Trial Outcomes & Findings for Drosophila-generated CTL (NCT NCT01271907)

NCT ID: NCT01271907

Last Updated: 2017-08-01

Results Overview

Clinical response is assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Complete response (CR) is a disappearance of all target lesions. Partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. Progression disease (PD) is at least a 20 % increase in the sum of the LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more lesions. Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum LD.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

3 participants

Primary outcome timeframe

7 months

Results posted on

2017-08-01

Participant Flow

Cohorts 1 and 2 did not enroll participants because the study was terminated due to poor accrual.

Participant milestones

Participant milestones
Measure	Cohort 0 Drosophila generated CTL + SQ IL-2 1 fludarabine, cyclophosphamide, Drosophila-peptide pulsed Melanoma-reactive autologous CD8+ PBL (CTL-05), aldesleukin : Fludarabine 25 mg/m2 x 5 days Cyclophosphamide 60 mg/kg IV x2 days, Up to 1x10e10 CTL-05 cells Aldesleukin 125,000 IU/kg/dose as a daily subcutaneous injection	Cohort 1 2 Experimental Lymphodepleting regimen +Cells+Low dose IL-2 2 fludarabine, cyclophosphamide, Drosophila-peptide pulsed Melanoma-reactive autologous CD8+ PBL, aldesleukin : Fludarabine 25 mg/m2 x 5 days Cyclophosphamide 60 mg/kg IV x2 days, Up to 1x10e10 CTL-05 cells Aldesleukin 125,000 IU/kg/dose as a daily subcutaneous injection	Cohort 2 1 Experimental Lymphodepleting regimen +Cells 3 fludarabine, cyclophosphamide, Drosophila-peptide pulsed Melanoma-reactive autologous CD8+ PBL : Fludarabine 25 mg/m2 x 5 days Cyclophosphamide 60 mg/kg IV x2 days, Up to 1x10e10 CTL-05 cells
Overall Study STARTED	3	0	0
Overall Study COMPLETED	3	0	0
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Drosophila-generated CTL

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cohort 0 n=3 Participants Drosophila generated CTL + SQ IL-2 1 fludarabine, cyclophosphamide, Drosophila-peptide pulsed Melanoma-reactive autologous CD8+ PBL (CTL-05), aldesleukin : Fludarabine 25 mg/m2 x 5 days Cyclophosphamide 60 mg/kg IV x2 days, Up to 1x10e10 CTL-05 cells Aldesleukin 125,000 IU/kg/dose as a daily subcutaneous injection	Cohort 1 2 Experimental Lymphodepleting regimen +Cells+Low dose IL-2 2 fludarabine, cyclophosphamide, Drosophila-peptide pulsed Melanoma-reactive autologous CD8+ PBL, aldesleukin : Fludarabine 25 mg/m2 x 5 days Cyclophosphamide 60 mg/kg IV x2 days, Up to 1x10e10 CTL-05 cells Aldesleukin 125,000 IU/kg/dose as a daily subcutaneous injection	Cohort 2 1 Experimental Lymphodepleting regimen +Cells 3 fludarabine, cyclophosphamide, Drosophila-peptide pulsed Melanoma-reactive autologous CD8+ PBL : Fludarabine 25 mg/m2 x 5 days Cyclophosphamide 60 mg/kg IV x2 days, Up to 1x10e10 CTL-05 cells	Total n=3 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	—	—	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants	—	—	3 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	—	—	0 Participants n=4 Participants
Age, Continuous	53.0 years STANDARD_DEVIATION 7.2 • n=5 Participants	—	—	53.0 years STANDARD_DEVIATION 7.2 • n=4 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	—	—	1 Participants n=4 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	—	—	2 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	—	—	0 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=5 Participants	—	—	3 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	—	—	0 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	—	—	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	—	—	0 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	—	—	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	—	—	0 Participants n=4 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants	—	—	3 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	—	—	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	—	—	0 Participants n=4 Participants
Region of Enrollment United States	3 participants n=5 Participants	—	—	3 participants n=4 Participants

PRIMARY outcome

Timeframe: 7 months

Population: Cohorts 1 and 2 did not enroll participants because the study was terminated due to poor accrual.

Outcome measures

Outcome measures
Measure	Cohort 0 n=3 Participants Drosophila generated CTL + SQ IL-2 1 fludarabine, cyclophosphamide, Drosophila-peptide pulsed Melanoma-reactive autologous CD8+ PBL (CTL-05), aldesleukin : Fludarabine 25 mg/m2 x 5 days Cyclophosphamide 60 mg/kg IV x2 days, Up to 1x10e10 CTL-05 cells Aldesleukin 125,000 IU/kg/dose as a daily subcutaneous injection	Cohort 1 2 Experimental Lymphodepleting regimen +Cells+Low dose IL-2 2 fludarabine, cyclophosphamide, Drosophila-peptide pulsed Melanoma-reactive autologous CD8+ PBL, aldesleukin : Fludarabine 25 mg/m2 x 5 days Cyclophosphamide 60 mg/kg IV x2 days, Up to 1x10e10 CTL-05 cells Aldesleukin 125,000 IU/kg/dose as a daily subcutaneous injection	Cohort 2 1 Experimental Lymphodepleting regimen +Cells 3 fludarabine, cyclophosphamide, Drosophila-peptide pulsed Melanoma-reactive autologous CD8+ PBL : Fludarabine 25 mg/m2 x 5 days Cyclophosphamide 60 mg/kg IV x2 days, Up to 1x10e10 CTL-05 cells
Clinical Response Complete Response	0 Participants	—	—
Clinical Response Partial Response	1 Participants	—	—
Clinical Response Progressive Disease	2 Participants	—	—
Clinical Response Stable Disease	0 Participants	—	—

PRIMARY outcome

Timeframe: 7 months

Population: Cohorts 1 and 2 did not enroll participants because the study was terminated due to poor accrual.

Here is the number of participants with adverse events. For a detailed list of adverse events see the adverse event module.

Outcome measures

Outcome measures
Measure	Cohort 0 n=3 Participants Drosophila generated CTL + SQ IL-2 1 fludarabine, cyclophosphamide, Drosophila-peptide pulsed Melanoma-reactive autologous CD8+ PBL (CTL-05), aldesleukin : Fludarabine 25 mg/m2 x 5 days Cyclophosphamide 60 mg/kg IV x2 days, Up to 1x10e10 CTL-05 cells Aldesleukin 125,000 IU/kg/dose as a daily subcutaneous injection	Cohort 1 2 Experimental Lymphodepleting regimen +Cells+Low dose IL-2 2 fludarabine, cyclophosphamide, Drosophila-peptide pulsed Melanoma-reactive autologous CD8+ PBL, aldesleukin : Fludarabine 25 mg/m2 x 5 days Cyclophosphamide 60 mg/kg IV x2 days, Up to 1x10e10 CTL-05 cells Aldesleukin 125,000 IU/kg/dose as a daily subcutaneous injection	Cohort 2 1 Experimental Lymphodepleting regimen +Cells 3 fludarabine, cyclophosphamide, Drosophila-peptide pulsed Melanoma-reactive autologous CD8+ PBL : Fludarabine 25 mg/m2 x 5 days Cyclophosphamide 60 mg/kg IV x2 days, Up to 1x10e10 CTL-05 cells
Safety of Drosophila Generated PBL Administered in Combination With a Lymphodepleting Preparative Regimen and Supportive Systemic Aldesleukin	3 Participants	—	—

SECONDARY outcome

Timeframe: 7 months

Population: Zero participants were analyzed for this outcome measure. Greater than 10 participants were needed to evaluate this outcome measure. These were not explored in the small number of patients studied.

Low-dose systemic aldesleukin will be evaluated to determine cell activity in metastatic melanoma.

Outcome measures

Outcome data not reported

Adverse Events

Cohort 0

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Cohort 1

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Cohort 2

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Cohort 0 n=3 participants at risk Drosophila generated CTL + SQ IL-2 1 fludarabine, cyclophosphamide, Drosophila-peptide pulsed Melanoma-reactive autologous CD8+ PBL (CTL-05), aldesleukin : Fludarabine 25 mg/m2 x 5 days Cyclophosphamide 60 mg/kg IV x2 days, Up to 1x10e10 CTL-05 cells Aldesleukin 125,000 IU/kg/dose as a daily subcutaneous injection	Cohort 1 2 Experimental Lymphodepleting regimen +Cells+Low dose IL-2 2 fludarabine, cyclophosphamide, Drosophila-peptide pulsed Melanoma-reactive autologous CD8+ PBL, aldesleukin : Fludarabine 25 mg/m2 x 5 days Cyclophosphamide 60 mg/kg IV x2 days, Up to 1x10e10 CTL-05 cells Aldesleukin 125,000 IU/kg/dose as a daily subcutaneous injection	Cohort 2 1 Experimental Lymphodepleting regimen +Cells 3 fludarabine, cyclophosphamide, Drosophila-peptide pulsed Melanoma-reactive autologous CD8+ PBL : Fludarabine 25 mg/m2 x 5 days Cyclophosphamide 60 mg/kg IV x2 days, Up to 1x10e10 CTL-05 cells
Blood and lymphatic system disorders Hemoglobin	33.3% 1/3 • Number of events 13 • 7 months	— 0/0 • 7 months	— 0/0 • 7 months
Blood and lymphatic system disorders Leukocytes (total WBC)	100.0% 3/3 • Number of events 3 • 7 months	— 0/0 • 7 months	— 0/0 • 7 months
Blood and lymphatic system disorders Lymphopenia	100.0% 3/3 • Number of events 3 • 7 months	— 0/0 • 7 months	— 0/0 • 7 months
Blood and lymphatic system disorders Neutrophils/granulocytes (ANC/AGC)	100.0% 3/3 • Number of events 3 • 7 months	— 0/0 • 7 months	— 0/0 • 7 months
Blood and lymphatic system disorders Platelets	66.7% 2/3 • Number of events 2 • 7 months	— 0/0 • 7 months	— 0/0 • 7 months
Skin and subcutaneous tissue disorders Rash/desquamation	33.3% 1/3 • Number of events 1 • 7 months	— 0/0 • 7 months	— 0/0 • 7 months
Infections and infestations Infection (documented clinically or microbiologically)	33.3% 1/3 • Number of events 1 • 7 months	— 0/0 • 7 months	— 0/0 • 7 months
Infections and infestations Infection with unknown ANC <1.0x10e9/L, fever >=3	33.3% 1/3 • Number of events 1 • 7 months	— 0/0 • 7 months	— 0/0 • 7 months
Infections and infestations Febrile neutropenia (fever of unknown origin without clinically or microbiologically documented infe	33.3% 1/3 • Number of events 1 • 7 months	— 0/0 • 7 months	— 0/0 • 7 months
Nervous system disorders Psychosis (hallucinations/delusions)	33.3% 1/3 • Number of events 1 • 7 months	— 0/0 • 7 months	— 0/0 • 7 months

Additional Information

James Yang, M.D.

National Cancer Institute, National Institutes of Health

Phone: 301-496-1574

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place