Trial Outcomes & Findings for QUILT-3.010: A Study of Gemcitabine and Nab-paclitaxel With or Without NPC-1C to Treat Patients With Pancreatic Cancer (NCT NCT01834235)

Last Updated: 2025-05-07

Results Overview

To determine the safety and tolerability of NPC-1C monoclonal antibody therapy in combination with Gemcitabine in subjects with metastatic, locally advanced unresectable or recurrent pancreatic cancer who failed or did not tolerate first line chemotherapy of FOLFIRINOX and whose tumors bind NPC-1C.

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

81 participants

Primary outcome timeframe

28 days

Results posted on

2025-05-07

Participant Flow

Participant milestones

Participant milestones
Measure	Phase 2 Randomization to Arm A Patients on arm A will receive Nab-paclitaxel at a dose of 125 mg/m2 as a 30 minute infusion followed by 1000 mg/m2 gemcitabine for 3 consecutive weeks followed by a week of rest (treatment on days 1, 8, and 15, during a 28-day cycle. NPC-1C (NEO-102) will be infused 30 minutes after completion of the gemcitabine infusion at a dose of 1.5mg/kg IV on days 1 and 15 of the 28 day cycle.	Phase 2 Randomization to Arm B Nab-paclitaxel will be administered at a dose of 125 mg/m2 as a 30 minute infusion (maximum infusion time not to exceed 40 minutes) followed by 1000 mg/m2 gemcitabine as a 30 minute infusion for 3 consecutive weeks followed by a week of rest (treatment on days 1, 8, and 15, during a 28-day cycle).	Phase 1-Dose Finding - Dose Level 1 Gemcitabine and NPC-1C at 1.5 mg/kg /dose
Overall Study STARTED	38	40	3
Overall Study COMPLETED	38	40	3
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

QUILT-3.010: A Study of Gemcitabine and Nab-paclitaxel With or Without NPC-1C to Treat Patients With Pancreatic Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Phase 1 Dose Finding: Dose Level 1 n=3 Participants Patients on arm B will receive NPC-1C(NEO-102) infusion at a dose of 1.5mg/kg IV on days 1 and 15 of a 4-week cycle. This will be administered 30minutes after completion of the gemcitabine 1000 mg/m2 as a 30 minute infusion on days 1, 8, and 15 of a 4 week cycle.	Phase 1 Dose Finding: Dose Level -1 Patients on arm B will receive NPC-1C(NEO-102) infusion at a dose of 1.0 mg/kg IV on days 1 and 15 of a 4-week cycle. This will be administered 30minutes after completion of the gemcitabine 1000 mg/m2 as a 30 minute infusion on days 1, 8, and 15 of a 4 week cycle.	Arm A: Abraxane, Gemcitabine, NPC-1C n=38 Participants Nab-paclitaxel will be administered at a dose of 125 mg/m2 as a 30 minute infusion (maximum infusion time not to exceed 40 minutes) followed by 1000 mg/m2 gemcitabine as a 30 minute infusion for 3 consecutive weeks followed by a week of rest. Patients on arm B will receive NPC-1C(NEO-102) infusion at a dose of 1.5mg/kg IV on days 1 and 15 of a 4-week cycle. This will be administered 30minutes after completion of the gemcitabine infusion. Gemcitabine: Gemcitabine IV at a dose of 1000mg/m2 on days 1, 8, and 15 of a 4 week cycle. nab-paclitaxel: Nab-paclitaxel will be administered at a dose of 125 mg/m2 as a 30 minute infusion (maximum infusion time not to exceed 40 minutes) on Days 1, 7 and 15 for a 28 day cycle NPC-1C: NPC-1C(NEO-102) infusion at a dose of 1.5mg/kg IV on days 1 and 15 of a 28 day cycle. This will be administered 30 minutes after completion of the gemcitabine infusion.	Arm B: Abraxane, Gemcitabine n=40 Participants Nab-paclitaxel will be administered at a dose of 125 mg/m2 as a 30 minute infusion (maximum infusion time not to exceed 40 minutes) followed by 1000 mg/m2 gemcitabine as a 30 minute infusion for 3 consecutive weeks followed by a week of rest. Gemcitabine: Gemcitabine IV at a dose of 1000mg/m2 on days 1, 8, and 15 of a 4 week cycle. nab-paclitaxel: Nab-paclitaxel will be administered at a dose of 125 mg/m2 as a 30 minute infusion (maximum infusion time not to exceed 40 minutes) on Days 1, 7 and 15 for a 28 day cycle	Total n=81 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=99 Participants	0 Participants n=107 Participants	26 Participants n=206 Participants	24 Participants n=7 Participants	52 Participants n=31 Participants
Age, Categorical >=65 years	1 Participants n=99 Participants	0 Participants n=107 Participants	12 Participants n=206 Participants	16 Participants n=7 Participants	29 Participants n=31 Participants
Age, Continuous	53 years n=99 Participants	—	62 years n=206 Participants	62.5 years n=7 Participants	62 years n=31 Participants
Sex: Female, Male Female	3 Participants n=99 Participants	—	19 Participants n=206 Participants	29 Participants n=7 Participants	51 Participants n=31 Participants
Sex: Female, Male Male	0 Participants n=99 Participants	—	19 Participants n=206 Participants	11 Participants n=7 Participants	30 Participants n=31 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=99 Participants	—	3 Participants n=206 Participants	4 Participants n=7 Participants	8 Participants n=31 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	2 Participants n=99 Participants	—	33 Participants n=206 Participants	34 Participants n=7 Participants	69 Participants n=31 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	—	2 Participants n=206 Participants	2 Participants n=7 Participants	4 Participants n=31 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants	—	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants
Race (NIH/OMB) Asian	0 Participants n=99 Participants	—	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants	—	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants
Race (NIH/OMB) Black or African American	2 Participants n=99 Participants	—	4 Participants n=206 Participants	5 Participants n=7 Participants	11 Participants n=31 Participants
Race (NIH/OMB) White	1 Participants n=99 Participants	—	32 Participants n=206 Participants	34 Participants n=7 Participants	67 Participants n=31 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants	—	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	—	2 Participants n=206 Participants	1 Participants n=7 Participants	3 Participants n=31 Participants
Region of Enrollment United States	3 participants n=99 Participants	—	38 participants n=206 Participants	40 participants n=7 Participants	81 participants n=31 Participants
NPC-1C IHC staining	3 participants positive n=99 Participants	—	38 participants positive n=206 Participants	40 participants positive n=7 Participants	81 participants positive n=31 Participants

PRIMARY outcome

Timeframe: 28 days

Population: Dose level -1 did not enroll any patients because dose level 1 was found to be safe when NEO-102 was given in combination with Gemcitabine. Hence there was no need to dose de-escalate.

Outcome measures

Outcome measures
Measure	Phase 1-Dose Finding Dose Level 1 n=3 Participants Gemcitabine will be administered at the dose of 1000 mg/m2 by IV infusions over 30 minutes on days 1, 8, and 15 followed in 30 minutes by NPC-1C(NEO-102) 1.5 mg/kg infusion on days 1 and 15 of a 4-week cycle.	Phase 1 Dose Finding: Dose Level -1 Gemcitabine will be administered at the dose of 1000 mg/m2 by IV infusions over 30 minutes on days 1, 8, and 15 followed in 30 minutes by NPC-1C(NEO-102) 1.5 mg/kg infusion on days 1 and 15 of a 4-week cycle. No patients were enrolled to this de-escalated dose because Dose Level 1 was found to be safe when given in combination with Gemcitabine.	Arm A: Abraxane, Gemcitabine, NPC-1C n=38 Participants Patients on arm A will receive Nab-paclitaxel at a dose of 125 mg/m2 as a 30 minute infusion followed by 1000 mg/m2 gemcitabine for 3 consecutive weeks followed by a week of rest (treatment on days 1, 8, and 15, during a 28-day cycle. NPC-1C (NEO-102) will be infused 30 minutes after completion of the gemcitabine infusion at a dose of 1.5mg/kg IV on days 1 and 15 of the 28 day cycle.	Arm B: Abraxane, Gemcitabine n=40 Participants Nab-paclitaxel will be administered at a dose of 125 mg/m2 as a 30 minute infusion (maximum infusion time not to exceed 40 minutes) followed by 1000 mg/m2 gemcitabine as a 30 minute infusion for 3 consecutive weeks followed by a week of rest (treatment on days 1, 8, and 15, during a 28-day cycle).
Safety and Tolerability	0 Participants	—	3 Participants	7 Participants

PRIMARY outcome

Timeframe: From 1st dose of study therapy until death in participants in Phase 2.

Population: 78 participants who received study therapy in the Phase 2 portion of the study. Patients in the Phase 1 portion of the study were not included in the Analysis of outcome measure #2 because they only received NPC-1C and Gemcitabine.

To determine whether (only in participants in the Phase 2 portion (Arm A and Arm B) NPC-1C (NEO-102) in combination with Gemcitabine and nab-Paclitaxel will increase the overall survival (OS) compared to Gemcitabine and nab-Paclitaxel alone in patients with metastatic, locally advanced unresectable or recurrent pancreatic cancer previously treated with FOLFIRINOX and whose tumors bind NPC-1C by at least 20% on IHC.

Outcome measures

Outcome measures
Measure	Phase 1-Dose Finding Dose Level 1 n=38 Participants Gemcitabine will be administered at the dose of 1000 mg/m2 by IV infusions over 30 minutes on days 1, 8, and 15 followed in 30 minutes by NPC-1C(NEO-102) 1.5 mg/kg infusion on days 1 and 15 of a 4-week cycle.	Phase 1 Dose Finding: Dose Level -1 n=40 Participants Gemcitabine will be administered at the dose of 1000 mg/m2 by IV infusions over 30 minutes on days 1, 8, and 15 followed in 30 minutes by NPC-1C(NEO-102) 1.5 mg/kg infusion on days 1 and 15 of a 4-week cycle. No patients were enrolled to this de-escalated dose because Dose Level 1 was found to be safe when given in combination with Gemcitabine.	Arm A: Abraxane, Gemcitabine, NPC-1C Patients on arm A will receive Nab-paclitaxel at a dose of 125 mg/m2 as a 30 minute infusion followed by 1000 mg/m2 gemcitabine for 3 consecutive weeks followed by a week of rest (treatment on days 1, 8, and 15, during a 28-day cycle. NPC-1C (NEO-102) will be infused 30 minutes after completion of the gemcitabine infusion at a dose of 1.5mg/kg IV on days 1 and 15 of the 28 day cycle.	Arm B: Abraxane, Gemcitabine Nab-paclitaxel will be administered at a dose of 125 mg/m2 as a 30 minute infusion (maximum infusion time not to exceed 40 minutes) followed by 1000 mg/m2 gemcitabine as a 30 minute infusion for 3 consecutive weeks followed by a week of rest (treatment on days 1, 8, and 15, during a 28-day cycle).
Overall Survival	6.6 Number of months survival Interval 4.7 to 8.4	5 Number of months survival Interval 3.3 to 6.5	—	—

SECONDARY outcome

Timeframe: Time from the 1st dose of study drug until progression in patients in Arm A

Population: 78 participants who received study therapy in the Phase 2 portion of the study. Patients in the Phase 1 portion of the study were not included in the Analysis of outcome measure #3 because they only received NPC-1C and Gemcitabine.

To determine the progression free survival (PFS) and response rate (RR) of patients with metastatic or locally advanced unresectable or recurrent pancreatic cancer who progressed following or did not tolerate chemotherapy of FOLFIRINOX or FOLFIRINOX-like regimen when receiving the combination of NPC-1C(NEO-102) monoclonal antibody, Gemcitabine and nab-Paclitaxel (Arm A).

Outcome measures

Outcome measures
Measure	Phase 1-Dose Finding Dose Level 1 n=38 Participants Gemcitabine will be administered at the dose of 1000 mg/m2 by IV infusions over 30 minutes on days 1, 8, and 15 followed in 30 minutes by NPC-1C(NEO-102) 1.5 mg/kg infusion on days 1 and 15 of a 4-week cycle.	Phase 1 Dose Finding: Dose Level -1 n=40 Participants Gemcitabine will be administered at the dose of 1000 mg/m2 by IV infusions over 30 minutes on days 1, 8, and 15 followed in 30 minutes by NPC-1C(NEO-102) 1.5 mg/kg infusion on days 1 and 15 of a 4-week cycle. No patients were enrolled to this de-escalated dose because Dose Level 1 was found to be safe when given in combination with Gemcitabine.	Arm A: Abraxane, Gemcitabine, NPC-1C Patients on arm A will receive Nab-paclitaxel at a dose of 125 mg/m2 as a 30 minute infusion followed by 1000 mg/m2 gemcitabine for 3 consecutive weeks followed by a week of rest (treatment on days 1, 8, and 15, during a 28-day cycle. NPC-1C (NEO-102) will be infused 30 minutes after completion of the gemcitabine infusion at a dose of 1.5mg/kg IV on days 1 and 15 of the 28 day cycle.	Arm B: Abraxane, Gemcitabine Nab-paclitaxel will be administered at a dose of 125 mg/m2 as a 30 minute infusion (maximum infusion time not to exceed 40 minutes) followed by 1000 mg/m2 gemcitabine as a 30 minute infusion for 3 consecutive weeks followed by a week of rest (treatment on days 1, 8, and 15, during a 28-day cycle).
Progression Free Survival	3.5 Median number of months without PD Interval 2.0 to 5.6	2.7 Median number of months without PD Interval 1.9 to 4.1	—	—

Adverse Events

Arm A

Serious events: 18 serious events

Other events: 32 other events

Deaths: 38 deaths

Arm B

Serious events: 12 serious events

Other events: 33 other events

Deaths: 40 deaths

Phase 1- Dose Finding -Dose Level 1

Serious events: 0 serious events

Other events: 0 other events

Deaths: 3 deaths

Phase 1- Dose Finding -Dose Level -1

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Arm A n=38 participants at risk Patients on arm A will receive Nab-paclitaxel at a dose of 125 mg/m2 as a 30 minute infusion followed by 1000 mg/m2 gemcitabine for 3 consecutive weeks followed by a week of rest (treatment on days 1, 8, and 15, during a 28-day cycle. NPC-1C (NEO-102) will be infused 30 minutes after completion of the gemcitabine infusion at a dose of 1.5mg/kg IV on days 1 and 15 of the 28 day cycle.	Arm B n=40 participants at risk Nab-paclitaxel will be administered at a dose of 125 mg/m2 as a 30 minute infusion (maximum infusion time not to exceed 40 minutes) followed by 1000 mg/m2 gemcitabine as a 30 minute infusion for 3 consecutive weeks followed by a week of rest (treatment on days 1, 8, and 15, during a 28-day cycle).	Phase 1- Dose Finding -Dose Level 1 n=3 participants at risk Gemcitabine and NPC-1c at 1.5 mg/kg/dose	Phase 1- Dose Finding -Dose Level -1 Gemcitabine and NPC-1c at 1.0 mg/kg/dose
Investigations Absolute Lymphocyte count decreased	7.9% 3/38 • Number of events 8 • Through study completion an average of 8 months A event is considered serious if it results in any of the following: * Death, * A life-threatening AE * Inpatient hospitalization or prolongation * Persistent or significant incapacity * A congenital anomaly/birth defect. * Important medical events that may not result in death, be life-threatening, or require hospitalization	7.5% 3/40 • Number of events 4 • Through study completion an average of 8 months A event is considered serious if it results in any of the following: * Death, * A life-threatening AE * Inpatient hospitalization or prolongation * Persistent or significant incapacity * A congenital anomaly/birth defect. * Important medical events that may not result in death, be life-threatening, or require hospitalization	0.00% 0/3 • Through study completion an average of 8 months A event is considered serious if it results in any of the following: * Death, * A life-threatening AE * Inpatient hospitalization or prolongation * Persistent or significant incapacity * A congenital anomaly/birth defect. * Important medical events that may not result in death, be life-threatening, or require hospitalization	— 0/0 • Through study completion an average of 8 months A event is considered serious if it results in any of the following: * Death, * A life-threatening AE * Inpatient hospitalization or prolongation * Persistent or significant incapacity * A congenital anomaly/birth defect. * Important medical events that may not result in death, be life-threatening, or require hospitalization
Investigations Alkaline Phosphatase increased	10.5% 4/38 • Number of events 4 • Through study completion an average of 8 months A event is considered serious if it results in any of the following: * Death, * A life-threatening AE * Inpatient hospitalization or prolongation * Persistent or significant incapacity * A congenital anomaly/birth defect. * Important medical events that may not result in death, be life-threatening, or require hospitalization	0.00% 0/40 • Through study completion an average of 8 months A event is considered serious if it results in any of the following: * Death, * A life-threatening AE * Inpatient hospitalization or prolongation * Persistent or significant incapacity * A congenital anomaly/birth defect. * Important medical events that may not result in death, be life-threatening, or require hospitalization	0.00% 0/3 • Through study completion an average of 8 months A event is considered serious if it results in any of the following: * Death, * A life-threatening AE * Inpatient hospitalization or prolongation * Persistent or significant incapacity * A congenital anomaly/birth defect. * Important medical events that may not result in death, be life-threatening, or require hospitalization	— 0/0 • Through study completion an average of 8 months A event is considered serious if it results in any of the following: * Death, * A life-threatening AE * Inpatient hospitalization or prolongation * Persistent or significant incapacity * A congenital anomaly/birth defect. * Important medical events that may not result in death, be life-threatening, or require hospitalization
Blood and lymphatic system disorders Anemia	39.5% 15/38 • Number of events 22 • Through study completion an average of 8 months A event is considered serious if it results in any of the following: * Death, * A life-threatening AE * Inpatient hospitalization or prolongation * Persistent or significant incapacity * A congenital anomaly/birth defect. * Important medical events that may not result in death, be life-threatening, or require hospitalization	10.0% 4/40 • Number of events 7 • Through study completion an average of 8 months A event is considered serious if it results in any of the following: * Death, * A life-threatening AE * Inpatient hospitalization or prolongation * Persistent or significant incapacity * A congenital anomaly/birth defect. * Important medical events that may not result in death, be life-threatening, or require hospitalization	0.00% 0/3 • Through study completion an average of 8 months A event is considered serious if it results in any of the following: * Death, * A life-threatening AE * Inpatient hospitalization or prolongation * Persistent or significant incapacity * A congenital anomaly/birth defect. * Important medical events that may not result in death, be life-threatening, or require hospitalization	— 0/0 • Through study completion an average of 8 months A event is considered serious if it results in any of the following: * Death, * A life-threatening AE * Inpatient hospitalization or prolongation * Persistent or significant incapacity * A congenital anomaly/birth defect. * Important medical events that may not result in death, be life-threatening, or require hospitalization
General disorders Fatigue	13.2% 5/38 • Number of events 5 • Through study completion an average of 8 months A event is considered serious if it results in any of the following: * Death, * A life-threatening AE * Inpatient hospitalization or prolongation * Persistent or significant incapacity * A congenital anomaly/birth defect. * Important medical events that may not result in death, be life-threatening, or require hospitalization	2.5% 1/40 • Number of events 2 • Through study completion an average of 8 months A event is considered serious if it results in any of the following: * Death, * A life-threatening AE * Inpatient hospitalization or prolongation * Persistent or significant incapacity * A congenital anomaly/birth defect. * Important medical events that may not result in death, be life-threatening, or require hospitalization	0.00% 0/3 • Through study completion an average of 8 months A event is considered serious if it results in any of the following: * Death, * A life-threatening AE * Inpatient hospitalization or prolongation * Persistent or significant incapacity * A congenital anomaly/birth defect. * Important medical events that may not result in death, be life-threatening, or require hospitalization	— 0/0 • Through study completion an average of 8 months A event is considered serious if it results in any of the following: * Death, * A life-threatening AE * Inpatient hospitalization or prolongation * Persistent or significant incapacity * A congenital anomaly/birth defect. * Important medical events that may not result in death, be life-threatening, or require hospitalization
Investigations Neutropenia	34.2% 13/38 • Number of events 15 • Through study completion an average of 8 months A event is considered serious if it results in any of the following: * Death, * A life-threatening AE * Inpatient hospitalization or prolongation * Persistent or significant incapacity * A congenital anomaly/birth defect. * Important medical events that may not result in death, be life-threatening, or require hospitalization	30.0% 12/40 • Number of events 16 • Through study completion an average of 8 months A event is considered serious if it results in any of the following: * Death, * A life-threatening AE * Inpatient hospitalization or prolongation * Persistent or significant incapacity * A congenital anomaly/birth defect. * Important medical events that may not result in death, be life-threatening, or require hospitalization	0.00% 0/3 • Through study completion an average of 8 months A event is considered serious if it results in any of the following: * Death, * A life-threatening AE * Inpatient hospitalization or prolongation * Persistent or significant incapacity * A congenital anomaly/birth defect. * Important medical events that may not result in death, be life-threatening, or require hospitalization	— 0/0 • Through study completion an average of 8 months A event is considered serious if it results in any of the following: * Death, * A life-threatening AE * Inpatient hospitalization or prolongation * Persistent or significant incapacity * A congenital anomaly/birth defect. * Important medical events that may not result in death, be life-threatening, or require hospitalization
Investigations Platelet count decreased	31.6% 12/38 • Number of events 13 • Through study completion an average of 8 months A event is considered serious if it results in any of the following: * Death, * A life-threatening AE * Inpatient hospitalization or prolongation * Persistent or significant incapacity * A congenital anomaly/birth defect. * Important medical events that may not result in death, be life-threatening, or require hospitalization	20.0% 8/40 • Number of events 13 • Through study completion an average of 8 months A event is considered serious if it results in any of the following: * Death, * A life-threatening AE * Inpatient hospitalization or prolongation * Persistent or significant incapacity * A congenital anomaly/birth defect. * Important medical events that may not result in death, be life-threatening, or require hospitalization	0.00% 0/3 • Through study completion an average of 8 months A event is considered serious if it results in any of the following: * Death, * A life-threatening AE * Inpatient hospitalization or prolongation * Persistent or significant incapacity * A congenital anomaly/birth defect. * Important medical events that may not result in death, be life-threatening, or require hospitalization	— 0/0 • Through study completion an average of 8 months A event is considered serious if it results in any of the following: * Death, * A life-threatening AE * Inpatient hospitalization or prolongation * Persistent or significant incapacity * A congenital anomaly/birth defect. * Important medical events that may not result in death, be life-threatening, or require hospitalization
Investigations White blood cell count decreased	23.7% 9/38 • Number of events 9 • Through study completion an average of 8 months A event is considered serious if it results in any of the following: * Death, * A life-threatening AE * Inpatient hospitalization or prolongation * Persistent or significant incapacity * A congenital anomaly/birth defect. * Important medical events that may not result in death, be life-threatening, or require hospitalization	12.5% 5/40 • Number of events 5 • Through study completion an average of 8 months A event is considered serious if it results in any of the following: * Death, * A life-threatening AE * Inpatient hospitalization or prolongation * Persistent or significant incapacity * A congenital anomaly/birth defect. * Important medical events that may not result in death, be life-threatening, or require hospitalization	0.00% 0/3 • Through study completion an average of 8 months A event is considered serious if it results in any of the following: * Death, * A life-threatening AE * Inpatient hospitalization or prolongation * Persistent or significant incapacity * A congenital anomaly/birth defect. * Important medical events that may not result in death, be life-threatening, or require hospitalization	— 0/0 • Through study completion an average of 8 months A event is considered serious if it results in any of the following: * Death, * A life-threatening AE * Inpatient hospitalization or prolongation * Persistent or significant incapacity * A congenital anomaly/birth defect. * Important medical events that may not result in death, be life-threatening, or require hospitalization

Additional Information

Dr. Philip Arlen President and CEO

Precision Biologics Inc.

Phone: 3015008646

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place