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A Trial to Evaluate the Safety and Efficacy of NCR300 in Preventing Recurrence of Acute Myeloid Leukemia（AML) After Transplantation

ConditionAcute Myeloid Leukemia
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorNuwacell Biotechnologies Co., Ltd.

About this trial

A Trial to Evaluate the Safety and Efficacy of iNK in the Treatment of Subjects for Preventing Recurrence of Acute Myeloid Leukemia After Allogeneic Blood Stem Cell Transplantation.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

Bone marrow examination shows hematological recurrence;

Have malignant tumors within 5 years before screening;

Subjects with acute promyelocytic leukemia(APL);

Subjects with severe respiratory diseases;

Trial design

Design model

Single group

Treatments tested in this trial

  • NCR300 injection

    Biological/Vaccine

    Subjects will receive at least 1 cycle of NCR300 injection.

Treatment groups

15 Participants
are divided into 1 treatment group
Group A: NCR300 injectionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Dose-Limiting Toxicity(DLT)

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

Time frame
4 weeks after initial infusion
2

Adverse Event(AE) or Serious Adverse Event(SAE)

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

Secondary outcomes

1

Maximum plasma concentration(Cmax)

Maximum plasma concentration of NCR300 in peripheral blood

Time frame
2 hours before initial infusion;4 hours ,24 hous, 3 Days after initial infusion.2 hours before second infusion; 24 hous, 3 Days after second infusion.
2

Time after doing at which maximun plasma concentration is reached(Tmax)

Time after doing at which maximun plasma concentration of NCR300 in peripheral blood is reached

Time frame
2 hours before initial infusion;4 hours ,24 hous, 3 Days after initial infusion.2 hours before second infusion; 24 hous, 3 Days after second infusion.
3

Cumulative Incidence of Relapse(CIR)

The proportion of patients with hematological recurrence within 6 months after initial infusion to all patients

Time frame
6 Months After Initial Infusion
4

Minimal Residual Disease(MRD)

Changes in MRD before and after treatment

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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

Nuwacell Biotechnologies Co., Ltd.

Lead sponsor

Beijing Friendship Hospital

Collaborator

Source ClinicalTrials.gov

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