Trial Outcomes & Findings for Genetically Modified Neural Stem Cells, Flucytosine, and Leucovorin for Treating Patients With Recurrent High-Grade Gliomas (NCT NCT02015819)

NCT ID: NCT02015819

Last Updated: 2021-10-20

Results Overview

Number of DLTs per dose level and the MTD/MFD.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

16 participants

Primary outcome timeframe

Day 28 of course 1

Results posted on

2021-10-20

Participant Flow

Participant milestones

Participant milestones
Measure	Dose Level 1 (NSC 5x10^7 and 5-FC 37.5 mg/kg) Patients receive CD-expressing neural stem cells intracranially on days 1 and 15. Flucytosine is taken orally every 6 hours on days 4-10 and 18-24. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.	Dose Level 2 (NSC 1x10^8 and 5-FC 37.5 mg/kg) Patients receive CD-expressing neural stem cells intracranially on days 1 and 15. Flucytosine is taken orally every 6 hours on days 4-10 and 18-24. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.	Dose Level 3 (NSC 1.5x10^8 and 5-FC 37.5 mg/kg) Patients receive CD-expressing neural stem cells intracranially on days 1 and 15. Flucytosine is taken orally every 6 hours on days 4-10 and 18-24. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.	Dose Level 4 (NSC 1.5x10^8 and 5-FC 37.5 mg/kg) + Leucovorin + Microdialysis Patients receive CD-expressing neural stem cells intracranially on days 1 and 15. Flucytosine is taken orally every 6 hours on days 4-10 and 18-24. They will also be given leucovorin orally every 6 hours on days 4-10 and 18-24. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Overall Study STARTED	3	3	3	7
Overall Study COMPLETED	3	3	3	6
Overall Study NOT COMPLETED	0	0	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Dose Level 1 (NSC 5x10^7 and 5-FC 37.5 mg/kg) Patients receive CD-expressing neural stem cells intracranially on days 1 and 15. Flucytosine is taken orally every 6 hours on days 4-10 and 18-24. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.	Dose Level 2 (NSC 1x10^8 and 5-FC 37.5 mg/kg) Patients receive CD-expressing neural stem cells intracranially on days 1 and 15. Flucytosine is taken orally every 6 hours on days 4-10 and 18-24. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.	Dose Level 3 (NSC 1.5x10^8 and 5-FC 37.5 mg/kg) Patients receive CD-expressing neural stem cells intracranially on days 1 and 15. Flucytosine is taken orally every 6 hours on days 4-10 and 18-24. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.	Dose Level 4 (NSC 1.5x10^8 and 5-FC 37.5 mg/kg) + Leucovorin + Microdialysis Patients receive CD-expressing neural stem cells intracranially on days 1 and 15. Flucytosine is taken orally every 6 hours on days 4-10 and 18-24. They will also be given leucovorin orally every 6 hours on days 4-10 and 18-24. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Overall Study Rickham catheter was misaligned	0	0	0	1

Baseline Characteristics

Genetically Modified Neural Stem Cells, Flucytosine, and Leucovorin for Treating Patients With Recurrent High-Grade Gliomas

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Dose Level 1 (NSC 5x10^7 and 5-FC 37.5 mg/kg) n=3 Participants Patients receive CD-expressing neural stem cells intracranially on days 1 and 15. Flucytosine is taken orally every 6 hours on days 4-10 and 18-24. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.	Dose Level 2 (NSC 1x10^8 and 5-FC 37.5 mg/kg) n=3 Participants Patients receive CD-expressing neural stem cells intracranially on days 1 and 15. Flucytosine is taken orally every 6 hours on days 4-10 and 18-24. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.	Dose Level 3 (NSC 1.5x10^8 and 5-FC 37.5 mg/kg) n=3 Participants Patients receive CD-expressing neural stem cells intracranially on days 1 and 15. Flucytosine is taken orally every 6 hours on days 4-10 and 18-24. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.	Dose Level 4 (NSC 1.5x10^8 and 5-FC 37.5 mg/kg) + Leucovorin + Microdialysis n=7 Participants Patients receive CD-expressing neural stem cells intracranially on days 1 and 15. Flucytosine is taken orally every 6 hours on days 4-10 and 18-24. Leucovorin orally every 6 hours on days 4-10 and 18-24. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.	Total n=16 Participants Total of all reporting groups
Age, Continuous	59 years n=93 Participants	40 years n=4 Participants	57 years n=27 Participants	58 years n=483 Participants	57 years n=36 Participants
Sex: Female, Male Female	2 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants	0 Participants n=483 Participants	3 Participants n=36 Participants
Sex: Female, Male Male	1 Participants n=93 Participants	3 Participants n=4 Participants	2 Participants n=27 Participants	7 Participants n=483 Participants	13 Participants n=36 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=93 Participants	0 Participants n=4 Participants	2 Participants n=27 Participants	2 Participants n=483 Participants	4 Participants n=36 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=93 Participants	3 Participants n=4 Participants	1 Participants n=27 Participants	5 Participants n=483 Participants	12 Participants n=36 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants
Race (NIH/OMB) Asian	1 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	1 Participants n=36 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants
Race (NIH/OMB) Black or African American	0 Participants n=93 Participants	1 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	1 Participants n=36 Participants
Race (NIH/OMB) White	2 Participants n=93 Participants	2 Participants n=4 Participants	3 Participants n=27 Participants	7 Participants n=483 Participants	14 Participants n=36 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants
Region of Enrollment United States	3 participants n=93 Participants	3 participants n=4 Participants	3 participants n=27 Participants	7 participants n=483 Participants	16 participants n=36 Participants

PRIMARY outcome

Timeframe: Day 28 of course 1

Population: 1 participant in dose level 4 was unevaluable and had to be replaced after receiving the first dose of CD-NSCs due to the tip of the Rickham catheter migrating into the lateral ventricle.

Number of DLTs per dose level and the MTD/MFD.

Outcome measures

Outcome measures
Measure	Dose Level 1: (NSC 5x10^7 and 5-FC 37.5 mg/kg) n=3 Participants Patients receive CD-expressing neural stem cells intracranially on days 1 and 15. Flucytosine is taken orally every 6 hours on days 4-10 and 18-24. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.	Dose Level 2: (NSC 1x10^8 and 5-FC 37.5 mg/kg) n=3 Participants Patients receive CD-expressing neural stem cells intracranially on days 1 and 15. Flucytosine is taken orally every 6 hours on days 4-10 and 18-24. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.	Dose Level 3 (NSC 1.5x10^8 and 5-FC 37.5 mg/kg) n=3 Participants Patients receive CD-expressing neural stem cells intracranially on days 1 and 15. Flucytosine is taken orally every 6 hours on days 4-10 and 18-24. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.	Dose Level 4 (NSC 1.5x10^8 and 5-FC 37.5 mg/kg + Leucovorin + Microdialysis n=6 Participants Patients receive CD-expressing neural stem cells intracranially on days 1 and 15. Flucytosine is taken orally every 6 hours on days 4-10 and 18-24. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Number of Participants With Dose Limiting Toxicities (DLTs) and Maximum Tolerated Dose (MTD)	0 Participants	0 Participants	0 Participants	1 Participants

PRIMARY outcome

Timeframe: 28 days after last infusion of NSCs, up to 6 months total

Number of participants with mechanical issues with repeat administrations of NSCs via Rickham.

Outcome measures

Outcome measures
Measure	Dose Level 1: (NSC 5x10^7 and 5-FC 37.5 mg/kg) n=3 Participants Patients receive CD-expressing neural stem cells intracranially on days 1 and 15. Flucytosine is taken orally every 6 hours on days 4-10 and 18-24. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.	Dose Level 2: (NSC 1x10^8 and 5-FC 37.5 mg/kg) n=3 Participants Patients receive CD-expressing neural stem cells intracranially on days 1 and 15. Flucytosine is taken orally every 6 hours on days 4-10 and 18-24. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.	Dose Level 3 (NSC 1.5x10^8 and 5-FC 37.5 mg/kg) n=3 Participants Patients receive CD-expressing neural stem cells intracranially on days 1 and 15. Flucytosine is taken orally every 6 hours on days 4-10 and 18-24. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.	Dose Level 4 (NSC 1.5x10^8 and 5-FC 37.5 mg/kg + Leucovorin + Microdialysis n=7 Participants Patients receive CD-expressing neural stem cells intracranially on days 1 and 15. Flucytosine is taken orally every 6 hours on days 4-10 and 18-24. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Number of Participants With Mechanical Issues With Repeat Administrations of NSCs Via Rickham	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: While receiving treatment, up to 6 months.

Population: 2 participants in dose level 4 were not assessed in this analysis because one participant only received one dose of CD-NSCs and the other we were unable to obtain post second CD-NSC dose serum sample to analyze.

Development of a antibody response to the NSCs will be evaluated by flow cytometry. Data from assessing for possible development of NSC immunogenicity with repeat exposure will be presented in an exploratory fashion using descriptive statistics.

Outcome measures

Outcome measures
Measure	Dose Level 1: (NSC 5x10^7 and 5-FC 37.5 mg/kg) n=3 Participants Patients receive CD-expressing neural stem cells intracranially on days 1 and 15. Flucytosine is taken orally every 6 hours on days 4-10 and 18-24. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.	Dose Level 2: (NSC 1x10^8 and 5-FC 37.5 mg/kg) n=3 Participants Patients receive CD-expressing neural stem cells intracranially on days 1 and 15. Flucytosine is taken orally every 6 hours on days 4-10 and 18-24. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.	Dose Level 3 (NSC 1.5x10^8 and 5-FC 37.5 mg/kg) n=3 Participants Patients receive CD-expressing neural stem cells intracranially on days 1 and 15. Flucytosine is taken orally every 6 hours on days 4-10 and 18-24. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.	Dose Level 4 (NSC 1.5x10^8 and 5-FC 37.5 mg/kg + Leucovorin + Microdialysis n=5 Participants Patients receive CD-expressing neural stem cells intracranially on days 1 and 15. Flucytosine is taken orally every 6 hours on days 4-10 and 18-24. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Number of Participants Developing Antibodies Against NSCs	0 Participants	2 Participants	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Following the first dose of 5-FC, samples were collected every hour for 24 hours and then every 3 hours thereafter until the end of the 7-day course of 5-FC or until the microdialysis catheter stopped functioning.

Population: Only participants in dose level 4 received intracerebral microdialysis and are included in this analysis

Pharmacokinetic (PK) data from the patients who undergo intracerebral microdialysis (dose level 4) will be summarized using descriptive statistics. All summaries will be exploratory in spirit.

Outcome measures

Outcome measures
Measure	Dose Level 1: (NSC 5x10^7 and 5-FC 37.5 mg/kg) n=7 Participants Patients receive CD-expressing neural stem cells intracranially on days 1 and 15. Flucytosine is taken orally every 6 hours on days 4-10 and 18-24. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.	Dose Level 2: (NSC 1x10^8 and 5-FC 37.5 mg/kg) Patients receive CD-expressing neural stem cells intracranially on days 1 and 15. Flucytosine is taken orally every 6 hours on days 4-10 and 18-24. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.	Dose Level 3 (NSC 1.5x10^8 and 5-FC 37.5 mg/kg) Patients receive CD-expressing neural stem cells intracranially on days 1 and 15. Flucytosine is taken orally every 6 hours on days 4-10 and 18-24. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.	Dose Level 4 (NSC 1.5x10^8 and 5-FC 37.5 mg/kg + Leucovorin + Microdialysis Patients receive CD-expressing neural stem cells intracranially on days 1 and 15. Flucytosine is taken orally every 6 hours on days 4-10 and 18-24. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Average Steady State Levels of 5-FC and 5-FU in the Brain average steady state levels of 5-FC in the brain	213 µmol/L Standard Deviation 58	—	—	—
Average Steady State Levels of 5-FC and 5-FU in the Brain average steady state levels of 5-FU in the brain	0.03 µmol/L Standard Deviation 0.01	—	—	—

SECONDARY outcome

Timeframe: Samples were obtained prior to the first dose of 5-FC then every 30 minutes for 3 hours, additional samples at 4 and 6 hours after the morning doses on days 4, 5. On days 6, 7, 8 blood samples were collected just before morning dose and 90 minutes later

Population: Only participants in dose level 4 received intracerebral microdialysis and are included in this analysis

PK data from the patients who undergo intracerebral microdialysis (dose level 4) will be summarized using descriptive statistics.

Outcome measures

Outcome measures
Measure	Dose Level 1: (NSC 5x10^7 and 5-FC 37.5 mg/kg) n=7 Participants Patients receive CD-expressing neural stem cells intracranially on days 1 and 15. Flucytosine is taken orally every 6 hours on days 4-10 and 18-24. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.	Dose Level 2: (NSC 1x10^8 and 5-FC 37.5 mg/kg) Patients receive CD-expressing neural stem cells intracranially on days 1 and 15. Flucytosine is taken orally every 6 hours on days 4-10 and 18-24. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.	Dose Level 3 (NSC 1.5x10^8 and 5-FC 37.5 mg/kg) Patients receive CD-expressing neural stem cells intracranially on days 1 and 15. Flucytosine is taken orally every 6 hours on days 4-10 and 18-24. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.	Dose Level 4 (NSC 1.5x10^8 and 5-FC 37.5 mg/kg + Leucovorin + Microdialysis Patients receive CD-expressing neural stem cells intracranially on days 1 and 15. Flucytosine is taken orally every 6 hours on days 4-10 and 18-24. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Average Steady State Levels of 5-FC Concentrations in Plasma	748 µmol/L Standard Error 218	—	—	—

SECONDARY outcome

Timeframe: The ratio of average brain interstitial 5-FC and 5-FU concentrations to average plasma steady-state levels was calculated using all measured data.

Population: Only participants in dose level 4 received intracerebral microdialysis and are included in this analysis

PK data from the patients who undergo intracerebral microdialysis (dose level 4) will be summarized using the mean ratio of average brain interstitial 5-FC concentrations to the average steady-state plasma levels.

Outcome measures

Outcome measures
Measure	Dose Level 1: (NSC 5x10^7 and 5-FC 37.5 mg/kg) n=7 Participants Patients receive CD-expressing neural stem cells intracranially on days 1 and 15. Flucytosine is taken orally every 6 hours on days 4-10 and 18-24. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.	Dose Level 2: (NSC 1x10^8 and 5-FC 37.5 mg/kg) Patients receive CD-expressing neural stem cells intracranially on days 1 and 15. Flucytosine is taken orally every 6 hours on days 4-10 and 18-24. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.	Dose Level 3 (NSC 1.5x10^8 and 5-FC 37.5 mg/kg) Patients receive CD-expressing neural stem cells intracranially on days 1 and 15. Flucytosine is taken orally every 6 hours on days 4-10 and 18-24. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.	Dose Level 4 (NSC 1.5x10^8 and 5-FC 37.5 mg/kg + Leucovorin + Microdialysis Patients receive CD-expressing neural stem cells intracranially on days 1 and 15. Flucytosine is taken orally every 6 hours on days 4-10 and 18-24. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Comparison of 5-FC in the Brain to 5-FC in the Plasma	29 ratio Standard Error 21	—	—	—

SECONDARY outcome

Timeframe: Up to 3 years post NSC infusion

Per RANO criteria: Complete Response (CR): Complete disappearance of all enhancing disease that is sustained for at least 4 weeks, stable or improved non-enhancing FLAIR/T2 lesions, no new lesions, off corticosteroids, and neurologically stable or improved. Partial Response (PR): \>= 50% decrease of all measurable enhancing lesions, sustained or at least 4 weeks, no progression of non-measurable disease, stable or improved non-enhancing FLAIR/T2 lesions, non new lesions, corticosteroid dose stable or reduced, and neurologically stable or improved. Stable Disease (SD): Dose not qualify for CR, PR, or PD, stable non-enhancing FLAIR/T2 lesions, stable or reduced corticosteroids, clinically stable. Progressive Disease (PD): \>=25% increase in enhancing lesion despite stable or increasing steroid dose, increase (significant) in non-enhancing T2/FLAIR lesions that is not attributable to other non-tumor causes, any new lesions, clinical deterioration

Outcome measures

Outcome measures
Measure	Dose Level 1: (NSC 5x10^7 and 5-FC 37.5 mg/kg) n=3 Participants Patients receive CD-expressing neural stem cells intracranially on days 1 and 15. Flucytosine is taken orally every 6 hours on days 4-10 and 18-24. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.	Dose Level 2: (NSC 1x10^8 and 5-FC 37.5 mg/kg) n=3 Participants Patients receive CD-expressing neural stem cells intracranially on days 1 and 15. Flucytosine is taken orally every 6 hours on days 4-10 and 18-24. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.	Dose Level 3 (NSC 1.5x10^8 and 5-FC 37.5 mg/kg) n=3 Participants Patients receive CD-expressing neural stem cells intracranially on days 1 and 15. Flucytosine is taken orally every 6 hours on days 4-10 and 18-24. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.	Dose Level 4 (NSC 1.5x10^8 and 5-FC 37.5 mg/kg + Leucovorin + Microdialysis n=7 Participants Patients receive CD-expressing neural stem cells intracranially on days 1 and 15. Flucytosine is taken orally every 6 hours on days 4-10 and 18-24. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Summary of Tumor Response Using the Response Assessment in Neuro-Oncology (RANO) Criteria Stable Disease	2 Participants	0 Participants	0 Participants	1 Participants
Summary of Tumor Response Using the Response Assessment in Neuro-Oncology (RANO) Criteria Progressive Disease	1 Participants	3 Participants	3 Participants	4 Participants
Summary of Tumor Response Using the Response Assessment in Neuro-Oncology (RANO) Criteria Ineligible for Disease Response	0 Participants	0 Participants	0 Participants	2 Participants

Adverse Events

Dose Level 1 (NSC 5x10^7 and 5-FC 37.5 mg/kg)

Serious events: 2 serious events

Other events: 3 other events

Deaths: 3 deaths

Dose Level 2 (NSC 1x10^8 and 5-FC 37.5 mg/kg)

Serious events: 1 serious events

Other events: 3 other events

Deaths: 3 deaths

Dose Level 3 (NSC 1.5x10^8 and 5-FC 37.5 mg/kg)

Serious events: 1 serious events

Other events: 3 other events

Deaths: 3 deaths

Dose Level 4 (NSC 1.5x10^8 and 5-FC 37.5 mg/kg) + Leucovorin + Microdialysis

Serious events: 4 serious events

Other events: 7 other events

Deaths: 7 deaths

Serious adverse events

Serious adverse events
Measure	Dose Level 1 (NSC 5x10^7 and 5-FC 37.5 mg/kg) n=3 participants at risk Patients receive CD-expressing neural stem cells intracranially on days 1 and 15. Flucytosine is taken orally every 6 hours on days 4-10 and 18-24. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.	Dose Level 2 (NSC 1x10^8 and 5-FC 37.5 mg/kg) n=3 participants at risk Patients receive CD-expressing neural stem cells intracranially on days 1 and 15. Flucytosine is taken orally every 6 hours on days 4-10 and 18-24. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.	Dose Level 3 (NSC 1.5x10^8 and 5-FC 37.5 mg/kg) n=3 participants at risk Patients receive CD-expressing neural stem cells intracranially on days 1 and 15. Flucytosine is taken orally every 6 hours on days 4-10 and 18-24. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.	Dose Level 4 (NSC 1.5x10^8 and 5-FC 37.5 mg/kg) + Leucovorin + Microdialysis n=7 participants at risk Patients receive CD-expressing neural stem cells intracranially on days 1 and 15. Flucytosine is taken orally every 6 hours on days 4-10 and 18-24. They will also be given leucovorin orally every 6 hours on days 4-10 and 18-24. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Nervous system disorders Seizure	33.3% 1/3 • During and after treatment, up to 20 months	0.00% 0/3 • During and after treatment, up to 20 months	33.3% 1/3 • During and after treatment, up to 20 months	14.3% 1/7 • During and after treatment, up to 20 months
Infections and infestations Skin infection	33.3% 1/3 • During and after treatment, up to 20 months	0.00% 0/3 • During and after treatment, up to 20 months	0.00% 0/3 • During and after treatment, up to 20 months	0.00% 0/7 • During and after treatment, up to 20 months
General disorders Death	0.00% 0/3 • During and after treatment, up to 20 months	33.3% 1/3 • During and after treatment, up to 20 months	33.3% 1/3 • During and after treatment, up to 20 months	14.3% 1/7 • During and after treatment, up to 20 months
Musculoskeletal and connective tissue disorders Muscle weakness left-sided	0.00% 0/3 • During and after treatment, up to 20 months	0.00% 0/3 • During and after treatment, up to 20 months	33.3% 1/3 • During and after treatment, up to 20 months	0.00% 0/7 • During and after treatment, up to 20 months
Vascular disorders Hypertension	0.00% 0/3 • During and after treatment, up to 20 months	0.00% 0/3 • During and after treatment, up to 20 months	0.00% 0/3 • During and after treatment, up to 20 months	14.3% 1/7 • During and after treatment, up to 20 months
Infections and infestations Brain abscess	0.00% 0/3 • During and after treatment, up to 20 months	0.00% 0/3 • During and after treatment, up to 20 months	0.00% 0/3 • During and after treatment, up to 20 months	14.3% 1/7 • During and after treatment, up to 20 months
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/3 • During and after treatment, up to 20 months	0.00% 0/3 • During and after treatment, up to 20 months	0.00% 0/3 • During and after treatment, up to 20 months	14.3% 1/7 • During and after treatment, up to 20 months
Nervous system disorders Intracranial hemorrhage	0.00% 0/3 • During and after treatment, up to 20 months	0.00% 0/3 • During and after treatment, up to 20 months	0.00% 0/3 • During and after treatment, up to 20 months	14.3% 1/7 • During and after treatment, up to 20 months
Vascular disorders Thromboembolic event	0.00% 0/3 • During and after treatment, up to 20 months	0.00% 0/3 • During and after treatment, up to 20 months	0.00% 0/3 • During and after treatment, up to 20 months	14.3% 1/7 • During and after treatment, up to 20 months
General disorders Fever	0.00% 0/3 • During and after treatment, up to 20 months	0.00% 0/3 • During and after treatment, up to 20 months	0.00% 0/3 • During and after treatment, up to 20 months	14.3% 1/7 • During and after treatment, up to 20 months
Infections and infestations Wound infection	0.00% 0/3 • During and after treatment, up to 20 months	0.00% 0/3 • During and after treatment, up to 20 months	0.00% 0/3 • During and after treatment, up to 20 months	14.3% 1/7 • During and after treatment, up to 20 months
Psychiatric disorders Confusion	0.00% 0/3 • During and after treatment, up to 20 months	0.00% 0/3 • During and after treatment, up to 20 months	0.00% 0/3 • During and after treatment, up to 20 months	14.3% 1/7 • During and after treatment, up to 20 months

Other adverse events

Additional Information

Dr. Jana Portnow

City of Hope Medical Center

Phone: 6262189200

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place