD).

  Up to 28-day after first dose of NK042.

• Objective Response Rate (ORR)

  The proportion of participants achieving a complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1).

  Up to 1 year after first dose of NK042.

Secondary Outcomes (8)

• Peak plasma concentration (Cmax)

  Predose, 4, 24, 48, 72, Day 8, Day 15, Day 22, Day 29 post-dose and every 2 months during the treatment follow-up period.

• Time to reach maximum concentration (Tmax)

  Predose, 4, 24, 48, 72 hours, Day 8, Day 15, Day 22, Day 29 post-dose, and every 2 months during the treatment follow-up period.

• Area under the plasma concentration versus time curve (AUC₀-ₜ)

  Predose, 4, 24, 48, 72 hours, Day 8, Day 15, Day 22, Day 29 post-dose, and every 2 months during the treatment follow-up period.

• Half-life (T₁/₂) of NK042

  Predose, 4, 24, 48, 72 hours, Day 8, Day 15, Day 22, Day 29 post-dose, and every 2 months during the treatment follow-up period.

• Progression-Free Survival (PFS)

  Up to 1 year after first dose of NK042 .

Study Arms (1)

NK042 - cellular therapy

EXPERIMENTAL

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.

Biological: NK042; Drug: Fludarabine (FLU); Drug: Cyclophosphamide (CTX)

Interventions

NK042 BIOLOGICAL

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

NK042 - cellular therapy

Fludarabine (FLU) DRUG

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

NK042 - cellular therapy

Cyclophosphamide (CTX) DRUG

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

NK042 - cellular therapy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Voluntary signing of a written informed consent form.
• Age between 18 and 70 years.
• 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.
• At least one assessable tumor lesion according to Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1).
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1.
• Expected survival ≥12 weeks.
• Must have adequate bone marrow, liver, and renal function.

You may not qualify if:

• Insufficient washout period for prior anti-tumor treatments before the first dose, including chemotherapy, targeted therapy, antibody therapy, and radiotherapy.
• Participation in another clinical trial and use of investigational drugs within 28 days before the first dose.
• Requirement for anticoagulation therapy.
• Symptomatic brain parenchymal metastases with less than 4 weeks of stability after treatment.
• Active pulmonary diseases, including but not limited to interstitial lung disease, pneumonitis.
• Uncontrolled active infections.
• Uncontrollable massive pleural effusion, ascites, or pericardial effusion.
• Previous receipt of other cellular therapies.
• Planned concurrent participation in other anti-tumor treatments during the study.
• Pregnant or breastfeeding women.

Sponsors & Collaborators

• Shanghai NK Cell Technology Co., LTD: lead

Study Sites (1)

Peking University Cancer Hospital

Beijing, 100142, China

RECRUITING

MeSH Terms

Interventions

fludarabine; Cyclophosphamide

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds

Study Officials

• Lin Shen, MD

  Peking University Cancer Hospital & Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wei Song, MD

CONTACT

+86 15900324279; wei.song@nk-celltech.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2025
• First Posted: January 14, 2025
• Study Start: February 7, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 11, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)