Trial Outcomes & Findings for Autologous CD4 T-Cells in HIV (C34-CXCR4) (NCT NCT03020524)
NCT ID: NCT03020524
Last Updated: 2022-11-15
Results Overview
assessed by DAIDS AE grading table v2.0 November 2014
Recruitment status
COMPLETED
Study phase
EARLY_PHASE1
Target enrollment
9 participants
Primary outcome timeframe
one year
Results posted on
2022-11-15
Participant Flow
Participant milestones
| Measure |
Dose Level 1
Autologous CD4 T-Cells0.8-1x10\^9 transduced CD4+T-cells administered IV as a single dose
|
Dose Level 2
Autologous CD4 T-Cells 2.4-3x10\^9 transduced CD4+ T-cells administered IV as a single dose
|
Dose Level 3
Autologous CD4 T-Cells 0.8-1x10\^10 transduced CD4+ T-cells administered IV as a single dose
|
|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
3
|
|
Overall Study
COMPLETED
|
3
|
3
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Autologous CD4 T-Cells in HIV (C34-CXCR4)
Baseline characteristics by cohort
| Measure |
Dose Level 1
n=3 Participants
Autologous CD4 T-Cells0.8-1x10\^9 transduced CD4+T-cells administered IV as a single dose
|
Dose Level 2
n=3 Participants
Autologous CD4 T-Cells 2.4-3x10\^9 transduced CD4+ T-cells administered IV as a single dose
|
Dose Level 3
n=3 Participants
Autologous CD4 T-Cells 0.8-1x10\^10 transduced CD4+ T-cells administered IV as a single dose
|
Total
n=9 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
38.0 years
STANDARD_DEVIATION 8.9 • n=113 Participants
|
40.7 years
STANDARD_DEVIATION 5.5 • n=163 Participants
|
33.3 years
STANDARD_DEVIATION 10.2 • n=160 Participants
|
37.3 years
STANDARD_DEVIATION 8.0 • n=483 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=113 Participants
|
0 Participants
n=163 Participants
|
0 Participants
n=160 Participants
|
1 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=113 Participants
|
3 Participants
n=163 Participants
|
3 Participants
n=160 Participants
|
8 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=113 Participants
|
1 Participants
n=163 Participants
|
1 Participants
n=160 Participants
|
3 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=113 Participants
|
2 Participants
n=163 Participants
|
2 Participants
n=160 Participants
|
6 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=113 Participants
|
0 Participants
n=163 Participants
|
0 Participants
n=160 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=113 Participants
|
0 Participants
n=163 Participants
|
0 Participants
n=160 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=113 Participants
|
0 Participants
n=163 Participants
|
0 Participants
n=160 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=113 Participants
|
0 Participants
n=163 Participants
|
0 Participants
n=160 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=113 Participants
|
1 Participants
n=163 Participants
|
2 Participants
n=160 Participants
|
5 Participants
n=483 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=113 Participants
|
2 Participants
n=163 Participants
|
1 Participants
n=160 Participants
|
4 Participants
n=483 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=113 Participants
|
0 Participants
n=163 Participants
|
0 Participants
n=160 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=113 Participants
|
0 Participants
n=163 Participants
|
0 Participants
n=160 Participants
|
0 Participants
n=483 Participants
|
|
Region of Enrollment
United States
|
3 Participants
n=113 Participants
|
3 Participants
n=163 Participants
|
3 Participants
n=160 Participants
|
9 Participants
n=483 Participants
|
PRIMARY outcome
Timeframe: one yearassessed by DAIDS AE grading table v2.0 November 2014
Outcome measures
| Measure |
Dose Level 1
n=3 Participants
Autologous CD4 T-Cells0.8-1x10\^9 transduced CD4+T-cells administered IV as a single dose
|
Dose Level 2
n=3 Participants
Autologous CD4 T-Cells 2.4-3x10\^9 transduced CD4+ T-cells administered IV as a single dose
|
Dose Level 3
n=3 Participants
Autologous CD4 T-Cells 0.8-1x10\^10 transduced CD4+ T-cells administered IV as a single dose
|
|---|---|---|---|
|
The Number of Subjects With Treatment Related Adverse Events
|
2 Participants
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 2 weeks post infusion, prior to ARV reinitiation, weeks 12, 16 and 20Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, week 2 post infusion, prior to ARV initiation, weeks 12, 16 20Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: week 2 post infusion, prior to ARV initiation, week 12, 16, 20Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: baseline through 1 yearOutcome measures
Outcome data not reported
Adverse Events
Dose Level 1
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Dose Level 2
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Dose Level 3
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Dose Level 1
n=3 participants at risk
Autologous CD4 T-Cells0.8-1x10\^9 transduced CD4+T-cells administered IV as a single dose
|
Dose Level 2
n=3 participants at risk
Autologous CD4 T-Cells 2.4-3x10\^9 transduced CD4+ T-cells administered IV as a single dose
|
Dose Level 3
n=3 participants at risk
Autologous CD4 T-Cells 0.8-1x10\^10 transduced CD4+ T-cells administered IV as a single dose
|
|---|---|---|---|
|
Blood and lymphatic system disorders
lymphadenopathy
|
0.00%
0/3 • One year - Adverse events were collected from the time of informed consent to the completion of the scheduled study visits following the administration of study treatment.
|
33.3%
1/3 • One year - Adverse events were collected from the time of informed consent to the completion of the scheduled study visits following the administration of study treatment.
|
0.00%
0/3 • One year - Adverse events were collected from the time of informed consent to the completion of the scheduled study visits following the administration of study treatment.
|
|
Gastrointestinal disorders
anal fissure
|
0.00%
0/3 • One year - Adverse events were collected from the time of informed consent to the completion of the scheduled study visits following the administration of study treatment.
|
0.00%
0/3 • One year - Adverse events were collected from the time of informed consent to the completion of the scheduled study visits following the administration of study treatment.
|
33.3%
1/3 • One year - Adverse events were collected from the time of informed consent to the completion of the scheduled study visits following the administration of study treatment.
|
|
Gastrointestinal disorders
diarrhea
|
0.00%
0/3 • One year - Adverse events were collected from the time of informed consent to the completion of the scheduled study visits following the administration of study treatment.
|
33.3%
1/3 • One year - Adverse events were collected from the time of informed consent to the completion of the scheduled study visits following the administration of study treatment.
|
0.00%
0/3 • One year - Adverse events were collected from the time of informed consent to the completion of the scheduled study visits following the administration of study treatment.
|
|
Gastrointestinal disorders
nausea
|
0.00%
0/3 • One year - Adverse events were collected from the time of informed consent to the completion of the scheduled study visits following the administration of study treatment.
|
33.3%
1/3 • One year - Adverse events were collected from the time of informed consent to the completion of the scheduled study visits following the administration of study treatment.
|
66.7%
2/3 • One year - Adverse events were collected from the time of informed consent to the completion of the scheduled study visits following the administration of study treatment.
|
|
Gastrointestinal disorders
rectal pain
|
0.00%
0/3 • One year - Adverse events were collected from the time of informed consent to the completion of the scheduled study visits following the administration of study treatment.
|
33.3%
1/3 • One year - Adverse events were collected from the time of informed consent to the completion of the scheduled study visits following the administration of study treatment.
|
0.00%
0/3 • One year - Adverse events were collected from the time of informed consent to the completion of the scheduled study visits following the administration of study treatment.
|
|
Gastrointestinal disorders
vomiting
|
0.00%
0/3 • One year - Adverse events were collected from the time of informed consent to the completion of the scheduled study visits following the administration of study treatment.
|
0.00%
0/3 • One year - Adverse events were collected from the time of informed consent to the completion of the scheduled study visits following the administration of study treatment.
|
33.3%
1/3 • One year - Adverse events were collected from the time of informed consent to the completion of the scheduled study visits following the administration of study treatment.
|
|
General disorders
chills
|
0.00%
0/3 • One year - Adverse events were collected from the time of informed consent to the completion of the scheduled study visits following the administration of study treatment.
|
33.3%
1/3 • One year - Adverse events were collected from the time of informed consent to the completion of the scheduled study visits following the administration of study treatment.
|
33.3%
1/3 • One year - Adverse events were collected from the time of informed consent to the completion of the scheduled study visits following the administration of study treatment.
|
|
General disorders
edema limbs
|
33.3%
1/3 • One year - Adverse events were collected from the time of informed consent to the completion of the scheduled study visits following the administration of study treatment.
|
0.00%
0/3 • One year - Adverse events were collected from the time of informed consent to the completion of the scheduled study visits following the administration of study treatment.
|
0.00%
0/3 • One year - Adverse events were collected from the time of informed consent to the completion of the scheduled study visits following the administration of study treatment.
|
|
General disorders
fatigue
|
66.7%
2/3 • One year - Adverse events were collected from the time of informed consent to the completion of the scheduled study visits following the administration of study treatment.
|
66.7%
2/3 • One year - Adverse events were collected from the time of informed consent to the completion of the scheduled study visits following the administration of study treatment.
|
0.00%
0/3 • One year - Adverse events were collected from the time of informed consent to the completion of the scheduled study visits following the administration of study treatment.
|
|
General disorders
pain
|
0.00%
0/3 • One year - Adverse events were collected from the time of informed consent to the completion of the scheduled study visits following the administration of study treatment.
|
33.3%
1/3 • One year - Adverse events were collected from the time of informed consent to the completion of the scheduled study visits following the administration of study treatment.
|
0.00%
0/3 • One year - Adverse events were collected from the time of informed consent to the completion of the scheduled study visits following the administration of study treatment.
|
|
General disorders
vaccination site lymphadenopathy
|
0.00%
0/3 • One year - Adverse events were collected from the time of informed consent to the completion of the scheduled study visits following the administration of study treatment.
|
33.3%
1/3 • One year - Adverse events were collected from the time of informed consent to the completion of the scheduled study visits following the administration of study treatment.
|
100.0%
3/3 • One year - Adverse events were collected from the time of informed consent to the completion of the scheduled study visits following the administration of study treatment.
|
|
Infections and infestations
abscess
|
0.00%
0/3 • One year - Adverse events were collected from the time of informed consent to the completion of the scheduled study visits following the administration of study treatment.
|
33.3%
1/3 • One year - Adverse events were collected from the time of informed consent to the completion of the scheduled study visits following the administration of study treatment.
|
0.00%
0/3 • One year - Adverse events were collected from the time of informed consent to the completion of the scheduled study visits following the administration of study treatment.
|
|
Infections and infestations
bronchial infection
|
0.00%
0/3 • One year - Adverse events were collected from the time of informed consent to the completion of the scheduled study visits following the administration of study treatment.
|
33.3%
1/3 • One year - Adverse events were collected from the time of informed consent to the completion of the scheduled study visits following the administration of study treatment.
|
0.00%
0/3 • One year - Adverse events were collected from the time of informed consent to the completion of the scheduled study visits following the administration of study treatment.
|
|
Infections and infestations
gum infection
|
33.3%
1/3 • One year - Adverse events were collected from the time of informed consent to the completion of the scheduled study visits following the administration of study treatment.
|
0.00%
0/3 • One year - Adverse events were collected from the time of informed consent to the completion of the scheduled study visits following the administration of study treatment.
|
0.00%
0/3 • One year - Adverse events were collected from the time of informed consent to the completion of the scheduled study visits following the administration of study treatment.
|
|
Infections and infestations
lymph gland infection
|
33.3%
1/3 • One year - Adverse events were collected from the time of informed consent to the completion of the scheduled study visits following the administration of study treatment.
|
0.00%
0/3 • One year - Adverse events were collected from the time of informed consent to the completion of the scheduled study visits following the administration of study treatment.
|
0.00%
0/3 • One year - Adverse events were collected from the time of informed consent to the completion of the scheduled study visits following the administration of study treatment.
|
|
Infections and infestations
penile infection
|
33.3%
1/3 • One year - Adverse events were collected from the time of informed consent to the completion of the scheduled study visits following the administration of study treatment.
|
33.3%
1/3 • One year - Adverse events were collected from the time of informed consent to the completion of the scheduled study visits following the administration of study treatment.
|
0.00%
0/3 • One year - Adverse events were collected from the time of informed consent to the completion of the scheduled study visits following the administration of study treatment.
|
|
Infections and infestations
pyuria
|
0.00%
0/3 • One year - Adverse events were collected from the time of informed consent to the completion of the scheduled study visits following the administration of study treatment.
|
33.3%
1/3 • One year - Adverse events were collected from the time of informed consent to the completion of the scheduled study visits following the administration of study treatment.
|
0.00%
0/3 • One year - Adverse events were collected from the time of informed consent to the completion of the scheduled study visits following the administration of study treatment.
|
|
Musculoskeletal and connective tissue disorders
back pain
|
33.3%
1/3 • One year - Adverse events were collected from the time of informed consent to the completion of the scheduled study visits following the administration of study treatment.
|
0.00%
0/3 • One year - Adverse events were collected from the time of informed consent to the completion of the scheduled study visits following the administration of study treatment.
|
0.00%
0/3 • One year - Adverse events were collected from the time of informed consent to the completion of the scheduled study visits following the administration of study treatment.
|
|
Musculoskeletal and connective tissue disorders
myalgia
|
33.3%
1/3 • One year - Adverse events were collected from the time of informed consent to the completion of the scheduled study visits following the administration of study treatment.
|
66.7%
2/3 • One year - Adverse events were collected from the time of informed consent to the completion of the scheduled study visits following the administration of study treatment.
|
0.00%
0/3 • One year - Adverse events were collected from the time of informed consent to the completion of the scheduled study visits following the administration of study treatment.
|
|
Musculoskeletal and connective tissue disorders
pain in extremity
|
0.00%
0/3 • One year - Adverse events were collected from the time of informed consent to the completion of the scheduled study visits following the administration of study treatment.
|
33.3%
1/3 • One year - Adverse events were collected from the time of informed consent to the completion of the scheduled study visits following the administration of study treatment.
|
0.00%
0/3 • One year - Adverse events were collected from the time of informed consent to the completion of the scheduled study visits following the administration of study treatment.
|
|
Nervous system disorders
dizziness
|
0.00%
0/3 • One year - Adverse events were collected from the time of informed consent to the completion of the scheduled study visits following the administration of study treatment.
|
33.3%
1/3 • One year - Adverse events were collected from the time of informed consent to the completion of the scheduled study visits following the administration of study treatment.
|
0.00%
0/3 • One year - Adverse events were collected from the time of informed consent to the completion of the scheduled study visits following the administration of study treatment.
|
|
Nervous system disorders
headache
|
33.3%
1/3 • One year - Adverse events were collected from the time of informed consent to the completion of the scheduled study visits following the administration of study treatment.
|
0.00%
0/3 • One year - Adverse events were collected from the time of informed consent to the completion of the scheduled study visits following the administration of study treatment.
|
0.00%
0/3 • One year - Adverse events were collected from the time of informed consent to the completion of the scheduled study visits following the administration of study treatment.
|
|
Nervous system disorders
paresthesia
|
0.00%
0/3 • One year - Adverse events were collected from the time of informed consent to the completion of the scheduled study visits following the administration of study treatment.
|
0.00%
0/3 • One year - Adverse events were collected from the time of informed consent to the completion of the scheduled study visits following the administration of study treatment.
|
33.3%
1/3 • One year - Adverse events were collected from the time of informed consent to the completion of the scheduled study visits following the administration of study treatment.
|
|
Nervous system disorders
strange smell sensation
|
66.7%
2/3 • One year - Adverse events were collected from the time of informed consent to the completion of the scheduled study visits following the administration of study treatment.
|
33.3%
1/3 • One year - Adverse events were collected from the time of informed consent to the completion of the scheduled study visits following the administration of study treatment.
|
0.00%
0/3 • One year - Adverse events were collected from the time of informed consent to the completion of the scheduled study visits following the administration of study treatment.
|
|
Renal and urinary disorders
dysuria
|
0.00%
0/3 • One year - Adverse events were collected from the time of informed consent to the completion of the scheduled study visits following the administration of study treatment.
|
0.00%
0/3 • One year - Adverse events were collected from the time of informed consent to the completion of the scheduled study visits following the administration of study treatment.
|
33.3%
1/3 • One year - Adverse events were collected from the time of informed consent to the completion of the scheduled study visits following the administration of study treatment.
|
|
Reproductive system and breast disorders
testicular mass
|
0.00%
0/3 • One year - Adverse events were collected from the time of informed consent to the completion of the scheduled study visits following the administration of study treatment.
|
33.3%
1/3 • One year - Adverse events were collected from the time of informed consent to the completion of the scheduled study visits following the administration of study treatment.
|
0.00%
0/3 • One year - Adverse events were collected from the time of informed consent to the completion of the scheduled study visits following the administration of study treatment.
|
|
Reproductive system and breast disorders
vaginal discharge
|
33.3%
1/3 • One year - Adverse events were collected from the time of informed consent to the completion of the scheduled study visits following the administration of study treatment.
|
0.00%
0/3 • One year - Adverse events were collected from the time of informed consent to the completion of the scheduled study visits following the administration of study treatment.
|
0.00%
0/3 • One year - Adverse events were collected from the time of informed consent to the completion of the scheduled study visits following the administration of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
chest congestion
|
33.3%
1/3 • One year - Adverse events were collected from the time of informed consent to the completion of the scheduled study visits following the administration of study treatment.
|
0.00%
0/3 • One year - Adverse events were collected from the time of informed consent to the completion of the scheduled study visits following the administration of study treatment.
|
0.00%
0/3 • One year - Adverse events were collected from the time of informed consent to the completion of the scheduled study visits following the administration of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
cough
|
66.7%
2/3 • One year - Adverse events were collected from the time of informed consent to the completion of the scheduled study visits following the administration of study treatment.
|
0.00%
0/3 • One year - Adverse events were collected from the time of informed consent to the completion of the scheduled study visits following the administration of study treatment.
|
0.00%
0/3 • One year - Adverse events were collected from the time of informed consent to the completion of the scheduled study visits following the administration of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
sneezing
|
0.00%
0/3 • One year - Adverse events were collected from the time of informed consent to the completion of the scheduled study visits following the administration of study treatment.
|
33.3%
1/3 • One year - Adverse events were collected from the time of informed consent to the completion of the scheduled study visits following the administration of study treatment.
|
0.00%
0/3 • One year - Adverse events were collected from the time of informed consent to the completion of the scheduled study visits following the administration of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
sore throat
|
0.00%
0/3 • One year - Adverse events were collected from the time of informed consent to the completion of the scheduled study visits following the administration of study treatment.
|
33.3%
1/3 • One year - Adverse events were collected from the time of informed consent to the completion of the scheduled study visits following the administration of study treatment.
|
33.3%
1/3 • One year - Adverse events were collected from the time of informed consent to the completion of the scheduled study visits following the administration of study treatment.
|
|
Skin and subcutaneous tissue disorders
body odor
|
0.00%
0/3 • One year - Adverse events were collected from the time of informed consent to the completion of the scheduled study visits following the administration of study treatment.
|
0.00%
0/3 • One year - Adverse events were collected from the time of informed consent to the completion of the scheduled study visits following the administration of study treatment.
|
66.7%
2/3 • One year - Adverse events were collected from the time of informed consent to the completion of the scheduled study visits following the administration of study treatment.
|
|
Skin and subcutaneous tissue disorders
night sweats
|
0.00%
0/3 • One year - Adverse events were collected from the time of informed consent to the completion of the scheduled study visits following the administration of study treatment.
|
0.00%
0/3 • One year - Adverse events were collected from the time of informed consent to the completion of the scheduled study visits following the administration of study treatment.
|
33.3%
1/3 • One year - Adverse events were collected from the time of informed consent to the completion of the scheduled study visits following the administration of study treatment.
|
|
Skin and subcutaneous tissue disorders
skin mass
|
0.00%
0/3 • One year - Adverse events were collected from the time of informed consent to the completion of the scheduled study visits following the administration of study treatment.
|
0.00%
0/3 • One year - Adverse events were collected from the time of informed consent to the completion of the scheduled study visits following the administration of study treatment.
|
33.3%
1/3 • One year - Adverse events were collected from the time of informed consent to the completion of the scheduled study visits following the administration of study treatment.
|
|
Skin and subcutaneous tissue disorders
skin rash
|
0.00%
0/3 • One year - Adverse events were collected from the time of informed consent to the completion of the scheduled study visits following the administration of study treatment.
|
33.3%
1/3 • One year - Adverse events were collected from the time of informed consent to the completion of the scheduled study visits following the administration of study treatment.
|
0.00%
0/3 • One year - Adverse events were collected from the time of informed consent to the completion of the scheduled study visits following the administration of study treatment.
|
|
Surgical and medical procedures
tooth extraction
|
33.3%
1/3 • One year - Adverse events were collected from the time of informed consent to the completion of the scheduled study visits following the administration of study treatment.
|
0.00%
0/3 • One year - Adverse events were collected from the time of informed consent to the completion of the scheduled study visits following the administration of study treatment.
|
0.00%
0/3 • One year - Adverse events were collected from the time of informed consent to the completion of the scheduled study visits following the administration of study treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place