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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.
This study is divided into two phases: Phase Ia and Phase Ib.
Dose-Escalation and Expansion:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NK042 | Biological | NK042 is an allogeneic, off-the-shelf cellular therapy derived from healthy donors and enriched with NKR+ NK cells. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Peak plasma concentration (Cmax) | Cmax of NK042 will be measured to determine the maximum concentration reached in the plasma following administration. | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yongling Fu | Contact | +0086 02150888199 | yongling.fu@nk-celltech.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University Cancer Hospital | Recruiting | Beijing | 100142 | China |
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| ID | Term |
|---|---|
| C024352 | fludarabine |
| D003520 | Cyclophosphamide |
| ID | Term |
|---|---|
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
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| Fludarabine (FLU) | Drug | Fludarabine (FLU) is administered as a lymphodepletion regimen prior to NK042 infusion. |
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| Cyclophosphamide (CTX) | Drug | Cyclophosphamide (CTX) is administered as a lymphodepletion regimen prior to NK042 infusion. |
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Tmax of NK042 will be assessed to determine the time point at which the highest plasma concentration is observed following administration. |
| 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) | AUC₀-ₜ will be assessed to determine the total NK042 exposure from the time of administration (0) to the last measurable concentration (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 | T₁/₂ of NK042 will be assessed to determine the time required for a 50% reduction in the maximum amount of circulating NK042 in the plasma. | 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) | The time from the first dose until objective tumor progression or death. | Up to 1 year after first dose of NK042 . |
| Overall Survival (OS) | The time from the first dose until death from any cause. | Up to 1 year after first dose of NK042 . |
| Duration of Response (DOR) | The time from the first documentation of CR or PR to disease progression or death. | Up to 1 year after first dose of NK042 . |
| Disease Control Rate (DCR) | The proportion of participants who achieve a CR, PR, or stable disease (SD) as assessed by RECIST 1.1. | Up to 1 year after first dose of NK042 . |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |