Trial Outcomes & Findings for ImmPACT Expanded Multiple Antigen Specific Endogenously Derived T Cells (MASE-T) to Patients With Metastatic Melanoma (NCT NCT04904185)
NCT ID: NCT04904185
Last Updated: 2025-07-25
Results Overview
Number of patients experiencing grade III or worse adverse events. The grading of adverse events was performed according to CTCAE ver. 5.0.
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
8 participants
Primary outcome timeframe
Through study completion, up to 2.8 years from begin of study
Results posted on
2025-07-25
Participant Flow
Participant milestones
| Measure |
Part A
Six patients will be included in Part A. After inclusion 300 mL blood will be drawn from the patients for the production of the MASE-T cell product. Four days prior to MASE-T infusion the patient will receive lymphodepleting chemotherapy (cyclophosphamide 500 mg/m2/day i.v. on day -4, -3, -2 and fludarabine 30 mg/m2/day i.v. on day -4, -3) followed by i.v. infusion of the MASE-T product on day 0.
Cyclophosphamide: Cyclophosphamide 500 mg/m2 is administered i.v. on day -4, -3 and -2
Fludarabine Phosphate: Fludarabine Phosphate 30 mg/m2 is administered on day -4 and -3
Multiple Antigen Specific Endogenously derived T cells: Antigen specific, ex vivo expanded T cells derived from peripheral blood T cells
|
Part B
No patients enrolled due to premature closure of the trial
|
|---|---|---|
|
Overall Study
STARTED
|
8
|
0
|
|
Overall Study
COMPLETED
|
6
|
0
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
Part A
Six patients will be included in Part A. After inclusion 300 mL blood will be drawn from the patients for the production of the MASE-T cell product. Four days prior to MASE-T infusion the patient will receive lymphodepleting chemotherapy (cyclophosphamide 500 mg/m2/day i.v. on day -4, -3, -2 and fludarabine 30 mg/m2/day i.v. on day -4, -3) followed by i.v. infusion of the MASE-T product on day 0.
Cyclophosphamide: Cyclophosphamide 500 mg/m2 is administered i.v. on day -4, -3 and -2
Fludarabine Phosphate: Fludarabine Phosphate 30 mg/m2 is administered on day -4 and -3
Multiple Antigen Specific Endogenously derived T cells: Antigen specific, ex vivo expanded T cells derived from peripheral blood T cells
|
Part B
No patients enrolled due to premature closure of the trial
|
|---|---|---|
|
Overall Study
Expansion failure
|
1
|
0
|
|
Overall Study
Late response on prior treatment
|
1
|
0
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Part A
n=6 Participants
Six patients were included in Part A. After inclusion 300 mL blood will be drawn from the patients for the production of the MASE-T cell product. Four days prior to MASE-T infusion the patient will receive lymphodepleting chemotherapy (cyclophosphamide 500 mg/m2/day i.v. on day -4, -3, -2 and fludarabine 30 mg/m2/day i.v. on day -4, -3) followed by i.v. infusion of the MASE-T product on day 0.
Cyclophosphamide: Cyclophosphamide 500 mg/m2 is administered i.v. on day -4, -3 and -2
Fludarabine Phosphate: Fludarabine Phosphate 30 mg/m2 is administered on day -4 and -3
Multiple Antigen Specific Endogenously derived T cells: Antigen specific, ex vivo expanded T cells derived from peripheral blood T cells
|
Part B
No patients enrolled due to premature closure of the trial
|
Total
n=6 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=6 Participants
|
0 Participants
|
0 Participants
n=6 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=6 Participants
|
0 Participants
|
4 Participants
n=6 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=6 Participants
|
0 Participants
|
2 Participants
n=6 Participants
|
|
Age, Continuous
|
61 years
n=6 Participants
|
—
|
61 years
n=6 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=6 Participants
|
0 Participants
|
4 Participants
n=6 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=6 Participants
|
0 Participants
|
2 Participants
n=6 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
HLA-A2*02:01 positive assessed by flow cytometry
|
6 participants
n=6 Participants
|
—
|
6 participants
n=6 Participants
|
|
TET+ T cells in peripheral blood assessed by flow cytometry
|
6 participants
n=6 Participants
|
—
|
6 participants
n=6 Participants
|
|
Performance status according to ECOG Performance Status Scale
ECOG PS 0
|
5 participants
n=6 Participants
|
—
|
5 participants
n=6 Participants
|
|
Performance status according to ECOG Performance Status Scale
ECOG PS 1
|
1 participants
n=6 Participants
|
—
|
1 participants
n=6 Participants
|
|
Number of prior treatment lines
|
3.5 lines of prior treatment
n=6 Participants
|
—
|
3.5 lines of prior treatment
n=6 Participants
|
PRIMARY outcome
Timeframe: Through study completion, up to 2.8 years from begin of studyPopulation: No patients were enrolled in part B due to premature closure of the trial
Number of patients experiencing grade III or worse adverse events. The grading of adverse events was performed according to CTCAE ver. 5.0.
Outcome measures
| Measure |
Part A
n=6 Participants
Multiple Antigen Specific endogenously derived T cells: After inclusion 300 mL blood will be drawn from the patients for the production of the MASE-T cell product ex vivo. Four days prior to MASE-T infusion the patient will receive lymphodepleting chemotherapy (cyclophosphamide 500 mg/m2/day i.v. on day -4, -3, -2 and fludarabine 30 mg/m2/day i.v. on day -4, -3) followed by i.v. infusion of the MASE-T product on day 0.
Cyclophosphamide: Cyclophosphamide 500 mg/m2 is administered i.v. on day -4, -3 and -2
Fludarabine Phosphate: Fludarabine Phosphate 30 mg/m2 is administered on day -4 and -3
Multiple Antigen Specific Endogenously derived T cells: Antigen specific, ex vivo expanded T cells derived from peripheral blood T cells
|
Part B
No patients enrolled due to premature closure of the trial
|
|---|---|---|
|
Tolerability of the Treatment
|
6 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Through study completion, up to 2.8 years from begin of studyPopulation: No patients were enrolled in part B due to premature closure of the trial
Number of patients excluded due to treatment related feasibility issues compared to the number of patients enrolled in the study.
Outcome measures
| Measure |
Part A
n=8 Participants
Multiple Antigen Specific endogenously derived T cells: After inclusion 300 mL blood will be drawn from the patients for the production of the MASE-T cell product ex vivo. Four days prior to MASE-T infusion the patient will receive lymphodepleting chemotherapy (cyclophosphamide 500 mg/m2/day i.v. on day -4, -3, -2 and fludarabine 30 mg/m2/day i.v. on day -4, -3) followed by i.v. infusion of the MASE-T product on day 0.
Cyclophosphamide: Cyclophosphamide 500 mg/m2 is administered i.v. on day -4, -3 and -2
Fludarabine Phosphate: Fludarabine Phosphate 30 mg/m2 is administered on day -4 and -3
Multiple Antigen Specific Endogenously derived T cells: Antigen specific, ex vivo expanded T cells derived from peripheral blood T cells
|
Part B
No patients enrolled due to premature closure of the trial
|
|---|---|---|
|
Number of Patients Excluded Due to Feasibility Issues
|
1 Participants
|
—
|
PRIMARY outcome
Timeframe: Through study completion, up to 2.8 years from begin of studyPopulation: No patients were enrolled in part B due to premature closure of the trial
Number of patients excluded due to treatment related safety issues compared to the number of patients enrolled in the study.
Outcome measures
| Measure |
Part A
n=8 Participants
Multiple Antigen Specific endogenously derived T cells: After inclusion 300 mL blood will be drawn from the patients for the production of the MASE-T cell product ex vivo. Four days prior to MASE-T infusion the patient will receive lymphodepleting chemotherapy (cyclophosphamide 500 mg/m2/day i.v. on day -4, -3, -2 and fludarabine 30 mg/m2/day i.v. on day -4, -3) followed by i.v. infusion of the MASE-T product on day 0.
Cyclophosphamide: Cyclophosphamide 500 mg/m2 is administered i.v. on day -4, -3 and -2
Fludarabine Phosphate: Fludarabine Phosphate 30 mg/m2 is administered on day -4 and -3
Multiple Antigen Specific Endogenously derived T cells: Antigen specific, ex vivo expanded T cells derived from peripheral blood T cells
|
Part B
No patients enrolled due to premature closure of the trial
|
|---|---|---|
|
Number of Patients Excluded Due to Safety Issues
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: The patients were evaluated every 6-12 weeks until study completion (minimum: 43 days, median: 69 days, maximum: 128 days)Population: No patients included in part B due to premature closure of the trial
Response Evaluation Criteria In Solid Tumors Criteria (RECIST 1.1) assessed by CT scan. Complete Response (CR): Disappearance of all target lesions Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions Progressive disease: \>= 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions Stable disease: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study
Outcome measures
| Measure |
Part A
n=6 Participants
Multiple Antigen Specific endogenously derived T cells: After inclusion 300 mL blood will be drawn from the patients for the production of the MASE-T cell product ex vivo. Four days prior to MASE-T infusion the patient will receive lymphodepleting chemotherapy (cyclophosphamide 500 mg/m2/day i.v. on day -4, -3, -2 and fludarabine 30 mg/m2/day i.v. on day -4, -3) followed by i.v. infusion of the MASE-T product on day 0.
Cyclophosphamide: Cyclophosphamide 500 mg/m2 is administered i.v. on day -4, -3 and -2
Fludarabine Phosphate: Fludarabine Phosphate 30 mg/m2 is administered on day -4 and -3
Multiple Antigen Specific Endogenously derived T cells: Antigen specific, ex vivo expanded T cells derived from peripheral blood T cells
|
Part B
No patients enrolled due to premature closure of the trial
|
|---|---|---|
|
Best Overall Response (BOR)
Stable disease
|
3 Participants
|
—
|
|
Best Overall Response (BOR)
Progressive disease
|
3 Participants
|
—
|
Adverse Events
Part A
Serious events: 0 serious events
Other events: 6 other events
Deaths: 5 deaths
Part B
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Part A
n=6 participants at risk
Six patients were included in Part A. After inclusion 300 mL blood will be drawn from the patients for the production of the MASE-T cell product. Four days prior to MASE-T infusion the patient will receive lymphodepleting chemotherapy (cyclophosphamide 500 mg/m2/day i.v. on day -4, -3, -2 and fludarabine 30 mg/m2/day i.v. on day -4, -3) followed by i.v. infusion of the MASE-T product on day 0.
Cyclophosphamide: Cyclophosphamide 500 mg/m2 is administered i.v. on day -4, -3 and -2
Fludarabine Phosphate: Fludarabine Phosphate 30 mg/m2 is administered on day -4 and -3
Multiple Antigen Specific Endogenously derived T cells: Antigen specific, ex vivo expanded T cells derived from peripheral blood T cells
|
Part B
No patients were enrolled in part B due to premature closure of the trial
|
|---|---|---|
|
General disorders
Dizziness and palor
|
16.7%
1/6 • Number of events 1 • The data was collected throughout the duration of the clinical trial, from September 2021 (enrollment of the first patient) and until exclusion of the last patient in June 2024 (2.8 years) Adverse events were collected every 6-12 weeks until study completion. For the individual patient, the reporting started at the study enrolment and ended with study exclusion (median 69 days, maximum 128 days from MASE-T infusion).
Serious adverse events also included AEs that: * Resulted in persistent or significant disability or incapacity; * Led to a congenital anomaly or birth defect; * Was a significant medical event. * Resulted in the transmission of an infectious agent * Pregnancy must follow the same transmission timing and process used for SAEs. A specific list of events that should not be reported is included in the protocol
|
—
0/0 • The data was collected throughout the duration of the clinical trial, from September 2021 (enrollment of the first patient) and until exclusion of the last patient in June 2024 (2.8 years) Adverse events were collected every 6-12 weeks until study completion. For the individual patient, the reporting started at the study enrolment and ended with study exclusion (median 69 days, maximum 128 days from MASE-T infusion).
Serious adverse events also included AEs that: * Resulted in persistent or significant disability or incapacity; * Led to a congenital anomaly or birth defect; * Was a significant medical event. * Resulted in the transmission of an infectious agent * Pregnancy must follow the same transmission timing and process used for SAEs. A specific list of events that should not be reported is included in the protocol
|
|
Immune system disorders
Neutropenia
|
66.7%
4/6 • Number of events 4 • The data was collected throughout the duration of the clinical trial, from September 2021 (enrollment of the first patient) and until exclusion of the last patient in June 2024 (2.8 years) Adverse events were collected every 6-12 weeks until study completion. For the individual patient, the reporting started at the study enrolment and ended with study exclusion (median 69 days, maximum 128 days from MASE-T infusion).
Serious adverse events also included AEs that: * Resulted in persistent or significant disability or incapacity; * Led to a congenital anomaly or birth defect; * Was a significant medical event. * Resulted in the transmission of an infectious agent * Pregnancy must follow the same transmission timing and process used for SAEs. A specific list of events that should not be reported is included in the protocol
|
—
0/0 • The data was collected throughout the duration of the clinical trial, from September 2021 (enrollment of the first patient) and until exclusion of the last patient in June 2024 (2.8 years) Adverse events were collected every 6-12 weeks until study completion. For the individual patient, the reporting started at the study enrolment and ended with study exclusion (median 69 days, maximum 128 days from MASE-T infusion).
Serious adverse events also included AEs that: * Resulted in persistent or significant disability or incapacity; * Led to a congenital anomaly or birth defect; * Was a significant medical event. * Resulted in the transmission of an infectious agent * Pregnancy must follow the same transmission timing and process used for SAEs. A specific list of events that should not be reported is included in the protocol
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
50.0%
3/6 • Number of events 3 • The data was collected throughout the duration of the clinical trial, from September 2021 (enrollment of the first patient) and until exclusion of the last patient in June 2024 (2.8 years) Adverse events were collected every 6-12 weeks until study completion. For the individual patient, the reporting started at the study enrolment and ended with study exclusion (median 69 days, maximum 128 days from MASE-T infusion).
Serious adverse events also included AEs that: * Resulted in persistent or significant disability or incapacity; * Led to a congenital anomaly or birth defect; * Was a significant medical event. * Resulted in the transmission of an infectious agent * Pregnancy must follow the same transmission timing and process used for SAEs. A specific list of events that should not be reported is included in the protocol
|
—
0/0 • The data was collected throughout the duration of the clinical trial, from September 2021 (enrollment of the first patient) and until exclusion of the last patient in June 2024 (2.8 years) Adverse events were collected every 6-12 weeks until study completion. For the individual patient, the reporting started at the study enrolment and ended with study exclusion (median 69 days, maximum 128 days from MASE-T infusion).
Serious adverse events also included AEs that: * Resulted in persistent or significant disability or incapacity; * Led to a congenital anomaly or birth defect; * Was a significant medical event. * Resulted in the transmission of an infectious agent * Pregnancy must follow the same transmission timing and process used for SAEs. A specific list of events that should not be reported is included in the protocol
|
|
Blood and lymphatic system disorders
Anemia
|
100.0%
6/6 • Number of events 21 • The data was collected throughout the duration of the clinical trial, from September 2021 (enrollment of the first patient) and until exclusion of the last patient in June 2024 (2.8 years) Adverse events were collected every 6-12 weeks until study completion. For the individual patient, the reporting started at the study enrolment and ended with study exclusion (median 69 days, maximum 128 days from MASE-T infusion).
Serious adverse events also included AEs that: * Resulted in persistent or significant disability or incapacity; * Led to a congenital anomaly or birth defect; * Was a significant medical event. * Resulted in the transmission of an infectious agent * Pregnancy must follow the same transmission timing and process used for SAEs. A specific list of events that should not be reported is included in the protocol
|
—
0/0 • The data was collected throughout the duration of the clinical trial, from September 2021 (enrollment of the first patient) and until exclusion of the last patient in June 2024 (2.8 years) Adverse events were collected every 6-12 weeks until study completion. For the individual patient, the reporting started at the study enrolment and ended with study exclusion (median 69 days, maximum 128 days from MASE-T infusion).
Serious adverse events also included AEs that: * Resulted in persistent or significant disability or incapacity; * Led to a congenital anomaly or birth defect; * Was a significant medical event. * Resulted in the transmission of an infectious agent * Pregnancy must follow the same transmission timing and process used for SAEs. A specific list of events that should not be reported is included in the protocol
|
|
Gastrointestinal disorders
Diarrhea
|
16.7%
1/6 • Number of events 1 • The data was collected throughout the duration of the clinical trial, from September 2021 (enrollment of the first patient) and until exclusion of the last patient in June 2024 (2.8 years) Adverse events were collected every 6-12 weeks until study completion. For the individual patient, the reporting started at the study enrolment and ended with study exclusion (median 69 days, maximum 128 days from MASE-T infusion).
Serious adverse events also included AEs that: * Resulted in persistent or significant disability or incapacity; * Led to a congenital anomaly or birth defect; * Was a significant medical event. * Resulted in the transmission of an infectious agent * Pregnancy must follow the same transmission timing and process used for SAEs. A specific list of events that should not be reported is included in the protocol
|
—
0/0 • The data was collected throughout the duration of the clinical trial, from September 2021 (enrollment of the first patient) and until exclusion of the last patient in June 2024 (2.8 years) Adverse events were collected every 6-12 weeks until study completion. For the individual patient, the reporting started at the study enrolment and ended with study exclusion (median 69 days, maximum 128 days from MASE-T infusion).
Serious adverse events also included AEs that: * Resulted in persistent or significant disability or incapacity; * Led to a congenital anomaly or birth defect; * Was a significant medical event. * Resulted in the transmission of an infectious agent * Pregnancy must follow the same transmission timing and process used for SAEs. A specific list of events that should not be reported is included in the protocol
|
|
General disorders
Dry mouth
|
33.3%
2/6 • Number of events 3 • The data was collected throughout the duration of the clinical trial, from September 2021 (enrollment of the first patient) and until exclusion of the last patient in June 2024 (2.8 years) Adverse events were collected every 6-12 weeks until study completion. For the individual patient, the reporting started at the study enrolment and ended with study exclusion (median 69 days, maximum 128 days from MASE-T infusion).
Serious adverse events also included AEs that: * Resulted in persistent or significant disability or incapacity; * Led to a congenital anomaly or birth defect; * Was a significant medical event. * Resulted in the transmission of an infectious agent * Pregnancy must follow the same transmission timing and process used for SAEs. A specific list of events that should not be reported is included in the protocol
|
—
0/0 • The data was collected throughout the duration of the clinical trial, from September 2021 (enrollment of the first patient) and until exclusion of the last patient in June 2024 (2.8 years) Adverse events were collected every 6-12 weeks until study completion. For the individual patient, the reporting started at the study enrolment and ended with study exclusion (median 69 days, maximum 128 days from MASE-T infusion).
Serious adverse events also included AEs that: * Resulted in persistent or significant disability or incapacity; * Led to a congenital anomaly or birth defect; * Was a significant medical event. * Resulted in the transmission of an infectious agent * Pregnancy must follow the same transmission timing and process used for SAEs. A specific list of events that should not be reported is included in the protocol
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
16.7%
1/6 • Number of events 1 • The data was collected throughout the duration of the clinical trial, from September 2021 (enrollment of the first patient) and until exclusion of the last patient in June 2024 (2.8 years) Adverse events were collected every 6-12 weeks until study completion. For the individual patient, the reporting started at the study enrolment and ended with study exclusion (median 69 days, maximum 128 days from MASE-T infusion).
Serious adverse events also included AEs that: * Resulted in persistent or significant disability or incapacity; * Led to a congenital anomaly or birth defect; * Was a significant medical event. * Resulted in the transmission of an infectious agent * Pregnancy must follow the same transmission timing and process used for SAEs. A specific list of events that should not be reported is included in the protocol
|
—
0/0 • The data was collected throughout the duration of the clinical trial, from September 2021 (enrollment of the first patient) and until exclusion of the last patient in June 2024 (2.8 years) Adverse events were collected every 6-12 weeks until study completion. For the individual patient, the reporting started at the study enrolment and ended with study exclusion (median 69 days, maximum 128 days from MASE-T infusion).
Serious adverse events also included AEs that: * Resulted in persistent or significant disability or incapacity; * Led to a congenital anomaly or birth defect; * Was a significant medical event. * Resulted in the transmission of an infectious agent * Pregnancy must follow the same transmission timing and process used for SAEs. A specific list of events that should not be reported is included in the protocol
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
16.7%
1/6 • Number of events 2 • The data was collected throughout the duration of the clinical trial, from September 2021 (enrollment of the first patient) and until exclusion of the last patient in June 2024 (2.8 years) Adverse events were collected every 6-12 weeks until study completion. For the individual patient, the reporting started at the study enrolment and ended with study exclusion (median 69 days, maximum 128 days from MASE-T infusion).
Serious adverse events also included AEs that: * Resulted in persistent or significant disability or incapacity; * Led to a congenital anomaly or birth defect; * Was a significant medical event. * Resulted in the transmission of an infectious agent * Pregnancy must follow the same transmission timing and process used for SAEs. A specific list of events that should not be reported is included in the protocol
|
—
0/0 • The data was collected throughout the duration of the clinical trial, from September 2021 (enrollment of the first patient) and until exclusion of the last patient in June 2024 (2.8 years) Adverse events were collected every 6-12 weeks until study completion. For the individual patient, the reporting started at the study enrolment and ended with study exclusion (median 69 days, maximum 128 days from MASE-T infusion).
Serious adverse events also included AEs that: * Resulted in persistent or significant disability or incapacity; * Led to a congenital anomaly or birth defect; * Was a significant medical event. * Resulted in the transmission of an infectious agent * Pregnancy must follow the same transmission timing and process used for SAEs. A specific list of events that should not be reported is included in the protocol
|
|
General disorders
Fatique
|
100.0%
6/6 • Number of events 19 • The data was collected throughout the duration of the clinical trial, from September 2021 (enrollment of the first patient) and until exclusion of the last patient in June 2024 (2.8 years) Adverse events were collected every 6-12 weeks until study completion. For the individual patient, the reporting started at the study enrolment and ended with study exclusion (median 69 days, maximum 128 days from MASE-T infusion).
Serious adverse events also included AEs that: * Resulted in persistent or significant disability or incapacity; * Led to a congenital anomaly or birth defect; * Was a significant medical event. * Resulted in the transmission of an infectious agent * Pregnancy must follow the same transmission timing and process used for SAEs. A specific list of events that should not be reported is included in the protocol
|
—
0/0 • The data was collected throughout the duration of the clinical trial, from September 2021 (enrollment of the first patient) and until exclusion of the last patient in June 2024 (2.8 years) Adverse events were collected every 6-12 weeks until study completion. For the individual patient, the reporting started at the study enrolment and ended with study exclusion (median 69 days, maximum 128 days from MASE-T infusion).
Serious adverse events also included AEs that: * Resulted in persistent or significant disability or incapacity; * Led to a congenital anomaly or birth defect; * Was a significant medical event. * Resulted in the transmission of an infectious agent * Pregnancy must follow the same transmission timing and process used for SAEs. A specific list of events that should not be reported is included in the protocol
|
|
General disorders
Fever
|
16.7%
1/6 • Number of events 1 • The data was collected throughout the duration of the clinical trial, from September 2021 (enrollment of the first patient) and until exclusion of the last patient in June 2024 (2.8 years) Adverse events were collected every 6-12 weeks until study completion. For the individual patient, the reporting started at the study enrolment and ended with study exclusion (median 69 days, maximum 128 days from MASE-T infusion).
Serious adverse events also included AEs that: * Resulted in persistent or significant disability or incapacity; * Led to a congenital anomaly or birth defect; * Was a significant medical event. * Resulted in the transmission of an infectious agent * Pregnancy must follow the same transmission timing and process used for SAEs. A specific list of events that should not be reported is included in the protocol
|
—
0/0 • The data was collected throughout the duration of the clinical trial, from September 2021 (enrollment of the first patient) and until exclusion of the last patient in June 2024 (2.8 years) Adverse events were collected every 6-12 weeks until study completion. For the individual patient, the reporting started at the study enrolment and ended with study exclusion (median 69 days, maximum 128 days from MASE-T infusion).
Serious adverse events also included AEs that: * Resulted in persistent or significant disability or incapacity; * Led to a congenital anomaly or birth defect; * Was a significant medical event. * Resulted in the transmission of an infectious agent * Pregnancy must follow the same transmission timing and process used for SAEs. A specific list of events that should not be reported is included in the protocol
|
|
Metabolism and nutrition disorders
Hyponatriemia
|
16.7%
1/6 • Number of events 1 • The data was collected throughout the duration of the clinical trial, from September 2021 (enrollment of the first patient) and until exclusion of the last patient in June 2024 (2.8 years) Adverse events were collected every 6-12 weeks until study completion. For the individual patient, the reporting started at the study enrolment and ended with study exclusion (median 69 days, maximum 128 days from MASE-T infusion).
Serious adverse events also included AEs that: * Resulted in persistent or significant disability or incapacity; * Led to a congenital anomaly or birth defect; * Was a significant medical event. * Resulted in the transmission of an infectious agent * Pregnancy must follow the same transmission timing and process used for SAEs. A specific list of events that should not be reported is included in the protocol
|
—
0/0 • The data was collected throughout the duration of the clinical trial, from September 2021 (enrollment of the first patient) and until exclusion of the last patient in June 2024 (2.8 years) Adverse events were collected every 6-12 weeks until study completion. For the individual patient, the reporting started at the study enrolment and ended with study exclusion (median 69 days, maximum 128 days from MASE-T infusion).
Serious adverse events also included AEs that: * Resulted in persistent or significant disability or incapacity; * Led to a congenital anomaly or birth defect; * Was a significant medical event. * Resulted in the transmission of an infectious agent * Pregnancy must follow the same transmission timing and process used for SAEs. A specific list of events that should not be reported is included in the protocol
|
|
General disorders
Increase in CRP
|
16.7%
1/6 • Number of events 1 • The data was collected throughout the duration of the clinical trial, from September 2021 (enrollment of the first patient) and until exclusion of the last patient in June 2024 (2.8 years) Adverse events were collected every 6-12 weeks until study completion. For the individual patient, the reporting started at the study enrolment and ended with study exclusion (median 69 days, maximum 128 days from MASE-T infusion).
Serious adverse events also included AEs that: * Resulted in persistent or significant disability or incapacity; * Led to a congenital anomaly or birth defect; * Was a significant medical event. * Resulted in the transmission of an infectious agent * Pregnancy must follow the same transmission timing and process used for SAEs. A specific list of events that should not be reported is included in the protocol
|
—
0/0 • The data was collected throughout the duration of the clinical trial, from September 2021 (enrollment of the first patient) and until exclusion of the last patient in June 2024 (2.8 years) Adverse events were collected every 6-12 weeks until study completion. For the individual patient, the reporting started at the study enrolment and ended with study exclusion (median 69 days, maximum 128 days from MASE-T infusion).
Serious adverse events also included AEs that: * Resulted in persistent or significant disability or incapacity; * Led to a congenital anomaly or birth defect; * Was a significant medical event. * Resulted in the transmission of an infectious agent * Pregnancy must follow the same transmission timing and process used for SAEs. A specific list of events that should not be reported is included in the protocol
|
|
Gastrointestinal disorders
Loss of appetite
|
16.7%
1/6 • Number of events 1 • The data was collected throughout the duration of the clinical trial, from September 2021 (enrollment of the first patient) and until exclusion of the last patient in June 2024 (2.8 years) Adverse events were collected every 6-12 weeks until study completion. For the individual patient, the reporting started at the study enrolment and ended with study exclusion (median 69 days, maximum 128 days from MASE-T infusion).
Serious adverse events also included AEs that: * Resulted in persistent or significant disability or incapacity; * Led to a congenital anomaly or birth defect; * Was a significant medical event. * Resulted in the transmission of an infectious agent * Pregnancy must follow the same transmission timing and process used for SAEs. A specific list of events that should not be reported is included in the protocol
|
—
0/0 • The data was collected throughout the duration of the clinical trial, from September 2021 (enrollment of the first patient) and until exclusion of the last patient in June 2024 (2.8 years) Adverse events were collected every 6-12 weeks until study completion. For the individual patient, the reporting started at the study enrolment and ended with study exclusion (median 69 days, maximum 128 days from MASE-T infusion).
Serious adverse events also included AEs that: * Resulted in persistent or significant disability or incapacity; * Led to a congenital anomaly or birth defect; * Was a significant medical event. * Resulted in the transmission of an infectious agent * Pregnancy must follow the same transmission timing and process used for SAEs. A specific list of events that should not be reported is included in the protocol
|
|
Immune system disorders
Lymphopenia
|
100.0%
6/6 • Number of events 12 • The data was collected throughout the duration of the clinical trial, from September 2021 (enrollment of the first patient) and until exclusion of the last patient in June 2024 (2.8 years) Adverse events were collected every 6-12 weeks until study completion. For the individual patient, the reporting started at the study enrolment and ended with study exclusion (median 69 days, maximum 128 days from MASE-T infusion).
Serious adverse events also included AEs that: * Resulted in persistent or significant disability or incapacity; * Led to a congenital anomaly or birth defect; * Was a significant medical event. * Resulted in the transmission of an infectious agent * Pregnancy must follow the same transmission timing and process used for SAEs. A specific list of events that should not be reported is included in the protocol
|
—
0/0 • The data was collected throughout the duration of the clinical trial, from September 2021 (enrollment of the first patient) and until exclusion of the last patient in June 2024 (2.8 years) Adverse events were collected every 6-12 weeks until study completion. For the individual patient, the reporting started at the study enrolment and ended with study exclusion (median 69 days, maximum 128 days from MASE-T infusion).
Serious adverse events also included AEs that: * Resulted in persistent or significant disability or incapacity; * Led to a congenital anomaly or birth defect; * Was a significant medical event. * Resulted in the transmission of an infectious agent * Pregnancy must follow the same transmission timing and process used for SAEs. A specific list of events that should not be reported is included in the protocol
|
|
Gastrointestinal disorders
Nausea
|
50.0%
3/6 • Number of events 3 • The data was collected throughout the duration of the clinical trial, from September 2021 (enrollment of the first patient) and until exclusion of the last patient in June 2024 (2.8 years) Adverse events were collected every 6-12 weeks until study completion. For the individual patient, the reporting started at the study enrolment and ended with study exclusion (median 69 days, maximum 128 days from MASE-T infusion).
Serious adverse events also included AEs that: * Resulted in persistent or significant disability or incapacity; * Led to a congenital anomaly or birth defect; * Was a significant medical event. * Resulted in the transmission of an infectious agent * Pregnancy must follow the same transmission timing and process used for SAEs. A specific list of events that should not be reported is included in the protocol
|
—
0/0 • The data was collected throughout the duration of the clinical trial, from September 2021 (enrollment of the first patient) and until exclusion of the last patient in June 2024 (2.8 years) Adverse events were collected every 6-12 weeks until study completion. For the individual patient, the reporting started at the study enrolment and ended with study exclusion (median 69 days, maximum 128 days from MASE-T infusion).
Serious adverse events also included AEs that: * Resulted in persistent or significant disability or incapacity; * Led to a congenital anomaly or birth defect; * Was a significant medical event. * Resulted in the transmission of an infectious agent * Pregnancy must follow the same transmission timing and process used for SAEs. A specific list of events that should not be reported is included in the protocol
|
|
Gastrointestinal disorders
Obstipation
|
16.7%
1/6 • Number of events 1 • The data was collected throughout the duration of the clinical trial, from September 2021 (enrollment of the first patient) and until exclusion of the last patient in June 2024 (2.8 years) Adverse events were collected every 6-12 weeks until study completion. For the individual patient, the reporting started at the study enrolment and ended with study exclusion (median 69 days, maximum 128 days from MASE-T infusion).
Serious adverse events also included AEs that: * Resulted in persistent or significant disability or incapacity; * Led to a congenital anomaly or birth defect; * Was a significant medical event. * Resulted in the transmission of an infectious agent * Pregnancy must follow the same transmission timing and process used for SAEs. A specific list of events that should not be reported is included in the protocol
|
—
0/0 • The data was collected throughout the duration of the clinical trial, from September 2021 (enrollment of the first patient) and until exclusion of the last patient in June 2024 (2.8 years) Adverse events were collected every 6-12 weeks until study completion. For the individual patient, the reporting started at the study enrolment and ended with study exclusion (median 69 days, maximum 128 days from MASE-T infusion).
Serious adverse events also included AEs that: * Resulted in persistent or significant disability or incapacity; * Led to a congenital anomaly or birth defect; * Was a significant medical event. * Resulted in the transmission of an infectious agent * Pregnancy must follow the same transmission timing and process used for SAEs. A specific list of events that should not be reported is included in the protocol
|
|
General disorders
Pain
|
33.3%
2/6 • Number of events 3 • The data was collected throughout the duration of the clinical trial, from September 2021 (enrollment of the first patient) and until exclusion of the last patient in June 2024 (2.8 years) Adverse events were collected every 6-12 weeks until study completion. For the individual patient, the reporting started at the study enrolment and ended with study exclusion (median 69 days, maximum 128 days from MASE-T infusion).
Serious adverse events also included AEs that: * Resulted in persistent or significant disability or incapacity; * Led to a congenital anomaly or birth defect; * Was a significant medical event. * Resulted in the transmission of an infectious agent * Pregnancy must follow the same transmission timing and process used for SAEs. A specific list of events that should not be reported is included in the protocol
|
—
0/0 • The data was collected throughout the duration of the clinical trial, from September 2021 (enrollment of the first patient) and until exclusion of the last patient in June 2024 (2.8 years) Adverse events were collected every 6-12 weeks until study completion. For the individual patient, the reporting started at the study enrolment and ended with study exclusion (median 69 days, maximum 128 days from MASE-T infusion).
Serious adverse events also included AEs that: * Resulted in persistent or significant disability or incapacity; * Led to a congenital anomaly or birth defect; * Was a significant medical event. * Resulted in the transmission of an infectious agent * Pregnancy must follow the same transmission timing and process used for SAEs. A specific list of events that should not be reported is included in the protocol
|
|
Blood and lymphatic system disorders
Trombocytopenia
|
33.3%
2/6 • Number of events 9 • The data was collected throughout the duration of the clinical trial, from September 2021 (enrollment of the first patient) and until exclusion of the last patient in June 2024 (2.8 years) Adverse events were collected every 6-12 weeks until study completion. For the individual patient, the reporting started at the study enrolment and ended with study exclusion (median 69 days, maximum 128 days from MASE-T infusion).
Serious adverse events also included AEs that: * Resulted in persistent or significant disability or incapacity; * Led to a congenital anomaly or birth defect; * Was a significant medical event. * Resulted in the transmission of an infectious agent * Pregnancy must follow the same transmission timing and process used for SAEs. A specific list of events that should not be reported is included in the protocol
|
—
0/0 • The data was collected throughout the duration of the clinical trial, from September 2021 (enrollment of the first patient) and until exclusion of the last patient in June 2024 (2.8 years) Adverse events were collected every 6-12 weeks until study completion. For the individual patient, the reporting started at the study enrolment and ended with study exclusion (median 69 days, maximum 128 days from MASE-T infusion).
Serious adverse events also included AEs that: * Resulted in persistent or significant disability or incapacity; * Led to a congenital anomaly or birth defect; * Was a significant medical event. * Resulted in the transmission of an infectious agent * Pregnancy must follow the same transmission timing and process used for SAEs. A specific list of events that should not be reported is included in the protocol
|
|
Gastrointestinal disorders
Vomiting
|
16.7%
1/6 • Number of events 1 • The data was collected throughout the duration of the clinical trial, from September 2021 (enrollment of the first patient) and until exclusion of the last patient in June 2024 (2.8 years) Adverse events were collected every 6-12 weeks until study completion. For the individual patient, the reporting started at the study enrolment and ended with study exclusion (median 69 days, maximum 128 days from MASE-T infusion).
Serious adverse events also included AEs that: * Resulted in persistent or significant disability or incapacity; * Led to a congenital anomaly or birth defect; * Was a significant medical event. * Resulted in the transmission of an infectious agent * Pregnancy must follow the same transmission timing and process used for SAEs. A specific list of events that should not be reported is included in the protocol
|
—
0/0 • The data was collected throughout the duration of the clinical trial, from September 2021 (enrollment of the first patient) and until exclusion of the last patient in June 2024 (2.8 years) Adverse events were collected every 6-12 weeks until study completion. For the individual patient, the reporting started at the study enrolment and ended with study exclusion (median 69 days, maximum 128 days from MASE-T infusion).
Serious adverse events also included AEs that: * Resulted in persistent or significant disability or incapacity; * Led to a congenital anomaly or birth defect; * Was a significant medical event. * Resulted in the transmission of an infectious agent * Pregnancy must follow the same transmission timing and process used for SAEs. A specific list of events that should not be reported is included in the protocol
|
Additional Information
MD, PhD Tine Juul Monberg
National Center for Cancer Immune Therapy (CCIT-DK)
Phone: 38682983
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place