Trial Outcomes & Findings for Adjuvant Tumor Lysate Vaccine and Iscomatrix With or Without Metronomic Oral Cyclophosphamide and Celecoxib in Patients With Malignancies Involving Lungs, Esophagus, Pleura, or Mediastinum (NCT NCT02054104)

NCT ID: NCT02054104

Last Updated: 2022-01-26

Results Overview

Immunologic responses are defined as an appearance of new serologic reactivity, or increase in existing antibody response to cancer-testis on the X chromosome (CT-X) antigen. Antigens such as New York esophageal squamous cell carcinoma-1 (NY-ESO1) and melanoma antigen gene (MAGE) family members assessed by enzyme-linked immunosorbent assay (ELISA) one month after the 6th vaccine.

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

21 participants

Primary outcome timeframe

one month after the 6th vaccine

Results posted on

2022-01-26

Participant Flow

Participant milestones

Participant milestones
Measure	Cohort 1/Vaccine Plus Chemotherapy H1299 cell lysates with iscomatrix vaccine with metronomic chemotherapy H1299 cell lysates: H1299 cell lysate with iscomatrix adjuvant vaccine via subcutaneous injections once every cycle (cycle=28 days) for 6 cycles total. Additional 2 injections for patients with immunologic response and no clinical evidence of active disease (NED). Cyclophosphamide: 50 mg by mouth (PO) twice a day (BID) for 7 days prior to the first dose of vaccine and then on days 8 through 14, and 22 through 28 of each treatment cycle. Celecoxib: 400 mg by mouth (PO) twice a day (BID) for 7 days prior to the first dose of vaccine and then on days 1 through 28 of each treatment cycle. Iscomatrix adjuvant: H1299 cell lysate with iscomatrix adjuvant vaccine via subcutaneous injections once every cycle (cycle=28 days) for 6 cycles total. Additional 2 injections for patients with immunologic response and no clinical evidence of active disease (NED).	Cohort 2/Vaccine Alone H1299 cell lysates with iscomatrix adjuvant vaccine H1299 cell lysates: H1299 cell lysate with iscomatrix adjuvant vaccine via subcutaneous injections once every cycle (cycle=28 days) for 6 cycles total. Additional 2 injections for patients with immunologic response and no clinical evidence of active disease (NED). Iscomatrix adjuvant: H1299 cell lysate with iscomatrix adjuvant vaccine via subcutaneous injections once every cycle (cycle=28 days) for 6 cycles total. Additional 2 injections for patients with immunologic response and no clinical evidence of active disease (NED).
Overall Study STARTED	10	11
Overall Study COMPLETED	2	2
Overall Study NOT COMPLETED	8	9

Reasons for withdrawal

Reasons for withdrawal
Measure	Cohort 1/Vaccine Plus Chemotherapy H1299 cell lysates with iscomatrix vaccine with metronomic chemotherapy H1299 cell lysates: H1299 cell lysate with iscomatrix adjuvant vaccine via subcutaneous injections once every cycle (cycle=28 days) for 6 cycles total. Additional 2 injections for patients with immunologic response and no clinical evidence of active disease (NED). Cyclophosphamide: 50 mg by mouth (PO) twice a day (BID) for 7 days prior to the first dose of vaccine and then on days 8 through 14, and 22 through 28 of each treatment cycle. Celecoxib: 400 mg by mouth (PO) twice a day (BID) for 7 days prior to the first dose of vaccine and then on days 1 through 28 of each treatment cycle. Iscomatrix adjuvant: H1299 cell lysate with iscomatrix adjuvant vaccine via subcutaneous injections once every cycle (cycle=28 days) for 6 cycles total. Additional 2 injections for patients with immunologic response and no clinical evidence of active disease (NED).	Cohort 2/Vaccine Alone H1299 cell lysates with iscomatrix adjuvant vaccine H1299 cell lysates: H1299 cell lysate with iscomatrix adjuvant vaccine via subcutaneous injections once every cycle (cycle=28 days) for 6 cycles total. Additional 2 injections for patients with immunologic response and no clinical evidence of active disease (NED). Iscomatrix adjuvant: H1299 cell lysate with iscomatrix adjuvant vaccine via subcutaneous injections once every cycle (cycle=28 days) for 6 cycles total. Additional 2 injections for patients with immunologic response and no clinical evidence of active disease (NED).
Overall Study Did not want to continue due to college classes	1	0
Overall Study Biopsy positive for malignancy, appears to be new primary	1	0
Overall Study No evidence of immunologic response	2	2
Overall Study Disease Progression On Study	4	5
Overall Study Diagnosis of lymphoma	0	1
Overall Study Inconclusive response	0	1

Baseline Characteristics

Adjuvant Tumor Lysate Vaccine and Iscomatrix With or Without Metronomic Oral Cyclophosphamide and Celecoxib in Patients With Malignancies Involving Lungs, Esophagus, Pleura, or Mediastinum

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cohort 1/Vaccine Plus Chemotherapy n=10 Participants H1299 cell lysates with iscomatrix vaccine with metronomic chemotherapy H1299 cell lysates: H1299 cell lysate with iscomatrix adjuvant vaccine via subcutaneous injections once every cycle (cycle=28 days) for 6 cycles total. Additional 2 injections for patients with immunologic response and no clinical evidence of active disease (NED). Cyclophosphamide: 50 mg by mouth (PO) twice a day (BID) for 7 days prior to the first dose of vaccine and then on days 8 through 14, and 22 through 28 of each treatment cycle. Celecoxib: 400 mg by mouth (PO) twice a day (BID) for 7 days prior to the first dose of vaccine and then on days 1 through 28 of each treatment cycle. Iscomatrix adjuvant: H1299 cell lysate with iscomatrix adjuvant vaccine via subcutaneous injections once every cycle (cycle=28 days) for 6 cycles total. Additional 2 injections for patients with immunologic response and no clinical evidence of active disease (NED).	Cohort 2/Vaccine Alone n=11 Participants H1299 cell lysates with iscomatrix adjuvant vaccine H1299 cell lysates: H1299 cell lysate with iscomatrix adjuvant vaccine via subcutaneous injections once every cycle (cycle=28 days) for 6 cycles total. Additional 2 injections for patients with immunologic response and no clinical evidence of active disease (NED). Iscomatrix adjuvant: H1299 cell lysate with iscomatrix adjuvant vaccine via subcutaneous injections once every cycle (cycle=28 days) for 6 cycles total. Additional 2 injections for patients with immunologic response and no clinical evidence of active disease (NED).	Total n=21 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	9 Participants n=5 Participants	8 Participants n=7 Participants	17 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Age, Continuous	46.48 years STANDARD_DEVIATION 16.96 • n=5 Participants	48.59 years STANDARD_DEVIATION 17.82 • n=7 Participants	47.59 years STANDARD_DEVIATION 17.01 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	7 Participants n=7 Participants	12 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	8 Participants n=5 Participants	11 Participants n=7 Participants	19 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 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
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) White	8 Participants n=5 Participants	10 Participants n=7 Participants	18 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	10 participants n=5 Participants	11 participants n=7 Participants	21 participants n=5 Participants

PRIMARY outcome

Timeframe: one month after the 6th vaccine

Outcome measures

Outcome measures
Measure	Cohort 1/Vaccine Plus Chemotherapy n=10 Participants H1299 cell lysates with iscomatrix vaccine with metronomic chemotherapy H1299 cell lysates: H1299 cell lysate with iscomatrix adjuvant vaccine via subcutaneous injections once every cycle (cycle=28 days) for 6 cycles total. Additional 2 injections for patients with immunologic response and no clinical evidence of active disease (NED). Cyclophosphamide: 50 mg by mouth (PO) twice a day (BID) for 7 days prior to the first dose of vaccine and then on days 8 through 14, and 22 through 28 of each treatment cycle. Celecoxib: 400 mg by mouth (PO) twice a day (BID) for 7 days prior to the first dose of vaccine and then on days 1 through 28 of each treatment cycle. Iscomatrix adjuvant: H1299 cell lysate with iscomatrix adjuvant vaccine via subcutaneous injections once every cycle (cycle=28 days) for 6 cycles total. Additional 2 injections for patients with immunologic response and no clinical evidence of active disease (NED).	Cohort 2/Vaccine Alone n=11 Participants H1299 cell lysates with iscomatrix adjuvant vaccine H1299 cell lysates: H1299 cell lysate with iscomatrix adjuvant vaccine via subcutaneous injections once every cycle (cycle=28 days) for 6 cycles total. Additional 2 injections for patients with immunologic response and no clinical evidence of active disease (NED). Iscomatrix adjuvant: H1299 cell lysate with iscomatrix adjuvant vaccine via subcutaneous injections once every cycle (cycle=28 days) for 6 cycles total. Additional 2 injections for patients with immunologic response and no clinical evidence of active disease (NED).
Number of Participants With an Immunologic Responses	4 Participants	4 Participants

SECONDARY outcome

Timeframe: one month after first 6 vaccinations

The Mann=Whitney U test was used to compare the fold change of intensity of PD-1 expression on Tregs between the two groups. A decrease in the fold change is consistent with a better outcome. The difference, or the relative difference, in the values at the two time points were obtained and tested to determine if the difference is equal to zero. If a paired t-test is able to be used, with at least 20 evaluable participants, there is 81% power to detect a change equal to ¾ of a standard deviation of the change at the two-sided 0.025 significance level. This was done in order to allow for a conservative adjustment due to determining the significance of the change in the percent of Tregs on two arms.

Outcome measures

Outcome measures
Measure	Cohort 1/Vaccine Plus Chemotherapy n=7 Participants H1299 cell lysates with iscomatrix vaccine with metronomic chemotherapy H1299 cell lysates: H1299 cell lysate with iscomatrix adjuvant vaccine via subcutaneous injections once every cycle (cycle=28 days) for 6 cycles total. Additional 2 injections for patients with immunologic response and no clinical evidence of active disease (NED). Cyclophosphamide: 50 mg by mouth (PO) twice a day (BID) for 7 days prior to the first dose of vaccine and then on days 8 through 14, and 22 through 28 of each treatment cycle. Celecoxib: 400 mg by mouth (PO) twice a day (BID) for 7 days prior to the first dose of vaccine and then on days 1 through 28 of each treatment cycle. Iscomatrix adjuvant: H1299 cell lysate with iscomatrix adjuvant vaccine via subcutaneous injections once every cycle (cycle=28 days) for 6 cycles total. Additional 2 injections for patients with immunologic response and no clinical evidence of active disease (NED).	Cohort 2/Vaccine Alone n=7 Participants H1299 cell lysates with iscomatrix adjuvant vaccine H1299 cell lysates: H1299 cell lysate with iscomatrix adjuvant vaccine via subcutaneous injections once every cycle (cycle=28 days) for 6 cycles total. Additional 2 injections for patients with immunologic response and no clinical evidence of active disease (NED). Iscomatrix adjuvant: H1299 cell lysate with iscomatrix adjuvant vaccine via subcutaneous injections once every cycle (cycle=28 days) for 6 cycles total. Additional 2 injections for patients with immunologic response and no clinical evidence of active disease (NED).
Fold Change From Baseline of Intensity of Programmed Cell Death Protein 1(PD-1) Expression on Tregs	0.84 fold change Interval 0.67 to 1.07	0.91 fold change Interval 0.79 to 1.03

SECONDARY outcome

Timeframe: one month after first 6 vaccinations

The Mann-Whitney U test was used to compare the fold change of percent Tregs between the two groups. A decrease in the fold change is consistent with a better outcome. The difference, or the relative difference, in the values at the two time points were obtained and tested to determine if the difference is equal to zero. If a paired t-test is able to be used, with at least 20 evaluable participants, there is 81% power to detect a change equal to ¾ of a standard deviation of the change at the two-sided 0.025 significance level. This was done in order to allow for a conservative adjustment due to determining the significance of the change in the percent of Tregs on two arms.

Outcome measures

Outcome measures
Measure	Cohort 1/Vaccine Plus Chemotherapy n=7 Participants H1299 cell lysates with iscomatrix vaccine with metronomic chemotherapy H1299 cell lysates: H1299 cell lysate with iscomatrix adjuvant vaccine via subcutaneous injections once every cycle (cycle=28 days) for 6 cycles total. Additional 2 injections for patients with immunologic response and no clinical evidence of active disease (NED). Cyclophosphamide: 50 mg by mouth (PO) twice a day (BID) for 7 days prior to the first dose of vaccine and then on days 8 through 14, and 22 through 28 of each treatment cycle. Celecoxib: 400 mg by mouth (PO) twice a day (BID) for 7 days prior to the first dose of vaccine and then on days 1 through 28 of each treatment cycle. Iscomatrix adjuvant: H1299 cell lysate with iscomatrix adjuvant vaccine via subcutaneous injections once every cycle (cycle=28 days) for 6 cycles total. Additional 2 injections for patients with immunologic response and no clinical evidence of active disease (NED).	Cohort 2/Vaccine Alone n=7 Participants H1299 cell lysates with iscomatrix adjuvant vaccine H1299 cell lysates: H1299 cell lysate with iscomatrix adjuvant vaccine via subcutaneous injections once every cycle (cycle=28 days) for 6 cycles total. Additional 2 injections for patients with immunologic response and no clinical evidence of active disease (NED). Iscomatrix adjuvant: H1299 cell lysate with iscomatrix adjuvant vaccine via subcutaneous injections once every cycle (cycle=28 days) for 6 cycles total. Additional 2 injections for patients with immunologic response and no clinical evidence of active disease (NED).
Fold Change From Baseline of Percent Tregs	0.87 fold change Interval 0.65 to 1.12	0.73 fold change Interval 0.23 to 1.13

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, and end of treatment

Population: This exploratory endpoint was not assessed because the trial was suspended after only 1/3rd of the total anticipated patient accrual.

The immunologic response to autologous tumor or epigenetically-modified autologous Epstein-Barr Virus (EBV)-transformed lymphocytes will be determined by the difference, or relative difference, in values (by percentage) of T-regulatory cells at the two timepoints. The percentage of T-regulatory cells will determine if oral cyclophosphamide and celecoxib therapy decreases the percentage of T cells on each Arm/Group.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Date treatment consent signed to final collection of AE data, approximately 9 months and 12 days for cohort 1 and 8 months and 22 days for cohort 2.

Here is the number of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.

Outcome measures

Outcome measures
Measure	Cohort 1/Vaccine Plus Chemotherapy n=10 Participants H1299 cell lysates with iscomatrix vaccine with metronomic chemotherapy H1299 cell lysates: H1299 cell lysate with iscomatrix adjuvant vaccine via subcutaneous injections once every cycle (cycle=28 days) for 6 cycles total. Additional 2 injections for patients with immunologic response and no clinical evidence of active disease (NED). Cyclophosphamide: 50 mg by mouth (PO) twice a day (BID) for 7 days prior to the first dose of vaccine and then on days 8 through 14, and 22 through 28 of each treatment cycle. Celecoxib: 400 mg by mouth (PO) twice a day (BID) for 7 days prior to the first dose of vaccine and then on days 1 through 28 of each treatment cycle. Iscomatrix adjuvant: H1299 cell lysate with iscomatrix adjuvant vaccine via subcutaneous injections once every cycle (cycle=28 days) for 6 cycles total. Additional 2 injections for patients with immunologic response and no clinical evidence of active disease (NED).	Cohort 2/Vaccine Alone n=11 Participants H1299 cell lysates with iscomatrix adjuvant vaccine H1299 cell lysates: H1299 cell lysate with iscomatrix adjuvant vaccine via subcutaneous injections once every cycle (cycle=28 days) for 6 cycles total. Additional 2 injections for patients with immunologic response and no clinical evidence of active disease (NED). Iscomatrix adjuvant: H1299 cell lysate with iscomatrix adjuvant vaccine via subcutaneous injections once every cycle (cycle=28 days) for 6 cycles total. Additional 2 injections for patients with immunologic response and no clinical evidence of active disease (NED).
Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0)	8 Participants	6 Participants

Adverse Events

Cohort 1/Vaccine Plus Chemotherapy

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Cohort 2/Vaccine Alone

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Cohort 1/Vaccine Plus Chemotherapy n=10 participants at risk H1299 cell lysates with iscomatrix vaccine with metronomic chemotherapy H1299 cell lysates: H1299 cell lysate with iscomatrix adjuvant vaccine via subcutaneous injections once every cycle (cycle=28 days) for 6 cycles total. Additional 2 injections for patients with immunologic response and no clinical evidence of active disease (NED). Cyclophosphamide: 50 mg by mouth (PO) twice a day (BID) for 7 days prior to the first dose of vaccine and then on days 8 through 14, and 22 through 28 of each treatment cycle. Celecoxib: 400 mg by mouth (PO) twice a day (BID) for 7 days prior to the first dose of vaccine and then on days 1 through 28 of each treatment cycle. Iscomatrix adjuvant: H1299 cell lysate with iscomatrix adjuvant vaccine via subcutaneous injections once every cycle (cycle=28 days) for 6 cycles total. Additional 2 injections for patients with immunologic response and no clinical evidence of active disease (NED).	Cohort 2/Vaccine Alone n=11 participants at risk H1299 cell lysates with iscomatrix adjuvant vaccine H1299 cell lysates: H1299 cell lysate with iscomatrix adjuvant vaccine via subcutaneous injections once every cycle (cycle=28 days) for 6 cycles total. Additional 2 injections for patients with immunologic response and no clinical evidence of active disease (NED). Iscomatrix adjuvant: H1299 cell lysate with iscomatrix adjuvant vaccine via subcutaneous injections once every cycle (cycle=28 days) for 6 cycles total. Additional 2 injections for patients with immunologic response and no clinical evidence of active disease (NED).
Blood and lymphatic system disorders Anemia	10.0% 1/10 • Number of events 1 • Date treatment consent signed to final collection of AE data, approximately 9 months and 12 days for cohort 1 and 8 months and 22 days for cohort 2.	0.00% 0/11 • Date treatment consent signed to final collection of AE data, approximately 9 months and 12 days for cohort 1 and 8 months and 22 days for cohort 2.
Investigations Aspartate aminotransferase increased	10.0% 1/10 • Number of events 1 • Date treatment consent signed to final collection of AE data, approximately 9 months and 12 days for cohort 1 and 8 months and 22 days for cohort 2.	0.00% 0/11 • Date treatment consent signed to final collection of AE data, approximately 9 months and 12 days for cohort 1 and 8 months and 22 days for cohort 2.
Investigations CPK increased	20.0% 2/10 • Number of events 2 • Date treatment consent signed to final collection of AE data, approximately 9 months and 12 days for cohort 1 and 8 months and 22 days for cohort 2.	0.00% 0/11 • Date treatment consent signed to final collection of AE data, approximately 9 months and 12 days for cohort 1 and 8 months and 22 days for cohort 2.
Investigations Creatinine increased	0.00% 0/10 • Date treatment consent signed to final collection of AE data, approximately 9 months and 12 days for cohort 1 and 8 months and 22 days for cohort 2.	9.1% 1/11 • Number of events 2 • Date treatment consent signed to final collection of AE data, approximately 9 months and 12 days for cohort 1 and 8 months and 22 days for cohort 2.
General disorders Flu like symptoms	10.0% 1/10 • Number of events 1 • Date treatment consent signed to final collection of AE data, approximately 9 months and 12 days for cohort 1 and 8 months and 22 days for cohort 2.	9.1% 1/11 • Number of events 1 • Date treatment consent signed to final collection of AE data, approximately 9 months and 12 days for cohort 1 and 8 months and 22 days for cohort 2.
Metabolism and nutrition disorders Hyperkalemia	10.0% 1/10 • Number of events 1 • Date treatment consent signed to final collection of AE data, approximately 9 months and 12 days for cohort 1 and 8 months and 22 days for cohort 2.	0.00% 0/11 • Date treatment consent signed to final collection of AE data, approximately 9 months and 12 days for cohort 1 and 8 months and 22 days for cohort 2.
Metabolism and nutrition disorders Hypophosphatemia	10.0% 1/10 • Number of events 1 • Date treatment consent signed to final collection of AE data, approximately 9 months and 12 days for cohort 1 and 8 months and 22 days for cohort 2.	18.2% 2/11 • Number of events 4 • Date treatment consent signed to final collection of AE data, approximately 9 months and 12 days for cohort 1 and 8 months and 22 days for cohort 2.
Investigations Lymphocyte count decreased	70.0% 7/10 • Number of events 16 • Date treatment consent signed to final collection of AE data, approximately 9 months and 12 days for cohort 1 and 8 months and 22 days for cohort 2.	27.3% 3/11 • Number of events 5 • Date treatment consent signed to final collection of AE data, approximately 9 months and 12 days for cohort 1 and 8 months and 22 days for cohort 2.
Gastrointestinal disorders Nausea	10.0% 1/10 • Number of events 1 • Date treatment consent signed to final collection of AE data, approximately 9 months and 12 days for cohort 1 and 8 months and 22 days for cohort 2.	0.00% 0/11 • Date treatment consent signed to final collection of AE data, approximately 9 months and 12 days for cohort 1 and 8 months and 22 days for cohort 2.
Investigations Neutrophil count decreased	30.0% 3/10 • Number of events 6 • Date treatment consent signed to final collection of AE data, approximately 9 months and 12 days for cohort 1 and 8 months and 22 days for cohort 2.	9.1% 1/11 • Number of events 1 • Date treatment consent signed to final collection of AE data, approximately 9 months and 12 days for cohort 1 and 8 months and 22 days for cohort 2.
Infections and infestations Skin infection	0.00% 0/10 • Date treatment consent signed to final collection of AE data, approximately 9 months and 12 days for cohort 1 and 8 months and 22 days for cohort 2.	9.1% 1/11 • Number of events 1 • Date treatment consent signed to final collection of AE data, approximately 9 months and 12 days for cohort 1 and 8 months and 22 days for cohort 2.
Gastrointestinal disorders Vomiting	10.0% 1/10 • Number of events 1 • Date treatment consent signed to final collection of AE data, approximately 9 months and 12 days for cohort 1 and 8 months and 22 days for cohort 2.	0.00% 0/11 • Date treatment consent signed to final collection of AE data, approximately 9 months and 12 days for cohort 1 and 8 months and 22 days for cohort 2.
Investigations White blood cell decreased	50.0% 5/10 • Number of events 8 • Date treatment consent signed to final collection of AE data, approximately 9 months and 12 days for cohort 1 and 8 months and 22 days for cohort 2.	9.1% 1/11 • Number of events 1 • Date treatment consent signed to final collection of AE data, approximately 9 months and 12 days for cohort 1 and 8 months and 22 days for cohort 2.

Additional Information

Dr. David Schrump

National Cancer Institute

Phone: 240-858-7000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place