Trial Outcomes & Findings for CNDO-109-AANK for AML in First Complete Remission (CR1) (NCT NCT01520558)
NCT ID: NCT01520558
Last Updated: 2017-06-29
Results Overview
The primary objective is to define the maximum tolerated dose (MTD), or the maximum tested dose where multiple dose-limiting toxicities (DLTs) are not observed, of CNDO-109-Activated Allogeneic Natural Killer Cells infused after preparative chemotherapy, administered to patients with acute myeloid leukemia (AML) who are in their first complete remission (CR1) at the time of enrollment and are considered to be at high risk for recurrence. The MTD outcome measure is presented as number of participants with DLTs.
Recruitment status
UNKNOWN
Study phase
PHASE1/PHASE2
Target enrollment
12 participants
Primary outcome timeframe
up to 30 days post dose
Results posted on
2017-06-29
Participant Flow
Participant milestones
| Measure |
CNDO-109-AANK Cells Dose 1
In stage 1, patients will receive one of three doses of CNDO-109-AANK cells, and the lowest of these three doses (dose 1) is 3×10\^5 cells/kg recipient body weight. In stage 2, the MTD will have been determined and all patients will receive either Dose 1, Dose 2 or Dose 3.
CNDO-109-AANK Cells: Single dose, infusion
|
CNDO-109-AANK Cells Dose 2
In stage 1, patients will receive one of three doses of CNDO-109-AANK cells, and the middle dose of these three doses (dose 2) is 1×10\^6 cells/kg recipient body weight. In stage 2, the MTD will have been determined and all patients will receive either Dose 1, Dose 2 or Dose 3.
CNDO-109-AANK Cells: Single dose, infusion
|
CNDO-109-AANK Cells Dose 3
In stage 1, patients will receive one of three doses of CNDO-109-AANK cells, and the highest dose of these three doses (dose 3) is 3×10\^6 cells/kg recipient body weight. In stage 2, the MTD will have been determined and all patients will receive either Dose 1, Dose 2 or Dose 3.
CNDO-109-AANK Cells: Single dose, infusion
|
|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
6
|
|
Overall Study
COMPLETED
|
1
|
1
|
3
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
CNDO-109-AANK for AML in First Complete Remission (CR1)
Baseline characteristics by cohort
| Measure |
CNDO-109-AANK Cells Dose 1
n=3 Participants
In stage 1, patients will receive one of three doses of CNDO-109-AANK cells, and the lowest of these three doses (dose 1) is 3×10\^5 cells/kg recipient body weight. In stage 2, the MTD will have been determined and all patients will receive either Dose 1, Dose 2 or Dose 3.
CNDO-109-AANK Cells: Single dose, infusion
|
CNDO-109-AANK Cells Dose 2
n=3 Participants
In stage 1, patients will receive one of three doses of CNDO-109-AANK cells, and the middle dose of these three doses (dose 2) is 1×10\^6 cells/kg recipient body weight. In stage 2, the MTD will have been determined and all patients will receive either Dose 1, Dose 2 or Dose 3.
CNDO-109-AANK Cells: Single dose, infusion
|
CNDO-109-AANK Cells Dose 3
n=6 Participants
In stage 1, patients will receive one of three doses of CNDO-109-AANK cells, and the highest dose of these three doses (dose 3) is 3×10\^6 cells/kg recipient body weight. In stage 2, the MTD will have been determined and all patients will receive either Dose 1, Dose 2 or Dose 3.
CNDO-109-AANK Cells: Single dose, infusion
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
73 years
STANDARD_DEVIATION 1.00 • n=99 Participants
|
76.3 years
STANDARD_DEVIATION 2.52 • n=107 Participants
|
67.3 years
STANDARD_DEVIATION 6.35 • n=206 Participants
|
71.0 years
STANDARD_DEVIATION 5.98 • n=7 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
8 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
12 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
12 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=99 Participants
|
3 participants
n=107 Participants
|
6 participants
n=206 Participants
|
12 participants
n=7 Participants
|
PRIMARY outcome
Timeframe: up to 30 days post doseThe primary objective is to define the maximum tolerated dose (MTD), or the maximum tested dose where multiple dose-limiting toxicities (DLTs) are not observed, of CNDO-109-Activated Allogeneic Natural Killer Cells infused after preparative chemotherapy, administered to patients with acute myeloid leukemia (AML) who are in their first complete remission (CR1) at the time of enrollment and are considered to be at high risk for recurrence. The MTD outcome measure is presented as number of participants with DLTs.
Outcome measures
| Measure |
CNDO-109-AANK Cells Dose 1
n=3 Participants
In stage 1, patients will receive one of three doses of CNDO-109-AANK cells, and the lowest of these three doses (dose 1) is 3×10\^5 cells/kg recipient body weight. In stage 2, the MTD will have been determined and all patients will receive either Dose 1, Dose 2 or Dose 3.
CNDO-109-AANK Cells: Single dose, infusion
|
CNDO-109-AANK Cells Dose 2
n=3 Participants
In stage 1, patients will receive one of three doses of CNDO-109-AANK cells, and the middle dose of these three doses (dose 2) is 1×10\^6 cells/kg recipient body weight. In stage 2, the MTD will have been determined and all patients will receive either Dose 1, Dose 2 or Dose 3.
CNDO-109-AANK Cells: Single dose, infusion
|
CNDO-109-AANK Cells Dose 3
n=6 Participants
In stage 1, patients will receive one of three doses of CNDO-109-AANK cells, and the highest dose of these three doses (dose 3) is 3×10\^6 cells/kg recipient body weight. In stage 2, the MTD will have been determined and all patients will receive either Dose 1, Dose 2 or Dose 3.
CNDO-109-AANK Cells: Single dose, infusion
|
|---|---|---|---|
|
Define MTD
|
3 Participants
|
3 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: up to 360 days post doseCharacterize the safety profile of CNDO-109-Activated Allogeneic Natural Killer Cells infusion after preparative therapy by measurement of adverse events, safety labs, vital signs, bone marrow biopsy/aspiration and physical examination.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: from the date of documented CR until the first documented progression date or until day 360 post dose whichever is soonerDetermine relapse free survival (RFS) and overall survival (OS) following infusion with CNDO-109-Activated Allogeneic Natural Killer Cells.
Outcome measures
Outcome data not reported
Adverse Events
CNDO-109-AANK Cells Dose 1
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
CNDO-109-AANK Cells Dose 2
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
CNDO-109-AANK Cells Dose 3
Serious events: 3 serious events
Other events: 6 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
CNDO-109-AANK Cells Dose 1
n=3 participants at risk
In stage 1, patients will receive one of three doses of CNDO-109-AANK cells, and the lowest of these three doses (dose 1) is 3×10\^5 cells/kg recipient body weight. In stage 2, the MTD will have been determined and all patients will receive either Dose 1, Dose 2 or Dose 3.
CNDO-109-AANK Cells: Single dose, infusion
|
CNDO-109-AANK Cells Dose 2
n=3 participants at risk
In stage 1, patients will receive one of three doses of CNDO-109-AANK cells, and the middle dose of these three doses (dose 2) is 1×10\^6 cells/kg recipient body weight. In stage 2, the MTD will have been determined and all patients will receive either Dose 1, Dose 2 or Dose 3.
CNDO-109-AANK Cells: Single dose, infusion
|
CNDO-109-AANK Cells Dose 3
n=6 participants at risk
In stage 1, patients will receive one of three doses of CNDO-109-AANK cells, and the highest dose of these three doses (dose 3) is 3×10\^6 cells/kg recipient body weight. In stage 2, the MTD will have been determined and all patients will receive either Dose 1, Dose 2 or Dose 3.
CNDO-109-AANK Cells: Single dose, infusion
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
33.3%
1/3 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
33.3%
2/6 • Number of events 3
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/3
|
0.00%
0/3
|
16.7%
1/6 • Number of events 2
|
|
Investigations
Blood creatinine increased
|
0.00%
0/3
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
Other adverse events
| Measure |
CNDO-109-AANK Cells Dose 1
n=3 participants at risk
In stage 1, patients will receive one of three doses of CNDO-109-AANK cells, and the lowest of these three doses (dose 1) is 3×10\^5 cells/kg recipient body weight. In stage 2, the MTD will have been determined and all patients will receive either Dose 1, Dose 2 or Dose 3.
CNDO-109-AANK Cells: Single dose, infusion
|
CNDO-109-AANK Cells Dose 2
n=3 participants at risk
In stage 1, patients will receive one of three doses of CNDO-109-AANK cells, and the middle dose of these three doses (dose 2) is 1×10\^6 cells/kg recipient body weight. In stage 2, the MTD will have been determined and all patients will receive either Dose 1, Dose 2 or Dose 3.
CNDO-109-AANK Cells: Single dose, infusion
|
CNDO-109-AANK Cells Dose 3
n=6 participants at risk
In stage 1, patients will receive one of three doses of CNDO-109-AANK cells, and the highest dose of these three doses (dose 3) is 3×10\^6 cells/kg recipient body weight. In stage 2, the MTD will have been determined and all patients will receive either Dose 1, Dose 2 or Dose 3.
CNDO-109-AANK Cells: Single dose, infusion
|
|---|---|---|---|
|
Investigations
Neutrophil count decreased
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
33.3%
2/6 • Number of events 2
|
|
Investigations
Platelet count decreased
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
33.3%
2/6 • Number of events 2
|
|
Investigations
WBC count decreased
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
33.3%
2/6 • Number of events 2
|
|
Investigations
Lymph count decreased
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
|
Investigations
ALT increased
|
0.00%
0/3
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
|
Investigations
Blood albumin decreased
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/6
|
|
Investigations
Blood Alk Phos increased
|
0.00%
0/3
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
|
Investigations
Lymph count increased
|
0.00%
0/3
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
|
Investigations
Weight decreased
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/6
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
33.3%
2/6 • Number of events 2
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
2/6 • Number of events 2
|
|
Metabolism and nutrition disorders
Oedema peripheral
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.00%
0/3
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypermagnesaemia
|
0.00%
0/3
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/3
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperurecemia
|
0.00%
0/3
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/3
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
|
Blood and lymphatic system disorders
Neutropenia
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/3
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
|
General disorders
Fatigue
|
66.7%
2/3 • Number of events 2
|
33.3%
1/3 • Number of events 1
|
50.0%
3/6 • Number of events 3
|
|
General disorders
Pyrexia
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
2/6 • Number of events 2
|
|
General disorders
Chills
|
0.00%
0/3
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
|
General disorders
Generalized oedema
|
0.00%
0/3
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
|
General disorders
Mucosal inflammation
|
0.00%
0/3
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/3
|
66.7%
2/3 • Number of events 2
|
33.3%
2/6 • Number of events 2
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
2/6 • Number of events 2
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/3
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
|
Gastrointestinal disorders
Retching
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/6
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/6
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
2/6 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Erythema
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/6
|
|
Skin and subcutaneous tissue disorders
Macule
|
0.00%
0/3
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/3
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/6
|
|
Skin and subcutaneous tissue disorders
Red man syndrome
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/6
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.00%
0/3
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Rales
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
|
Reproductive system and breast disorders
Atelectasis
|
0.00%
0/3
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/3
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
|
Reproductive system and breast disorders
Dyspnoea
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/3
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract congestion
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/3
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
|
Vascular disorders
Hypotension
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
33.3%
2/6 • Number of events 2
|
|
Vascular disorders
Hypertension
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
2/6 • Number of events 2
|
|
Vascular disorders
Haematoma
|
0.00%
0/3
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
|
Psychiatric disorders
Anxiety
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
50.0%
3/6 • Number of events 3
|
|
Psychiatric disorders
Delirium
|
0.00%
0/3
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/3
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
|
Cardiac disorders
Sinus tachycardia
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
|
Renal and urinary disorders
Oliguria
|
0.00%
0/3
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/3
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
|
Renal and urinary disorders
Polyuria
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/6
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/3
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
|
Infections and infestations
Pneumonia
|
0.00%
0/3
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
|
Infections and infestations
Septic shock
|
0.00%
0/3
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/3
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
|
Injury, poisoning and procedural complications
Renal injury
|
0.00%
0/3
|
0.00%
0/3
|
33.3%
2/6 • Number of events 2
|
|
Nervous system disorders
Headache
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/6
|
|
Nervous system disorders
Somnolence
|
0.00%
0/3
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
|
Ear and labyrinth disorders
Vertigo
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/6
|
|
Immune system disorders
Urticaria
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/6
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/3
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Agreement is specific to clinical trial agreement
- Publication restrictions are in place
Restriction type: OTHER