Safety Evaluation Study for Patients With Aggressive NK-cell Leukemia

Hiroshima University Hospital

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Aggressive NK Cell Leukemia

Treatments: Drug: PPMX-T003

Study type: Interventional

Funder types: Other

Identifiers

NCT05863234

PPMX-T003-CT103

Details and patient eligibility

About

This is Phase I/II Dose-Escalation Study to evaluate the tolerability, safety, efficacy and pharmacokinetics of PPMX-T003 in aggressive NK-cell leukemia.

Enrollment: 7 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients diagnosed with ANKL (regardless of whether the disease is first or recurrent) based on diagnostic criteria developed with reference to the World Health Organization (WHO) 4th edition (2017) criteria.

Exclusion criteria

• Patients eligible to receive chemotherapy as treatment for ANKL

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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7 participants in 1 patient group

Treatment with PPMX-T003

Experimental group

Treatment:

Drug: PPMX-T003