Trial Outcomes & Findings for Th1/Tc1 Immunotherapy Following Stem Cell Transplantation in Multiple Myeloma (NCT NCT01239368)
NCT ID: NCT01239368
Last Updated: 2019-12-10
Results Overview
Participants were assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0)
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
34 participants
Primary outcome timeframe
2 months
Results posted on
2019-12-10
Participant Flow
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the max. number that could be manufactured due to limiting reagents for cell culture. 3/34 pts signed consent but did not receive therapy due to progressive malignancy.
Participant milestones
| Measure |
Cohort 1 - 1x10(5) T Cells/kg
1x10(5) Th1/Tc1 Rapa cells/kg of body weight
|
Cohort 2 - 5x10(5) T Cells/kg
5x10(5) Th1/Tc1 Rapa cells/kg of body weight
|
Cohort 3 - 1x10(6) T Cells/kg
1x10(6) Th1/Tc1 Rapa cells/kg of body weight
|
Cohort 4 - 3x10(6) T Cells/kg
3x10(6) Th1/Tc1 Rapa cells/kg of body weight
|
Cohort 5 - 5x10(6) T Cells/kg
5x10(6) Th1/Tc1 Rapa cells/kg of body weight
|
Cohort 5B - 5x10(6) T Rapa Cells/kg
5x10(6) Th1/Tc1 Rapa cells/kg of body weight; Three sequential infusions with at least two months between infusions.
|
Cohort 6 - 15x10(6) T Cells/kg
15x10(6) Th1/Tc1 Rapa cells/kg of body weight
|
Cohort 7 - 45x10(6) T Cells/kg of
45x10(6) Th1/Tc1 Rapa cells/kg of body weight
|
Cohort A - Th1/Tc1.Rapa Prevention of Relapse
Th1/Tc1.Rapa Prevention of Relapse
Adoptive Immunotherapy: Th1/Tc1 Rapa cell infusion will be evaluated after administration of a 7-day or 14-day course of immune depleting chemotherapy (pentostatin plus cyclophosphamide regimen).
Rapamycin-Generated Autologous Th1/Tc1 Rapa Cells: Six Th1.rapa cell doses will be tested in cohorts of 1-6 subjects each: ranging from 10e(5) to 15 x 10e(6) cells/kg of body weight.
Th1/Tc1 Rapa Cell Therapy: Th1/Tc1Rapa: 5 x 10e(6) cells/kg
|
Cohort B - Th1/Tc1.Rapa for Relapsed Multiple Myeloma
Th1/Tc1.Rapa for Relapsed Multiple Myeloma
Adoptive Immunotherapy: Th1/Tc1 Rapa cell infusion will be evaluated after administration of a 7-day or 14-day course of immune depleting chemotherapy (pentostatin plus cyclophosphamide regimen).
Th1/Tc1 Rapa Cell Therapy: Th1/Tc1rapa: 5 x 10e(6) cells/kg
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
2
|
1
|
1
|
2
|
7
|
5
|
7
|
0
|
1
|
5
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
1
|
2
|
1
|
1
|
0
|
1
|
1
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
1
|
1
|
5
|
4
|
6
|
0
|
0
|
4
|
Reasons for withdrawal
| Measure |
Cohort 1 - 1x10(5) T Cells/kg
1x10(5) Th1/Tc1 Rapa cells/kg of body weight
|
Cohort 2 - 5x10(5) T Cells/kg
5x10(5) Th1/Tc1 Rapa cells/kg of body weight
|
Cohort 3 - 1x10(6) T Cells/kg
1x10(6) Th1/Tc1 Rapa cells/kg of body weight
|
Cohort 4 - 3x10(6) T Cells/kg
3x10(6) Th1/Tc1 Rapa cells/kg of body weight
|
Cohort 5 - 5x10(6) T Cells/kg
5x10(6) Th1/Tc1 Rapa cells/kg of body weight
|
Cohort 5B - 5x10(6) T Rapa Cells/kg
5x10(6) Th1/Tc1 Rapa cells/kg of body weight; Three sequential infusions with at least two months between infusions.
|
Cohort 6 - 15x10(6) T Cells/kg
15x10(6) Th1/Tc1 Rapa cells/kg of body weight
|
Cohort 7 - 45x10(6) T Cells/kg of
45x10(6) Th1/Tc1 Rapa cells/kg of body weight
|
Cohort A - Th1/Tc1.Rapa Prevention of Relapse
Th1/Tc1.Rapa Prevention of Relapse
Adoptive Immunotherapy: Th1/Tc1 Rapa cell infusion will be evaluated after administration of a 7-day or 14-day course of immune depleting chemotherapy (pentostatin plus cyclophosphamide regimen).
Rapamycin-Generated Autologous Th1/Tc1 Rapa Cells: Six Th1.rapa cell doses will be tested in cohorts of 1-6 subjects each: ranging from 10e(5) to 15 x 10e(6) cells/kg of body weight.
Th1/Tc1 Rapa Cell Therapy: Th1/Tc1Rapa: 5 x 10e(6) cells/kg
|
Cohort B - Th1/Tc1.Rapa for Relapsed Multiple Myeloma
Th1/Tc1.Rapa for Relapsed Multiple Myeloma
Adoptive Immunotherapy: Th1/Tc1 Rapa cell infusion will be evaluated after administration of a 7-day or 14-day course of immune depleting chemotherapy (pentostatin plus cyclophosphamide regimen).
Th1/Tc1 Rapa Cell Therapy: Th1/Tc1rapa: 5 x 10e(6) cells/kg
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Principal investigator discretion
|
1
|
0
|
0
|
0
|
1
|
2
|
0
|
0
|
0
|
1
|
|
Overall Study
Disease progression on study
|
1
|
1
|
1
|
1
|
4
|
2
|
5
|
0
|
0
|
2
|
|
Overall Study
Refused further treatment
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Death
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
Baseline Characteristics
Th1/Tc1 Immunotherapy Following Stem Cell Transplantation in Multiple Myeloma
Baseline characteristics by cohort
| Measure |
Cohort 1 - 1x10(5) T Cells/kg
n=2 Participants
1x10(5) Th1/Tc1.Rapa cells/kg of body weight
|
Cohort 2 - 5x10(5) T Cells/kg
n=1 Participants
5x10(5) Th1/Tc1.Rapa cells/kg of body weight
|
Cohort 3 - 1x10(6) T Cells/kg
n=1 Participants
1x10(6) Th1/Tc1.Rapa cells/kg of body weight
|
Cohort 4 - 3x10(6) T Cells/kg
n=2 Participants
3x10(6) Th1/Tc1.Rapa cells/kg of body weight
|
Cohort 5 - 5x10(6) T Cells/kg
n=7 Participants
5x10(6) Th1/Tc1.Rapa cells/kg of body weight
|
Cohort 5B - 5x10(6) T Rapa Cells/kg
n=5 Participants
5x10(6) Th1/Tc1.Rapa cells/kg of body weight; Three sequential infusions with at least two months between infusions.
|
Cohort 6 - 15x10(6) T Cells/kg
n=7 Participants
15x10(6) Th1/Tc1.Rapa cells/kg of body weight
|
Cohort 7 - 45x10(6) T Cells/kg
45x10(6) Th1/Tc1.Rapa cells/kg of body weight
|
Cohort A - Th1/Tc1.Rapa Prevention of Relapse
n=1 Participants
Th1/Tc1.Rapa Prevention of Relapse
Adoptive Immunotherapy: Th1/Tc1.Rapa cell infusion will be evaluated after administration of a 7-day or 14-day course of immune depleting chemotherapy (pentostatin plus cyclophosphamide regimen).
Rapamycin-Generated Autologous Th1/Tc1 Cells: Six Th1/Tc1.Rapa cell doses will be tested in cohorts of 1-6 subjects each: ranging from 10e(5) to 15 x 10e(6) cells/kg of body weight.
Th1/TC1 Rapa Cell Therapy: Th1/TC1rapa: 5 x 10e(6) cells/kg
|
Cohort B - Th1/Tc1.Rapa for Relapsed Multiple Myeloma
n=5 Participants
Th1/Tc1.Rapa for Relapsed Multiple Myeloma
Adoptive Immunotherapy: Th1/Tc1.Rapa cell infusion will be evaluated after administration of a 7-day or 14-day course of immune depleting chemotherapy (pentostatin plus cyclophosphamide regimen).
Th1/TC1 Rapa Cell Therapy: Th1/Tc1.Rapa: 5 x 10e(6) cells/kg
|
Total
n=31 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=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
20 Participants
n=42 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
11 Participants
n=42 Participants
|
|
Age, Continuous
|
45.4 years
STANDARD_DEVIATION 13.58 • n=5 Participants
|
41.3 years
STANDARD_DEVIATION 0 • n=7 Participants
|
65.8 years
STANDARD_DEVIATION 0 • n=5 Participants
|
46.7 years
STANDARD_DEVIATION 15.56 • n=4 Participants
|
58.19 years
STANDARD_DEVIATION 13.79 • n=21 Participants
|
57.64 years
STANDARD_DEVIATION 6.18 • n=8 Participants
|
59.29 years
STANDARD_DEVIATION 9.58 • n=8 Participants
|
—
|
66.9 years
STANDARD_DEVIATION 0 • n=42 Participants
|
63.6 years
STANDARD_DEVIATION 9.08 • n=42 Participants
|
55.8 years
STANDARD_DEVIATION 11.65 • n=42 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
—
|
1 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
18 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
—
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
13 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
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=8 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
6 Participants
n=8 Participants
|
—
|
1 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
29 Participants
n=42 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=8 Participants
|
0 Participants
n=8 Participants
|
—
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 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=8 Participants
|
0 Participants
n=8 Participants
|
—
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Asian
|
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=8 Participants
|
0 Participants
n=8 Participants
|
—
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 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=8 Participants
|
0 Participants
n=8 Participants
|
—
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
—
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
5 Participants
n=42 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
5 Participants
n=8 Participants
|
—
|
1 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
21 Participants
n=42 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=8 Participants
|
0 Participants
n=8 Participants
|
—
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
—
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
5 Participants
n=42 Participants
|
|
Region of Enrollment
United States
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
7 Participants
n=8 Participants
|
—
|
1 Participants
n=42 Participants
|
5 Participants
n=42 Participants
|
31 Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: 2 monthsPopulation: For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
Participants were assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0)
Outcome measures
| Measure |
Cohort 1 - 1x10(5) T Cells/kg
n=2 Participants
1x10(5) Th1/Tc1.Rapa cells/kg of body weight
|
Cohort 2 - 5x10(5) T Cells/kg
n=1 Participants
5x10(5) Th1/Tc1.Rapa cells/kg of body weight
|
Cohort 3 - 1x10(6) T Cells/kg
n=1 Participants
1x10(6) Th1/Tc1.Rapa cells/kg of body weight
|
Cohort 4 - 3x10(6) T Cells/kg
n=2 Participants
3x10(6) Th1/Tc1.Rapa cells/kg of body weight
|
Cohort 5 - 5x10(6) T Cells/kg
n=7 Participants
5x10(6) Th1/Tc1.Rapa cells/kg of body weight
|
Cohort 5B - - 5x10(6) T Cells/kg
n=5 Participants
5x10(6) Th1/Tc1.Rapa cells/kg of body weight; Three sequential infusions with at least two months between infusions.
|
Cohort 6 - 15x10(6) T Cells/kg
n=7 Participants
15x10(6) Th1/Tc1.Rapac ells/kg of body weight
|
Cohort 7- 45x10(6) T Cells/kg
45x10(6) Th1/Tc1.Rapa cells/kg of body weight
|
Cohort A - Th1/Tc1.Rapa Prevention of Relapse
n=1 Participants
Th1/Tc1.Rapa Prevention of Relapse
Adoptive Immunotherapy: Th1/Tc1.Rapa cell infusion will be evaluated after administration of a 7-day or 14-day course of immune depleting chemotherapy (pentostatin plus cyclophosphamide regimen).
Rapamycin-Generated Autologous Th1/Tc1 Cells: Six Th1/Tc1.Rapa cell doses will be tested in cohorts of 1-6 subjects each: ranging from 10e(5) to 15 x 10e(6) cells/kg of body weight.
Th1/Tc1 Rapa Cell Therapy: Th1/Tc1.Rapa 5 x 10e(6) cells/kg
|
Cohort B - Th1/Tc1.Rapa Prevention of Relapse
n=5 Participants
Th1/Tc1.Rapa for Relapsed Multiple Myeloma
Adoptive Immunotherapy: Th1.rapa cell infusion will be evaluated after administration of a 7-day or 14-day course of immune depleting chemotherapy (pentostatin plus cyclophosphamide regimen).
Th1/Tc1 Rapa Cell Therapy: Th1/Tc1.Rapa: 5 x 10e(6) cells/kg
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Patients With an Adverse Event Attributable to the Investigational Therapy
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Study completion at 22 monthsPopulation: The PFS was only used in cohort A, which had just one patient.
Progressive disease is assessed by the Consensus of the International Myeloma Working Group criteria and is defined as one or more of the following: Increases of greater or equal to 25% in serum M-component (minimum absolute increase of 0.5 g/dl) or urine M-component (minimum absolute increase of 200mg/24h) or percentage of bone marrow plasma cells (minimum absolute percentage of 10%) or size of bone lesions or new plasmacytoma, or development of hypercalcemia solely attributable to the disease.
Outcome measures
| Measure |
Cohort 1 - 1x10(5) T Cells/kg
n=1 Participants
1x10(5) Th1/Tc1.Rapa cells/kg of body weight
|
Cohort 2 - 5x10(5) T Cells/kg
5x10(5) Th1/Tc1.Rapa cells/kg of body weight
|
Cohort 3 - 1x10(6) T Cells/kg
1x10(6) Th1/Tc1.Rapa cells/kg of body weight
|
Cohort 4 - 3x10(6) T Cells/kg
3x10(6) Th1/Tc1.Rapa cells/kg of body weight
|
Cohort 5 - 5x10(6) T Cells/kg
5x10(6) Th1/Tc1.Rapa cells/kg of body weight
|
Cohort 5B - - 5x10(6) T Cells/kg
5x10(6) Th1/Tc1.Rapa cells/kg of body weight; Three sequential infusions with at least two months between infusions.
|
Cohort 6 - 15x10(6) T Cells/kg
15x10(6) Th1/Tc1.Rapac ells/kg of body weight
|
Cohort 7- 45x10(6) T Cells/kg
45x10(6) Th1/Tc1.Rapa cells/kg of body weight
|
Cohort A - Th1/Tc1.Rapa Prevention of Relapse
Th1/Tc1.Rapa Prevention of Relapse
Adoptive Immunotherapy: Th1/Tc1.Rapa cell infusion will be evaluated after administration of a 7-day or 14-day course of immune depleting chemotherapy (pentostatin plus cyclophosphamide regimen).
Rapamycin-Generated Autologous Th1/Tc1 Cells: Six Th1/Tc1.Rapa cell doses will be tested in cohorts of 1-6 subjects each: ranging from 10e(5) to 15 x 10e(6) cells/kg of body weight.
Th1/Tc1 Rapa Cell Therapy: Th1/Tc1.Rapa 5 x 10e(6) cells/kg
|
Cohort B - Th1/Tc1.Rapa Prevention of Relapse
Th1/Tc1.Rapa for Relapsed Multiple Myeloma
Adoptive Immunotherapy: Th1.rapa cell infusion will be evaluated after administration of a 7-day or 14-day course of immune depleting chemotherapy (pentostatin plus cyclophosphamide regimen).
Th1/Tc1 Rapa Cell Therapy: Th1/Tc1.Rapa: 5 x 10e(6) cells/kg
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Progression Free Survival in Cohort A Th1 (Type 1 T Helper Cells)/Tc1 (T Cytotoxic Cells, Type 1) Rapa Prevention of Relapse
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Study completion at 22 monthsPatients whose tumors shrunk and were disease free after therapy in cohort B. Partial response and complete response were assessed by the Consensus of the International Myeloma Working Group criteria. Partial response is defined as 50% or greater reduction in serum M-protein and 90% or greater reduction in 24-h urinary M-protein (or to less than 200 mg per 24h), 50% or greater reduction in the size of soft tissue plasmacytomas, if present at baseline, no evidence of progressive or new bone lesions if radiographic studies were performed (X-rays not required in absence of clinical indication). Complete response is defined as negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and 5% or less plasma cells in bone marrow and no evidence of progressive or new bone lesion if radiographic studies were performed. Progressive disease is increases of ≥25% in serum M-component/urine M-component, or size of bone lesions.
Outcome measures
| Measure |
Cohort 1 - 1x10(5) T Cells/kg
n=5 Participants
1x10(5) Th1/Tc1.Rapa cells/kg of body weight
|
Cohort 2 - 5x10(5) T Cells/kg
5x10(5) Th1/Tc1.Rapa cells/kg of body weight
|
Cohort 3 - 1x10(6) T Cells/kg
1x10(6) Th1/Tc1.Rapa cells/kg of body weight
|
Cohort 4 - 3x10(6) T Cells/kg
3x10(6) Th1/Tc1.Rapa cells/kg of body weight
|
Cohort 5 - 5x10(6) T Cells/kg
5x10(6) Th1/Tc1.Rapa cells/kg of body weight
|
Cohort 5B - - 5x10(6) T Cells/kg
5x10(6) Th1/Tc1.Rapa cells/kg of body weight; Three sequential infusions with at least two months between infusions.
|
Cohort 6 - 15x10(6) T Cells/kg
15x10(6) Th1/Tc1.Rapac ells/kg of body weight
|
Cohort 7- 45x10(6) T Cells/kg
45x10(6) Th1/Tc1.Rapa cells/kg of body weight
|
Cohort A - Th1/Tc1.Rapa Prevention of Relapse
Th1/Tc1.Rapa Prevention of Relapse
Adoptive Immunotherapy: Th1/Tc1.Rapa cell infusion will be evaluated after administration of a 7-day or 14-day course of immune depleting chemotherapy (pentostatin plus cyclophosphamide regimen).
Rapamycin-Generated Autologous Th1/Tc1 Cells: Six Th1/Tc1.Rapa cell doses will be tested in cohorts of 1-6 subjects each: ranging from 10e(5) to 15 x 10e(6) cells/kg of body weight.
Th1/Tc1 Rapa Cell Therapy: Th1/Tc1.Rapa 5 x 10e(6) cells/kg
|
Cohort B - Th1/Tc1.Rapa Prevention of Relapse
Th1/Tc1.Rapa for Relapsed Multiple Myeloma
Adoptive Immunotherapy: Th1.rapa cell infusion will be evaluated after administration of a 7-day or 14-day course of immune depleting chemotherapy (pentostatin plus cyclophosphamide regimen).
Th1/Tc1 Rapa Cell Therapy: Th1/Tc1.Rapa: 5 x 10e(6) cells/kg
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Patients Who Developed a Partial Response (PR)+Complete Response (CR) in Cohort B at Any Time Point Post Therapy With PR/CR Being Maintained Until Study Completed
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, prior to chemotherapy, and 2 weeks, 1, 2, and 3 months after final T cell infusionPopulation: For the planned protocol cohort 7, no pts were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the max. # that could be manufactured due to limiting reagents for cell culture. Outcome measure not done; data not collected in real-time due to premature closure of study.
Immune reconstitution in recipients of Th1.rapa cells was determined by flow cytometry.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Date treatment consent signed to last date off study, 81 months and 6 daysPopulation: For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.
Outcome measures
| Measure |
Cohort 1 - 1x10(5) T Cells/kg
n=2 Participants
1x10(5) Th1/Tc1.Rapa cells/kg of body weight
|
Cohort 2 - 5x10(5) T Cells/kg
n=1 Participants
5x10(5) Th1/Tc1.Rapa cells/kg of body weight
|
Cohort 3 - 1x10(6) T Cells/kg
n=1 Participants
1x10(6) Th1/Tc1.Rapa cells/kg of body weight
|
Cohort 4 - 3x10(6) T Cells/kg
n=2 Participants
3x10(6) Th1/Tc1.Rapa cells/kg of body weight
|
Cohort 5 - 5x10(6) T Cells/kg
n=7 Participants
5x10(6) Th1/Tc1.Rapa cells/kg of body weight
|
Cohort 5B - - 5x10(6) T Cells/kg
n=5 Participants
5x10(6) Th1/Tc1.Rapa cells/kg of body weight; Three sequential infusions with at least two months between infusions.
|
Cohort 6 - 15x10(6) T Cells/kg
n=7 Participants
15x10(6) Th1/Tc1.Rapac ells/kg of body weight
|
Cohort 7- 45x10(6) T Cells/kg
45x10(6) Th1/Tc1.Rapa cells/kg of body weight
|
Cohort A - Th1/Tc1.Rapa Prevention of Relapse
n=1 Participants
Th1/Tc1.Rapa Prevention of Relapse
Adoptive Immunotherapy: Th1/Tc1.Rapa cell infusion will be evaluated after administration of a 7-day or 14-day course of immune depleting chemotherapy (pentostatin plus cyclophosphamide regimen).
Rapamycin-Generated Autologous Th1/Tc1 Cells: Six Th1/Tc1.Rapa cell doses will be tested in cohorts of 1-6 subjects each: ranging from 10e(5) to 15 x 10e(6) cells/kg of body weight.
Th1/Tc1 Rapa Cell Therapy: Th1/Tc1.Rapa 5 x 10e(6) cells/kg
|
Cohort B - Th1/Tc1.Rapa Prevention of Relapse
n=5 Participants
Th1/Tc1.Rapa for Relapsed Multiple Myeloma
Adoptive Immunotherapy: Th1.rapa cell infusion will be evaluated after administration of a 7-day or 14-day course of immune depleting chemotherapy (pentostatin plus cyclophosphamide regimen).
Th1/Tc1 Rapa Cell Therapy: Th1/Tc1.Rapa: 5 x 10e(6) cells/kg
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Count of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0)
|
1 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
5 Participants
|
2 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
4 Participants
|
Adverse Events
Cohort 1 - 1x10(5) T Cells/kg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohort 2 - 5x10(5) T Cells/kg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohort 3 - 1x10(6) T Cells/kg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohort 4 - 3x10(6) T Cells/kg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Cohort 5 - 5x10(6) T Cells/kg
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Cohort 5B - 5x10(6) T Rapa Cells/kg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Cohort 6 - 15x10(6) T Cells/kg
Serious events: 1 serious events
Other events: 3 other events
Deaths: 1 deaths
Cohort 7 - 45x10(6) T Cells/kg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cohort A - Th1/Tc1.Rapa Prevention of Relapse
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohort B - Th1/Tc1.Rapa for Relapsed Multiple Myeloma
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort 1 - 1x10(5) T Cells/kg
n=2 participants at risk
1x10(5) Th1/Tc1.Rapa cells/kg of body weight
|
Cohort 2 - 5x10(5) T Cells/kg
n=1 participants at risk
5x10(5) Th1/Tc1.Rapa cells/kg of body weight
|
Cohort 3 - 1x10(6) T Cells/kg
n=1 participants at risk
1x10(6) Th1/Tc1.Rapa cells/kg of body weight
|
Cohort 4 - 3x10(6) T Cells/kg
n=2 participants at risk
3x10(6) Th1/Tc1.Rapa cells/kg of body weight
|
Cohort 5 - 5x10(6) T Cells/kg
n=7 participants at risk
5x10(6) Th1/Tc1.Rapa cells/kg of body weight
|
Cohort 5B - 5x10(6) T Rapa Cells/kg
n=5 participants at risk
5x10(6) Th1/Tc1.Rapa cells/kg of body weight; Three sequential infusions with at least two months between infusions.
|
Cohort 6 - 15x10(6) T Cells/kg
n=7 participants at risk
15x10(6) Th1/Tc1.Rapa cells/kg of body weight
|
Cohort 7 - 45x10(6) T Cells/kg
45x10(6) Th1/Tc1.Rapa cells/kg of body weight
|
Cohort A - Th1/Tc1.Rapa Prevention of Relapse
n=1 participants at risk
Th1/Tc1.Rapa Prevention of Relapse
Adoptive Immunotherapy: Th1/Tc1.Rapa cell infusion will be evaluated after administration of a 7-day or 14-day course of immune depleting chemotherapy (pentostatin plus cyclophosphamide regimen).
Rapamycin-Generated Autologous Th1/Tc1 Cells: Six Th1.rapa cell doses will be tested in cohorts of 1-6 subjects each: ranging from 10e(5) to 15 x 10e(6) cells/kg of body weight.
Th1/TC1 Rapa Cell Therapy: Th1/TC1rapa: 5 x 10e(6) cells/kg
|
Cohort B - Th1/Tc1.Rapa for Relapsed Multiple Myeloma
n=5 participants at risk
Th1/Tc1.Rapa for Relapsed Multiple Myeloma
Adoptive Immunotherapy: Th1/Tc1.Rapa cell infusion will be evaluated after administration of a 7-day or 14-day course of immune depleting chemotherapy (pentostatin plus cyclophosphamide regimen).
Th1/TC1 Rapa Cell Therapy: Th1/TC1rapa: 5 x 10e(6) cells/kg
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Nervous system disorders
Intracranial hemorrhage
|
0.00%
0/2 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
0.00%
0/1 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
0.00%
0/1 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
0.00%
0/2 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
0.00%
0/7 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
0.00%
0/5 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
14.3%
1/7 • Number of events 1 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
—
0/0 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
0.00%
0/1 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
0.00%
0/5 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
|
Cardiac disorders
Heart failure
|
0.00%
0/2 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
0.00%
0/1 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
0.00%
0/1 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
0.00%
0/2 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
0.00%
0/7 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
0.00%
0/5 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
0.00%
0/7 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
—
0/0 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
0.00%
0/1 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
|
Infections and infestations
Sepsis
|
0.00%
0/2 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
0.00%
0/1 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
0.00%
0/1 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
0.00%
0/2 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
14.3%
1/7 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
0.00%
0/5 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
0.00%
0/7 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
—
0/0 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
0.00%
0/1 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
0.00%
0/5 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
|
General disorders
Death
|
0.00%
0/2 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
0.00%
0/1 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
0.00%
0/1 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
0.00%
0/2 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
0.00%
0/7 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
0.00%
0/5 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
14.3%
1/7 • Number of events 1 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
—
0/0 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
0.00%
0/1 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
0.00%
0/5 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
Other adverse events
| Measure |
Cohort 1 - 1x10(5) T Cells/kg
n=2 participants at risk
1x10(5) Th1/Tc1.Rapa cells/kg of body weight
|
Cohort 2 - 5x10(5) T Cells/kg
n=1 participants at risk
5x10(5) Th1/Tc1.Rapa cells/kg of body weight
|
Cohort 3 - 1x10(6) T Cells/kg
n=1 participants at risk
1x10(6) Th1/Tc1.Rapa cells/kg of body weight
|
Cohort 4 - 3x10(6) T Cells/kg
n=2 participants at risk
3x10(6) Th1/Tc1.Rapa cells/kg of body weight
|
Cohort 5 - 5x10(6) T Cells/kg
n=7 participants at risk
5x10(6) Th1/Tc1.Rapa cells/kg of body weight
|
Cohort 5B - 5x10(6) T Rapa Cells/kg
n=5 participants at risk
5x10(6) Th1/Tc1.Rapa cells/kg of body weight; Three sequential infusions with at least two months between infusions.
|
Cohort 6 - 15x10(6) T Cells/kg
n=7 participants at risk
15x10(6) Th1/Tc1.Rapa cells/kg of body weight
|
Cohort 7 - 45x10(6) T Cells/kg
45x10(6) Th1/Tc1.Rapa cells/kg of body weight
|
Cohort A - Th1/Tc1.Rapa Prevention of Relapse
n=1 participants at risk
Th1/Tc1.Rapa Prevention of Relapse
Adoptive Immunotherapy: Th1/Tc1.Rapa cell infusion will be evaluated after administration of a 7-day or 14-day course of immune depleting chemotherapy (pentostatin plus cyclophosphamide regimen).
Rapamycin-Generated Autologous Th1/Tc1 Cells: Six Th1.rapa cell doses will be tested in cohorts of 1-6 subjects each: ranging from 10e(5) to 15 x 10e(6) cells/kg of body weight.
Th1/TC1 Rapa Cell Therapy: Th1/TC1rapa: 5 x 10e(6) cells/kg
|
Cohort B - Th1/Tc1.Rapa for Relapsed Multiple Myeloma
n=5 participants at risk
Th1/Tc1.Rapa for Relapsed Multiple Myeloma
Adoptive Immunotherapy: Th1/Tc1.Rapa cell infusion will be evaluated after administration of a 7-day or 14-day course of immune depleting chemotherapy (pentostatin plus cyclophosphamide regimen).
Th1/TC1 Rapa Cell Therapy: Th1/TC1rapa: 5 x 10e(6) cells/kg
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
50.0%
1/2 • Number of events 2 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
0.00%
0/1 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
0.00%
0/1 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
0.00%
0/2 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
0.00%
0/7 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
0.00%
0/5 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
0.00%
0/7 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
—
0/0 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
0.00%
0/1 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
0.00%
0/5 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
|
Investigations
Alkaline phosphatase increased
|
50.0%
1/2 • Number of events 1 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
0.00%
0/1 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
0.00%
0/1 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
0.00%
0/2 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
0.00%
0/7 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
0.00%
0/5 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
0.00%
0/7 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
—
0/0 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
0.00%
0/1 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
0.00%
0/5 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
|
Blood and lymphatic system disorders
Anemia
|
50.0%
1/2 • Number of events 3 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
0.00%
0/1 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
50.0%
1/2 • Number of events 2 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
42.9%
3/7 • Number of events 3 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
14.3%
1/7 • Number of events 1 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
—
0/0 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
0.00%
0/1 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
0.00%
0/5 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
|
Investigations
Aspartate aminotransferase increased
|
50.0%
1/2 • Number of events 4 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
0.00%
0/1 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
0.00%
0/2 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
0.00%
0/7 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
0.00%
0/5 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
0.00%
0/7 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
—
0/0 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
0.00%
0/1 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
0.00%
0/5 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
50.0%
1/2 • Number of events 1 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
0.00%
0/1 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
0.00%
0/2 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
28.6%
2/7 • Number of events 4 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
0.00%
0/5 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
14.3%
1/7 • Number of events 1 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
—
0/0 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
0.00%
0/1 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
0.00%
0/5 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
|
Infections and infestations
Lung infection
|
50.0%
1/2 • Number of events 1 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
0.00%
0/1 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
0.00%
0/1 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
0.00%
0/2 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
0.00%
0/7 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
0.00%
0/5 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
0.00%
0/7 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
—
0/0 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
0.00%
0/1 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
0.00%
0/5 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
|
Investigations
Neutrophil count decreased
|
50.0%
1/2 • Number of events 4 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
100.0%
1/1 • Number of events 7 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
100.0%
1/1 • Number of events 3 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
50.0%
1/2 • Number of events 3 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
28.6%
2/7 • Number of events 10 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
40.0%
2/5 • Number of events 3 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
28.6%
2/7 • Number of events 2 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
—
0/0 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
0.00%
0/1 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
40.0%
2/5 • Number of events 2 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
|
Investigations
Platelet count decreased
|
50.0%
1/2 • Number of events 7 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
0.00%
0/1 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
0.00%
0/1 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
0.00%
0/2 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
0.00%
0/7 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
0.00%
0/5 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
0.00%
0/7 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
—
0/0 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
0.00%
0/1 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
0.00%
0/5 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
|
Investigations
White blood cell decreased
|
50.0%
1/2 • Number of events 9 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
100.0%
1/1 • Number of events 6 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
100.0%
1/1 • Number of events 2 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
0.00%
0/2 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
57.1%
4/7 • Number of events 7 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
40.0%
2/5 • Number of events 5 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
0.00%
0/7 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
—
0/0 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
0.00%
0/1 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
40.0%
2/5 • Number of events 2 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
|
Investigations
CPK increased
|
0.00%
0/2 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
100.0%
1/1 • Number of events 2 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
0.00%
0/1 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
0.00%
0/2 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
0.00%
0/7 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
0.00%
0/5 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
0.00%
0/7 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
—
0/0 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
0.00%
0/1 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/2 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
0.00%
0/1 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
0.00%
0/2 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
0.00%
0/7 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
0.00%
0/5 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
0.00%
0/7 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
—
0/0 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
0.00%
0/1 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
0.00%
0/5 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/2 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
0.00%
0/1 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
0.00%
0/2 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
0.00%
0/7 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
0.00%
0/5 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
0.00%
0/7 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
—
0/0 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
0.00%
0/1 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
0.00%
0/5 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
|
Skin and subcutaneous tissue disorders
Papulopustular rash
|
0.00%
0/2 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
0.00%
0/1 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
0.00%
0/2 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
0.00%
0/7 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
0.00%
0/5 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
0.00%
0/7 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
—
0/0 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
0.00%
0/1 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
0.00%
0/5 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
|
Investigations
Lung infection
|
0.00%
0/2 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
0.00%
0/1 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
0.00%
0/1 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
50.0%
1/2 • Number of events 1 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
0.00%
0/7 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
0.00%
0/5 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
0.00%
0/7 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
—
0/0 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
0.00%
0/1 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
0.00%
0/5 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/2 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
0.00%
0/1 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
0.00%
0/1 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
0.00%
0/2 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
28.6%
2/7 • Number of events 4 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
0.00%
0/5 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
14.3%
1/7 • Number of events 1 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
—
0/0 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
0.00%
0/1 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
0.00%
0/5 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/2 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
0.00%
0/1 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
0.00%
0/1 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
0.00%
0/2 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
14.3%
1/7 • Number of events 1 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
0.00%
0/5 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
0.00%
0/7 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
—
0/0 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
0.00%
0/1 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
0.00%
0/5 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
|
Vascular disorders
Hypotension
|
0.00%
0/2 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
0.00%
0/1 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
0.00%
0/1 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
0.00%
0/2 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
14.3%
1/7 • Number of events 1 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
0.00%
0/5 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
0.00%
0/7 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
—
0/0 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
0.00%
0/1 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
0.00%
0/5 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
|
Eye disorders
Nausea
|
0.00%
0/2 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
0.00%
0/1 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
0.00%
0/1 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
0.00%
0/2 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
14.3%
1/7 • Number of events 1 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
0.00%
0/5 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
0.00%
0/7 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
—
0/0 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
0.00%
0/1 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
0.00%
0/5 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
|
Infections and infestations
Upper respiratory infection
|
0.00%
0/2 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
0.00%
0/1 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
0.00%
0/1 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
0.00%
0/2 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
28.6%
2/7 • Number of events 3 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
0.00%
0/5 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
14.3%
1/7 • Number of events 3 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
—
0/0 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
|
General disorders
Fatigue
|
0.00%
0/2 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
0.00%
0/1 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
0.00%
0/1 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
0.00%
0/2 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
0.00%
0/7 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
0.00%
0/5 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
14.3%
1/7 • Number of events 1 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
—
0/0 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
0.00%
0/1 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
0.00%
0/5 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/2 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
0.00%
0/1 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
0.00%
0/1 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
0.00%
0/2 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
0.00%
0/7 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
0.00%
0/5 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
14.3%
1/7 • Number of events 1 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
—
0/0 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
0.00%
0/1 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
0.00%
0/5 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
0.00%
0/2 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
0.00%
0/1 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
0.00%
0/1 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
0.00%
0/2 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
0.00%
0/7 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
0.00%
0/5 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
0.00%
0/7 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
—
0/0 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
0.00%
0/1 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/2 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
0.00%
0/1 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
0.00%
0/1 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
0.00%
0/2 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
0.00%
0/7 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
0.00%
0/5 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
0.00%
0/7 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
—
0/0 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
0.00%
0/1 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to last date off study, 81 months and 6 days.
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place