Trial Outcomes & Findings for Autologous CMV-Specific Cytotoxic T Cells and Temozolomide in Treating Patients With Glioblastoma (NCT NCT02661282)
NCT ID: NCT02661282
Last Updated: 2023-06-18
Results Overview
The number of participants who were treated at the respective dose level without DLT
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
65 participants
Primary outcome timeframe
Up to 42 days
Results posted on
2023-06-18
Participant Flow
Phase I/II CMV Clinical trial TCELL ( Leukapheresis performed over2-3 hrs to collect white blood cells. Will start receiving Temozolomide and CMV CTLs
65 participants were consented, 40 participants were inevaluable
Participant milestones
| Measure |
Phase I: Recurrent Glioblastoma Dose Level 5 x 10^6
Dose escalation component in participants with recurrent glioblastoma to determine the maximum feasible dose (MFD) or maximum tolerated dose (MTD) of CMV-specific T cells in combination with dose-dense temozolomide. We will follow a 3+3 design exploring 4 dose levels of CMV-T cells: 5 x 106, 1 x 107, 5 x 107, and 1 x 108 CMV CTLs. 4 cycles total of dose-dense TMZ and CMV-T cell infusion. Following completion of 4 cycles of dose-dense TMZ and CMV-T cell infusion, participants can receive additional 42-day cycles of dose-dense TMZ for up to 12 cycles or tumor PD.
|
Phase I: Recurrent Glioblastoma Dose Level 1 x 10^7
Dose escalation component in participants with recurrent glioblastoma to determine the maximum feasible dose (MFD) or maximum tolerated dose (MTD) of CMV-specific T cells in combination with dose-dense temozolomide. We will follow a 3+3 design exploring 4 dose levels of CMV-T cells: 5 x 106, 1 x 107, 5 x 107, and 1 x 108 CMV CTLs. 4 cycles total of dose-dense TMZ and CMV-T cell infusion. Following completion of 4 cycles of dose-dense TMZ and CMV-T cell infusion, participants can receive additional 42-day cycles of dose-dense TMZ for up to 12 cycles or tumor PD.
|
Phase I: Recurrent Glioblastoma Dose Level 5 x 10^7
Dose escalation component in participants with recurrent glioblastoma to determine the maximum feasible dose (MFD) or maximum tolerated dose (MTD) of CMV-specific T cells in combination with dose-dense temozolomide. We will follow a 3+3 design exploring 4 dose levels of CMV-T cells: 5 x 106, 1 x 107, 5 x 107, and 1 x 108 CMV CTLs. 4 cycles total of dose-dense TMZ and CMV-T cell infusion. Following completion of 4 cycles of dose-dense TMZ and CMV-T cell infusion, participants can receive additional 42-day cycles of dose-dense TMZ for up to 12 cycles or tumor PD.
|
Phase I: Recurrent Glioblastoma Dose Level 1 x 10^8
Dose escalation component in participants with recurrent glioblastoma to determine the maximum feasible dose (MFD) or maximum tolerated dose (MTD) of CMV-specific T cells in combination with dose-dense temozolomide. We will follow a 3+3 design exploring 4 dose levels of CMV-T cells: 5 x 106, 1 x 107, 5 x 107, and 1 x 108 CMV CTLs. 4 cycles total of dose-dense TMZ and CMV-T cell infusion. Following completion of 4 cycles of dose-dense TMZ and CMV-T cell infusion, participants can receive additional 42-day cycles of dose-dense TMZ for up to 12 cycles or tumor PD.
|
Phase II: Newly Diagnosed Dose Level 1 x 10^8
Participants will receive 4 cycles total of dose-dense TMZ followed by adoptive CMV T cell infusion. Following completion of 4 cycles of dose-dense TMZ and CMV T cell infusion, patients can receive standard dose TMZ 200 mg/m\^ 2 days 1-5 every 28 days up to 12 cycles or tumor PD.
|
Phase II: Recurrent Glioblastoma Dose Level 1 x 10^8
Participants will receive a total of 3 cycles of dose-dense temozolomide followed by fixed doses of CMV-specific T cell infusion in the post-surgical phase, after which they can remain on dose-dense temozolomide until tumor progression, as long as there are no unacceptable toxicities or until completion of 12 cycles of treatment with dose-dense temozolomide (whichever occurs first).
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
3
|
7
|
3
|
1
|
|
Overall Study
COMPLETED
|
3
|
3
|
3
|
7
|
3
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Autologous CMV-Specific Cytotoxic T Cells and Temozolomide in Treating Patients With Glioblastoma
Baseline characteristics by cohort
| Measure |
Phase I: Recurrent Glioblastoma Dose Level 5 x 10^6
n=3 Participants
Dose escalation component in participants with recurrent glioblastoma to determine the maximum feasible dose (MFD) or maximum tolerated dose (MTD) of CMV-specific T cells in combination with dose-dense temozolomide. We will follow a 3+3 design exploring 4 dose levels of CMV-T cells: 5 x 106, 1 x 107, 5 x 107, and 1 x 108 CMV CTLs. 4 cycles total of dose-dense TMZ and CMV-T cell infusion. Following completion of 4 cycles of dose-dense TMZ and CMV-T cell infusion, participants can receive additional 42-day cycles of dose-dense TMZ for up to 12 cycles or tumor PD.
|
Phase I: Recurrent Glioblastoma Dose Level 1 x 10^7
n=3 Participants
Dose escalation component in participants with recurrent glioblastoma to determine the maximum feasible dose (MFD) or maximum tolerated dose (MTD) of CMV-specific T cells in combination with dose-dense temozolomide. We will follow a 3+3 design exploring 4 dose levels of CMV-T cells: 5 x 106, 1 x 107, 5 x 107, and 1 x 108 CMV CTLs. 4 cycles total of dose-dense TMZ and CMV-T cell infusion. Following completion of 4 cycles of dose-dense TMZ and CMV-T cell infusion, participants can receive additional 42-day cycles of dose-dense TMZ for up to 12 cycles or tumor PD.
|
Phase I: Recurrent Glioblastoma Dose Level 5 x 10^7
n=3 Participants
Dose escalation component in participants with recurrent glioblastoma to determine the maximum feasible dose (MFD) or maximum tolerated dose (MTD) of CMV-specific T cells in combination with dose-dense temozolomide. We will follow a 3+3 design exploring 4 dose levels of CMV-T cells: 5 x 106, 1 x 107, 5 x 107, and 1 x 108 CMV CTLs. 4 cycles total of dose-dense TMZ and CMV-T cell infusion. Following completion of 4 cycles of dose-dense TMZ and CMV-T cell infusion, participants can receive additional 42-day cycles of dose-dense TMZ for up to 12 cycles or tumor PD.
|
Phase I: Recurrent Glioblastoma Dose Level 1 x 10^8
n=7 Participants
Dose escalation component in participants with recurrent glioblastoma to determine the maximum feasible dose (MFD) or maximum tolerated dose (MTD) of CMV-specific T cells in combination with dose-dense temozolomide. We will follow a 3+3 design exploring 4 dose levels of CMV-T cells: 5 x 106, 1 x 107, 5 x 107, and 1 x 108 CMV CTLs. 4 cycles total of dose-dense TMZ and CMV-T cell infusion. Following completion of 4 cycles of dose-dense TMZ and CMV-T cell infusion, participants can receive additional 42-day cycles of dose-dense TMZ for up to 12 cycles or tumor PD.
|
Phase II: Newly Diagnosed Dose Level 1 x 10^8
n=3 Participants
Participants received 4 cycles total of dose-dense TMZ followed by adoptive CMV T cell infusion. Following completion of 4 cycles of dose-dense TMZ and CMV T cell infusion, patients can receive standard dose TMZ 200 mg/m\^ 2 days 1-5 every 28 days up to 12 cycles or tumor PD.
|
Phase II: Recurrent Glioblastoma Dose Level 1 x 10^8
n=1 Participants
Participants will receive a total of 3 cycles of dose-dense temozolomide followed by fixed doses of CMV-specific T cell infusion in the post-surgical phase, after which they can remain on dose-dense temozolomide until tumor progression, as long as there are no unacceptable toxicities or until completion of 12 cycles of treatment with dose-dense temozolomide (whichever occurs first).
|
Total
n=20 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
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
19 Participants
n=115 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
10 Participants
n=115 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
10 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
17 Participants
n=115 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
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 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
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 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
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 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
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
19 Participants
n=115 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
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 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
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
3 participants
n=5 Participants
|
7 participants
n=4 Participants
|
3 participants
n=21 Participants
|
1 participants
n=10 Participants
|
20 participants
n=115 Participants
|
PRIMARY outcome
Timeframe: Up to 42 daysThe number of participants who were treated at the respective dose level without DLT
Outcome measures
| Measure |
Phase I: Recurrent Glioblastoma Dose Level 5 x 10^6
n=3 Participants
Dose escalation component in participants with recurrent glioblastoma to determine the maximum feasible dose (MFD) or maximum tolerated dose (MTD) of CMV-specific T cells in combination with dose-dense temozolomide. We will follow a 3+3 design exploring 4 dose levels of CMV-T cells: 5 x 106, 1 x 107, 5 x 107, and 1 x 108 CMV CTLs. 4 cycles total of dose-dense TMZ and CMV-T cell infusion. Following completion of 4 cycles of dose-dense TMZ and CMV-T cell infusion, participants can receive additional 42-day cycles of dose-dense TMZ for up to 12 cycles or tumor PD.
|
Phase I: Recurrent Glioblastoma Dose Level 1 x 10^7
n=3 Participants
Dose escalation component in participants with recurrent glioblastoma to determine the maximum feasible dose (MFD) or maximum tolerated dose (MTD) of CMV-specific T cells in combination with dose-dense temozolomide. We will follow a 3+3 design exploring 4 dose levels of CMV-T cells: 5 x 106, 1 x 107, 5 x 107, and 1 x 108 CMV CTLs. 4 cycles total of dose-dense TMZ and CMV-T cell infusion. Following completion of 4 cycles of dose-dense TMZ and CMV-T cell infusion, participants can receive additional 42-day cycles of dose-dense TMZ for up to 12 cycles or tumor PD.
|
Phase I: Recurrent Glioblastoma Dose Level 5 x 10^7
n=3 Participants
Dose escalation component in participants with recurrent glioblastoma to determine the maximum feasible dose (MFD) or maximum tolerated dose (MTD) of CMV-specific T cells in combination with dose-dense temozolomide. We will follow a 3+3 design exploring 4 dose levels of CMV-T cells: 5 x 106, 1 x 107, 5 x 107, and 1 x 108 CMV CTLs. 4 cycles total of dose-dense TMZ and CMV-T cell infusion. Following completion of 4 cycles of dose-dense TMZ and CMV-T cell infusion, participants can receive additional 42-day cycles of dose-dense TMZ for up to 12 cycles or tumor PD.
|
Phase I: Recurrent Glioblastoma (MTD) Dose Level 1 x 10^8
n=7 Participants
Dose escalation component in participants with recurrent glioblastoma to determine the maximum feasible dose (MFD) or maximum tolerated dose (MTD) of CMV-specific T cells in combination with dose-dense temozolomide. We will follow a 3+3 design exploring 4 dose levels of CMV-T cells: 5 x 106, 1 x 107, 5 x 107, and 1 x 108 CMV CTLs. 4 cycles total of dose-dense TMZ and CMV-T cell infusion. Following completion of 4 cycles of dose-dense TMZ and CMV-T cell infusion, participants can receive additional 42-day cycles of dose-dense TMZ for up to 12 cycles or tumor PD.
|
|---|---|---|---|---|
|
Maximum Tolerated Dose (MTD) (Recurrent Glioblastoma Participant Cohort)- Phase I
|
3 participants
|
3 participants
|
3 participants
|
7 participants
|
PRIMARY outcome
Timeframe: Up to 4 yearsDescriptive statistics will be used to summarize immunological effect. To evaluate the tumor-mediated immune suppression at the effector location, the markers (interferon, interleukin-2, and tumor necrosis factor alpha, perforin, granzyme B) will be measured for immune responses in the tumor microenvironment rather than in the peripheral blood.
Outcome measures
| Measure |
Phase I: Recurrent Glioblastoma Dose Level 5 x 10^6
n=1 Participants
Dose escalation component in participants with recurrent glioblastoma to determine the maximum feasible dose (MFD) or maximum tolerated dose (MTD) of CMV-specific T cells in combination with dose-dense temozolomide. We will follow a 3+3 design exploring 4 dose levels of CMV-T cells: 5 x 106, 1 x 107, 5 x 107, and 1 x 108 CMV CTLs. 4 cycles total of dose-dense TMZ and CMV-T cell infusion. Following completion of 4 cycles of dose-dense TMZ and CMV-T cell infusion, participants can receive additional 42-day cycles of dose-dense TMZ for up to 12 cycles or tumor PD.
|
Phase I: Recurrent Glioblastoma Dose Level 1 x 10^7
Dose escalation component in participants with recurrent glioblastoma to determine the maximum feasible dose (MFD) or maximum tolerated dose (MTD) of CMV-specific T cells in combination with dose-dense temozolomide. We will follow a 3+3 design exploring 4 dose levels of CMV-T cells: 5 x 106, 1 x 107, 5 x 107, and 1 x 108 CMV CTLs. 4 cycles total of dose-dense TMZ and CMV-T cell infusion. Following completion of 4 cycles of dose-dense TMZ and CMV-T cell infusion, participants can receive additional 42-day cycles of dose-dense TMZ for up to 12 cycles or tumor PD.
|
Phase I: Recurrent Glioblastoma Dose Level 5 x 10^7
Dose escalation component in participants with recurrent glioblastoma to determine the maximum feasible dose (MFD) or maximum tolerated dose (MTD) of CMV-specific T cells in combination with dose-dense temozolomide. We will follow a 3+3 design exploring 4 dose levels of CMV-T cells: 5 x 106, 1 x 107, 5 x 107, and 1 x 108 CMV CTLs. 4 cycles total of dose-dense TMZ and CMV-T cell infusion. Following completion of 4 cycles of dose-dense TMZ and CMV-T cell infusion, participants can receive additional 42-day cycles of dose-dense TMZ for up to 12 cycles or tumor PD.
|
Phase I: Recurrent Glioblastoma (MTD) Dose Level 1 x 10^8
Dose escalation component in participants with recurrent glioblastoma to determine the maximum feasible dose (MFD) or maximum tolerated dose (MTD) of CMV-specific T cells in combination with dose-dense temozolomide. We will follow a 3+3 design exploring 4 dose levels of CMV-T cells: 5 x 106, 1 x 107, 5 x 107, and 1 x 108 CMV CTLs. 4 cycles total of dose-dense TMZ and CMV-T cell infusion. Following completion of 4 cycles of dose-dense TMZ and CMV-T cell infusion, participants can receive additional 42-day cycles of dose-dense TMZ for up to 12 cycles or tumor PD.
|
|---|---|---|---|---|
|
Number of Participants With Immunological Effects in Tumor Tissue (Recurrent Glioblastoma Cohort)- Phase II
|
1 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 6 monthsProgression-free survival (PFS) is defined as the time from study enrollment until the time of first disease progression, relapse, or death due to disease. Patients who are alive without progression or relapse will be censored at the time of last contact. The point estimate of 6-month progression-free survival (PFS6) will be analyzed. Kaplan-Meier curves will be generated and median survival time will be derived.
Outcome measures
| Measure |
Phase I: Recurrent Glioblastoma Dose Level 5 x 10^6
n=1 Participants
Dose escalation component in participants with recurrent glioblastoma to determine the maximum feasible dose (MFD) or maximum tolerated dose (MTD) of CMV-specific T cells in combination with dose-dense temozolomide. We will follow a 3+3 design exploring 4 dose levels of CMV-T cells: 5 x 106, 1 x 107, 5 x 107, and 1 x 108 CMV CTLs. 4 cycles total of dose-dense TMZ and CMV-T cell infusion. Following completion of 4 cycles of dose-dense TMZ and CMV-T cell infusion, participants can receive additional 42-day cycles of dose-dense TMZ for up to 12 cycles or tumor PD.
|
Phase I: Recurrent Glioblastoma Dose Level 1 x 10^7
Dose escalation component in participants with recurrent glioblastoma to determine the maximum feasible dose (MFD) or maximum tolerated dose (MTD) of CMV-specific T cells in combination with dose-dense temozolomide. We will follow a 3+3 design exploring 4 dose levels of CMV-T cells: 5 x 106, 1 x 107, 5 x 107, and 1 x 108 CMV CTLs. 4 cycles total of dose-dense TMZ and CMV-T cell infusion. Following completion of 4 cycles of dose-dense TMZ and CMV-T cell infusion, participants can receive additional 42-day cycles of dose-dense TMZ for up to 12 cycles or tumor PD.
|
Phase I: Recurrent Glioblastoma Dose Level 5 x 10^7
Dose escalation component in participants with recurrent glioblastoma to determine the maximum feasible dose (MFD) or maximum tolerated dose (MTD) of CMV-specific T cells in combination with dose-dense temozolomide. We will follow a 3+3 design exploring 4 dose levels of CMV-T cells: 5 x 106, 1 x 107, 5 x 107, and 1 x 108 CMV CTLs. 4 cycles total of dose-dense TMZ and CMV-T cell infusion. Following completion of 4 cycles of dose-dense TMZ and CMV-T cell infusion, participants can receive additional 42-day cycles of dose-dense TMZ for up to 12 cycles or tumor PD.
|
Phase I: Recurrent Glioblastoma (MTD) Dose Level 1 x 10^8
Dose escalation component in participants with recurrent glioblastoma to determine the maximum feasible dose (MFD) or maximum tolerated dose (MTD) of CMV-specific T cells in combination with dose-dense temozolomide. We will follow a 3+3 design exploring 4 dose levels of CMV-T cells: 5 x 106, 1 x 107, 5 x 107, and 1 x 108 CMV CTLs. 4 cycles total of dose-dense TMZ and CMV-T cell infusion. Following completion of 4 cycles of dose-dense TMZ and CMV-T cell infusion, participants can receive additional 42-day cycles of dose-dense TMZ for up to 12 cycles or tumor PD.
|
|---|---|---|---|---|
|
Progression Free Survival (PFS) (Recurrent Glioblastoma Cohort) at 6 Months- Phase II
|
2.5 months
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Time from definitive histological diagnosis until deathOverall Survival is defined as the time from definitive histological diagnosis until the time of death.
Outcome measures
| Measure |
Phase I: Recurrent Glioblastoma Dose Level 5 x 10^6
n=3 Participants
Dose escalation component in participants with recurrent glioblastoma to determine the maximum feasible dose (MFD) or maximum tolerated dose (MTD) of CMV-specific T cells in combination with dose-dense temozolomide. We will follow a 3+3 design exploring 4 dose levels of CMV-T cells: 5 x 106, 1 x 107, 5 x 107, and 1 x 108 CMV CTLs. 4 cycles total of dose-dense TMZ and CMV-T cell infusion. Following completion of 4 cycles of dose-dense TMZ and CMV-T cell infusion, participants can receive additional 42-day cycles of dose-dense TMZ for up to 12 cycles or tumor PD.
|
Phase I: Recurrent Glioblastoma Dose Level 1 x 10^7
Dose escalation component in participants with recurrent glioblastoma to determine the maximum feasible dose (MFD) or maximum tolerated dose (MTD) of CMV-specific T cells in combination with dose-dense temozolomide. We will follow a 3+3 design exploring 4 dose levels of CMV-T cells: 5 x 106, 1 x 107, 5 x 107, and 1 x 108 CMV CTLs. 4 cycles total of dose-dense TMZ and CMV-T cell infusion. Following completion of 4 cycles of dose-dense TMZ and CMV-T cell infusion, participants can receive additional 42-day cycles of dose-dense TMZ for up to 12 cycles or tumor PD.
|
Phase I: Recurrent Glioblastoma Dose Level 5 x 10^7
Dose escalation component in participants with recurrent glioblastoma to determine the maximum feasible dose (MFD) or maximum tolerated dose (MTD) of CMV-specific T cells in combination with dose-dense temozolomide. We will follow a 3+3 design exploring 4 dose levels of CMV-T cells: 5 x 106, 1 x 107, 5 x 107, and 1 x 108 CMV CTLs. 4 cycles total of dose-dense TMZ and CMV-T cell infusion. Following completion of 4 cycles of dose-dense TMZ and CMV-T cell infusion, participants can receive additional 42-day cycles of dose-dense TMZ for up to 12 cycles or tumor PD.
|
Phase I: Recurrent Glioblastoma (MTD) Dose Level 1 x 10^8
Dose escalation component in participants with recurrent glioblastoma to determine the maximum feasible dose (MFD) or maximum tolerated dose (MTD) of CMV-specific T cells in combination with dose-dense temozolomide. We will follow a 3+3 design exploring 4 dose levels of CMV-T cells: 5 x 106, 1 x 107, 5 x 107, and 1 x 108 CMV CTLs. 4 cycles total of dose-dense TMZ and CMV-T cell infusion. Following completion of 4 cycles of dose-dense TMZ and CMV-T cell infusion, participants can receive additional 42-day cycles of dose-dense TMZ for up to 12 cycles or tumor PD.
|
|---|---|---|---|---|
|
Overall Survival (OS) (Newly Diagnosed Glioblastoma Cohort)- Phase II
|
24 weeks
Interval 13.0 to 24.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to disease progression, assessed up to 4 yearsThe length of time from the date of diagnosis or the start of treatment for a disease until the disease starts to get worse or spread to other parts of the body.
Outcome measures
| Measure |
Phase I: Recurrent Glioblastoma Dose Level 5 x 10^6
n=1 Participants
Dose escalation component in participants with recurrent glioblastoma to determine the maximum feasible dose (MFD) or maximum tolerated dose (MTD) of CMV-specific T cells in combination with dose-dense temozolomide. We will follow a 3+3 design exploring 4 dose levels of CMV-T cells: 5 x 106, 1 x 107, 5 x 107, and 1 x 108 CMV CTLs. 4 cycles total of dose-dense TMZ and CMV-T cell infusion. Following completion of 4 cycles of dose-dense TMZ and CMV-T cell infusion, participants can receive additional 42-day cycles of dose-dense TMZ for up to 12 cycles or tumor PD.
|
Phase I: Recurrent Glioblastoma Dose Level 1 x 10^7
Dose escalation component in participants with recurrent glioblastoma to determine the maximum feasible dose (MFD) or maximum tolerated dose (MTD) of CMV-specific T cells in combination with dose-dense temozolomide. We will follow a 3+3 design exploring 4 dose levels of CMV-T cells: 5 x 106, 1 x 107, 5 x 107, and 1 x 108 CMV CTLs. 4 cycles total of dose-dense TMZ and CMV-T cell infusion. Following completion of 4 cycles of dose-dense TMZ and CMV-T cell infusion, participants can receive additional 42-day cycles of dose-dense TMZ for up to 12 cycles or tumor PD.
|
Phase I: Recurrent Glioblastoma Dose Level 5 x 10^7
Dose escalation component in participants with recurrent glioblastoma to determine the maximum feasible dose (MFD) or maximum tolerated dose (MTD) of CMV-specific T cells in combination with dose-dense temozolomide. We will follow a 3+3 design exploring 4 dose levels of CMV-T cells: 5 x 106, 1 x 107, 5 x 107, and 1 x 108 CMV CTLs. 4 cycles total of dose-dense TMZ and CMV-T cell infusion. Following completion of 4 cycles of dose-dense TMZ and CMV-T cell infusion, participants can receive additional 42-day cycles of dose-dense TMZ for up to 12 cycles or tumor PD.
|
Phase I: Recurrent Glioblastoma (MTD) Dose Level 1 x 10^8
Dose escalation component in participants with recurrent glioblastoma to determine the maximum feasible dose (MFD) or maximum tolerated dose (MTD) of CMV-specific T cells in combination with dose-dense temozolomide. We will follow a 3+3 design exploring 4 dose levels of CMV-T cells: 5 x 106, 1 x 107, 5 x 107, and 1 x 108 CMV CTLs. 4 cycles total of dose-dense TMZ and CMV-T cell infusion. Following completion of 4 cycles of dose-dense TMZ and CMV-T cell infusion, participants can receive additional 42-day cycles of dose-dense TMZ for up to 12 cycles or tumor PD.
|
|---|---|---|---|---|
|
Time to Progression (Recurrent Glioblastoma Cohort)- Phase II
|
2.5 months
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 4 yearsThe number of participants with stable disease according to Response Evaluation Criteria in Solid Tumors (RECIST).
Outcome measures
| Measure |
Phase I: Recurrent Glioblastoma Dose Level 5 x 10^6
n=3 Participants
Dose escalation component in participants with recurrent glioblastoma to determine the maximum feasible dose (MFD) or maximum tolerated dose (MTD) of CMV-specific T cells in combination with dose-dense temozolomide. We will follow a 3+3 design exploring 4 dose levels of CMV-T cells: 5 x 106, 1 x 107, 5 x 107, and 1 x 108 CMV CTLs. 4 cycles total of dose-dense TMZ and CMV-T cell infusion. Following completion of 4 cycles of dose-dense TMZ and CMV-T cell infusion, participants can receive additional 42-day cycles of dose-dense TMZ for up to 12 cycles or tumor PD.
|
Phase I: Recurrent Glioblastoma Dose Level 1 x 10^7
Dose escalation component in participants with recurrent glioblastoma to determine the maximum feasible dose (MFD) or maximum tolerated dose (MTD) of CMV-specific T cells in combination with dose-dense temozolomide. We will follow a 3+3 design exploring 4 dose levels of CMV-T cells: 5 x 106, 1 x 107, 5 x 107, and 1 x 108 CMV CTLs. 4 cycles total of dose-dense TMZ and CMV-T cell infusion. Following completion of 4 cycles of dose-dense TMZ and CMV-T cell infusion, participants can receive additional 42-day cycles of dose-dense TMZ for up to 12 cycles or tumor PD.
|
Phase I: Recurrent Glioblastoma Dose Level 5 x 10^7
Dose escalation component in participants with recurrent glioblastoma to determine the maximum feasible dose (MFD) or maximum tolerated dose (MTD) of CMV-specific T cells in combination with dose-dense temozolomide. We will follow a 3+3 design exploring 4 dose levels of CMV-T cells: 5 x 106, 1 x 107, 5 x 107, and 1 x 108 CMV CTLs. 4 cycles total of dose-dense TMZ and CMV-T cell infusion. Following completion of 4 cycles of dose-dense TMZ and CMV-T cell infusion, participants can receive additional 42-day cycles of dose-dense TMZ for up to 12 cycles or tumor PD.
|
Phase I: Recurrent Glioblastoma (MTD) Dose Level 1 x 10^8
Dose escalation component in participants with recurrent glioblastoma to determine the maximum feasible dose (MFD) or maximum tolerated dose (MTD) of CMV-specific T cells in combination with dose-dense temozolomide. We will follow a 3+3 design exploring 4 dose levels of CMV-T cells: 5 x 106, 1 x 107, 5 x 107, and 1 x 108 CMV CTLs. 4 cycles total of dose-dense TMZ and CMV-T cell infusion. Following completion of 4 cycles of dose-dense TMZ and CMV-T cell infusion, participants can receive additional 42-day cycles of dose-dense TMZ for up to 12 cycles or tumor PD.
|
|---|---|---|---|---|
|
Overall Objective Response Rate (ORR) (Newly Diagnosed Glioblastoma Cohort)- Phase II
|
3 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to response, assessed up to 4 yearsCox proportional hazard regression will be employed for multivariate analysis.
Outcome measures
| Measure |
Phase I: Recurrent Glioblastoma Dose Level 5 x 10^6
n=3 Participants
Dose escalation component in participants with recurrent glioblastoma to determine the maximum feasible dose (MFD) or maximum tolerated dose (MTD) of CMV-specific T cells in combination with dose-dense temozolomide. We will follow a 3+3 design exploring 4 dose levels of CMV-T cells: 5 x 106, 1 x 107, 5 x 107, and 1 x 108 CMV CTLs. 4 cycles total of dose-dense TMZ and CMV-T cell infusion. Following completion of 4 cycles of dose-dense TMZ and CMV-T cell infusion, participants can receive additional 42-day cycles of dose-dense TMZ for up to 12 cycles or tumor PD.
|
Phase I: Recurrent Glioblastoma Dose Level 1 x 10^7
Dose escalation component in participants with recurrent glioblastoma to determine the maximum feasible dose (MFD) or maximum tolerated dose (MTD) of CMV-specific T cells in combination with dose-dense temozolomide. We will follow a 3+3 design exploring 4 dose levels of CMV-T cells: 5 x 106, 1 x 107, 5 x 107, and 1 x 108 CMV CTLs. 4 cycles total of dose-dense TMZ and CMV-T cell infusion. Following completion of 4 cycles of dose-dense TMZ and CMV-T cell infusion, participants can receive additional 42-day cycles of dose-dense TMZ for up to 12 cycles or tumor PD.
|
Phase I: Recurrent Glioblastoma Dose Level 5 x 10^7
Dose escalation component in participants with recurrent glioblastoma to determine the maximum feasible dose (MFD) or maximum tolerated dose (MTD) of CMV-specific T cells in combination with dose-dense temozolomide. We will follow a 3+3 design exploring 4 dose levels of CMV-T cells: 5 x 106, 1 x 107, 5 x 107, and 1 x 108 CMV CTLs. 4 cycles total of dose-dense TMZ and CMV-T cell infusion. Following completion of 4 cycles of dose-dense TMZ and CMV-T cell infusion, participants can receive additional 42-day cycles of dose-dense TMZ for up to 12 cycles or tumor PD.
|
Phase I: Recurrent Glioblastoma (MTD) Dose Level 1 x 10^8
Dose escalation component in participants with recurrent glioblastoma to determine the maximum feasible dose (MFD) or maximum tolerated dose (MTD) of CMV-specific T cells in combination with dose-dense temozolomide. We will follow a 3+3 design exploring 4 dose levels of CMV-T cells: 5 x 106, 1 x 107, 5 x 107, and 1 x 108 CMV CTLs. 4 cycles total of dose-dense TMZ and CMV-T cell infusion. Following completion of 4 cycles of dose-dense TMZ and CMV-T cell infusion, participants can receive additional 42-day cycles of dose-dense TMZ for up to 12 cycles or tumor PD.
|
|---|---|---|---|---|
|
Median Duration of Response (Newly Diagnosed Glioblastoma Cohort)- Phase II
|
5.3 months
Interval 4.0 to 10.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At 6 monthsProgression free survival is defined as time in weeks from start of study treatment to first documentation of objective tumor progression or up to death due to any cause, whichever occurs first.
Outcome measures
| Measure |
Phase I: Recurrent Glioblastoma Dose Level 5 x 10^6
n=3 Participants
Dose escalation component in participants with recurrent glioblastoma to determine the maximum feasible dose (MFD) or maximum tolerated dose (MTD) of CMV-specific T cells in combination with dose-dense temozolomide. We will follow a 3+3 design exploring 4 dose levels of CMV-T cells: 5 x 106, 1 x 107, 5 x 107, and 1 x 108 CMV CTLs. 4 cycles total of dose-dense TMZ and CMV-T cell infusion. Following completion of 4 cycles of dose-dense TMZ and CMV-T cell infusion, participants can receive additional 42-day cycles of dose-dense TMZ for up to 12 cycles or tumor PD.
|
Phase I: Recurrent Glioblastoma Dose Level 1 x 10^7
Dose escalation component in participants with recurrent glioblastoma to determine the maximum feasible dose (MFD) or maximum tolerated dose (MTD) of CMV-specific T cells in combination with dose-dense temozolomide. We will follow a 3+3 design exploring 4 dose levels of CMV-T cells: 5 x 106, 1 x 107, 5 x 107, and 1 x 108 CMV CTLs. 4 cycles total of dose-dense TMZ and CMV-T cell infusion. Following completion of 4 cycles of dose-dense TMZ and CMV-T cell infusion, participants can receive additional 42-day cycles of dose-dense TMZ for up to 12 cycles or tumor PD.
|
Phase I: Recurrent Glioblastoma Dose Level 5 x 10^7
Dose escalation component in participants with recurrent glioblastoma to determine the maximum feasible dose (MFD) or maximum tolerated dose (MTD) of CMV-specific T cells in combination with dose-dense temozolomide. We will follow a 3+3 design exploring 4 dose levels of CMV-T cells: 5 x 106, 1 x 107, 5 x 107, and 1 x 108 CMV CTLs. 4 cycles total of dose-dense TMZ and CMV-T cell infusion. Following completion of 4 cycles of dose-dense TMZ and CMV-T cell infusion, participants can receive additional 42-day cycles of dose-dense TMZ for up to 12 cycles or tumor PD.
|
Phase I: Recurrent Glioblastoma (MTD) Dose Level 1 x 10^8
Dose escalation component in participants with recurrent glioblastoma to determine the maximum feasible dose (MFD) or maximum tolerated dose (MTD) of CMV-specific T cells in combination with dose-dense temozolomide. We will follow a 3+3 design exploring 4 dose levels of CMV-T cells: 5 x 106, 1 x 107, 5 x 107, and 1 x 108 CMV CTLs. 4 cycles total of dose-dense TMZ and CMV-T cell infusion. Following completion of 4 cycles of dose-dense TMZ and CMV-T cell infusion, participants can receive additional 42-day cycles of dose-dense TMZ for up to 12 cycles or tumor PD.
|
|---|---|---|---|---|
|
Progression Free Survival (PFS) (Newly Diagnosed Glioblastoma Cohort)- Phase II
|
19 weeks
Interval 9.0 to 20.0
|
—
|
—
|
—
|
Adverse Events
Phase I: Recurrent Glioblastoma Dose Level 5 x 10^6
Serious events: 2 serious events
Other events: 3 other events
Deaths: 1 deaths
Phase I: Recurrent Glioblastoma Dose Level 1 x 10^7
Serious events: 1 serious events
Other events: 3 other events
Deaths: 2 deaths
Phase I: Recurrent Glioblastoma Dose Level 5 x 10^7
Serious events: 1 serious events
Other events: 2 other events
Deaths: 3 deaths
Phase I: Recurrent Glioblastoma Dose Level 1 x 10^8
Serious events: 3 serious events
Other events: 5 other events
Deaths: 7 deaths
Phase II: Newly Diagnosed Dose Level 1 x 10^8
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Phase II: Recurrent Glioblastoma Dose Level 1 x 10^8
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Phase I: Recurrent Glioblastoma Dose Level 5 x 10^6
n=3 participants at risk
Dose escalation component in participants with recurrent glioblastoma to determine the maximum feasible dose (MFD) or maximum tolerated dose (MTD) of CMV-specific T cells in combination with dose-dense temozolomide. We will follow a 3+3 design exploring 4 dose levels of CMV-T cells: 5 x 106, 1 x 107, 5 x 107, and 1 x 108 CMV CTLs. 4 cycles total of dose-dense TMZ and CMV-T cell infusion. Following completion of 4 cycles of dose-dense TMZ and CMV-T cell infusion, participants can receive additional 42-day cycles of dose-dense TMZ for up to 12 cycles or tumor PD.
|
Phase I: Recurrent Glioblastoma Dose Level 1 x 10^7
n=3 participants at risk
Dose escalation component in participants with recurrent glioblastoma to determine the maximum feasible dose (MFD) or maximum tolerated dose (MTD) of CMV-specific T cells in combination with dose-dense temozolomide. We will follow a 3+3 design exploring 4 dose levels of CMV-T cells: 5 x 106, 1 x 107, 5 x 107, and 1 x 108 CMV CTLs. 4 cycles total of dose-dense TMZ and CMV-T cell infusion. Following completion of 4 cycles of dose-dense TMZ and CMV-T cell infusion, participants can receive additional 42-day cycles of dose-dense TMZ for up to 12 cycles or tumor PD.
|
Phase I: Recurrent Glioblastoma Dose Level 5 x 10^7
n=3 participants at risk
Dose escalation component in participants with recurrent glioblastoma to determine the maximum feasible dose (MFD) or maximum tolerated dose (MTD) of CMV-specific T cells in combination with dose-dense temozolomide. We will follow a 3+3 design exploring 4 dose levels of CMV-T cells: 5 x 106, 1 x 107, 5 x 107, and 1 x 108 CMV CTLs. 4 cycles total of dose-dense TMZ and CMV-T cell infusion. Following completion of 4 cycles of dose-dense TMZ and CMV-T cell infusion, participants can receive additional 42-day cycles of dose-dense TMZ for up to 12 cycles or tumor PD.
|
Phase I: Recurrent Glioblastoma Dose Level 1 x 10^8
n=7 participants at risk
Dose escalation component in participants with recurrent glioblastoma to determine the maximum feasible dose (MFD) or maximum tolerated dose (MTD) of CMV-specific T cells in combination with dose-dense temozolomide. We will follow a 3+3 design exploring 4 dose levels of CMV-T cells: 5 x 106, 1 x 107, 5 x 107, and 1 x 108 CMV CTLs. 4 cycles total of dose-dense TMZ and CMV-T cell infusion. Following completion of 4 cycles of dose-dense TMZ and CMV-T cell infusion, participants can receive additional 42-day cycles of dose-dense TMZ for up to 12 cycles or tumor PD.
|
Phase II: Newly Diagnosed Dose Level 1 x 10^8
n=3 participants at risk
Participants will receive 4 cycles total of dose-dense TMZ followed by adoptive CMV T cell infusion. Following completion of 4 cycles of dose-dense TMZ and CMV T cell infusion, patients can receive standard dose TMZ 200 mg/m\^ 2 days 1-5 every 28 days up to 12 cycles or tumor PD
|
Phase II: Recurrent Glioblastoma Dose Level 1 x 10^8
n=1 participants at risk
Participants will receive a total of 3 cycles of dose-dense temozolomide (TMZ) followed by fixed doses of CMV-specific T cell infusion in the post-surgical phase, after which they can remain on dose-dense temozolomide until tumor progression, as long as there are no unacceptable toxicities or until completion of 12 cycles of treatment with dose-dense temozolomide (whichever occurs first).
|
|---|---|---|---|---|---|---|
|
Psychiatric disorders
Confusion
|
0.00%
0/3 • from the first dose through 30 days after the completion of study treatment, up to 4 years
No Phase 2 participants died and 13 out of 16 Phase 1 participants died unrelated to study treatment. For the Phase 2 newly diagnosed participants the median survival weeks was 24 at the time of last follow up.
|
0.00%
0/3 • from the first dose through 30 days after the completion of study treatment, up to 4 years
No Phase 2 participants died and 13 out of 16 Phase 1 participants died unrelated to study treatment. For the Phase 2 newly diagnosed participants the median survival weeks was 24 at the time of last follow up.
|
0.00%
0/3 • from the first dose through 30 days after the completion of study treatment, up to 4 years
No Phase 2 participants died and 13 out of 16 Phase 1 participants died unrelated to study treatment. For the Phase 2 newly diagnosed participants the median survival weeks was 24 at the time of last follow up.
|
14.3%
1/7 • from the first dose through 30 days after the completion of study treatment, up to 4 years
No Phase 2 participants died and 13 out of 16 Phase 1 participants died unrelated to study treatment. For the Phase 2 newly diagnosed participants the median survival weeks was 24 at the time of last follow up.
|
0.00%
0/3 • from the first dose through 30 days after the completion of study treatment, up to 4 years
No Phase 2 participants died and 13 out of 16 Phase 1 participants died unrelated to study treatment. For the Phase 2 newly diagnosed participants the median survival weeks was 24 at the time of last follow up.
|
0.00%
0/1 • from the first dose through 30 days after the completion of study treatment, up to 4 years
No Phase 2 participants died and 13 out of 16 Phase 1 participants died unrelated to study treatment. For the Phase 2 newly diagnosed participants the median survival weeks was 24 at the time of last follow up.
|
|
Nervous system disorders
Headache
|
33.3%
1/3 • from the first dose through 30 days after the completion of study treatment, up to 4 years
No Phase 2 participants died and 13 out of 16 Phase 1 participants died unrelated to study treatment. For the Phase 2 newly diagnosed participants the median survival weeks was 24 at the time of last follow up.
|
33.3%
1/3 • from the first dose through 30 days after the completion of study treatment, up to 4 years
No Phase 2 participants died and 13 out of 16 Phase 1 participants died unrelated to study treatment. For the Phase 2 newly diagnosed participants the median survival weeks was 24 at the time of last follow up.
|
0.00%
0/3 • from the first dose through 30 days after the completion of study treatment, up to 4 years
No Phase 2 participants died and 13 out of 16 Phase 1 participants died unrelated to study treatment. For the Phase 2 newly diagnosed participants the median survival weeks was 24 at the time of last follow up.
|
14.3%
1/7 • from the first dose through 30 days after the completion of study treatment, up to 4 years
No Phase 2 participants died and 13 out of 16 Phase 1 participants died unrelated to study treatment. For the Phase 2 newly diagnosed participants the median survival weeks was 24 at the time of last follow up.
|
0.00%
0/3 • from the first dose through 30 days after the completion of study treatment, up to 4 years
No Phase 2 participants died and 13 out of 16 Phase 1 participants died unrelated to study treatment. For the Phase 2 newly diagnosed participants the median survival weeks was 24 at the time of last follow up.
|
0.00%
0/1 • from the first dose through 30 days after the completion of study treatment, up to 4 years
No Phase 2 participants died and 13 out of 16 Phase 1 participants died unrelated to study treatment. For the Phase 2 newly diagnosed participants the median survival weeks was 24 at the time of last follow up.
|
|
Musculoskeletal and connective tissue disorders
Muscle Weakness
|
0.00%
0/3 • from the first dose through 30 days after the completion of study treatment, up to 4 years
No Phase 2 participants died and 13 out of 16 Phase 1 participants died unrelated to study treatment. For the Phase 2 newly diagnosed participants the median survival weeks was 24 at the time of last follow up.
|
0.00%
0/3 • from the first dose through 30 days after the completion of study treatment, up to 4 years
No Phase 2 participants died and 13 out of 16 Phase 1 participants died unrelated to study treatment. For the Phase 2 newly diagnosed participants the median survival weeks was 24 at the time of last follow up.
|
0.00%
0/3 • from the first dose through 30 days after the completion of study treatment, up to 4 years
No Phase 2 participants died and 13 out of 16 Phase 1 participants died unrelated to study treatment. For the Phase 2 newly diagnosed participants the median survival weeks was 24 at the time of last follow up.
|
14.3%
1/7 • from the first dose through 30 days after the completion of study treatment, up to 4 years
No Phase 2 participants died and 13 out of 16 Phase 1 participants died unrelated to study treatment. For the Phase 2 newly diagnosed participants the median survival weeks was 24 at the time of last follow up.
|
0.00%
0/3 • from the first dose through 30 days after the completion of study treatment, up to 4 years
No Phase 2 participants died and 13 out of 16 Phase 1 participants died unrelated to study treatment. For the Phase 2 newly diagnosed participants the median survival weeks was 24 at the time of last follow up.
|
0.00%
0/1 • from the first dose through 30 days after the completion of study treatment, up to 4 years
No Phase 2 participants died and 13 out of 16 Phase 1 participants died unrelated to study treatment. For the Phase 2 newly diagnosed participants the median survival weeks was 24 at the time of last follow up.
|
|
Surgical and medical procedures
Surgical and medical procedures, other-removal of facial cyst
|
33.3%
1/3 • from the first dose through 30 days after the completion of study treatment, up to 4 years
No Phase 2 participants died and 13 out of 16 Phase 1 participants died unrelated to study treatment. For the Phase 2 newly diagnosed participants the median survival weeks was 24 at the time of last follow up.
|
0.00%
0/3 • from the first dose through 30 days after the completion of study treatment, up to 4 years
No Phase 2 participants died and 13 out of 16 Phase 1 participants died unrelated to study treatment. For the Phase 2 newly diagnosed participants the median survival weeks was 24 at the time of last follow up.
|
0.00%
0/3 • from the first dose through 30 days after the completion of study treatment, up to 4 years
No Phase 2 participants died and 13 out of 16 Phase 1 participants died unrelated to study treatment. For the Phase 2 newly diagnosed participants the median survival weeks was 24 at the time of last follow up.
|
0.00%
0/7 • from the first dose through 30 days after the completion of study treatment, up to 4 years
No Phase 2 participants died and 13 out of 16 Phase 1 participants died unrelated to study treatment. For the Phase 2 newly diagnosed participants the median survival weeks was 24 at the time of last follow up.
|
0.00%
0/3 • from the first dose through 30 days after the completion of study treatment, up to 4 years
No Phase 2 participants died and 13 out of 16 Phase 1 participants died unrelated to study treatment. For the Phase 2 newly diagnosed participants the median survival weeks was 24 at the time of last follow up.
|
0.00%
0/1 • from the first dose through 30 days after the completion of study treatment, up to 4 years
No Phase 2 participants died and 13 out of 16 Phase 1 participants died unrelated to study treatment. For the Phase 2 newly diagnosed participants the median survival weeks was 24 at the time of last follow up.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/3 • from the first dose through 30 days after the completion of study treatment, up to 4 years
No Phase 2 participants died and 13 out of 16 Phase 1 participants died unrelated to study treatment. For the Phase 2 newly diagnosed participants the median survival weeks was 24 at the time of last follow up.
|
0.00%
0/3 • from the first dose through 30 days after the completion of study treatment, up to 4 years
No Phase 2 participants died and 13 out of 16 Phase 1 participants died unrelated to study treatment. For the Phase 2 newly diagnosed participants the median survival weeks was 24 at the time of last follow up.
|
33.3%
1/3 • from the first dose through 30 days after the completion of study treatment, up to 4 years
No Phase 2 participants died and 13 out of 16 Phase 1 participants died unrelated to study treatment. For the Phase 2 newly diagnosed participants the median survival weeks was 24 at the time of last follow up.
|
0.00%
0/7 • from the first dose through 30 days after the completion of study treatment, up to 4 years
No Phase 2 participants died and 13 out of 16 Phase 1 participants died unrelated to study treatment. For the Phase 2 newly diagnosed participants the median survival weeks was 24 at the time of last follow up.
|
0.00%
0/3 • from the first dose through 30 days after the completion of study treatment, up to 4 years
No Phase 2 participants died and 13 out of 16 Phase 1 participants died unrelated to study treatment. For the Phase 2 newly diagnosed participants the median survival weeks was 24 at the time of last follow up.
|
0.00%
0/1 • from the first dose through 30 days after the completion of study treatment, up to 4 years
No Phase 2 participants died and 13 out of 16 Phase 1 participants died unrelated to study treatment. For the Phase 2 newly diagnosed participants the median survival weeks was 24 at the time of last follow up.
|
|
Psychiatric disorders
Cognitive Disturbance
|
0.00%
0/3 • from the first dose through 30 days after the completion of study treatment, up to 4 years
No Phase 2 participants died and 13 out of 16 Phase 1 participants died unrelated to study treatment. For the Phase 2 newly diagnosed participants the median survival weeks was 24 at the time of last follow up.
|
0.00%
0/3 • from the first dose through 30 days after the completion of study treatment, up to 4 years
No Phase 2 participants died and 13 out of 16 Phase 1 participants died unrelated to study treatment. For the Phase 2 newly diagnosed participants the median survival weeks was 24 at the time of last follow up.
|
0.00%
0/3 • from the first dose through 30 days after the completion of study treatment, up to 4 years
No Phase 2 participants died and 13 out of 16 Phase 1 participants died unrelated to study treatment. For the Phase 2 newly diagnosed participants the median survival weeks was 24 at the time of last follow up.
|
14.3%
1/7 • from the first dose through 30 days after the completion of study treatment, up to 4 years
No Phase 2 participants died and 13 out of 16 Phase 1 participants died unrelated to study treatment. For the Phase 2 newly diagnosed participants the median survival weeks was 24 at the time of last follow up.
|
0.00%
0/3 • from the first dose through 30 days after the completion of study treatment, up to 4 years
No Phase 2 participants died and 13 out of 16 Phase 1 participants died unrelated to study treatment. For the Phase 2 newly diagnosed participants the median survival weeks was 24 at the time of last follow up.
|
0.00%
0/1 • from the first dose through 30 days after the completion of study treatment, up to 4 years
No Phase 2 participants died and 13 out of 16 Phase 1 participants died unrelated to study treatment. For the Phase 2 newly diagnosed participants the median survival weeks was 24 at the time of last follow up.
|
Other adverse events
| Measure |
Phase I: Recurrent Glioblastoma Dose Level 5 x 10^6
n=3 participants at risk
Dose escalation component in participants with recurrent glioblastoma to determine the maximum feasible dose (MFD) or maximum tolerated dose (MTD) of CMV-specific T cells in combination with dose-dense temozolomide. We will follow a 3+3 design exploring 4 dose levels of CMV-T cells: 5 x 106, 1 x 107, 5 x 107, and 1 x 108 CMV CTLs. 4 cycles total of dose-dense TMZ and CMV-T cell infusion. Following completion of 4 cycles of dose-dense TMZ and CMV-T cell infusion, participants can receive additional 42-day cycles of dose-dense TMZ for up to 12 cycles or tumor PD.
|
Phase I: Recurrent Glioblastoma Dose Level 1 x 10^7
n=3 participants at risk
Dose escalation component in participants with recurrent glioblastoma to determine the maximum feasible dose (MFD) or maximum tolerated dose (MTD) of CMV-specific T cells in combination with dose-dense temozolomide. We will follow a 3+3 design exploring 4 dose levels of CMV-T cells: 5 x 106, 1 x 107, 5 x 107, and 1 x 108 CMV CTLs. 4 cycles total of dose-dense TMZ and CMV-T cell infusion. Following completion of 4 cycles of dose-dense TMZ and CMV-T cell infusion, participants can receive additional 42-day cycles of dose-dense TMZ for up to 12 cycles or tumor PD.
|
Phase I: Recurrent Glioblastoma Dose Level 5 x 10^7
n=3 participants at risk
Dose escalation component in participants with recurrent glioblastoma to determine the maximum feasible dose (MFD) or maximum tolerated dose (MTD) of CMV-specific T cells in combination with dose-dense temozolomide. We will follow a 3+3 design exploring 4 dose levels of CMV-T cells: 5 x 106, 1 x 107, 5 x 107, and 1 x 108 CMV CTLs. 4 cycles total of dose-dense TMZ and CMV-T cell infusion. Following completion of 4 cycles of dose-dense TMZ and CMV-T cell infusion, participants can receive additional 42-day cycles of dose-dense TMZ for up to 12 cycles or tumor PD.
|
Phase I: Recurrent Glioblastoma Dose Level 1 x 10^8
n=7 participants at risk
Dose escalation component in participants with recurrent glioblastoma to determine the maximum feasible dose (MFD) or maximum tolerated dose (MTD) of CMV-specific T cells in combination with dose-dense temozolomide. We will follow a 3+3 design exploring 4 dose levels of CMV-T cells: 5 x 106, 1 x 107, 5 x 107, and 1 x 108 CMV CTLs. 4 cycles total of dose-dense TMZ and CMV-T cell infusion. Following completion of 4 cycles of dose-dense TMZ and CMV-T cell infusion, participants can receive additional 42-day cycles of dose-dense TMZ for up to 12 cycles or tumor PD.
|
Phase II: Newly Diagnosed Dose Level 1 x 10^8
n=3 participants at risk
Participants will receive 4 cycles total of dose-dense TMZ followed by adoptive CMV T cell infusion. Following completion of 4 cycles of dose-dense TMZ and CMV T cell infusion, patients can receive standard dose TMZ 200 mg/m\^ 2 days 1-5 every 28 days up to 12 cycles or tumor PD
|
Phase II: Recurrent Glioblastoma Dose Level 1 x 10^8
n=1 participants at risk
Participants will receive a total of 3 cycles of dose-dense temozolomide (TMZ) followed by fixed doses of CMV-specific T cell infusion in the post-surgical phase, after which they can remain on dose-dense temozolomide until tumor progression, as long as there are no unacceptable toxicities or until completion of 12 cycles of treatment with dose-dense temozolomide (whichever occurs first).
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/3 • from the first dose through 30 days after the completion of study treatment, up to 4 years
No Phase 2 participants died and 13 out of 16 Phase 1 participants died unrelated to study treatment. For the Phase 2 newly diagnosed participants the median survival weeks was 24 at the time of last follow up.
|
0.00%
0/3 • from the first dose through 30 days after the completion of study treatment, up to 4 years
No Phase 2 participants died and 13 out of 16 Phase 1 participants died unrelated to study treatment. For the Phase 2 newly diagnosed participants the median survival weeks was 24 at the time of last follow up.
|
33.3%
1/3 • from the first dose through 30 days after the completion of study treatment, up to 4 years
No Phase 2 participants died and 13 out of 16 Phase 1 participants died unrelated to study treatment. For the Phase 2 newly diagnosed participants the median survival weeks was 24 at the time of last follow up.
|
0.00%
0/7 • from the first dose through 30 days after the completion of study treatment, up to 4 years
No Phase 2 participants died and 13 out of 16 Phase 1 participants died unrelated to study treatment. For the Phase 2 newly diagnosed participants the median survival weeks was 24 at the time of last follow up.
|
0.00%
0/3 • from the first dose through 30 days after the completion of study treatment, up to 4 years
No Phase 2 participants died and 13 out of 16 Phase 1 participants died unrelated to study treatment. For the Phase 2 newly diagnosed participants the median survival weeks was 24 at the time of last follow up.
|
0.00%
0/1 • from the first dose through 30 days after the completion of study treatment, up to 4 years
No Phase 2 participants died and 13 out of 16 Phase 1 participants died unrelated to study treatment. For the Phase 2 newly diagnosed participants the median survival weeks was 24 at the time of last follow up.
|
|
Metabolism and nutrition disorders
Anorexia
|
33.3%
1/3 • from the first dose through 30 days after the completion of study treatment, up to 4 years
No Phase 2 participants died and 13 out of 16 Phase 1 participants died unrelated to study treatment. For the Phase 2 newly diagnosed participants the median survival weeks was 24 at the time of last follow up.
|
33.3%
1/3 • from the first dose through 30 days after the completion of study treatment, up to 4 years
No Phase 2 participants died and 13 out of 16 Phase 1 participants died unrelated to study treatment. For the Phase 2 newly diagnosed participants the median survival weeks was 24 at the time of last follow up.
|
66.7%
2/3 • from the first dose through 30 days after the completion of study treatment, up to 4 years
No Phase 2 participants died and 13 out of 16 Phase 1 participants died unrelated to study treatment. For the Phase 2 newly diagnosed participants the median survival weeks was 24 at the time of last follow up.
|
28.6%
2/7 • from the first dose through 30 days after the completion of study treatment, up to 4 years
No Phase 2 participants died and 13 out of 16 Phase 1 participants died unrelated to study treatment. For the Phase 2 newly diagnosed participants the median survival weeks was 24 at the time of last follow up.
|
33.3%
1/3 • from the first dose through 30 days after the completion of study treatment, up to 4 years
No Phase 2 participants died and 13 out of 16 Phase 1 participants died unrelated to study treatment. For the Phase 2 newly diagnosed participants the median survival weeks was 24 at the time of last follow up.
|
0.00%
0/1 • from the first dose through 30 days after the completion of study treatment, up to 4 years
No Phase 2 participants died and 13 out of 16 Phase 1 participants died unrelated to study treatment. For the Phase 2 newly diagnosed participants the median survival weeks was 24 at the time of last follow up.
|
|
Psychiatric disorders
Anxiety
|
33.3%
1/3 • from the first dose through 30 days after the completion of study treatment, up to 4 years
No Phase 2 participants died and 13 out of 16 Phase 1 participants died unrelated to study treatment. For the Phase 2 newly diagnosed participants the median survival weeks was 24 at the time of last follow up.
|
33.3%
1/3 • from the first dose through 30 days after the completion of study treatment, up to 4 years
No Phase 2 participants died and 13 out of 16 Phase 1 participants died unrelated to study treatment. For the Phase 2 newly diagnosed participants the median survival weeks was 24 at the time of last follow up.
|
0.00%
0/3 • from the first dose through 30 days after the completion of study treatment, up to 4 years
No Phase 2 participants died and 13 out of 16 Phase 1 participants died unrelated to study treatment. For the Phase 2 newly diagnosed participants the median survival weeks was 24 at the time of last follow up.
|
0.00%
0/7 • from the first dose through 30 days after the completion of study treatment, up to 4 years
No Phase 2 participants died and 13 out of 16 Phase 1 participants died unrelated to study treatment. For the Phase 2 newly diagnosed participants the median survival weeks was 24 at the time of last follow up.
|
0.00%
0/3 • from the first dose through 30 days after the completion of study treatment, up to 4 years
No Phase 2 participants died and 13 out of 16 Phase 1 participants died unrelated to study treatment. For the Phase 2 newly diagnosed participants the median survival weeks was 24 at the time of last follow up.
|
0.00%
0/1 • from the first dose through 30 days after the completion of study treatment, up to 4 years
No Phase 2 participants died and 13 out of 16 Phase 1 participants died unrelated to study treatment. For the Phase 2 newly diagnosed participants the median survival weeks was 24 at the time of last follow up.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/3 • from the first dose through 30 days after the completion of study treatment, up to 4 years
No Phase 2 participants died and 13 out of 16 Phase 1 participants died unrelated to study treatment. For the Phase 2 newly diagnosed participants the median survival weeks was 24 at the time of last follow up.
|
33.3%
1/3 • from the first dose through 30 days after the completion of study treatment, up to 4 years
No Phase 2 participants died and 13 out of 16 Phase 1 participants died unrelated to study treatment. For the Phase 2 newly diagnosed participants the median survival weeks was 24 at the time of last follow up.
|
33.3%
1/3 • from the first dose through 30 days after the completion of study treatment, up to 4 years
No Phase 2 participants died and 13 out of 16 Phase 1 participants died unrelated to study treatment. For the Phase 2 newly diagnosed participants the median survival weeks was 24 at the time of last follow up.
|
14.3%
1/7 • from the first dose through 30 days after the completion of study treatment, up to 4 years
No Phase 2 participants died and 13 out of 16 Phase 1 participants died unrelated to study treatment. For the Phase 2 newly diagnosed participants the median survival weeks was 24 at the time of last follow up.
|
0.00%
0/3 • from the first dose through 30 days after the completion of study treatment, up to 4 years
No Phase 2 participants died and 13 out of 16 Phase 1 participants died unrelated to study treatment. For the Phase 2 newly diagnosed participants the median survival weeks was 24 at the time of last follow up.
|
0.00%
0/1 • from the first dose through 30 days after the completion of study treatment, up to 4 years
No Phase 2 participants died and 13 out of 16 Phase 1 participants died unrelated to study treatment. For the Phase 2 newly diagnosed participants the median survival weeks was 24 at the time of last follow up.
|
|
Nervous system disorders
Cognitive Disturbance
|
33.3%
1/3 • from the first dose through 30 days after the completion of study treatment, up to 4 years
No Phase 2 participants died and 13 out of 16 Phase 1 participants died unrelated to study treatment. For the Phase 2 newly diagnosed participants the median survival weeks was 24 at the time of last follow up.
|
33.3%
1/3 • from the first dose through 30 days after the completion of study treatment, up to 4 years
No Phase 2 participants died and 13 out of 16 Phase 1 participants died unrelated to study treatment. For the Phase 2 newly diagnosed participants the median survival weeks was 24 at the time of last follow up.
|
0.00%
0/3 • from the first dose through 30 days after the completion of study treatment, up to 4 years
No Phase 2 participants died and 13 out of 16 Phase 1 participants died unrelated to study treatment. For the Phase 2 newly diagnosed participants the median survival weeks was 24 at the time of last follow up.
|
0.00%
0/7 • from the first dose through 30 days after the completion of study treatment, up to 4 years
No Phase 2 participants died and 13 out of 16 Phase 1 participants died unrelated to study treatment. For the Phase 2 newly diagnosed participants the median survival weeks was 24 at the time of last follow up.
|
0.00%
0/3 • from the first dose through 30 days after the completion of study treatment, up to 4 years
No Phase 2 participants died and 13 out of 16 Phase 1 participants died unrelated to study treatment. For the Phase 2 newly diagnosed participants the median survival weeks was 24 at the time of last follow up.
|
0.00%
0/1 • from the first dose through 30 days after the completion of study treatment, up to 4 years
No Phase 2 participants died and 13 out of 16 Phase 1 participants died unrelated to study treatment. For the Phase 2 newly diagnosed participants the median survival weeks was 24 at the time of last follow up.
|
|
Psychiatric disorders
Confusion
|
0.00%
0/3 • from the first dose through 30 days after the completion of study treatment, up to 4 years
No Phase 2 participants died and 13 out of 16 Phase 1 participants died unrelated to study treatment. For the Phase 2 newly diagnosed participants the median survival weeks was 24 at the time of last follow up.
|
33.3%
1/3 • from the first dose through 30 days after the completion of study treatment, up to 4 years
No Phase 2 participants died and 13 out of 16 Phase 1 participants died unrelated to study treatment. For the Phase 2 newly diagnosed participants the median survival weeks was 24 at the time of last follow up.
|
33.3%
1/3 • from the first dose through 30 days after the completion of study treatment, up to 4 years
No Phase 2 participants died and 13 out of 16 Phase 1 participants died unrelated to study treatment. For the Phase 2 newly diagnosed participants the median survival weeks was 24 at the time of last follow up.
|
14.3%
1/7 • from the first dose through 30 days after the completion of study treatment, up to 4 years
No Phase 2 participants died and 13 out of 16 Phase 1 participants died unrelated to study treatment. For the Phase 2 newly diagnosed participants the median survival weeks was 24 at the time of last follow up.
|
0.00%
0/3 • from the first dose through 30 days after the completion of study treatment, up to 4 years
No Phase 2 participants died and 13 out of 16 Phase 1 participants died unrelated to study treatment. For the Phase 2 newly diagnosed participants the median survival weeks was 24 at the time of last follow up.
|
0.00%
0/1 • from the first dose through 30 days after the completion of study treatment, up to 4 years
No Phase 2 participants died and 13 out of 16 Phase 1 participants died unrelated to study treatment. For the Phase 2 newly diagnosed participants the median survival weeks was 24 at the time of last follow up.
|
|
Gastrointestinal disorders
Constipation
|
100.0%
3/3 • from the first dose through 30 days after the completion of study treatment, up to 4 years
No Phase 2 participants died and 13 out of 16 Phase 1 participants died unrelated to study treatment. For the Phase 2 newly diagnosed participants the median survival weeks was 24 at the time of last follow up.
|
100.0%
3/3 • from the first dose through 30 days after the completion of study treatment, up to 4 years
No Phase 2 participants died and 13 out of 16 Phase 1 participants died unrelated to study treatment. For the Phase 2 newly diagnosed participants the median survival weeks was 24 at the time of last follow up.
|
66.7%
2/3 • from the first dose through 30 days after the completion of study treatment, up to 4 years
No Phase 2 participants died and 13 out of 16 Phase 1 participants died unrelated to study treatment. For the Phase 2 newly diagnosed participants the median survival weeks was 24 at the time of last follow up.
|
57.1%
4/7 • from the first dose through 30 days after the completion of study treatment, up to 4 years
No Phase 2 participants died and 13 out of 16 Phase 1 participants died unrelated to study treatment. For the Phase 2 newly diagnosed participants the median survival weeks was 24 at the time of last follow up.
|
0.00%
0/3 • from the first dose through 30 days after the completion of study treatment, up to 4 years
No Phase 2 participants died and 13 out of 16 Phase 1 participants died unrelated to study treatment. For the Phase 2 newly diagnosed participants the median survival weeks was 24 at the time of last follow up.
|
100.0%
1/1 • from the first dose through 30 days after the completion of study treatment, up to 4 years
No Phase 2 participants died and 13 out of 16 Phase 1 participants died unrelated to study treatment. For the Phase 2 newly diagnosed participants the median survival weeks was 24 at the time of last follow up.
|
|
Psychiatric disorders
Depression
|
33.3%
1/3 • from the first dose through 30 days after the completion of study treatment, up to 4 years
No Phase 2 participants died and 13 out of 16 Phase 1 participants died unrelated to study treatment. For the Phase 2 newly diagnosed participants the median survival weeks was 24 at the time of last follow up.
|
0.00%
0/3 • from the first dose through 30 days after the completion of study treatment, up to 4 years
No Phase 2 participants died and 13 out of 16 Phase 1 participants died unrelated to study treatment. For the Phase 2 newly diagnosed participants the median survival weeks was 24 at the time of last follow up.
|
0.00%
0/3 • from the first dose through 30 days after the completion of study treatment, up to 4 years
No Phase 2 participants died and 13 out of 16 Phase 1 participants died unrelated to study treatment. For the Phase 2 newly diagnosed participants the median survival weeks was 24 at the time of last follow up.
|
0.00%
0/7 • from the first dose through 30 days after the completion of study treatment, up to 4 years
No Phase 2 participants died and 13 out of 16 Phase 1 participants died unrelated to study treatment. For the Phase 2 newly diagnosed participants the median survival weeks was 24 at the time of last follow up.
|
0.00%
0/3 • from the first dose through 30 days after the completion of study treatment, up to 4 years
No Phase 2 participants died and 13 out of 16 Phase 1 participants died unrelated to study treatment. For the Phase 2 newly diagnosed participants the median survival weeks was 24 at the time of last follow up.
|
0.00%
0/1 • from the first dose through 30 days after the completion of study treatment, up to 4 years
No Phase 2 participants died and 13 out of 16 Phase 1 participants died unrelated to study treatment. For the Phase 2 newly diagnosed participants the median survival weeks was 24 at the time of last follow up.
|
|
Skin and subcutaneous tissue disorders
Rash Maculo-Papular
|
0.00%
0/3 • from the first dose through 30 days after the completion of study treatment, up to 4 years
No Phase 2 participants died and 13 out of 16 Phase 1 participants died unrelated to study treatment. For the Phase 2 newly diagnosed participants the median survival weeks was 24 at the time of last follow up.
|
0.00%
0/3 • from the first dose through 30 days after the completion of study treatment, up to 4 years
No Phase 2 participants died and 13 out of 16 Phase 1 participants died unrelated to study treatment. For the Phase 2 newly diagnosed participants the median survival weeks was 24 at the time of last follow up.
|
0.00%
0/3 • from the first dose through 30 days after the completion of study treatment, up to 4 years
No Phase 2 participants died and 13 out of 16 Phase 1 participants died unrelated to study treatment. For the Phase 2 newly diagnosed participants the median survival weeks was 24 at the time of last follow up.
|
14.3%
1/7 • from the first dose through 30 days after the completion of study treatment, up to 4 years
No Phase 2 participants died and 13 out of 16 Phase 1 participants died unrelated to study treatment. For the Phase 2 newly diagnosed participants the median survival weeks was 24 at the time of last follow up.
|
33.3%
1/3 • from the first dose through 30 days after the completion of study treatment, up to 4 years
No Phase 2 participants died and 13 out of 16 Phase 1 participants died unrelated to study treatment. For the Phase 2 newly diagnosed participants the median survival weeks was 24 at the time of last follow up.
|
0.00%
0/1 • from the first dose through 30 days after the completion of study treatment, up to 4 years
No Phase 2 participants died and 13 out of 16 Phase 1 participants died unrelated to study treatment. For the Phase 2 newly diagnosed participants the median survival weeks was 24 at the time of last follow up.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3 • from the first dose through 30 days after the completion of study treatment, up to 4 years
No Phase 2 participants died and 13 out of 16 Phase 1 participants died unrelated to study treatment. For the Phase 2 newly diagnosed participants the median survival weeks was 24 at the time of last follow up.
|
33.3%
1/3 • from the first dose through 30 days after the completion of study treatment, up to 4 years
No Phase 2 participants died and 13 out of 16 Phase 1 participants died unrelated to study treatment. For the Phase 2 newly diagnosed participants the median survival weeks was 24 at the time of last follow up.
|
0.00%
0/3 • from the first dose through 30 days after the completion of study treatment, up to 4 years
No Phase 2 participants died and 13 out of 16 Phase 1 participants died unrelated to study treatment. For the Phase 2 newly diagnosed participants the median survival weeks was 24 at the time of last follow up.
|
14.3%
1/7 • from the first dose through 30 days after the completion of study treatment, up to 4 years
No Phase 2 participants died and 13 out of 16 Phase 1 participants died unrelated to study treatment. For the Phase 2 newly diagnosed participants the median survival weeks was 24 at the time of last follow up.
|
0.00%
0/3 • from the first dose through 30 days after the completion of study treatment, up to 4 years
No Phase 2 participants died and 13 out of 16 Phase 1 participants died unrelated to study treatment. For the Phase 2 newly diagnosed participants the median survival weeks was 24 at the time of last follow up.
|
100.0%
1/1 • from the first dose through 30 days after the completion of study treatment, up to 4 years
No Phase 2 participants died and 13 out of 16 Phase 1 participants died unrelated to study treatment. For the Phase 2 newly diagnosed participants the median survival weeks was 24 at the time of last follow up.
|
|
Metabolism and nutrition disorders
Malaise
|
33.3%
1/3 • from the first dose through 30 days after the completion of study treatment, up to 4 years
No Phase 2 participants died and 13 out of 16 Phase 1 participants died unrelated to study treatment. For the Phase 2 newly diagnosed participants the median survival weeks was 24 at the time of last follow up.
|
33.3%
1/3 • from the first dose through 30 days after the completion of study treatment, up to 4 years
No Phase 2 participants died and 13 out of 16 Phase 1 participants died unrelated to study treatment. For the Phase 2 newly diagnosed participants the median survival weeks was 24 at the time of last follow up.
|
0.00%
0/3 • from the first dose through 30 days after the completion of study treatment, up to 4 years
No Phase 2 participants died and 13 out of 16 Phase 1 participants died unrelated to study treatment. For the Phase 2 newly diagnosed participants the median survival weeks was 24 at the time of last follow up.
|
0.00%
0/7 • from the first dose through 30 days after the completion of study treatment, up to 4 years
No Phase 2 participants died and 13 out of 16 Phase 1 participants died unrelated to study treatment. For the Phase 2 newly diagnosed participants the median survival weeks was 24 at the time of last follow up.
|
0.00%
0/3 • from the first dose through 30 days after the completion of study treatment, up to 4 years
No Phase 2 participants died and 13 out of 16 Phase 1 participants died unrelated to study treatment. For the Phase 2 newly diagnosed participants the median survival weeks was 24 at the time of last follow up.
|
0.00%
0/1 • from the first dose through 30 days after the completion of study treatment, up to 4 years
No Phase 2 participants died and 13 out of 16 Phase 1 participants died unrelated to study treatment. For the Phase 2 newly diagnosed participants the median survival weeks was 24 at the time of last follow up.
|
|
General disorders
Nausea
|
0.00%
0/3 • from the first dose through 30 days after the completion of study treatment, up to 4 years
No Phase 2 participants died and 13 out of 16 Phase 1 participants died unrelated to study treatment. For the Phase 2 newly diagnosed participants the median survival weeks was 24 at the time of last follow up.
|
100.0%
3/3 • from the first dose through 30 days after the completion of study treatment, up to 4 years
No Phase 2 participants died and 13 out of 16 Phase 1 participants died unrelated to study treatment. For the Phase 2 newly diagnosed participants the median survival weeks was 24 at the time of last follow up.
|
0.00%
0/3 • from the first dose through 30 days after the completion of study treatment, up to 4 years
No Phase 2 participants died and 13 out of 16 Phase 1 participants died unrelated to study treatment. For the Phase 2 newly diagnosed participants the median survival weeks was 24 at the time of last follow up.
|
0.00%
0/7 • from the first dose through 30 days after the completion of study treatment, up to 4 years
No Phase 2 participants died and 13 out of 16 Phase 1 participants died unrelated to study treatment. For the Phase 2 newly diagnosed participants the median survival weeks was 24 at the time of last follow up.
|
0.00%
0/3 • from the first dose through 30 days after the completion of study treatment, up to 4 years
No Phase 2 participants died and 13 out of 16 Phase 1 participants died unrelated to study treatment. For the Phase 2 newly diagnosed participants the median survival weeks was 24 at the time of last follow up.
|
0.00%
0/1 • from the first dose through 30 days after the completion of study treatment, up to 4 years
No Phase 2 participants died and 13 out of 16 Phase 1 participants died unrelated to study treatment. For the Phase 2 newly diagnosed participants the median survival weeks was 24 at the time of last follow up.
|
|
Metabolism and nutrition disorders
Fatigue
|
0.00%
0/3 • from the first dose through 30 days after the completion of study treatment, up to 4 years
No Phase 2 participants died and 13 out of 16 Phase 1 participants died unrelated to study treatment. For the Phase 2 newly diagnosed participants the median survival weeks was 24 at the time of last follow up.
|
66.7%
2/3 • from the first dose through 30 days after the completion of study treatment, up to 4 years
No Phase 2 participants died and 13 out of 16 Phase 1 participants died unrelated to study treatment. For the Phase 2 newly diagnosed participants the median survival weeks was 24 at the time of last follow up.
|
0.00%
0/3 • from the first dose through 30 days after the completion of study treatment, up to 4 years
No Phase 2 participants died and 13 out of 16 Phase 1 participants died unrelated to study treatment. For the Phase 2 newly diagnosed participants the median survival weeks was 24 at the time of last follow up.
|
0.00%
0/7 • from the first dose through 30 days after the completion of study treatment, up to 4 years
No Phase 2 participants died and 13 out of 16 Phase 1 participants died unrelated to study treatment. For the Phase 2 newly diagnosed participants the median survival weeks was 24 at the time of last follow up.
|
33.3%
1/3 • from the first dose through 30 days after the completion of study treatment, up to 4 years
No Phase 2 participants died and 13 out of 16 Phase 1 participants died unrelated to study treatment. For the Phase 2 newly diagnosed participants the median survival weeks was 24 at the time of last follow up.
|
0.00%
0/1 • from the first dose through 30 days after the completion of study treatment, up to 4 years
No Phase 2 participants died and 13 out of 16 Phase 1 participants died unrelated to study treatment. For the Phase 2 newly diagnosed participants the median survival weeks was 24 at the time of last follow up.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • from the first dose through 30 days after the completion of study treatment, up to 4 years
No Phase 2 participants died and 13 out of 16 Phase 1 participants died unrelated to study treatment. For the Phase 2 newly diagnosed participants the median survival weeks was 24 at the time of last follow up.
|
33.3%
1/3 • from the first dose through 30 days after the completion of study treatment, up to 4 years
No Phase 2 participants died and 13 out of 16 Phase 1 participants died unrelated to study treatment. For the Phase 2 newly diagnosed participants the median survival weeks was 24 at the time of last follow up.
|
0.00%
0/3 • from the first dose through 30 days after the completion of study treatment, up to 4 years
No Phase 2 participants died and 13 out of 16 Phase 1 participants died unrelated to study treatment. For the Phase 2 newly diagnosed participants the median survival weeks was 24 at the time of last follow up.
|
0.00%
0/7 • from the first dose through 30 days after the completion of study treatment, up to 4 years
No Phase 2 participants died and 13 out of 16 Phase 1 participants died unrelated to study treatment. For the Phase 2 newly diagnosed participants the median survival weeks was 24 at the time of last follow up.
|
0.00%
0/3 • from the first dose through 30 days after the completion of study treatment, up to 4 years
No Phase 2 participants died and 13 out of 16 Phase 1 participants died unrelated to study treatment. For the Phase 2 newly diagnosed participants the median survival weeks was 24 at the time of last follow up.
|
0.00%
0/1 • from the first dose through 30 days after the completion of study treatment, up to 4 years
No Phase 2 participants died and 13 out of 16 Phase 1 participants died unrelated to study treatment. For the Phase 2 newly diagnosed participants the median survival weeks was 24 at the time of last follow up.
|
|
Nervous system disorders
Headache
|
0.00%
0/3 • from the first dose through 30 days after the completion of study treatment, up to 4 years
No Phase 2 participants died and 13 out of 16 Phase 1 participants died unrelated to study treatment. For the Phase 2 newly diagnosed participants the median survival weeks was 24 at the time of last follow up.
|
0.00%
0/3 • from the first dose through 30 days after the completion of study treatment, up to 4 years
No Phase 2 participants died and 13 out of 16 Phase 1 participants died unrelated to study treatment. For the Phase 2 newly diagnosed participants the median survival weeks was 24 at the time of last follow up.
|
0.00%
0/3 • from the first dose through 30 days after the completion of study treatment, up to 4 years
No Phase 2 participants died and 13 out of 16 Phase 1 participants died unrelated to study treatment. For the Phase 2 newly diagnosed participants the median survival weeks was 24 at the time of last follow up.
|
0.00%
0/7 • from the first dose through 30 days after the completion of study treatment, up to 4 years
No Phase 2 participants died and 13 out of 16 Phase 1 participants died unrelated to study treatment. For the Phase 2 newly diagnosed participants the median survival weeks was 24 at the time of last follow up.
|
33.3%
1/3 • from the first dose through 30 days after the completion of study treatment, up to 4 years
No Phase 2 participants died and 13 out of 16 Phase 1 participants died unrelated to study treatment. For the Phase 2 newly diagnosed participants the median survival weeks was 24 at the time of last follow up.
|
0.00%
0/1 • from the first dose through 30 days after the completion of study treatment, up to 4 years
No Phase 2 participants died and 13 out of 16 Phase 1 participants died unrelated to study treatment. For the Phase 2 newly diagnosed participants the median survival weeks was 24 at the time of last follow up.
|
|
Investigations
Weight loss
|
100.0%
3/3 • from the first dose through 30 days after the completion of study treatment, up to 4 years
No Phase 2 participants died and 13 out of 16 Phase 1 participants died unrelated to study treatment. For the Phase 2 newly diagnosed participants the median survival weeks was 24 at the time of last follow up.
|
0.00%
0/3 • from the first dose through 30 days after the completion of study treatment, up to 4 years
No Phase 2 participants died and 13 out of 16 Phase 1 participants died unrelated to study treatment. For the Phase 2 newly diagnosed participants the median survival weeks was 24 at the time of last follow up.
|
0.00%
0/3 • from the first dose through 30 days after the completion of study treatment, up to 4 years
No Phase 2 participants died and 13 out of 16 Phase 1 participants died unrelated to study treatment. For the Phase 2 newly diagnosed participants the median survival weeks was 24 at the time of last follow up.
|
0.00%
0/7 • from the first dose through 30 days after the completion of study treatment, up to 4 years
No Phase 2 participants died and 13 out of 16 Phase 1 participants died unrelated to study treatment. For the Phase 2 newly diagnosed participants the median survival weeks was 24 at the time of last follow up.
|
0.00%
0/3 • from the first dose through 30 days after the completion of study treatment, up to 4 years
No Phase 2 participants died and 13 out of 16 Phase 1 participants died unrelated to study treatment. For the Phase 2 newly diagnosed participants the median survival weeks was 24 at the time of last follow up.
|
0.00%
0/1 • from the first dose through 30 days after the completion of study treatment, up to 4 years
No Phase 2 participants died and 13 out of 16 Phase 1 participants died unrelated to study treatment. For the Phase 2 newly diagnosed participants the median survival weeks was 24 at the time of last follow up.
|
|
Nervous system disorders
Seizure
|
33.3%
1/3 • from the first dose through 30 days after the completion of study treatment, up to 4 years
No Phase 2 participants died and 13 out of 16 Phase 1 participants died unrelated to study treatment. For the Phase 2 newly diagnosed participants the median survival weeks was 24 at the time of last follow up.
|
0.00%
0/3 • from the first dose through 30 days after the completion of study treatment, up to 4 years
No Phase 2 participants died and 13 out of 16 Phase 1 participants died unrelated to study treatment. For the Phase 2 newly diagnosed participants the median survival weeks was 24 at the time of last follow up.
|
33.3%
1/3 • from the first dose through 30 days after the completion of study treatment, up to 4 years
No Phase 2 participants died and 13 out of 16 Phase 1 participants died unrelated to study treatment. For the Phase 2 newly diagnosed participants the median survival weeks was 24 at the time of last follow up.
|
14.3%
1/7 • from the first dose through 30 days after the completion of study treatment, up to 4 years
No Phase 2 participants died and 13 out of 16 Phase 1 participants died unrelated to study treatment. For the Phase 2 newly diagnosed participants the median survival weeks was 24 at the time of last follow up.
|
66.7%
2/3 • from the first dose through 30 days after the completion of study treatment, up to 4 years
No Phase 2 participants died and 13 out of 16 Phase 1 participants died unrelated to study treatment. For the Phase 2 newly diagnosed participants the median survival weeks was 24 at the time of last follow up.
|
0.00%
0/1 • from the first dose through 30 days after the completion of study treatment, up to 4 years
No Phase 2 participants died and 13 out of 16 Phase 1 participants died unrelated to study treatment. For the Phase 2 newly diagnosed participants the median survival weeks was 24 at the time of last follow up.
|
|
Renal and urinary disorders
Urinary tract infection
|
33.3%
1/3 • from the first dose through 30 days after the completion of study treatment, up to 4 years
No Phase 2 participants died and 13 out of 16 Phase 1 participants died unrelated to study treatment. For the Phase 2 newly diagnosed participants the median survival weeks was 24 at the time of last follow up.
|
0.00%
0/3 • from the first dose through 30 days after the completion of study treatment, up to 4 years
No Phase 2 participants died and 13 out of 16 Phase 1 participants died unrelated to study treatment. For the Phase 2 newly diagnosed participants the median survival weeks was 24 at the time of last follow up.
|
33.3%
1/3 • from the first dose through 30 days after the completion of study treatment, up to 4 years
No Phase 2 participants died and 13 out of 16 Phase 1 participants died unrelated to study treatment. For the Phase 2 newly diagnosed participants the median survival weeks was 24 at the time of last follow up.
|
14.3%
1/7 • from the first dose through 30 days after the completion of study treatment, up to 4 years
No Phase 2 participants died and 13 out of 16 Phase 1 participants died unrelated to study treatment. For the Phase 2 newly diagnosed participants the median survival weeks was 24 at the time of last follow up.
|
33.3%
1/3 • from the first dose through 30 days after the completion of study treatment, up to 4 years
No Phase 2 participants died and 13 out of 16 Phase 1 participants died unrelated to study treatment. For the Phase 2 newly diagnosed participants the median survival weeks was 24 at the time of last follow up.
|
0.00%
0/1 • from the first dose through 30 days after the completion of study treatment, up to 4 years
No Phase 2 participants died and 13 out of 16 Phase 1 participants died unrelated to study treatment. For the Phase 2 newly diagnosed participants the median survival weeks was 24 at the time of last follow up.
|
|
Nervous system disorders
Concentration impairment
|
33.3%
1/3 • from the first dose through 30 days after the completion of study treatment, up to 4 years
No Phase 2 participants died and 13 out of 16 Phase 1 participants died unrelated to study treatment. For the Phase 2 newly diagnosed participants the median survival weeks was 24 at the time of last follow up.
|
33.3%
1/3 • from the first dose through 30 days after the completion of study treatment, up to 4 years
No Phase 2 participants died and 13 out of 16 Phase 1 participants died unrelated to study treatment. For the Phase 2 newly diagnosed participants the median survival weeks was 24 at the time of last follow up.
|
33.3%
1/3 • from the first dose through 30 days after the completion of study treatment, up to 4 years
No Phase 2 participants died and 13 out of 16 Phase 1 participants died unrelated to study treatment. For the Phase 2 newly diagnosed participants the median survival weeks was 24 at the time of last follow up.
|
28.6%
2/7 • from the first dose through 30 days after the completion of study treatment, up to 4 years
No Phase 2 participants died and 13 out of 16 Phase 1 participants died unrelated to study treatment. For the Phase 2 newly diagnosed participants the median survival weeks was 24 at the time of last follow up.
|
0.00%
0/3 • from the first dose through 30 days after the completion of study treatment, up to 4 years
No Phase 2 participants died and 13 out of 16 Phase 1 participants died unrelated to study treatment. For the Phase 2 newly diagnosed participants the median survival weeks was 24 at the time of last follow up.
|
0.00%
0/1 • from the first dose through 30 days after the completion of study treatment, up to 4 years
No Phase 2 participants died and 13 out of 16 Phase 1 participants died unrelated to study treatment. For the Phase 2 newly diagnosed participants the median survival weeks was 24 at the time of last follow up.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/3 • from the first dose through 30 days after the completion of study treatment, up to 4 years
No Phase 2 participants died and 13 out of 16 Phase 1 participants died unrelated to study treatment. For the Phase 2 newly diagnosed participants the median survival weeks was 24 at the time of last follow up.
|
0.00%
0/3 • from the first dose through 30 days after the completion of study treatment, up to 4 years
No Phase 2 participants died and 13 out of 16 Phase 1 participants died unrelated to study treatment. For the Phase 2 newly diagnosed participants the median survival weeks was 24 at the time of last follow up.
|
33.3%
1/3 • from the first dose through 30 days after the completion of study treatment, up to 4 years
No Phase 2 participants died and 13 out of 16 Phase 1 participants died unrelated to study treatment. For the Phase 2 newly diagnosed participants the median survival weeks was 24 at the time of last follow up.
|
0.00%
0/7 • from the first dose through 30 days after the completion of study treatment, up to 4 years
No Phase 2 participants died and 13 out of 16 Phase 1 participants died unrelated to study treatment. For the Phase 2 newly diagnosed participants the median survival weeks was 24 at the time of last follow up.
|
0.00%
0/3 • from the first dose through 30 days after the completion of study treatment, up to 4 years
No Phase 2 participants died and 13 out of 16 Phase 1 participants died unrelated to study treatment. For the Phase 2 newly diagnosed participants the median survival weeks was 24 at the time of last follow up.
|
0.00%
0/1 • from the first dose through 30 days after the completion of study treatment, up to 4 years
No Phase 2 participants died and 13 out of 16 Phase 1 participants died unrelated to study treatment. For the Phase 2 newly diagnosed participants the median survival weeks was 24 at the time of last follow up.
|
|
Nervous system disorders
Memory impairment
|
66.7%
2/3 • from the first dose through 30 days after the completion of study treatment, up to 4 years
No Phase 2 participants died and 13 out of 16 Phase 1 participants died unrelated to study treatment. For the Phase 2 newly diagnosed participants the median survival weeks was 24 at the time of last follow up.
|
66.7%
2/3 • from the first dose through 30 days after the completion of study treatment, up to 4 years
No Phase 2 participants died and 13 out of 16 Phase 1 participants died unrelated to study treatment. For the Phase 2 newly diagnosed participants the median survival weeks was 24 at the time of last follow up.
|
33.3%
1/3 • from the first dose through 30 days after the completion of study treatment, up to 4 years
No Phase 2 participants died and 13 out of 16 Phase 1 participants died unrelated to study treatment. For the Phase 2 newly diagnosed participants the median survival weeks was 24 at the time of last follow up.
|
42.9%
3/7 • from the first dose through 30 days after the completion of study treatment, up to 4 years
No Phase 2 participants died and 13 out of 16 Phase 1 participants died unrelated to study treatment. For the Phase 2 newly diagnosed participants the median survival weeks was 24 at the time of last follow up.
|
33.3%
1/3 • from the first dose through 30 days after the completion of study treatment, up to 4 years
No Phase 2 participants died and 13 out of 16 Phase 1 participants died unrelated to study treatment. For the Phase 2 newly diagnosed participants the median survival weeks was 24 at the time of last follow up.
|
100.0%
1/1 • from the first dose through 30 days after the completion of study treatment, up to 4 years
No Phase 2 participants died and 13 out of 16 Phase 1 participants died unrelated to study treatment. For the Phase 2 newly diagnosed participants the median survival weeks was 24 at the time of last follow up.
|
|
Psychiatric disorders
Insomnia
|
33.3%
1/3 • from the first dose through 30 days after the completion of study treatment, up to 4 years
No Phase 2 participants died and 13 out of 16 Phase 1 participants died unrelated to study treatment. For the Phase 2 newly diagnosed participants the median survival weeks was 24 at the time of last follow up.
|
66.7%
2/3 • from the first dose through 30 days after the completion of study treatment, up to 4 years
No Phase 2 participants died and 13 out of 16 Phase 1 participants died unrelated to study treatment. For the Phase 2 newly diagnosed participants the median survival weeks was 24 at the time of last follow up.
|
33.3%
1/3 • from the first dose through 30 days after the completion of study treatment, up to 4 years
No Phase 2 participants died and 13 out of 16 Phase 1 participants died unrelated to study treatment. For the Phase 2 newly diagnosed participants the median survival weeks was 24 at the time of last follow up.
|
14.3%
1/7 • from the first dose through 30 days after the completion of study treatment, up to 4 years
No Phase 2 participants died and 13 out of 16 Phase 1 participants died unrelated to study treatment. For the Phase 2 newly diagnosed participants the median survival weeks was 24 at the time of last follow up.
|
0.00%
0/3 • from the first dose through 30 days after the completion of study treatment, up to 4 years
No Phase 2 participants died and 13 out of 16 Phase 1 participants died unrelated to study treatment. For the Phase 2 newly diagnosed participants the median survival weeks was 24 at the time of last follow up.
|
0.00%
0/1 • from the first dose through 30 days after the completion of study treatment, up to 4 years
No Phase 2 participants died and 13 out of 16 Phase 1 participants died unrelated to study treatment. For the Phase 2 newly diagnosed participants the median survival weeks was 24 at the time of last follow up.
|
|
Nervous system disorders
Lethargy
|
33.3%
1/3 • from the first dose through 30 days after the completion of study treatment, up to 4 years
No Phase 2 participants died and 13 out of 16 Phase 1 participants died unrelated to study treatment. For the Phase 2 newly diagnosed participants the median survival weeks was 24 at the time of last follow up.
|
33.3%
1/3 • from the first dose through 30 days after the completion of study treatment, up to 4 years
No Phase 2 participants died and 13 out of 16 Phase 1 participants died unrelated to study treatment. For the Phase 2 newly diagnosed participants the median survival weeks was 24 at the time of last follow up.
|
0.00%
0/3 • from the first dose through 30 days after the completion of study treatment, up to 4 years
No Phase 2 participants died and 13 out of 16 Phase 1 participants died unrelated to study treatment. For the Phase 2 newly diagnosed participants the median survival weeks was 24 at the time of last follow up.
|
14.3%
1/7 • from the first dose through 30 days after the completion of study treatment, up to 4 years
No Phase 2 participants died and 13 out of 16 Phase 1 participants died unrelated to study treatment. For the Phase 2 newly diagnosed participants the median survival weeks was 24 at the time of last follow up.
|
0.00%
0/3 • from the first dose through 30 days after the completion of study treatment, up to 4 years
No Phase 2 participants died and 13 out of 16 Phase 1 participants died unrelated to study treatment. For the Phase 2 newly diagnosed participants the median survival weeks was 24 at the time of last follow up.
|
0.00%
0/1 • from the first dose through 30 days after the completion of study treatment, up to 4 years
No Phase 2 participants died and 13 out of 16 Phase 1 participants died unrelated to study treatment. For the Phase 2 newly diagnosed participants the median survival weeks was 24 at the time of last follow up.
|
|
Investigations
Decreased platelet count
|
0.00%
0/3 • from the first dose through 30 days after the completion of study treatment, up to 4 years
No Phase 2 participants died and 13 out of 16 Phase 1 participants died unrelated to study treatment. For the Phase 2 newly diagnosed participants the median survival weeks was 24 at the time of last follow up.
|
33.3%
1/3 • from the first dose through 30 days after the completion of study treatment, up to 4 years
No Phase 2 participants died and 13 out of 16 Phase 1 participants died unrelated to study treatment. For the Phase 2 newly diagnosed participants the median survival weeks was 24 at the time of last follow up.
|
0.00%
0/3 • from the first dose through 30 days after the completion of study treatment, up to 4 years
No Phase 2 participants died and 13 out of 16 Phase 1 participants died unrelated to study treatment. For the Phase 2 newly diagnosed participants the median survival weeks was 24 at the time of last follow up.
|
28.6%
2/7 • from the first dose through 30 days after the completion of study treatment, up to 4 years
No Phase 2 participants died and 13 out of 16 Phase 1 participants died unrelated to study treatment. For the Phase 2 newly diagnosed participants the median survival weeks was 24 at the time of last follow up.
|
0.00%
0/3 • from the first dose through 30 days after the completion of study treatment, up to 4 years
No Phase 2 participants died and 13 out of 16 Phase 1 participants died unrelated to study treatment. For the Phase 2 newly diagnosed participants the median survival weeks was 24 at the time of last follow up.
|
0.00%
0/1 • from the first dose through 30 days after the completion of study treatment, up to 4 years
No Phase 2 participants died and 13 out of 16 Phase 1 participants died unrelated to study treatment. For the Phase 2 newly diagnosed participants the median survival weeks was 24 at the time of last follow up.
|
|
Investigations
Decreased lymphocyte count
|
0.00%
0/3 • from the first dose through 30 days after the completion of study treatment, up to 4 years
No Phase 2 participants died and 13 out of 16 Phase 1 participants died unrelated to study treatment. For the Phase 2 newly diagnosed participants the median survival weeks was 24 at the time of last follow up.
|
66.7%
2/3 • from the first dose through 30 days after the completion of study treatment, up to 4 years
No Phase 2 participants died and 13 out of 16 Phase 1 participants died unrelated to study treatment. For the Phase 2 newly diagnosed participants the median survival weeks was 24 at the time of last follow up.
|
33.3%
1/3 • from the first dose through 30 days after the completion of study treatment, up to 4 years
No Phase 2 participants died and 13 out of 16 Phase 1 participants died unrelated to study treatment. For the Phase 2 newly diagnosed participants the median survival weeks was 24 at the time of last follow up.
|
28.6%
2/7 • from the first dose through 30 days after the completion of study treatment, up to 4 years
No Phase 2 participants died and 13 out of 16 Phase 1 participants died unrelated to study treatment. For the Phase 2 newly diagnosed participants the median survival weeks was 24 at the time of last follow up.
|
0.00%
0/3 • from the first dose through 30 days after the completion of study treatment, up to 4 years
No Phase 2 participants died and 13 out of 16 Phase 1 participants died unrelated to study treatment. For the Phase 2 newly diagnosed participants the median survival weeks was 24 at the time of last follow up.
|
0.00%
0/1 • from the first dose through 30 days after the completion of study treatment, up to 4 years
No Phase 2 participants died and 13 out of 16 Phase 1 participants died unrelated to study treatment. For the Phase 2 newly diagnosed participants the median survival weeks was 24 at the time of last follow up.
|
|
Investigations
Decreased neutrophil count
|
0.00%
0/3 • from the first dose through 30 days after the completion of study treatment, up to 4 years
No Phase 2 participants died and 13 out of 16 Phase 1 participants died unrelated to study treatment. For the Phase 2 newly diagnosed participants the median survival weeks was 24 at the time of last follow up.
|
0.00%
0/3 • from the first dose through 30 days after the completion of study treatment, up to 4 years
No Phase 2 participants died and 13 out of 16 Phase 1 participants died unrelated to study treatment. For the Phase 2 newly diagnosed participants the median survival weeks was 24 at the time of last follow up.
|
0.00%
0/3 • from the first dose through 30 days after the completion of study treatment, up to 4 years
No Phase 2 participants died and 13 out of 16 Phase 1 participants died unrelated to study treatment. For the Phase 2 newly diagnosed participants the median survival weeks was 24 at the time of last follow up.
|
14.3%
1/7 • from the first dose through 30 days after the completion of study treatment, up to 4 years
No Phase 2 participants died and 13 out of 16 Phase 1 participants died unrelated to study treatment. For the Phase 2 newly diagnosed participants the median survival weeks was 24 at the time of last follow up.
|
0.00%
0/3 • from the first dose through 30 days after the completion of study treatment, up to 4 years
No Phase 2 participants died and 13 out of 16 Phase 1 participants died unrelated to study treatment. For the Phase 2 newly diagnosed participants the median survival weeks was 24 at the time of last follow up.
|
0.00%
0/1 • from the first dose through 30 days after the completion of study treatment, up to 4 years
No Phase 2 participants died and 13 out of 16 Phase 1 participants died unrelated to study treatment. For the Phase 2 newly diagnosed participants the median survival weeks was 24 at the time of last follow up.
|
|
Gastrointestinal disorders
Mucositis
|
0.00%
0/3 • from the first dose through 30 days after the completion of study treatment, up to 4 years
No Phase 2 participants died and 13 out of 16 Phase 1 participants died unrelated to study treatment. For the Phase 2 newly diagnosed participants the median survival weeks was 24 at the time of last follow up.
|
0.00%
0/3 • from the first dose through 30 days after the completion of study treatment, up to 4 years
No Phase 2 participants died and 13 out of 16 Phase 1 participants died unrelated to study treatment. For the Phase 2 newly diagnosed participants the median survival weeks was 24 at the time of last follow up.
|
0.00%
0/3 • from the first dose through 30 days after the completion of study treatment, up to 4 years
No Phase 2 participants died and 13 out of 16 Phase 1 participants died unrelated to study treatment. For the Phase 2 newly diagnosed participants the median survival weeks was 24 at the time of last follow up.
|
0.00%
0/7 • from the first dose through 30 days after the completion of study treatment, up to 4 years
No Phase 2 participants died and 13 out of 16 Phase 1 participants died unrelated to study treatment. For the Phase 2 newly diagnosed participants the median survival weeks was 24 at the time of last follow up.
|
33.3%
1/3 • from the first dose through 30 days after the completion of study treatment, up to 4 years
No Phase 2 participants died and 13 out of 16 Phase 1 participants died unrelated to study treatment. For the Phase 2 newly diagnosed participants the median survival weeks was 24 at the time of last follow up.
|
0.00%
0/1 • from the first dose through 30 days after the completion of study treatment, up to 4 years
No Phase 2 participants died and 13 out of 16 Phase 1 participants died unrelated to study treatment. For the Phase 2 newly diagnosed participants the median survival weeks was 24 at the time of last follow up.
|
Additional Information
Shiao-Pei Weathers, MD, Associate Professor, Neuro-Oncology
UT MD Anderson Cancer Center
Phone: (713) 792-3906
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place