Trial Outcomes & Findings for A Study to Evaluate the Safety, Pharmacokinetics, and Hematopoietic Stem Cell Mobilization of TG-0054 Alone or in Combination With G-CSF in Patients With Multiple Myeloma, Non-Hodgkin Lymphoma or Hodgkin Disease (NCT NCT01458288)

Last Updated: 2021-04-19

Results Overview

Patients were all with multiple myeloma (MM), Non-Hodgkin lymphoma (NHL) or Hodgkin disease (HD). Number of patients who mobilized the targeted total number of CD34+ cells within a maximum of 4 leukapheresis sessions in study arm 1 and arm 3. Patients in arm 1 followed administration of TG-0054 (3.14 mg/kg) alone and leukapheresis start from study day 1. Patients in arm 3 followed administration of TG-0054 (3.14 mg/kg) combined with granulocyte colony-stimulating factor (G-CSF) and leukapheresis start from study day 8.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

12 participants

Primary outcome timeframe

1 week

Results posted on

2021-04-19

Participant Flow

Duration of the Study: This study will consist of a 14-day screening period, a 2- to 11-day treatment period, and a 7-day follow-up period. Number of Patients: Approximately 12 treatment evaluable patients will be enrolled in this study. Study Location: Single site in US.

Participant milestones

Participant milestones
Measure	TG-0054 (3.14 mg/kg TG-0054 Administrated Via 15-min IV Infus) TG-0054 (3.14 mg/kg) TG-0054: 3.14 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of four leukapheresis sessions)
Overall Study STARTED	12
Overall Study COMPLETED	12
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study to Evaluate the Safety, Pharmacokinetics, and Hematopoietic Stem Cell Mobilization of TG-0054 Alone or in Combination With G-CSF in Patients With Multiple Myeloma, Non-Hodgkin Lymphoma or Hodgkin Disease

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	TG-0054 (3.14 mg/kg Administrated Via 15-min IV Infusion) n=12 Participants TG-0054 (3.14 mg/kg) TG-0054: 3.14 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of four leukapheresis sessions)
Age, Customized 18 to 75 years old	12 participants n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
Region of Enrollment United States	12 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 week

Outcome measures

Outcome measures
Measure	TG-0054 (3.14 mg/kg) n=7 Participants Patients followed administration of TG-0054 (3.14 mg/kg) alone and leukapheresis start from study day 1.	TG-0054 (3.14 mg/kg)+G-CSF n=5 Participants Patients followed administration of TG-0054 (3.14 mg/kg) combined with granulocyte colony-stimulating factor (G-CSF) and leukapheresis start from study day 8.
Number of Patients Achieving the CD34+ Hematopoietic Stem Cell (HSC) Mobilization Target of ≧2.5×1000000 Cells/kg	7 participants	5 participants

SECONDARY outcome

Timeframe: 1 week

To determine the average number of leukapheresis sessions required to collect 2.5 x10\^6 CD34+ cells/kg.

Outcome measures

Outcome measures
Measure	TG-0054 (3.14 mg/kg) n=7 Participants Patients followed administration of TG-0054 (3.14 mg/kg) alone and leukapheresis start from study day 1.	TG-0054 (3.14 mg/kg)+G-CSF n=5 Participants Patients followed administration of TG-0054 (3.14 mg/kg) combined with granulocyte colony-stimulating factor (G-CSF) and leukapheresis start from study day 8.
the Average Number of Leukapheresis Sessions	2.0 number of leukapheresis sessions Standard Deviation 0.82	1.4 number of leukapheresis sessions Standard Deviation 0.55

SECONDARY outcome

Timeframe: pre-dose(-2 to 0 h),2, 4 and 6 hr after dosing.

Calculate the median total CD34+ cell counts across all leukapheresis sessions following TG 0054 administration alone and in combination with G-CSF mobilization in order to evaluate the pharmacodynamics (PD) of TG-0054 by determining circulating CD34+ cell counts in peripheral blood.

Outcome measures

Outcome measures
Measure	TG-0054 (3.14 mg/kg) n=7 Participants Patients followed administration of TG-0054 (3.14 mg/kg) alone and leukapheresis start from study day 1.	TG-0054 (3.14 mg/kg)+G-CSF n=5 Participants Patients followed administration of TG-0054 (3.14 mg/kg) combined with granulocyte colony-stimulating factor (G-CSF) and leukapheresis start from study day 8.
Circulating CD34+ Cell Count in Peripheral Blood	6000000 cells/kg Interval 4000000.0 to 10000000.0	5000000 cells/kg Interval 4000000.0 to 21000000.0

Adverse Events

TG-0054 (3.14 mg/kg Administrated Via 15-min IV Infusion)

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	TG-0054 (3.14 mg/kg Administrated Via 15-min IV Infusion) n=12 participants at risk TG-0054 (3.14 mg/kg) TG-0054: 3.14 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of four leukapheresis sessions)
Gastrointestinal disorders Diarrhoea	33.3% 4/12 • 9 months, from 23-Oct-2012 to 09-Jul-2013
Gastrointestinal disorders Abdominal pain	16.7% 2/12 • 9 months, from 23-Oct-2012 to 09-Jul-2013
Gastrointestinal disorders Nausea	16.7% 2/12 • 9 months, from 23-Oct-2012 to 09-Jul-2013
Gastrointestinal disorders Paraesthesia oral	16.7% 2/12 • 9 months, from 23-Oct-2012 to 09-Jul-2013
Investigations Blood pressure increased	16.7% 2/12 • 9 months, from 23-Oct-2012 to 09-Jul-2013
Investigations Haemoglobin decreased	16.7% 2/12 • 9 months, from 23-Oct-2012 to 09-Jul-2013
Investigations Platelet count decreased	16.7% 2/12 • 9 months, from 23-Oct-2012 to 09-Jul-2013
Nervous system disorders Neuropathy peripheral	33.3% 4/12 • 9 months, from 23-Oct-2012 to 09-Jul-2013
Nervous system disorders Paraesthesia	16.7% 2/12 • 9 months, from 23-Oct-2012 to 09-Jul-2013
Respiratory, thoracic and mediastinal disorders Cough	16.7% 2/12 • 9 months, from 23-Oct-2012 to 09-Jul-2013
Respiratory, thoracic and mediastinal disorders Dyspnoea	8.3% 1/12 • 9 months, from 23-Oct-2012 to 09-Jul-2013
Respiratory, thoracic and mediastinal disorders Nasal congestion	8.3% 1/12 • 9 months, from 23-Oct-2012 to 09-Jul-2013
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	8.3% 1/12 • 9 months, from 23-Oct-2012 to 09-Jul-2013
Blood and lymphatic system disorders Anaemia	8.3% 1/12 • 9 months, from 23-Oct-2012 to 09-Jul-2013
Blood and lymphatic system disorders Thrombocytopenia	8.3% 1/12 • 9 months, from 23-Oct-2012 to 09-Jul-2013
General disorders Chest discomfort	8.3% 1/12 • 9 months, from 23-Oct-2012 to 09-Jul-2013
Musculoskeletal and connective tissue disorders Arthralgia	8.3% 1/12 • 9 months, from 23-Oct-2012 to 09-Jul-2013
Pregnancy, puerperium and perinatal conditions Pregnancy	8.3% 1/12 • 9 months, from 23-Oct-2012 to 09-Jul-2013

Additional Information

Chen-En Tsai, M.D., Ph.D.

TaiGen Biotechnology Co., Ltd.

Phone: +886-2-8177-7072

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60