A Trial to Evaluate the Safety and Preliminary Efficacy of iNK in the Treatment of Subjects With Solid Tumor

ConditionSolid Tumor
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNuwacell Biotechnologies Co., Ltd.

About this trial

This trial is to investigate the safety, efficacy of iNK in subjects with solid tumor. It is a dose escalation and extension trial.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

≥18 years old.

Subjects with recurrent or metastatic solid tumors that cannot accept radical locoregional therapy;

Systemic standard treatment failed or cannot tolerate serious toxicity or lack of standard treatment.

Have 1 or more focus can be accessed according to RECIST 1.1

Disqualifiers

Central nervous system metastasis or meningeal metastasis with clinical symptoms;

With active infection during screening

Have serious or uncontrolled basic diseases;

Have continuous adverse event caused by previous anti-tumor therapy that might affect the evaluation of drug safety;

Trial design

Design model

Sequential

Treatments tested in this trial

  • iNK Injection

    Biological/Vaccine

    Subjects will receive about 4 cycles of iNK

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: iNK InjectionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Adverse Event(AE) ,Serious Adverse Event(SAE),Treatment Emergent Adverse Event(TEAE)and Treatment Related Adverse Event(TRAE)

Number of participants with treatment-related adverse events or serious adverse events as assessed by CTCAE v5.0

Time frame
From the date of initial infusion to a year after initial infusion
2

Dose-Limiting Toxicity(DLT)

Number of participants with Dose-limiting toxicity in 28 days after injection

Time frame
4 weeks after initial infusion

Secondary outcomes

1

Objective Response Rate(ORR)

Percentage of participants achieved Complete Response(CR) or Partial Response(PR)

Time frame
During the whole study
2

Disease Control Rate(DCR)

Percentage of participants achieved Complete Response(CR) or Partial Response(PR) or Stable Disease(SD)

Time frame
From the date of initial infusion to a year after initial infusion
3

Duration Of Response(DOR)

Duration for the first PR to the first Progressive Disease(PD)

Time frame
First Injection to a year after Last Injection

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: