Phase 1 Clinical Trial of CordSTEM-ST (CBT210-POI_P1)

CHA Biotech

Status and phase: Completed; Phase 1

Conditions: Premature Ovarian Insufficiency

Treatments: Biological: umbilical cord-derived mesenchymal stem cell

Study type: Interventional

Funder types: Industry

Identifiers

NCT06578039

CBT210-POI_P1

Details and patient eligibility

About

This clinical study will evaluate the safety and tolerability of CordSTEM-ST after administering a single dose in patients with premature ovarian insufficiency (POI), as well as identify the maximum tolerated dose (MTD) and evaluate the potential therapeutic effects.

Full description

3 or 6 subjects will be enrolled sequentially by applying the "traditional 3+3 design" to evaluate the dose limiting toxicities (DLTs) for 28 days from the first administration date of the investigational product according to the protocol. A DLT is defined as the occurrence of a grade 3 or higher adverse drug reaction (ADR) according to the National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.

First three subjects will be enrolled in Study Group 1 (low dose group) to be evaluated for DLTs up to 28 days after IP administration. If none of three subjects develope DLT, three subjects for Study Group 2 (high dose group) will be recruited. If one out of three subjects in Study Group 1 develop DLT, additional three subjects in Study Group 1 will be enrolled to be evaluated for DLT. If two or more subjects develop DLT in initial three subjects, the study will be terminated.

This study will be followed up by a long-term follow-up study under the separate protocol.

Enrollment: 6 patients

Sex: Female

Ages: 25 to 39 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Females aged ≥ 25 years and < 40 years
• Individuals diagnosed with premature ovarian insufficiency: Individuals who have a follicle stimulating hormone (FSH) level of 40 IU/L or higher in the results of two tests conducted at least 4 weeks apart and are amenorrheic for at least 4 months
• Individuals who voluntarily decide to participate and provide written consent

Exclusion criteria

• Individuals diagnosed with primary amenorrhea*

  * No secondary sex characteristics by age 13, Absence of menarche for 5 years after initial breast development, or Absence of menstruation by age 15

• Individuals diagnosed with polycystic ovary syndrome

• Individuals with any other conditions that may affect the result of this study.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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6 participants in 2 patient groups

Study Group 1 (Low dose CordSTEM-ST)

Experimental group

Description:

Low dose CordSTEM-ST, 1 (single) administration

Treatment:

Biological: umbilical cord-derived mesenchymal stem cell

Study Group 2 (High dose CordSTEM-ST)

Experimental group

Description:

High dose CordSTM-ST, 1 (single) administration

Treatment:

Biological: umbilical cord-derived mesenchymal stem cell