Trial Outcomes & Findings for AlloStim® Immunotherapy Dosing Alone or in Combination With Cryoablation in Metastatic Colorectal Cancer (NCT NCT02380443)
NCT ID: NCT02380443
Last Updated: 2025-05-16
Results Overview
Subjects are followed for survival monthly after completion of dosing
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
13 participants
Primary outcome timeframe
from time of signing informed consent for up to 18 months or until death
Results posted on
2025-05-16
Participant Flow
Participant milestones
| Measure |
Dosing Schedule A (With Cryoablation)
* The priming step with ID injections of AlloStim on Days 0, 7, and 14
* The vaccination step with cryoablation and IT (intratumoral) injection of AlloStim on Day 21
* The activation step with IV infusion of AlloStim on Day 28
* The booster step with two IV booster infusions of AlloStim on Days 56 and 84
Protocol follow-up procedures continue until day 112. Efficacy evaluation will continue monthly for each subject until death or loss to follow-up
AlloStim: AlloStim is an activated living CD4+ Th1 memory cell derived from the blood of normal blood donors and intentionally mismatched to the recipient. AlloStim is bioengineered to express high levels of Type 1 inflammatory cytokines (such as interferon-gamma, TNF-alpha, GM-CSF) and immunomodulatory molecules such as CD40L. AlloStim has CD3/CD28-coated microbeads attached to assure activation upon infusion.
Cryoablation: Percutaneous partial cryoablation of a single metastatic tumor lesion in the liver. The procedure is conducted under CT or ultrasound image-guidance
|
Dosing Schedule B Without Cryoablation
The priming step with ID injections of AlloStim on Days 0, 3, 7, 10 and day 14
* IV AlloStim on Day 21
* The booster step with two IV booster infusions of AlloStim on Days 49 and 77
Protocol follow-up procedures continue until day 105. Efficacy evaluation will continue monthly for each subject until death or loss to follow-up Protocol follow-up procedures continue until day 105. Efficacy evaluation will continue monthly for each subject until death or loss to follow-up
AlloStim: AlloStim is an activated living CD4+ Th1 memory cell derived from the blood of normal blood donors and intentionally mismatched to the recipient. AlloStim is bioengineered to express high levels of Type 1 inflammatory cytokines (such as interferon-gamma, TNF-alpha, GM-CSF) and immunomodulatory molecules such as CD40L. AlloStim has CD3/CD28-coated microbeads attached to assure activation upon infusion.
|
|---|---|---|
|
Overall Study
STARTED
|
4
|
9
|
|
Overall Study
COMPLETED
|
3
|
9
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Dosing Schedule A (With Cryoablation)
n=4 Participants
* The priming step with ID injections of AlloStim on Days 0, 7, and 14
* The vaccination step with cryoablation and IT (intratumoral) injection of AlloStim on Day 21
* The activation step with IV infusion of AlloStim on Day 28
* The booster step with two IV booster infusions of AlloStim on Days 56 and 84
Protocol follow-up procedures continue until day 112. Efficacy evaluation will continue monthly for each subject until death or loss to follow-up
AlloStim: AlloStim is an activated living CD4+ Th1 memory cell derived from the blood of normal blood donors and intentionally mismatched to the recipient. AlloStim is bioengineered to express high levels of Type 1 inflammatory cytokines (such as interferon-gamma, TNF-alpha, GM-CSF) and immunomodulatory molecules such as CD40L. AlloStim has CD3/CD28-coated microbeads attached to assure activation upon infusion.
Cryoablation: Percutaneous partial cryoablation of a single metastatic tumor lesion in the liver. The procedure is conducted under CT or ultrasound image-guidance
|
Dosing Schedule B Without Cryoablation
n=9 Participants
The priming step with ID injections of AlloStim on Days 0, 3, 7, 10 and day 14
* IV AlloStim on Day 21
* The booster step with two IV booster infusions of AlloStim on Days 49 and 77
Protocol follow-up procedures continue until day 105. Efficacy evaluation will continue monthly for each subject until death or loss to follow-up Protocol follow-up procedures continue until day 105. Efficacy evaluation will continue monthly for each subject until death or loss to follow-up
AlloStim: AlloStim is an activated living CD4+ Th1 memory cell derived from the blood of normal blood donors and intentionally mismatched to the recipient. AlloStim is bioengineered to express high levels of Type 1 inflammatory cytokines (such as interferon-gamma, TNF-alpha, GM-CSF) and immunomodulatory molecules such as CD40L. AlloStim has CD3/CD28-coated microbeads attached to assure activation upon infusion.
|
Total
n=13 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=4 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=13 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=4 Participants
|
3 Participants
n=9 Participants
|
5 Participants
n=13 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=4 Participants
|
6 Participants
n=9 Participants
|
8 Participants
n=13 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=4 Participants
|
3 Participants
n=9 Participants
|
4 Participants
n=13 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=4 Participants
|
6 Participants
n=9 Participants
|
9 Participants
n=13 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
4 participants
n=4 Participants
|
9 participants
n=9 Participants
|
13 participants
n=13 Participants
|
|
third-line MSS metastatic colorectal cancer
|
4 Participants
n=4 Participants
|
9 Participants
n=9 Participants
|
13 Participants
n=13 Participants
|
PRIMARY outcome
Timeframe: from time of signing informed consent for up to 18 months or until deathSubjects are followed for survival monthly after completion of dosing
Outcome measures
| Measure |
Dosing Schedule A (With Cryoablation)
n=3 Participants
* The priming step with ID injections of AlloStim on Days 0, 7, and 14
* The vaccination step with cryoablation and IT (intratumoral) injection of AlloStim on Day 21
* The activation step with IV infusion of AlloStim on Day 28
* The booster step with two IV booster infusions of AlloStim on Days 56 and 84
Protocol follow-up procedures continue until day 112. Efficacy evaluation will continue monthly for each subject until death or loss to follow-up
AlloStim: AlloStim is an activated living CD4+ Th1 memory cell derived from the blood of normal blood donors and intentionally mismatched to the recipient. AlloStim is bioengineered to express high levels of Type 1 inflammatory cytokines (such as interferon-gamma, TNF-alpha, GM-CSF) and immunomodulatory molecules such as CD40L. AlloStim has CD3/CD28-coated microbeads attached to assure activation upon infusion.
Cryoablation: Percutaneous partial cryoablation of a single metastatic tumor lesion in the liver. The procedure is conducted under CT or ultrasound image-guidance
|
Dosing Schedule B Without Cryoablation
n=9 Participants
The priming step with ID injections of AlloStim on Days 0, 3, 7, 10 and day 14
* IV AlloStim on Day 21
* The booster step with two IV booster infusions of AlloStim on Days 49 and 77
Protocol follow-up procedures continue until day 105. Efficacy evaluation will continue monthly for each subject until death or loss to follow-up Protocol follow-up procedures continue until day 105. Efficacy evaluation will continue monthly for each subject until death or loss to follow-up
AlloStim: AlloStim is an activated living CD4+ Th1 memory cell derived from the blood of normal blood donors and intentionally mismatched to the recipient. AlloStim is bioengineered to express high levels of Type 1 inflammatory cytokines (such as interferon-gamma, TNF-alpha, GM-CSF) and immunomodulatory molecules such as CD40L. AlloStim has CD3/CD28-coated microbeads attached to assure activation upon infusion.
|
|---|---|---|
|
Evaluate the Overall Survival
|
97 days
Interval 34.0 to 188.0
|
368 days
Interval 184.0 to 440.0
|
Adverse Events
Dosing Schedule A (With Cryoablation)
Serious events: 2 serious events
Other events: 3 other events
Deaths: 3 deaths
Dosing Schedule B Without Cryoablation
Serious events: 1 serious events
Other events: 7 other events
Deaths: 9 deaths
Serious adverse events
| Measure |
Dosing Schedule A (With Cryoablation)
n=3 participants at risk
* The priming step with ID injections of AlloStim on Days 0, 7, and 14
* The vaccination step with cryoablation and IT (intratumoral) injection of AlloStim on Day 21
* The activation step with IV infusion of AlloStim on Day 28
* The booster step with two IV booster infusions of AlloStim on Days 56 and 84
Protocol follow-up procedures continue until day 112. Efficacy evaluation will continue monthly for each subject until death or loss to follow-up
AlloStim: AlloStim is an activated living CD4+ Th1 memory cell derived from the blood of normal blood donors and intentionally mismatched to the recipient. AlloStim is bioengineered to express high levels of Type 1 inflammatory cytokines (such as interferon-gamma, TNF-alpha, GM-CSF) and immunomodulatory molecules such as CD40L. AlloStim has CD3/CD28-coated microbeads attached to assure activation upon infusion.
Cryoablation: Percutaneous partial cryoablation of a single metastatic tumor lesion in the liver. The procedure is conducted under CT or ultrasound image-guidance
|
Dosing Schedule B Without Cryoablation
n=9 participants at risk
The priming step with ID injections of AlloStim on Days 0, 3, 7, 10 and day 14
* IV AlloStim on Day 21
* The booster step with two IV booster infusions of AlloStim on Days 49 and 77
Protocol follow-up procedures continue until day 105. Efficacy evaluation will continue monthly for each subject until death or loss to follow-up Protocol follow-up procedures continue until day 105. Efficacy evaluation will continue monthly for each subject until death or loss to follow-up
AlloStim: AlloStim is an activated living CD4+ Th1 memory cell derived from the blood of normal blood donors and intentionally mismatched to the recipient. AlloStim is bioengineered to express high levels of Type 1 inflammatory cytokines (such as interferon-gamma, TNF-alpha, GM-CSF) and immunomodulatory molecules such as CD40L. AlloStim has CD3/CD28-coated microbeads attached to assure activation upon infusion.
|
|---|---|---|
|
Investigations
Fatigue
|
66.7%
2/3 • Number of events 2 • 18 months
weekly for first 90 days and monthly thereafter
|
11.1%
1/9 • Number of events 1 • 18 months
weekly for first 90 days and monthly thereafter
|
|
Gastrointestinal disorders
Pancreatitis
|
33.3%
1/3 • Number of events 1 • 18 months
weekly for first 90 days and monthly thereafter
|
0.00%
0/9 • 18 months
weekly for first 90 days and monthly thereafter
|
|
Respiratory, thoracic and mediastinal disorders
pneumonia
|
33.3%
1/3 • Number of events 2 • 18 months
weekly for first 90 days and monthly thereafter
|
0.00%
0/9 • 18 months
weekly for first 90 days and monthly thereafter
|
Other adverse events
| Measure |
Dosing Schedule A (With Cryoablation)
n=3 participants at risk
* The priming step with ID injections of AlloStim on Days 0, 7, and 14
* The vaccination step with cryoablation and IT (intratumoral) injection of AlloStim on Day 21
* The activation step with IV infusion of AlloStim on Day 28
* The booster step with two IV booster infusions of AlloStim on Days 56 and 84
Protocol follow-up procedures continue until day 112. Efficacy evaluation will continue monthly for each subject until death or loss to follow-up
AlloStim: AlloStim is an activated living CD4+ Th1 memory cell derived from the blood of normal blood donors and intentionally mismatched to the recipient. AlloStim is bioengineered to express high levels of Type 1 inflammatory cytokines (such as interferon-gamma, TNF-alpha, GM-CSF) and immunomodulatory molecules such as CD40L. AlloStim has CD3/CD28-coated microbeads attached to assure activation upon infusion.
Cryoablation: Percutaneous partial cryoablation of a single metastatic tumor lesion in the liver. The procedure is conducted under CT or ultrasound image-guidance
|
Dosing Schedule B Without Cryoablation
n=9 participants at risk
The priming step with ID injections of AlloStim on Days 0, 3, 7, 10 and day 14
* IV AlloStim on Day 21
* The booster step with two IV booster infusions of AlloStim on Days 49 and 77
Protocol follow-up procedures continue until day 105. Efficacy evaluation will continue monthly for each subject until death or loss to follow-up Protocol follow-up procedures continue until day 105. Efficacy evaluation will continue monthly for each subject until death or loss to follow-up
AlloStim: AlloStim is an activated living CD4+ Th1 memory cell derived from the blood of normal blood donors and intentionally mismatched to the recipient. AlloStim is bioengineered to express high levels of Type 1 inflammatory cytokines (such as interferon-gamma, TNF-alpha, GM-CSF) and immunomodulatory molecules such as CD40L. AlloStim has CD3/CD28-coated microbeads attached to assure activation upon infusion.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
injection site reaction
|
100.0%
3/3 • Number of events 3 • 18 months
weekly for first 90 days and monthly thereafter
|
77.8%
7/9 • Number of events 7 • 18 months
weekly for first 90 days and monthly thereafter
|
|
Investigations
Fatigue
|
100.0%
3/3 • Number of events 7 • 18 months
weekly for first 90 days and monthly thereafter
|
22.2%
2/9 • Number of events 3 • 18 months
weekly for first 90 days and monthly thereafter
|
|
Investigations
flu symptoms
|
33.3%
1/3 • Number of events 1 • 18 months
weekly for first 90 days and monthly thereafter
|
22.2%
2/9 • Number of events 2 • 18 months
weekly for first 90 days and monthly thereafter
|
|
General disorders
pain
|
100.0%
3/3 • Number of events 8 • 18 months
weekly for first 90 days and monthly thereafter
|
33.3%
3/9 • Number of events 3 • 18 months
weekly for first 90 days and monthly thereafter
|
|
Blood and lymphatic system disorders
anemia
|
100.0%
3/3 • Number of events 3 • 18 months
weekly for first 90 days and monthly thereafter
|
11.1%
1/9 • Number of events 1 • 18 months
weekly for first 90 days and monthly thereafter
|
|
Skin and subcutaneous tissue disorders
edema
|
33.3%
1/3 • Number of events 1 • 18 months
weekly for first 90 days and monthly thereafter
|
33.3%
3/9 • Number of events 3 • 18 months
weekly for first 90 days and monthly thereafter
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place