Trial Outcomes & Findings for A Two-part Phase IIb Trial of Vigil (Bi-shRNAfurin and GMCSF Augmented Autologous Tumor Cell Immunotherapy) in Ewing's Sarcoma (NCT NCT02511132)

Last Updated: 2022-12-22

Results Overview

To determine safety profile of Vigil immunotherapy in combination with irinotecan and temozolomide with 30 days of last dose in patients with metastatic Ewing's sarcoma refractory or intolerant to at least 1 prior line of systemic chemotherapy. • To determine safety profile of Vigil immunotherapy in combination with irinotecan and temozolimidetemozolomide in patients with metastatic Ewing's sarcoma refractory or intolerant to at least 1 prior line of systemic chemotherapy.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

22 participants

Primary outcome timeframe

30 days of last treatment dosing

Results posted on

2022-12-22

Participant Flow

Participant milestones

Participant milestones
Measure	Part 1: Vigil Alone Vigil immunotherapy 1.0 X 10\^7 cells/injection; minimum of 4 to a maximum of 12 administrations every 28 days.	Part 1: Gemicitabine and Docetaxel Gemcitabine 675 mg/m2 IV at 10 mg/m2/min D1 and Docetaxel 75 mg/m2 IV starting on D8 and given every 21 days.	Part 2: Vigil in Combination With Temozolomide and Irinotecan (i) oral temozolomide 100 mg/m2 daily (Days 1 - 5, total dose 500 mg/m2/cycle), (ii) irinotecan 50 mg/m2 daily (Days 1 - 5, total dose 250mg/m2/cycle), orally or irinotecan 20mg/m2 daily (Days 1 - 5, total dose 100mg/m2/cycle ), intravenously (iii) peg-filgrastim 100μg/kg (Day 6) subcutaneously (optional and may be administered at home), and (iv) Vigil 1.0 x 107 cells/injection, intradermally on Day 15 and every 3 weeks thereafter. One cycle = 21 days.
Overall Study STARTED	5	8	9
Overall Study COMPLETED	5	7	9
Overall Study NOT COMPLETED	0	1	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Two-part Phase IIb Trial of Vigil (Bi-shRNAfurin and GMCSF Augmented Autologous Tumor Cell Immunotherapy) in Ewing's Sarcoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Part 1: Vigil Alone n=5 Participants Vigil immunotherapy 1.0 X 10\^7 cells/injection; minimum of 4 to a maximum of 12 administrations every 28 days.	Part 1: Gemicitabine and Docetaxel n=8 Participants Gemcitabine 675 mg/m2 IV at 10 mg/m2/min D1 and Docetaxel 75 mg/m2 IV starting on D8 and given every 21 days.	Part 2: Vigil in Combination With Temozolomide and Irinotecan n=9 Participants (i) oral temozolomide 100 mg/m2 daily (Days 1 - 5, total dose 500 mg/m2/cycle), (ii) irinotecan 50 mg/m2 daily (Days 1 - 5, total dose 250mg/m2/cycle), orally or irinotecan 20mg/m2 daily (Days 1 - 5, total dose 100mg/m2/cycle ), intravenously (iii) peg-filgrastim 100μg/kg (Day 6) subcutaneously (optional and may be administered at home), and (iv) Vigil 1.0 x 107 cells/injection, intradermally on Day 15 and every 3 weeks thereafter. One cycle = 21 days.	Total n=22 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	4 Participants n=7 Participants	3 Participants n=5 Participants	7 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants	15 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	6 Participants n=7 Participants	4 Participants n=5 Participants	13 Participants n=4 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants	9 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	4 Participants n=5 Participants	7 Participants n=7 Participants	8 Participants n=5 Participants	19 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) White	5 Participants n=5 Participants	7 Participants n=7 Participants	9 Participants n=5 Participants	21 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Region of Enrollment United States	5 participants n=5 Participants	8 participants n=7 Participants	9 participants n=5 Participants	22 participants n=4 Participants

PRIMARY outcome

Timeframe: 30 days of last treatment dosing

Outcome measures

Outcome measures
Measure	Part 1: Vigil Alone n=5 Participants Vigil immunotherapy 1.0 X 10\^7 cells/injection; minimum of 4 to a maximum of 12 administrations every 28 days.	Part 1: Gemcitabine and Docetaxel n=8 Participants Gemcitabine 675 mg/m2 IV at 10 mg/m2/min D1 and Docetaxel 75 mg/m2 IV starting on D8 and given every 21 days.	Part 2: Vigil in Combination With Temozolomide and Irinotecan n=9 Participants (i) oral temozolomide 100 mg/m2 daily (Days 1 - 5, total dose 500 mg/m2/cycle), (ii) irinotecan 50 mg/m2 daily (Days 1 - 5, total dose 250mg/m2/cycle), orally or irinotecan 20mg/m2 daily (Days 1 - 5, total dose 100mg/m2/cycle ), intravenously (iii) peg-filgrastim 100μg/kg (Day 6) subcutaneously (optional and may be administered at home), and (iv) Vigil 1.0 x 107 cells/injection, intradermally on Day 15 and every 3 weeks thereafter. One cycle = 21 days.
Number of Participants With Adverse Events Determined by Laboratory Assessments and Physical Examinations	5 Participants	6 Participants	9 Participants

SECONDARY outcome

Timeframe: Estimated median 1.3 years

Progression Free Survival (PFS) is defined as the time from randomization to the event of disease recurrence/progression defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) or death due to any cause. To determine the progression free survival of subjects dosed with Vigil immunotherapy in combination with irinotecan and temozolomide.

Outcome measures

Outcome measures
Measure	Part 1: Vigil Alone n=5 Participants Vigil immunotherapy 1.0 X 10\^7 cells/injection; minimum of 4 to a maximum of 12 administrations every 28 days.	Part 1: Gemcitabine and Docetaxel n=8 Participants Gemcitabine 675 mg/m2 IV at 10 mg/m2/min D1 and Docetaxel 75 mg/m2 IV starting on D8 and given every 21 days.	Part 2: Vigil in Combination With Temozolomide and Irinotecan n=9 Participants (i) oral temozolomide 100 mg/m2 daily (Days 1 - 5, total dose 500 mg/m2/cycle), (ii) irinotecan 50 mg/m2 daily (Days 1 - 5, total dose 250mg/m2/cycle), orally or irinotecan 20mg/m2 daily (Days 1 - 5, total dose 100mg/m2/cycle ), intravenously (iii) peg-filgrastim 100μg/kg (Day 6) subcutaneously (optional and may be administered at home), and (iv) Vigil 1.0 x 107 cells/injection, intradermally on Day 15 and every 3 weeks thereafter. One cycle = 21 days.
Progression Free Survival	5 Participants	6 Participants	9 Participants

SECONDARY outcome

Timeframe: Estimated median 2 years

OS is defined as time from randomization to death or to the date of last follow-up. The date of last follow-up confirming survival will be used as the censoring date for subjects who are alive and/or do not have a known date of death.

Outcome measures

Outcome measures
Measure	Part 1: Vigil Alone n=5 Participants Vigil immunotherapy 1.0 X 10\^7 cells/injection; minimum of 4 to a maximum of 12 administrations every 28 days.	Part 1: Gemcitabine and Docetaxel n=8 Participants Gemcitabine 675 mg/m2 IV at 10 mg/m2/min D1 and Docetaxel 75 mg/m2 IV starting on D8 and given every 21 days.	Part 2: Vigil in Combination With Temozolomide and Irinotecan n=9 Participants (i) oral temozolomide 100 mg/m2 daily (Days 1 - 5, total dose 500 mg/m2/cycle), (ii) irinotecan 50 mg/m2 daily (Days 1 - 5, total dose 250mg/m2/cycle), orally or irinotecan 20mg/m2 daily (Days 1 - 5, total dose 100mg/m2/cycle ), intravenously (iii) peg-filgrastim 100μg/kg (Day 6) subcutaneously (optional and may be administered at home), and (iv) Vigil 1.0 x 107 cells/injection, intradermally on Day 15 and every 3 weeks thereafter. One cycle = 21 days.
Overall Survival	3 Participants	6 Participants	5 Participants

Adverse Events

Part 1: Vigil Alone

Serious events: 2 serious events

Other events: 2 other events

Deaths: 4 deaths

Part 1: Gemicitabine and Docetaxel

Serious events: 5 serious events

Other events: 5 other events

Deaths: 8 deaths

Part 2: Vigil Plus Temozolomide and Irinotecan

Serious events: 5 serious events

Other events: 9 other events

Deaths: 9 deaths

Serious adverse events

Other adverse events

Additional Information

Clinical and Regulatory Operations

Gradalis, Inc.

Phone: 214-442-8100

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60

Measure	Part 1: Vigil Alone n=5 participants at risk Vigil immunotherapy 1.0 x 107 cells/injection; minimum of 4 to a maximum of 12 administrations every 28 days Vigil: Vigil 1.0 x 10e7 cells/injection, minimum of 4 to a maximum of 12 administrations.	Part 1: Gemicitabine and Docetaxel n=8 participants at risk Gemcitabine 675 mg/m2 IV at 10 mg/m2/min D1 and Docetaxel 75 mg/m2 IV starting on D8 and given every 21 days. Gemcitabine: 675 mg/m2 IV at a rate of 10 mg/m2/min on Day 1 and Day 8 every 21 days Docetaxel: 75 mg/m2 IV administered on Day 8 and every 21 days	Part 2: Vigil Plus Temozolomide and Irinotecan n=9 participants at risk (i) oral temozolomide 100 mg/m2 daily (Days 1 - 5, total dose 500 mg/m2/cycle), (ii) irinotecan 50 mg/m2 daily (Days 1 - 5, total dose 250mg/m2/cycle), orally or irinotecan 20mg/m2 daily (Days 1 - 5, total dose 100mg/m2/cycle ), intravenously (iii) peg-filgrastim 100μg/kg (Day 6) subcutaneously (optional and may be administered at home), and (iv) Vigil 1.0 x 107 cells/injection, intradermally on Day 15 and every 3 weeks thereafter. One cycle = 21 days. Vigil: Vigil 1.0 x 10e7 cells/injection, minimum of 4 to a maximum of 12 administrations. Temozolomide: oral temozolimidetemozolomide 100 mg/m2 daily (Days 1 - 5, total dose 500 mg/m2/cycle) Irinotecan: irinotecan 50 mg/m2 daily (Days 1 - 5, total dose 250mg/m2/cycle), orally or irinotecan 20mg/m2 daily (Days 1 - 5, total dose 100mg/m2/cycle ), intravenously
General disorders Edema extremities	20.0% 1/5 • Number of events 1 • Adverse events were recorded for the duration of a patient's study treatment: from the first dose of the Investigational Product to 30 days following the last study treatment (up to 10 months).	0.00% 0/8 • Adverse events were recorded for the duration of a patient's study treatment: from the first dose of the Investigational Product to 30 days following the last study treatment (up to 10 months).	0.00% 0/9 • Adverse events were recorded for the duration of a patient's study treatment: from the first dose of the Investigational Product to 30 days following the last study treatment (up to 10 months).
General disorders Disease progression	20.0% 1/5 • Number of events 1 • Adverse events were recorded for the duration of a patient's study treatment: from the first dose of the Investigational Product to 30 days following the last study treatment (up to 10 months).	0.00% 0/8 • Adverse events were recorded for the duration of a patient's study treatment: from the first dose of the Investigational Product to 30 days following the last study treatment (up to 10 months).	11.1% 1/9 • Number of events 1 • Adverse events were recorded for the duration of a patient's study treatment: from the first dose of the Investigational Product to 30 days following the last study treatment (up to 10 months).
Musculoskeletal and connective tissue disorders Back pain	20.0% 1/5 • Number of events 1 • Adverse events were recorded for the duration of a patient's study treatment: from the first dose of the Investigational Product to 30 days following the last study treatment (up to 10 months).	0.00% 0/8 • Adverse events were recorded for the duration of a patient's study treatment: from the first dose of the Investigational Product to 30 days following the last study treatment (up to 10 months).	11.1% 1/9 • Number of events 1 • Adverse events were recorded for the duration of a patient's study treatment: from the first dose of the Investigational Product to 30 days following the last study treatment (up to 10 months).
Respiratory, thoracic and mediastinal disorders Dyspnea	20.0% 1/5 • Number of events 1 • Adverse events were recorded for the duration of a patient's study treatment: from the first dose of the Investigational Product to 30 days following the last study treatment (up to 10 months).	0.00% 0/8 • Adverse events were recorded for the duration of a patient's study treatment: from the first dose of the Investigational Product to 30 days following the last study treatment (up to 10 months).	0.00% 0/9 • Adverse events were recorded for the duration of a patient's study treatment: from the first dose of the Investigational Product to 30 days following the last study treatment (up to 10 months).
Nervous system disorders Brain mass	0.00% 0/5 • Adverse events were recorded for the duration of a patient's study treatment: from the first dose of the Investigational Product to 30 days following the last study treatment (up to 10 months).	12.5% 1/8 • Number of events 1 • Adverse events were recorded for the duration of a patient's study treatment: from the first dose of the Investigational Product to 30 days following the last study treatment (up to 10 months).	0.00% 0/9 • Adverse events were recorded for the duration of a patient's study treatment: from the first dose of the Investigational Product to 30 days following the last study treatment (up to 10 months).
Skin and subcutaneous tissue disorders Blisters	0.00% 0/5 • Adverse events were recorded for the duration of a patient's study treatment: from the first dose of the Investigational Product to 30 days following the last study treatment (up to 10 months).	12.5% 1/8 • Number of events 1 • Adverse events were recorded for the duration of a patient's study treatment: from the first dose of the Investigational Product to 30 days following the last study treatment (up to 10 months).	0.00% 0/9 • Adverse events were recorded for the duration of a patient's study treatment: from the first dose of the Investigational Product to 30 days following the last study treatment (up to 10 months).
Skin and subcutaneous tissue disorders Facial swelling	0.00% 0/5 • Adverse events were recorded for the duration of a patient's study treatment: from the first dose of the Investigational Product to 30 days following the last study treatment (up to 10 months).	12.5% 1/8 • Number of events 1 • Adverse events were recorded for the duration of a patient's study treatment: from the first dose of the Investigational Product to 30 days following the last study treatment (up to 10 months).	0.00% 0/9 • Adverse events were recorded for the duration of a patient's study treatment: from the first dose of the Investigational Product to 30 days following the last study treatment (up to 10 months).
Nervous system disorders Headache	0.00% 0/5 • Adverse events were recorded for the duration of a patient's study treatment: from the first dose of the Investigational Product to 30 days following the last study treatment (up to 10 months).	12.5% 1/8 • Number of events 2 • Adverse events were recorded for the duration of a patient's study treatment: from the first dose of the Investigational Product to 30 days following the last study treatment (up to 10 months).	11.1% 1/9 • Number of events 1 • Adverse events were recorded for the duration of a patient's study treatment: from the first dose of the Investigational Product to 30 days following the last study treatment (up to 10 months).
Vascular disorders Hypertension	0.00% 0/5 • Adverse events were recorded for the duration of a patient's study treatment: from the first dose of the Investigational Product to 30 days following the last study treatment (up to 10 months).	12.5% 1/8 • Number of events 2 • Adverse events were recorded for the duration of a patient's study treatment: from the first dose of the Investigational Product to 30 days following the last study treatment (up to 10 months).	0.00% 0/9 • Adverse events were recorded for the duration of a patient's study treatment: from the first dose of the Investigational Product to 30 days following the last study treatment (up to 10 months).
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/5 • Adverse events were recorded for the duration of a patient's study treatment: from the first dose of the Investigational Product to 30 days following the last study treatment (up to 10 months).	0.00% 0/8 • Adverse events were recorded for the duration of a patient's study treatment: from the first dose of the Investigational Product to 30 days following the last study treatment (up to 10 months).	11.1% 1/9 • Number of events 1 • Adverse events were recorded for the duration of a patient's study treatment: from the first dose of the Investigational Product to 30 days following the last study treatment (up to 10 months).
Gastrointestinal disorders Diarrhea	0.00% 0/5 • Adverse events were recorded for the duration of a patient's study treatment: from the first dose of the Investigational Product to 30 days following the last study treatment (up to 10 months).	0.00% 0/8 • Adverse events were recorded for the duration of a patient's study treatment: from the first dose of the Investigational Product to 30 days following the last study treatment (up to 10 months).	11.1% 1/9 • Number of events 1 • Adverse events were recorded for the duration of a patient's study treatment: from the first dose of the Investigational Product to 30 days following the last study treatment (up to 10 months).
Gastrointestinal disorders Nausea	0.00% 0/5 • Adverse events were recorded for the duration of a patient's study treatment: from the first dose of the Investigational Product to 30 days following the last study treatment (up to 10 months).	0.00% 0/8 • Adverse events were recorded for the duration of a patient's study treatment: from the first dose of the Investigational Product to 30 days following the last study treatment (up to 10 months).	11.1% 1/9 • Number of events 1 • Adverse events were recorded for the duration of a patient's study treatment: from the first dose of the Investigational Product to 30 days following the last study treatment (up to 10 months).
Gastrointestinal disorders Vomiting	0.00% 0/5 • Adverse events were recorded for the duration of a patient's study treatment: from the first dose of the Investigational Product to 30 days following the last study treatment (up to 10 months).	0.00% 0/8 • Adverse events were recorded for the duration of a patient's study treatment: from the first dose of the Investigational Product to 30 days following the last study treatment (up to 10 months).	22.2% 2/9 • Number of events 2 • Adverse events were recorded for the duration of a patient's study treatment: from the first dose of the Investigational Product to 30 days following the last study treatment (up to 10 months).
General disorders Fever	0.00% 0/5 • Adverse events were recorded for the duration of a patient's study treatment: from the first dose of the Investigational Product to 30 days following the last study treatment (up to 10 months).	12.5% 1/8 • Number of events 1 • Adverse events were recorded for the duration of a patient's study treatment: from the first dose of the Investigational Product to 30 days following the last study treatment (up to 10 months).	11.1% 1/9 • Number of events 1 • Adverse events were recorded for the duration of a patient's study treatment: from the first dose of the Investigational Product to 30 days following the last study treatment (up to 10 months).
General disorders Pain	0.00% 0/5 • Adverse events were recorded for the duration of a patient's study treatment: from the first dose of the Investigational Product to 30 days following the last study treatment (up to 10 months).	12.5% 1/8 • Number of events 1 • Adverse events were recorded for the duration of a patient's study treatment: from the first dose of the Investigational Product to 30 days following the last study treatment (up to 10 months).	11.1% 1/9 • Number of events 1 • Adverse events were recorded for the duration of a patient's study treatment: from the first dose of the Investigational Product to 30 days following the last study treatment (up to 10 months).
Infections and infestations Empyema	0.00% 0/5 • Adverse events were recorded for the duration of a patient's study treatment: from the first dose of the Investigational Product to 30 days following the last study treatment (up to 10 months).	0.00% 0/8 • Adverse events were recorded for the duration of a patient's study treatment: from the first dose of the Investigational Product to 30 days following the last study treatment (up to 10 months).	11.1% 1/9 • Number of events 1 • Adverse events were recorded for the duration of a patient's study treatment: from the first dose of the Investigational Product to 30 days following the last study treatment (up to 10 months).
Infections and infestations Pneumonia	0.00% 0/5 • Adverse events were recorded for the duration of a patient's study treatment: from the first dose of the Investigational Product to 30 days following the last study treatment (up to 10 months).	0.00% 0/8 • Adverse events were recorded for the duration of a patient's study treatment: from the first dose of the Investigational Product to 30 days following the last study treatment (up to 10 months).	11.1% 1/9 • Number of events 1 • Adverse events were recorded for the duration of a patient's study treatment: from the first dose of the Investigational Product to 30 days following the last study treatment (up to 10 months).
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/5 • Adverse events were recorded for the duration of a patient's study treatment: from the first dose of the Investigational Product to 30 days following the last study treatment (up to 10 months).	0.00% 0/8 • Adverse events were recorded for the duration of a patient's study treatment: from the first dose of the Investigational Product to 30 days following the last study treatment (up to 10 months).	11.1% 1/9 • Number of events 1 • Adverse events were recorded for the duration of a patient's study treatment: from the first dose of the Investigational Product to 30 days following the last study treatment (up to 10 months).
Investigations Platelets decreased	0.00% 0/5 • Adverse events were recorded for the duration of a patient's study treatment: from the first dose of the Investigational Product to 30 days following the last study treatment (up to 10 months).	12.5% 1/8 • Number of events 1 • Adverse events were recorded for the duration of a patient's study treatment: from the first dose of the Investigational Product to 30 days following the last study treatment (up to 10 months).	0.00% 0/9 • Adverse events were recorded for the duration of a patient's study treatment: from the first dose of the Investigational Product to 30 days following the last study treatment (up to 10 months).
Investigations WBC decreased	0.00% 0/5 • Adverse events were recorded for the duration of a patient's study treatment: from the first dose of the Investigational Product to 30 days following the last study treatment (up to 10 months).	12.5% 1/8 • Number of events 1 • Adverse events were recorded for the duration of a patient's study treatment: from the first dose of the Investigational Product to 30 days following the last study treatment (up to 10 months).	0.00% 0/9 • Adverse events were recorded for the duration of a patient's study treatment: from the first dose of the Investigational Product to 30 days following the last study treatment (up to 10 months).
Immune system disorders Anaphylaxis	0.00% 0/5 • Adverse events were recorded for the duration of a patient's study treatment: from the first dose of the Investigational Product to 30 days following the last study treatment (up to 10 months).	12.5% 1/8 • Number of events 1 • Adverse events were recorded for the duration of a patient's study treatment: from the first dose of the Investigational Product to 30 days following the last study treatment (up to 10 months).	0.00% 0/9 • Adverse events were recorded for the duration of a patient's study treatment: from the first dose of the Investigational Product to 30 days following the last study treatment (up to 10 months).
Blood and lymphatic system disorders Neutropenia	0.00% 0/5 • Adverse events were recorded for the duration of a patient's study treatment: from the first dose of the Investigational Product to 30 days following the last study treatment (up to 10 months).	12.5% 1/8 • Number of events 1 • Adverse events were recorded for the duration of a patient's study treatment: from the first dose of the Investigational Product to 30 days following the last study treatment (up to 10 months).	0.00% 0/9 • Adverse events were recorded for the duration of a patient's study treatment: from the first dose of the Investigational Product to 30 days following the last study treatment (up to 10 months).