Trial Outcomes & Findings for Trial of Third Party Donor Derived CMVpp65 Specific T-cells for The Treatment of CMV Infection or Persistent CMV Viremia After Allogeneic Hematopoietic Stem Cell Transplantation (NCT NCT02136797)
NCT ID: NCT02136797
Last Updated: 2024-10-17
Results Overview
defined as the clearance of the CMV infection 3-7 weeks following completion of the last cycle of CMV CTLs.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
77 participants
Primary outcome timeframe
2 years
Results posted on
2024-10-17
Participant Flow
Participant milestones
| Measure |
CMVpp65-CTL T-cells
The T-cells to be infused will be selected from our bank of GMP grade CMVpp65-CTL. T-cells will be administered by bolus intravenous infusion. In this phase II trial, patients will be treated at doses of 1 x 10\^6 CMVpp65-CTL/kg/dose/week for 3 weeks. Patients will be observed for the following 3 weeks. Additional 3 week courses of CMVpp65-CTL may be administered if levels of CMV DNA in blood are still detectable despite disease stabilization or improvement.
CMVpp65 Specific T-cells
|
|---|---|
|
Overall Study
STARTED
|
77
|
|
Overall Study
COMPLETED
|
69
|
|
Overall Study
NOT COMPLETED
|
8
|
Reasons for withdrawal
| Measure |
CMVpp65-CTL T-cells
The T-cells to be infused will be selected from our bank of GMP grade CMVpp65-CTL. T-cells will be administered by bolus intravenous infusion. In this phase II trial, patients will be treated at doses of 1 x 10\^6 CMVpp65-CTL/kg/dose/week for 3 weeks. Patients will be observed for the following 3 weeks. Additional 3 week courses of CMVpp65-CTL may be administered if levels of CMV DNA in blood are still detectable despite disease stabilization or improvement.
CMVpp65 Specific T-cells
|
|---|---|
|
Overall Study
Not Treated
|
8
|
Baseline Characteristics
Trial of Third Party Donor Derived CMVpp65 Specific T-cells for The Treatment of CMV Infection or Persistent CMV Viremia After Allogeneic Hematopoietic Stem Cell Transplantation
Baseline characteristics by cohort
| Measure |
CMVpp65-CTL T-cells
n=77 Participants
The T-cells to be infused will be selected from our bank of GMP grade CMVpp65-CTL. T-cells will be administered by bolus intravenous infusion. In this phase II trial, patients will be treated at doses of 1 x 10\^6 CMVpp65-CTL/kg/dose/week for 3 weeks. Patients will be observed for the following 3 weeks. Additional 3 week courses of CMVpp65-CTL may be administered if levels of CMV DNA in blood are still detectable despite disease stabilization or improvement.
CMVpp65 Specific T-cells
|
|---|---|
|
Age, Continuous
|
43 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
36 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
41 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
13 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
64 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
51 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
77 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 yearsdefined as the clearance of the CMV infection 3-7 weeks following completion of the last cycle of CMV CTLs.
Outcome measures
| Measure |
CMVpp65-CTL T-cells
n=77 Participants
The T-cells to be infused will be selected from our bank of GMP grade CMVpp65-CTL. T-cells will be administered by bolus intravenous infusion. In this phase II trial, patients will be treated at doses of 1 x 10\^6 CMVpp65-CTL/kg/dose/week for 3 weeks. Patients will be observed for the following 3 weeks. Additional 3 week courses of CMVpp65-CTL may be administered if levels of CMV DNA in blood are still detectable despite disease stabilization or improvement.
CMVpp65 Specific T-cells
|
|---|---|
|
Complete Response
Participants with Complete Response
|
20 Participants
|
|
Complete Response
Participants without Complete Response
|
57 Participants
|
SECONDARY outcome
Timeframe: 2 yearsWill be capturing and tracking Grade 3-5 toxicities which occur within 30 days following an infusion of CMVpp65-specific. For the evaluation of toxicities, the NCI Standard Toxicity Scale 4.0 will be employed.
Outcome measures
| Measure |
CMVpp65-CTL T-cells
n=77 Participants
The T-cells to be infused will be selected from our bank of GMP grade CMVpp65-CTL. T-cells will be administered by bolus intravenous infusion. In this phase II trial, patients will be treated at doses of 1 x 10\^6 CMVpp65-CTL/kg/dose/week for 3 weeks. Patients will be observed for the following 3 weeks. Additional 3 week courses of CMVpp65-CTL may be administered if levels of CMV DNA in blood are still detectable despite disease stabilization or improvement.
CMVpp65 Specific T-cells
|
|---|---|
|
Number of Participants With SAE's Possibly Related to Study Treatment
Participants with possibly related SAE
|
6 Participants
|
|
Number of Participants With SAE's Possibly Related to Study Treatment
Participants without possibly related SAE
|
71 Participants
|
Adverse Events
CMVpp65-CTL T-cells
Serious events: 22 serious events
Other events: 9 other events
Deaths: 16 deaths
Serious adverse events
| Measure |
CMVpp65-CTL T-cells
n=77 participants at risk
The T-cells to be infused will be selected from our bank of GMP grade CMVpp65-CTL. T-cells will be administered by bolus intravenous infusion. In this phase II trial, patients will be treated at doses of 1 x 10\^6 CMVpp65-CTL/kg/dose/week for 3 weeks. Patients will be observed for the following 3 weeks. Additional 3 week courses of CMVpp65-CTL may be administered if levels of CMV DNA in blood are still detectable despite disease stabilization or improvement.
CMVpp65 Specific T-cells
|
|---|---|
|
Cardiac disorders
Acute coronary syndrome
|
1.3%
1/77 • 2 years
|
|
Renal and urinary disorders
Acute kidney injury
|
1.3%
1/77 • 2 years
|
|
Blood and lymphatic system disorders
Anemia
|
1.3%
1/77 • 2 years
|
|
Metabolism and nutrition disorders
Anorexia
|
1.3%
1/77 • 2 years
|
|
Immune system disorders
Autoimmune disorder
|
2.6%
2/77 • 2 years
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other
|
3.9%
3/77 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopulmonary hemorrhage
|
1.3%
1/77 • 2 years
|
|
Infections and infestations
Catheter related infection
|
5.2%
4/77 • 2 years
|
|
Psychiatric disorders
Confusion
|
1.3%
1/77 • 2 years
|
|
General disorders
Death NOS
|
5.2%
4/77 • 2 years
|
|
Metabolism and nutrition disorders
Dehydration
|
1.3%
1/77 • 2 years
|
|
Nervous system disorders
Depressed level of consciousness
|
1.3%
1/77 • 2 years
|
|
Gastrointestinal disorders
Diarrhea
|
1.3%
1/77 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
2.6%
2/77 • 2 years
|
|
Investigations
Ejection fraction decreased
|
1.3%
1/77 • 2 years
|
|
Infections and infestations
Enterocolitis infectious
|
1.3%
1/77 • 2 years
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
2.6%
2/77 • 2 years
|
|
General disorders
Fever
|
1.3%
1/77 • 2 years
|
|
Nervous system disorders
Headache
|
1.3%
1/77 • 2 years
|
|
Cardiac disorders
Heart failure
|
3.9%
3/77 • 2 years
|
|
Renal and urinary disorders
Hematuria
|
1.3%
1/77 • 2 years
|
|
Hepatobiliary disorders
Hepatobiliary disorders - Other, specify
|
1.3%
1/77 • 2 years
|
|
Vascular disorders
Hypertension
|
1.3%
1/77 • 2 years
|
|
Endocrine disorders
Hyperthyroidism
|
1.3%
1/77 • 2 years
|
|
Vascular disorders
Hypotension
|
2.6%
2/77 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
3.9%
3/77 • 2 years
|
|
Metabolism and nutrition disorders
Iron overload
|
1.3%
1/77 • 2 years
|
|
Infections and infestations
Lung infection
|
3.9%
3/77 • 2 years
|
|
Investigations
Lymphocyte count decreased
|
1.3%
1/77 • 2 years
|
|
General disorders
Multi-organ failure
|
2.6%
2/77 • 2 years
|
|
Gastrointestinal disorders
Nausea
|
1.3%
1/77 • 2 years
|
|
Investigations
Neutrophil count decreased
|
3.9%
3/77 • 2 years
|
|
Cardiac disorders
Pericardial effusion
|
1.3%
1/77 • 2 years
|
|
Investigations
Platelet count decreased
|
5.2%
4/77 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Resp, thoracic & mediastinal disorder Other, spec
|
2.6%
2/77 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
11.7%
9/77 • 2 years
|
|
Eye disorders
Retinal detachment
|
1.3%
1/77 • 2 years
|
|
Infections and infestations
Sepsis
|
5.2%
4/77 • 2 years
|
|
Cardiac disorders
Sinus bradycardia
|
1.3%
1/77 • 2 years
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
1.3%
1/77 • 2 years
|
|
Skin and subcutaneous tissue disorders
Toxic epidermal necrolysis
|
1.3%
1/77 • 2 years
|
Other adverse events
| Measure |
CMVpp65-CTL T-cells
n=77 participants at risk
The T-cells to be infused will be selected from our bank of GMP grade CMVpp65-CTL. T-cells will be administered by bolus intravenous infusion. In this phase II trial, patients will be treated at doses of 1 x 10\^6 CMVpp65-CTL/kg/dose/week for 3 weeks. Patients will be observed for the following 3 weeks. Additional 3 week courses of CMVpp65-CTL may be administered if levels of CMV DNA in blood are still detectable despite disease stabilization or improvement.
CMVpp65 Specific T-cells
|
|---|---|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other, spec
|
1.3%
1/77 • 2 years
|
|
Infections and infestations
Encephalitis infection
|
1.3%
1/77 • 2 years
|
|
Cardiac disorders
Heart failure
|
1.3%
1/77 • 2 years
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
1.3%
1/77 • 2 years
|
|
Infections and infestations
Lung infection
|
1.3%
1/77 • 2 years
|
|
Cardiac disorders
Pericardial effusion
|
1.3%
1/77 • 2 years
|
|
Investigations
Platelet count decreased
|
1.3%
1/77 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.3%
1/77 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
1.3%
1/77 • 2 years
|
Additional Information
Dr. Kevin Curran, MD
Memorial Sloan Kettering Cancer Center
Phone: 212-639-5836
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place