Trial Outcomes & Findings for Safety and PK/PD of TG-0054 in Multiple Myeloma, Non-Hodgkin Lymphoma and Hodgkin Disease Patients (NCT NCT01018979)
NCT ID: NCT01018979
Last Updated: 2021-05-11
Results Overview
Patients who met the target CD34+ cell collection of ≧2 x 106 cells/kg after two apheresis sessions were classified as achieving mobilization success.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
19 participants
Primary outcome timeframe
1 week
Results posted on
2021-05-11
Participant Flow
A total of 20 subjects were randomized. Among these, 19 subjects met all eligibility criteria and received at least one dose of TG-0054.
Participant milestones
| Measure |
TG-0054 (2.24 mg/kg)
TG-0054: 2.24 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)
|
TG-0054 (3.14 mg/kg)
TG-0054: 3.14 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)
|
|---|---|---|
|
Overall Study
STARTED
|
7
|
13
|
|
Overall Study
Received at Least One Dose
|
7
|
12
|
|
Overall Study
COMPLETED
|
4
|
3
|
|
Overall Study
NOT COMPLETED
|
3
|
10
|
Reasons for withdrawal
| Measure |
TG-0054 (2.24 mg/kg)
TG-0054: 2.24 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)
|
TG-0054 (3.14 mg/kg)
TG-0054: 3.14 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)
|
|---|---|---|
|
Overall Study
Peak CD34+ cell count in PB < 10 cell/uL
|
3
|
9
|
|
Overall Study
Not received at least one dose
|
0
|
1
|
Baseline Characteristics
Safety and PK/PD of TG-0054 in Multiple Myeloma, Non-Hodgkin Lymphoma and Hodgkin Disease Patients
Baseline characteristics by cohort
| Measure |
TG-0054 (2.24 mg/kg)
n=7 Participants
TG-0054: 2.24 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)
|
TG-0054 (3.14 mg/kg)
n=12 Participants
TG-0054: 3.14 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)
|
Total
n=19 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
47.3 years
STANDARD_DEVIATION 15.5 • n=5 Participants
|
52.4 years
STANDARD_DEVIATION 9.3 • n=7 Participants
|
50.5 years
STANDARD_DEVIATION 11.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Height
|
162.7 centimeters
STANDARD_DEVIATION 10.1 • n=5 Participants
|
158.7 centimeters
STANDARD_DEVIATION 8.6 • n=7 Participants
|
160.2 centimeters
STANDARD_DEVIATION 9.1 • n=5 Participants
|
|
Weight
|
67.3 kilogram
STANDARD_DEVIATION 23.1 • n=5 Participants
|
60.6 kilogram
STANDARD_DEVIATION 10.2 • n=7 Participants
|
63.1 kilogram
STANDARD_DEVIATION 15.9 • n=5 Participants
|
|
Body Mass Index
|
25.1 kilogram/ meter^2
STANDARD_DEVIATION 6.0 • n=5 Participants
|
24.0 kilogram/ meter^2
STANDARD_DEVIATION 3.0 • n=7 Participants
|
24.4 kilogram/ meter^2
STANDARD_DEVIATION 4.2 • n=5 Participants
|
|
Diagnosis
Multiple myeloma
|
3 participants
n=5 Participants
|
4 participants
n=7 Participants
|
7 participants
n=5 Participants
|
|
Diagnosis
Non-Hodgkin lymphoma
|
3 participants
n=5 Participants
|
7 participants
n=7 Participants
|
10 participants
n=5 Participants
|
|
Diagnosis
Hodgkin disease
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 weekPopulation: In TG-0054 (2.24 mg/kg) group, A total of 4 patients (2 with MM, 1 with NHL, and 1 with HD) underwent apheresis procedure. In TG-0054 (3.14 mg/kg) group, A total of 3 patients (1 with MM and 2 with NHL) underwent apheresis procedure.
Patients who met the target CD34+ cell collection of ≧2 x 106 cells/kg after two apheresis sessions were classified as achieving mobilization success.
Outcome measures
| Measure |
TG-0054 (2.24 mg/kg)
n=4 Participants
TG-0054: 2.24 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)
|
TG-0054 (3.14 mg/kg)
n=3 Participants
TG-0054: 3.14 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)
|
All Patients
All patents = MM + NHL + HD
|
|---|---|---|---|
|
Number of Patients Who Achieved Mobilization Success of Hematopoietic Stem Cells in Patients With Multiple Myeloma (MM), Non-Hodgkin Lymphoma (NHL) or Hodgkin Disease (HD).
MM
|
1 participants
|
1 participants
|
—
|
|
Number of Patients Who Achieved Mobilization Success of Hematopoietic Stem Cells in Patients With Multiple Myeloma (MM), Non-Hodgkin Lymphoma (NHL) or Hodgkin Disease (HD).
NHL
|
1 participants
|
0 participants
|
—
|
|
Number of Patients Who Achieved Mobilization Success of Hematopoietic Stem Cells in Patients With Multiple Myeloma (MM), Non-Hodgkin Lymphoma (NHL) or Hodgkin Disease (HD).
HD
|
0 participants
|
0 participants
|
—
|
SECONDARY outcome
Timeframe: 36 hrs after infusionPopulation: According to the protocol, blood samples for PK assessment of TG-0054 were obtained from 6 consenting patients in each arm on study Day 1 at pre-dose, end of infusion, and 1 hr, 3 hr, 6 hr, 9 hr, 12 hr, 24 hr and 36 hrs after infusion.
Plasma concentrations of TG-0054 were determinate by validated LC-MS/MS method.
Outcome measures
| Measure |
TG-0054 (2.24 mg/kg)
n=6 Participants
TG-0054: 2.24 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)
|
TG-0054 (3.14 mg/kg)
n=6 Participants
TG-0054: 3.14 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)
|
All Patients
All patents = MM + NHL + HD
|
|---|---|---|---|
|
Maximum Plasma Concentration (Cmax) of TG-0054 in 12 Consented Patients With MM, NHL or HD.
|
20971 ng/mL
Standard Deviation 6995
|
29665 ng/mL
Standard Deviation 18583
|
—
|
SECONDARY outcome
Timeframe: Baseline, 3 hours and 6 hours after infusionOutcome measures
| Measure |
TG-0054 (2.24 mg/kg)
n=7 Participants
TG-0054: 2.24 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)
|
TG-0054 (3.14 mg/kg)
n=12 Participants
TG-0054: 3.14 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)
|
All Patients
n=19 Participants
All patents = MM + NHL + HD
|
|---|---|---|---|
|
Fold Increase of Circulating CD34+ Cell Counts in Peripheral Blood.
Fold increase (3 hours after infusion)
|
7.0 fold
Standard Deviation 5.9
|
6.1 fold
Standard Deviation 6.1
|
6.4 fold
Standard Deviation 5.9
|
|
Fold Increase of Circulating CD34+ Cell Counts in Peripheral Blood.
Fold increase (6 hours after infusion)
|
7.8 fold
Standard Deviation 7.2
|
7.8 fold
Standard Deviation 10.4
|
7.8 fold
Standard Deviation 9.1
|
|
Fold Increase of Circulating CD34+ Cell Counts in Peripheral Blood.
Fold increase (Maximum increase)
|
9.3 fold
Standard Deviation 7.5
|
10.3 fold
Standard Deviation 8.9
|
10.0 fold
Standard Deviation 8.4
|
SECONDARY outcome
Timeframe: 36 hrs after infusionPopulation: According to the protocol, blood samples for PK assessment of TG-0054 were obtained from 6 consenting patients in each arm on study Day 1 at pre-dose, end of infusion, and 1 hr, 3 hr, 6 hr, 9 hr, 12 hr, 24 hr and 36 hrs after infusion.
Plasma concentrations of TG-0054 were determinate by validated LC-MS/MS method.
Outcome measures
| Measure |
TG-0054 (2.24 mg/kg)
n=6 Participants
TG-0054: 2.24 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)
|
TG-0054 (3.14 mg/kg)
n=6 Participants
TG-0054: 3.14 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)
|
All Patients
All patents = MM + NHL + HD
|
|---|---|---|---|
|
Time at Which Maximum Plasma Concentration is Observed (Tmax) of TG-0054 in 12 Consented Patients With MM, NHL or HD.
|
0.25 hr
Standard Deviation 0
|
0.25 hr
Standard Deviation 0
|
—
|
SECONDARY outcome
Timeframe: 36 hrs after infusionPopulation: According to the protocol, blood samples for PK assessment of TG-0054 were obtained from 6 consenting patients in each arm on study Day 1 at pre-dose, end of infusion, and 1 hr, 3 hr, 6 hr, 9 hr, 12 hr, 24 hr and 36 hrs after infusion.
Plasma concentrations of TG-0054 were determinate by validated LC-MS/MS method.
Outcome measures
| Measure |
TG-0054 (2.24 mg/kg)
n=6 Participants
TG-0054: 2.24 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)
|
TG-0054 (3.14 mg/kg)
n=6 Participants
TG-0054: 3.14 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)
|
All Patients
All patents = MM + NHL + HD
|
|---|---|---|---|
|
Terminal Elimination Half-life (t1/2) of TG-0054 in 12 Consented Patients With MM, NHL or HD.
|
4.65 hr
Standard Deviation 0.4
|
4.28 hr
Standard Deviation 0.6
|
—
|
SECONDARY outcome
Timeframe: 36 hrs after infusionPopulation: According to the protocol, blood samples for PK assessment of TG-0054 were obtained from 6 consenting patients in each arm on study Day 1 at pre-dose, end of infusion, and 1 hr, 3 hr, 6 hr, 9 hr, 12 hr, 24 hr and 36 hrs after infusion.
Plasma concentrations of TG-0054 were determinate by validated LC-MS/MS method.
Outcome measures
| Measure |
TG-0054 (2.24 mg/kg)
n=6 Participants
TG-0054: 2.24 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)
|
TG-0054 (3.14 mg/kg)
n=6 Participants
TG-0054: 3.14 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)
|
All Patients
All patents = MM + NHL + HD
|
|---|---|---|---|
|
Terminal Elimination Rate Constant (λz) of TG-0054 in 12 Consented Patients With MM, NHL or HD.
|
0.15 1/hr
Standard Deviation 0.01
|
0.16 1/hr
Standard Deviation 0.02
|
—
|
SECONDARY outcome
Timeframe: 36 hrs after infusionPopulation: According to the protocol, blood samples for PK assessment of TG-0054 were obtained from 6 consenting patients in each arm on study Day 1 at pre-dose, end of infusion, and 1 hr, 3 hr, 6 hr, 9 hr, 12 hr, 24 hr and 36 hrs after infusion.
Plasma concentrations of TG-0054 were determinate by validated LC-MS/MS method.
Outcome measures
| Measure |
TG-0054 (2.24 mg/kg)
n=6 Participants
TG-0054: 2.24 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)
|
TG-0054 (3.14 mg/kg)
n=6 Participants
TG-0054: 3.14 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)
|
All Patients
All patents = MM + NHL + HD
|
|---|---|---|---|
|
The Area Under the Plasma Concentration Time Curve (AUC) From 0 Hours to Time t of TG-0054 in 12 Consented Patients With MM, NHL or HD.
|
43610 hr*ng/mL
Standard Deviation 7034
|
55814 hr*ng/mL
Standard Deviation 12153
|
—
|
SECONDARY outcome
Timeframe: 36 hrs after infusionPopulation: According to the protocol, blood samples for PK assessment of TG-0054 were obtained from 6 consenting patients in each arm on study Day 1 at pre-dose, end of infusion, and 1 hr, 3 hr, 6 hr, 9 hr, 12 hr, 24 hr and 36 hrs after infusion.
Plasma concentrations of TG-0054 were determinate by validated LC-MS/MS method.
Outcome measures
| Measure |
TG-0054 (2.24 mg/kg)
n=6 Participants
TG-0054: 2.24 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)
|
TG-0054 (3.14 mg/kg)
n=6 Participants
TG-0054: 3.14 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)
|
All Patients
All patents = MM + NHL + HD
|
|---|---|---|---|
|
The Area Under the Plasma Concentration Time Curve (AUC) From 0 Hours to Infinity of TG-0054 in 12 Consented Patients With MM, NHL or HD.
|
43713 hr*ng/mL
Standard Deviation 7039
|
55920 hr*ng/mL
Standard Deviation 12170
|
—
|
SECONDARY outcome
Timeframe: 36 hrs after infusionPopulation: According to the protocol, blood samples for PK assessment of TG-0054 were obtained from 6 consenting patients in each arm on study Day 1 at pre-dose, end of infusion, and 1 hr, 3 hr, 6 hr, 9 hr, 12 hr, 24 hr and 36 hrs after infusion.
Plasma concentrations of TG-0054 were determinate by validated LC-MS/MS method.
Outcome measures
| Measure |
TG-0054 (2.24 mg/kg)
n=6 Participants
TG-0054: 2.24 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)
|
TG-0054 (3.14 mg/kg)
n=6 Participants
TG-0054: 3.14 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)
|
All Patients
All patents = MM + NHL + HD
|
|---|---|---|---|
|
Clearance (CL) of TG-0054 in 12 Consented Patients With MM, NHL or HD.
|
52.5 mL/ hr/kg
Standard Deviation 9.4
|
58.6 mL/ hr/kg
Standard Deviation 13.0
|
—
|
SECONDARY outcome
Timeframe: 36 hrs after infusionPopulation: According to the protocol, blood samples for PK assessment of TG-0054 were obtained from 6 consenting patients in each arm on study Day 1 at pre-dose, end of infusion, and 1 hr, 3 hr, 6 hr, 9 hr, 12 hr, 24 hr and 36 hrs after infusion.
Plasma concentrations of TG-0054 were determinate by validated LC-MS/MS method.
Outcome measures
| Measure |
TG-0054 (2.24 mg/kg)
n=6 Participants
TG-0054: 2.24 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)
|
TG-0054 (3.14 mg/kg)
n=6 Participants
TG-0054: 3.14 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)
|
All Patients
All patents = MM + NHL + HD
|
|---|---|---|---|
|
Volume of Distribution at the Terminal State (Vz) of TG-0054 in 12 Consented Patients With MM, NHL or HD.
|
351 mL/kg
Standard Deviation 62
|
366 mL/kg
Standard Deviation 112
|
—
|
SECONDARY outcome
Timeframe: 36 hrs after infusionPopulation: According to the protocol, blood samples for PK assessment of TG-0054 were obtained from 6 consenting patients in each arm on study Day 1 at pre-dose, end of infusion, and 1 hr, 3 hr, 6 hr, 9 hr, 12 hr, 24 hr and 36 hrs after infusion.
Plasma concentrations of TG-0054 were determinate by validated LC-MS/MS method.
Outcome measures
| Measure |
TG-0054 (2.24 mg/kg)
n=6 Participants
TG-0054: 2.24 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)
|
TG-0054 (3.14 mg/kg)
n=6 Participants
TG-0054: 3.14 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)
|
All Patients
All patents = MM + NHL + HD
|
|---|---|---|---|
|
Volume of Distribution at Steady State (Vss) of TG-0054 in 12 Consented Patients With MM, NHL or HD.
|
179 mL/kg
Standard Deviation 64
|
193 mL/kg
Standard Deviation 76
|
—
|
SECONDARY outcome
Timeframe: Baseline, 3 hours and 6 hours after infusionOutcome measures
| Measure |
TG-0054 (2.24 mg/kg)
n=7 Participants
TG-0054: 2.24 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)
|
TG-0054 (3.14 mg/kg)
n=12 Participants
TG-0054: 3.14 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)
|
All Patients
n=19 Participants
All patents = MM + NHL + HD
|
|---|---|---|---|
|
Circulating CD34+ Cell Counts in Peripheral Blood.
PB CD34+ count (Baseline)
|
1.0 cells/μL
Standard Deviation 0.7
|
0.9 cells/μL
Standard Deviation 0.5
|
1.0 cells/μL
Standard Deviation 0.6
|
|
Circulating CD34+ Cell Counts in Peripheral Blood.
PB CD34+ count (3 hours after infusion)
|
5.7 cells/μL
Standard Deviation 4.0
|
4.0 cells/μL
Standard Deviation 2.1
|
4.6 cells/μL
Standard Deviation 2.9
|
|
Circulating CD34+ Cell Counts in Peripheral Blood.
PB CD34+ count (6 hours after infusion)
|
6.3 cells/μL
Standard Deviation 3.9
|
4.3 cells/μL
Standard Deviation 2.7
|
5.1 cells/μL
Standard Deviation 3.3
|
|
Circulating CD34+ Cell Counts in Peripheral Blood.
PB CD34+ count (Maximum increase)
|
7.8 cells/μL
Standard Deviation 4.4
|
5.2 cells/μL
Standard Deviation 3.7
|
6.5 cells/μL
Standard Deviation 4.1
|
Adverse Events
TG-0054 (2.24 mg/kg)
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
TG-0054 (3.14 mg/kg)
Serious events: 6 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
TG-0054 (2.24 mg/kg)
n=7 participants at risk
TG-0054: 2.24 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)
|
TG-0054 (3.14 mg/kg)
n=12 participants at risk
TG-0054: 3.14 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)
|
|---|---|---|
|
Surgical and medical procedures
ADMISSION FOR PREPARATION OF PERIPHERAL BLOOD STEM CELL HARVEST
|
0.00%
0/7 • The whole study period, from Visit 1 (screening, day -14) to Visit 9 (7 days after the last dose)
There were 8 serious AEs (SAE) reported that were all unrelated to study drug. No AEs led to discontinuation of study drug treatment and there were no deaths reported in this study.
|
25.0%
3/12 • The whole study period, from Visit 1 (screening, day -14) to Visit 9 (7 days after the last dose)
There were 8 serious AEs (SAE) reported that were all unrelated to study drug. No AEs led to discontinuation of study drug treatment and there were no deaths reported in this study.
|
|
Surgical and medical procedures
AUTOLOGOUS STEM CELL TRANSPLANT
|
0.00%
0/7 • The whole study period, from Visit 1 (screening, day -14) to Visit 9 (7 days after the last dose)
There were 8 serious AEs (SAE) reported that were all unrelated to study drug. No AEs led to discontinuation of study drug treatment and there were no deaths reported in this study.
|
8.3%
1/12 • The whole study period, from Visit 1 (screening, day -14) to Visit 9 (7 days after the last dose)
There were 8 serious AEs (SAE) reported that were all unrelated to study drug. No AEs led to discontinuation of study drug treatment and there were no deaths reported in this study.
|
|
Surgical and medical procedures
HOSPITALIZATION FOR BONE MARROW TRANSPLANTATION
|
14.3%
1/7 • The whole study period, from Visit 1 (screening, day -14) to Visit 9 (7 days after the last dose)
There were 8 serious AEs (SAE) reported that were all unrelated to study drug. No AEs led to discontinuation of study drug treatment and there were no deaths reported in this study.
|
0.00%
0/12 • The whole study period, from Visit 1 (screening, day -14) to Visit 9 (7 days after the last dose)
There were 8 serious AEs (SAE) reported that were all unrelated to study drug. No AEs led to discontinuation of study drug treatment and there were no deaths reported in this study.
|
|
Surgical and medical procedures
AUTOLOGOUS HEMATOPOIETIC STEM CELL TRANSPLANTATION
|
14.3%
1/7 • The whole study period, from Visit 1 (screening, day -14) to Visit 9 (7 days after the last dose)
There were 8 serious AEs (SAE) reported that were all unrelated to study drug. No AEs led to discontinuation of study drug treatment and there were no deaths reported in this study.
|
0.00%
0/12 • The whole study period, from Visit 1 (screening, day -14) to Visit 9 (7 days after the last dose)
There were 8 serious AEs (SAE) reported that were all unrelated to study drug. No AEs led to discontinuation of study drug treatment and there were no deaths reported in this study.
|
|
Surgical and medical procedures
TREATMENT OF NON-HODGKIN LYMPHOMA
|
0.00%
0/7 • The whole study period, from Visit 1 (screening, day -14) to Visit 9 (7 days after the last dose)
There were 8 serious AEs (SAE) reported that were all unrelated to study drug. No AEs led to discontinuation of study drug treatment and there were no deaths reported in this study.
|
8.3%
1/12 • The whole study period, from Visit 1 (screening, day -14) to Visit 9 (7 days after the last dose)
There were 8 serious AEs (SAE) reported that were all unrelated to study drug. No AEs led to discontinuation of study drug treatment and there were no deaths reported in this study.
|
|
Surgical and medical procedures
PEIPHERAL BLOOD STEM CELL HARVEST
|
0.00%
0/7 • The whole study period, from Visit 1 (screening, day -14) to Visit 9 (7 days after the last dose)
There were 8 serious AEs (SAE) reported that were all unrelated to study drug. No AEs led to discontinuation of study drug treatment and there were no deaths reported in this study.
|
8.3%
1/12 • The whole study period, from Visit 1 (screening, day -14) to Visit 9 (7 days after the last dose)
There were 8 serious AEs (SAE) reported that were all unrelated to study drug. No AEs led to discontinuation of study drug treatment and there were no deaths reported in this study.
|
Other adverse events
| Measure |
TG-0054 (2.24 mg/kg)
n=7 participants at risk
TG-0054: 2.24 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)
|
TG-0054 (3.14 mg/kg)
n=12 participants at risk
TG-0054: 3.14 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)
|
|---|---|---|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
14.3%
1/7 • Number of events 1 • The whole study period, from Visit 1 (screening, day -14) to Visit 9 (7 days after the last dose)
There were 8 serious AEs (SAE) reported that were all unrelated to study drug. No AEs led to discontinuation of study drug treatment and there were no deaths reported in this study.
|
0.00%
0/12 • The whole study period, from Visit 1 (screening, day -14) to Visit 9 (7 days after the last dose)
There were 8 serious AEs (SAE) reported that were all unrelated to study drug. No AEs led to discontinuation of study drug treatment and there were no deaths reported in this study.
|
|
Investigations
ABNORMAL DATA OF INCREASE BILIRUBIN
|
14.3%
1/7 • Number of events 1 • The whole study period, from Visit 1 (screening, day -14) to Visit 9 (7 days after the last dose)
There were 8 serious AEs (SAE) reported that were all unrelated to study drug. No AEs led to discontinuation of study drug treatment and there were no deaths reported in this study.
|
0.00%
0/12 • The whole study period, from Visit 1 (screening, day -14) to Visit 9 (7 days after the last dose)
There were 8 serious AEs (SAE) reported that were all unrelated to study drug. No AEs led to discontinuation of study drug treatment and there were no deaths reported in this study.
|
|
Investigations
CARDIAC DISORDERS-OTHER:QT PROLONG AT 24HR-36HR AFTER INFUSION
|
0.00%
0/7 • The whole study period, from Visit 1 (screening, day -14) to Visit 9 (7 days after the last dose)
There were 8 serious AEs (SAE) reported that were all unrelated to study drug. No AEs led to discontinuation of study drug treatment and there were no deaths reported in this study.
|
8.3%
1/12 • Number of events 1 • The whole study period, from Visit 1 (screening, day -14) to Visit 9 (7 days after the last dose)
There were 8 serious AEs (SAE) reported that were all unrelated to study drug. No AEs led to discontinuation of study drug treatment and there were no deaths reported in this study.
|
|
Respiratory, thoracic and mediastinal disorders
CHEST TIGHTNESS
|
14.3%
1/7 • Number of events 2 • The whole study period, from Visit 1 (screening, day -14) to Visit 9 (7 days after the last dose)
There were 8 serious AEs (SAE) reported that were all unrelated to study drug. No AEs led to discontinuation of study drug treatment and there were no deaths reported in this study.
|
0.00%
0/12 • The whole study period, from Visit 1 (screening, day -14) to Visit 9 (7 days after the last dose)
There were 8 serious AEs (SAE) reported that were all unrelated to study drug. No AEs led to discontinuation of study drug treatment and there were no deaths reported in this study.
|
|
Nervous system disorders
CLONIC OF RIGHT KNEE
|
14.3%
1/7 • Number of events 1 • The whole study period, from Visit 1 (screening, day -14) to Visit 9 (7 days after the last dose)
There were 8 serious AEs (SAE) reported that were all unrelated to study drug. No AEs led to discontinuation of study drug treatment and there were no deaths reported in this study.
|
0.00%
0/12 • The whole study period, from Visit 1 (screening, day -14) to Visit 9 (7 days after the last dose)
There were 8 serious AEs (SAE) reported that were all unrelated to study drug. No AEs led to discontinuation of study drug treatment and there were no deaths reported in this study.
|
|
Gastrointestinal disorders
DIARRHEA
|
14.3%
1/7 • Number of events 1 • The whole study period, from Visit 1 (screening, day -14) to Visit 9 (7 days after the last dose)
There were 8 serious AEs (SAE) reported that were all unrelated to study drug. No AEs led to discontinuation of study drug treatment and there were no deaths reported in this study.
|
8.3%
1/12 • Number of events 1 • The whole study period, from Visit 1 (screening, day -14) to Visit 9 (7 days after the last dose)
There were 8 serious AEs (SAE) reported that were all unrelated to study drug. No AEs led to discontinuation of study drug treatment and there were no deaths reported in this study.
|
|
Nervous system disorders
DIZZINESS
|
28.6%
2/7 • Number of events 2 • The whole study period, from Visit 1 (screening, day -14) to Visit 9 (7 days after the last dose)
There were 8 serious AEs (SAE) reported that were all unrelated to study drug. No AEs led to discontinuation of study drug treatment and there were no deaths reported in this study.
|
8.3%
1/12 • Number of events 1 • The whole study period, from Visit 1 (screening, day -14) to Visit 9 (7 days after the last dose)
There were 8 serious AEs (SAE) reported that were all unrelated to study drug. No AEs led to discontinuation of study drug treatment and there were no deaths reported in this study.
|
|
Respiratory, thoracic and mediastinal disorders
DRY COUGH
|
0.00%
0/7 • The whole study period, from Visit 1 (screening, day -14) to Visit 9 (7 days after the last dose)
There were 8 serious AEs (SAE) reported that were all unrelated to study drug. No AEs led to discontinuation of study drug treatment and there were no deaths reported in this study.
|
8.3%
1/12 • Number of events 1 • The whole study period, from Visit 1 (screening, day -14) to Visit 9 (7 days after the last dose)
There were 8 serious AEs (SAE) reported that were all unrelated to study drug. No AEs led to discontinuation of study drug treatment and there were no deaths reported in this study.
|
|
General disorders
ECCHYMOSIS OVER FEMORAL PUNCTURE SITE
|
0.00%
0/7 • The whole study period, from Visit 1 (screening, day -14) to Visit 9 (7 days after the last dose)
There were 8 serious AEs (SAE) reported that were all unrelated to study drug. No AEs led to discontinuation of study drug treatment and there were no deaths reported in this study.
|
8.3%
1/12 • Number of events 1 • The whole study period, from Visit 1 (screening, day -14) to Visit 9 (7 days after the last dose)
There were 8 serious AEs (SAE) reported that were all unrelated to study drug. No AEs led to discontinuation of study drug treatment and there were no deaths reported in this study.
|
|
Gastrointestinal disorders
EMESIS
|
0.00%
0/7 • The whole study period, from Visit 1 (screening, day -14) to Visit 9 (7 days after the last dose)
There were 8 serious AEs (SAE) reported that were all unrelated to study drug. No AEs led to discontinuation of study drug treatment and there were no deaths reported in this study.
|
8.3%
1/12 • Number of events 1 • The whole study period, from Visit 1 (screening, day -14) to Visit 9 (7 days after the last dose)
There were 8 serious AEs (SAE) reported that were all unrelated to study drug. No AEs led to discontinuation of study drug treatment and there were no deaths reported in this study.
|
|
General disorders
FEVER
|
0.00%
0/7 • The whole study period, from Visit 1 (screening, day -14) to Visit 9 (7 days after the last dose)
There were 8 serious AEs (SAE) reported that were all unrelated to study drug. No AEs led to discontinuation of study drug treatment and there were no deaths reported in this study.
|
8.3%
1/12 • Number of events 1 • The whole study period, from Visit 1 (screening, day -14) to Visit 9 (7 days after the last dose)
There were 8 serious AEs (SAE) reported that were all unrelated to study drug. No AEs led to discontinuation of study drug treatment and there were no deaths reported in this study.
|
|
Metabolism and nutrition disorders
HYPERCALCEMIA
|
14.3%
1/7 • Number of events 3 • The whole study period, from Visit 1 (screening, day -14) to Visit 9 (7 days after the last dose)
There were 8 serious AEs (SAE) reported that were all unrelated to study drug. No AEs led to discontinuation of study drug treatment and there were no deaths reported in this study.
|
0.00%
0/12 • The whole study period, from Visit 1 (screening, day -14) to Visit 9 (7 days after the last dose)
There were 8 serious AEs (SAE) reported that were all unrelated to study drug. No AEs led to discontinuation of study drug treatment and there were no deaths reported in this study.
|
|
Vascular disorders
HYPERTENSION
|
0.00%
0/7 • The whole study period, from Visit 1 (screening, day -14) to Visit 9 (7 days after the last dose)
There were 8 serious AEs (SAE) reported that were all unrelated to study drug. No AEs led to discontinuation of study drug treatment and there were no deaths reported in this study.
|
8.3%
1/12 • Number of events 1 • The whole study period, from Visit 1 (screening, day -14) to Visit 9 (7 days after the last dose)
There were 8 serious AEs (SAE) reported that were all unrelated to study drug. No AEs led to discontinuation of study drug treatment and there were no deaths reported in this study.
|
|
Metabolism and nutrition disorders
HYPOCALCEMIA
|
0.00%
0/7 • The whole study period, from Visit 1 (screening, day -14) to Visit 9 (7 days after the last dose)
There were 8 serious AEs (SAE) reported that were all unrelated to study drug. No AEs led to discontinuation of study drug treatment and there were no deaths reported in this study.
|
8.3%
1/12 • Number of events 1 • The whole study period, from Visit 1 (screening, day -14) to Visit 9 (7 days after the last dose)
There were 8 serious AEs (SAE) reported that were all unrelated to study drug. No AEs led to discontinuation of study drug treatment and there were no deaths reported in this study.
|
|
Metabolism and nutrition disorders
HYPOCALCIUM
|
14.3%
1/7 • Number of events 2 • The whole study period, from Visit 1 (screening, day -14) to Visit 9 (7 days after the last dose)
There were 8 serious AEs (SAE) reported that were all unrelated to study drug. No AEs led to discontinuation of study drug treatment and there were no deaths reported in this study.
|
0.00%
0/12 • The whole study period, from Visit 1 (screening, day -14) to Visit 9 (7 days after the last dose)
There were 8 serious AEs (SAE) reported that were all unrelated to study drug. No AEs led to discontinuation of study drug treatment and there were no deaths reported in this study.
|
|
Metabolism and nutrition disorders
HYPOKALEMIA
|
14.3%
1/7 • Number of events 1 • The whole study period, from Visit 1 (screening, day -14) to Visit 9 (7 days after the last dose)
There were 8 serious AEs (SAE) reported that were all unrelated to study drug. No AEs led to discontinuation of study drug treatment and there were no deaths reported in this study.
|
8.3%
1/12 • Number of events 1 • The whole study period, from Visit 1 (screening, day -14) to Visit 9 (7 days after the last dose)
There were 8 serious AEs (SAE) reported that were all unrelated to study drug. No AEs led to discontinuation of study drug treatment and there were no deaths reported in this study.
|
|
Vascular disorders
HYPOTENSION
|
0.00%
0/7 • The whole study period, from Visit 1 (screening, day -14) to Visit 9 (7 days after the last dose)
There were 8 serious AEs (SAE) reported that were all unrelated to study drug. No AEs led to discontinuation of study drug treatment and there were no deaths reported in this study.
|
8.3%
1/12 • Number of events 1 • The whole study period, from Visit 1 (screening, day -14) to Visit 9 (7 days after the last dose)
There were 8 serious AEs (SAE) reported that were all unrelated to study drug. No AEs led to discontinuation of study drug treatment and there were no deaths reported in this study.
|
|
Vascular disorders
HYPOTENSION BP 82/51MMHG
|
14.3%
1/7 • Number of events 1 • The whole study period, from Visit 1 (screening, day -14) to Visit 9 (7 days after the last dose)
There were 8 serious AEs (SAE) reported that were all unrelated to study drug. No AEs led to discontinuation of study drug treatment and there were no deaths reported in this study.
|
0.00%
0/12 • The whole study period, from Visit 1 (screening, day -14) to Visit 9 (7 days after the last dose)
There were 8 serious AEs (SAE) reported that were all unrelated to study drug. No AEs led to discontinuation of study drug treatment and there were no deaths reported in this study.
|
|
Vascular disorders
HYPOVOLEMIC HYPOTENSION BP 78/56MMHG
|
14.3%
1/7 • Number of events 1 • The whole study period, from Visit 1 (screening, day -14) to Visit 9 (7 days after the last dose)
There were 8 serious AEs (SAE) reported that were all unrelated to study drug. No AEs led to discontinuation of study drug treatment and there were no deaths reported in this study.
|
0.00%
0/12 • The whole study period, from Visit 1 (screening, day -14) to Visit 9 (7 days after the last dose)
There were 8 serious AEs (SAE) reported that were all unrelated to study drug. No AEs led to discontinuation of study drug treatment and there were no deaths reported in this study.
|
|
Investigations
INCREASE ALANINE AMINOTRANS-FERASE
|
14.3%
1/7 • Number of events 1 • The whole study period, from Visit 1 (screening, day -14) to Visit 9 (7 days after the last dose)
There were 8 serious AEs (SAE) reported that were all unrelated to study drug. No AEs led to discontinuation of study drug treatment and there were no deaths reported in this study.
|
0.00%
0/12 • The whole study period, from Visit 1 (screening, day -14) to Visit 9 (7 days after the last dose)
There were 8 serious AEs (SAE) reported that were all unrelated to study drug. No AEs led to discontinuation of study drug treatment and there were no deaths reported in this study.
|
|
Investigations
INCREASE ALPHA-GANNA GLUTAMYL TRANSPEPTIDASE
|
14.3%
1/7 • Number of events 1 • The whole study period, from Visit 1 (screening, day -14) to Visit 9 (7 days after the last dose)
There were 8 serious AEs (SAE) reported that were all unrelated to study drug. No AEs led to discontinuation of study drug treatment and there were no deaths reported in this study.
|
0.00%
0/12 • The whole study period, from Visit 1 (screening, day -14) to Visit 9 (7 days after the last dose)
There were 8 serious AEs (SAE) reported that were all unrelated to study drug. No AEs led to discontinuation of study drug treatment and there were no deaths reported in this study.
|
|
Skin and subcutaneous tissue disorders
ITCHY SKIN
|
0.00%
0/7 • The whole study period, from Visit 1 (screening, day -14) to Visit 9 (7 days after the last dose)
There were 8 serious AEs (SAE) reported that were all unrelated to study drug. No AEs led to discontinuation of study drug treatment and there were no deaths reported in this study.
|
8.3%
1/12 • Number of events 1 • The whole study period, from Visit 1 (screening, day -14) to Visit 9 (7 days after the last dose)
There were 8 serious AEs (SAE) reported that were all unrelated to study drug. No AEs led to discontinuation of study drug treatment and there were no deaths reported in this study.
|
|
Blood and lymphatic system disorders
LEUKOCYTOSIS
|
28.6%
2/7 • Number of events 3 • The whole study period, from Visit 1 (screening, day -14) to Visit 9 (7 days after the last dose)
There were 8 serious AEs (SAE) reported that were all unrelated to study drug. No AEs led to discontinuation of study drug treatment and there were no deaths reported in this study.
|
16.7%
2/12 • Number of events 2 • The whole study period, from Visit 1 (screening, day -14) to Visit 9 (7 days after the last dose)
There were 8 serious AEs (SAE) reported that were all unrelated to study drug. No AEs led to discontinuation of study drug treatment and there were no deaths reported in this study.
|
|
Musculoskeletal and connective tissue disorders
LOW BACK PAIN
|
0.00%
0/7 • The whole study period, from Visit 1 (screening, day -14) to Visit 9 (7 days after the last dose)
There were 8 serious AEs (SAE) reported that were all unrelated to study drug. No AEs led to discontinuation of study drug treatment and there were no deaths reported in this study.
|
8.3%
1/12 • Number of events 1 • The whole study period, from Visit 1 (screening, day -14) to Visit 9 (7 days after the last dose)
There were 8 serious AEs (SAE) reported that were all unrelated to study drug. No AEs led to discontinuation of study drug treatment and there were no deaths reported in this study.
|
|
Gastrointestinal disorders
MILD ABDOMINAL PAIN
|
14.3%
1/7 • Number of events 1 • The whole study period, from Visit 1 (screening, day -14) to Visit 9 (7 days after the last dose)
There were 8 serious AEs (SAE) reported that were all unrelated to study drug. No AEs led to discontinuation of study drug treatment and there were no deaths reported in this study.
|
0.00%
0/12 • The whole study period, from Visit 1 (screening, day -14) to Visit 9 (7 days after the last dose)
There were 8 serious AEs (SAE) reported that were all unrelated to study drug. No AEs led to discontinuation of study drug treatment and there were no deaths reported in this study.
|
|
Gastrointestinal disorders
MILD DIARRHEA
|
14.3%
1/7 • Number of events 1 • The whole study period, from Visit 1 (screening, day -14) to Visit 9 (7 days after the last dose)
There were 8 serious AEs (SAE) reported that were all unrelated to study drug. No AEs led to discontinuation of study drug treatment and there were no deaths reported in this study.
|
0.00%
0/12 • The whole study period, from Visit 1 (screening, day -14) to Visit 9 (7 days after the last dose)
There were 8 serious AEs (SAE) reported that were all unrelated to study drug. No AEs led to discontinuation of study drug treatment and there were no deaths reported in this study.
|
|
Nervous system disorders
MILD DIZZINESS
|
14.3%
1/7 • Number of events 1 • The whole study period, from Visit 1 (screening, day -14) to Visit 9 (7 days after the last dose)
There were 8 serious AEs (SAE) reported that were all unrelated to study drug. No AEs led to discontinuation of study drug treatment and there were no deaths reported in this study.
|
0.00%
0/12 • The whole study period, from Visit 1 (screening, day -14) to Visit 9 (7 days after the last dose)
There were 8 serious AEs (SAE) reported that were all unrelated to study drug. No AEs led to discontinuation of study drug treatment and there were no deaths reported in this study.
|
|
Nervous system disorders
MILD HEADACHE
|
14.3%
1/7 • Number of events 1 • The whole study period, from Visit 1 (screening, day -14) to Visit 9 (7 days after the last dose)
There were 8 serious AEs (SAE) reported that were all unrelated to study drug. No AEs led to discontinuation of study drug treatment and there were no deaths reported in this study.
|
0.00%
0/12 • The whole study period, from Visit 1 (screening, day -14) to Visit 9 (7 days after the last dose)
There were 8 serious AEs (SAE) reported that were all unrelated to study drug. No AEs led to discontinuation of study drug treatment and there were no deaths reported in this study.
|
|
Gastrointestinal disorders
NAUSEA
|
14.3%
1/7 • Number of events 1 • The whole study period, from Visit 1 (screening, day -14) to Visit 9 (7 days after the last dose)
There were 8 serious AEs (SAE) reported that were all unrelated to study drug. No AEs led to discontinuation of study drug treatment and there were no deaths reported in this study.
|
0.00%
0/12 • The whole study period, from Visit 1 (screening, day -14) to Visit 9 (7 days after the last dose)
There were 8 serious AEs (SAE) reported that were all unrelated to study drug. No AEs led to discontinuation of study drug treatment and there were no deaths reported in this study.
|
|
Nervous system disorders
NUMBNESS OF FACE
|
0.00%
0/7 • The whole study period, from Visit 1 (screening, day -14) to Visit 9 (7 days after the last dose)
There were 8 serious AEs (SAE) reported that were all unrelated to study drug. No AEs led to discontinuation of study drug treatment and there were no deaths reported in this study.
|
8.3%
1/12 • Number of events 2 • The whole study period, from Visit 1 (screening, day -14) to Visit 9 (7 days after the last dose)
There were 8 serious AEs (SAE) reported that were all unrelated to study drug. No AEs led to discontinuation of study drug treatment and there were no deaths reported in this study.
|
|
Nervous system disorders
NUMBNESS OF FACE AND PALM
|
14.3%
1/7 • Number of events 1 • The whole study period, from Visit 1 (screening, day -14) to Visit 9 (7 days after the last dose)
There were 8 serious AEs (SAE) reported that were all unrelated to study drug. No AEs led to discontinuation of study drug treatment and there were no deaths reported in this study.
|
0.00%
0/12 • The whole study period, from Visit 1 (screening, day -14) to Visit 9 (7 days after the last dose)
There were 8 serious AEs (SAE) reported that were all unrelated to study drug. No AEs led to discontinuation of study drug treatment and there were no deaths reported in this study.
|
|
Nervous system disorders
NUMBNESS OF FACE HANDS AND LEGS
|
14.3%
1/7 • Number of events 1 • The whole study period, from Visit 1 (screening, day -14) to Visit 9 (7 days after the last dose)
There were 8 serious AEs (SAE) reported that were all unrelated to study drug. No AEs led to discontinuation of study drug treatment and there were no deaths reported in this study.
|
0.00%
0/12 • The whole study period, from Visit 1 (screening, day -14) to Visit 9 (7 days after the last dose)
There were 8 serious AEs (SAE) reported that were all unrelated to study drug. No AEs led to discontinuation of study drug treatment and there were no deaths reported in this study.
|
|
Nervous system disorders
NUMBNESS OF LEGS AND LIPS
|
14.3%
1/7 • Number of events 1 • The whole study period, from Visit 1 (screening, day -14) to Visit 9 (7 days after the last dose)
There were 8 serious AEs (SAE) reported that were all unrelated to study drug. No AEs led to discontinuation of study drug treatment and there were no deaths reported in this study.
|
0.00%
0/12 • The whole study period, from Visit 1 (screening, day -14) to Visit 9 (7 days after the last dose)
There were 8 serious AEs (SAE) reported that were all unrelated to study drug. No AEs led to discontinuation of study drug treatment and there were no deaths reported in this study.
|
|
Nervous system disorders
NUMBNESS OF LIPS
|
14.3%
1/7 • Number of events 1 • The whole study period, from Visit 1 (screening, day -14) to Visit 9 (7 days after the last dose)
There were 8 serious AEs (SAE) reported that were all unrelated to study drug. No AEs led to discontinuation of study drug treatment and there were no deaths reported in this study.
|
0.00%
0/12 • The whole study period, from Visit 1 (screening, day -14) to Visit 9 (7 days after the last dose)
There were 8 serious AEs (SAE) reported that were all unrelated to study drug. No AEs led to discontinuation of study drug treatment and there were no deaths reported in this study.
|
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 PI needs to inform sponsor and asks for permission before he/she discusses or publishes trial results after the trial is completed.
- Publication restrictions are in place
Restriction type: OTHER