TriangleNCT02663518 · OUTCOME
Part 4: Number of Participants With Positive Anti-Drug Antibody (ADA) and Neutralizing Antibodies (NAb)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- Part 4: From pre-infusion on day 1 up to end of study treatment (maximum treatment exposure for Part 4 was 667 days)
What was measured
A participant was ADA (or NAb) positive if: (1) baseline titer is missing or negative and participants had \>1 post-treatment positive titer (treatment-induced), or (2) positive titer at baseline and had a \> \[4-fold dilution increase\] in titer from baseline in \> 1 post-treatment sample (treatment-boosted).
Analysis population: Immunogenicity analysis population includes all treated participants with at least one (ADA) Anti-Drug Antibody sample (pre-dose or post-treatment) analyzed. Here, "Number of Participants Analyzed" refers to participants evaluable for this outcome measure.
Groups in this outcome
Part 4: Ontorpacept (PF-07901800/TTI-621) 0.5 mg/kg
Participants with relapsed or refractory CTCL received TTI-621 0.5 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
Part 4: Ontorpacept (PF-07901800/TTI-621) 0.7 mg/kg
Participants with relapsed or refractory CTCL received TTI-621 0.7 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
Part 4: Ontorpacept (PF-07901800/TTI-621) 1.0 mg/kg
Participants with relapsed or refractory CTCL received TTI-621 1.0 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
Part 4: Ontorpacept (PF-07901800/TTI-621) 1.4 mg/kg
Participants with relapsed or refractory CTCL received TTI-621 1.4 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
Part 4: Ontorpacept (PF-07901800/TTI-621) 2.0 mg/kg
Participants with relapsed or refractory CTCL received TTI-621 2.0 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
Part 4: Ontorpacept (PF-07901800/TTI-621) Q2W / 2.0 mg/kg
Participants with relapsed or refractory CTCL received a 2.0 mg/kg TTI-621 infusion once every 2 weeks until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
| Group | Source count |
|---|---|
| Part 4: Ontorpacept (PF-07901800/TTI-621) 0.5 mg/kg | 3 |
| Part 4: Ontorpacept (PF-07901800/TTI-621) 0.7 mg/kg | 3 |
| Part 4: Ontorpacept (PF-07901800/TTI-621) 1.0 mg/kg | 6 |
| Part 4: Ontorpacept (PF-07901800/TTI-621) 1.4 mg/kg | 3 |
| Part 4: Ontorpacept (PF-07901800/TTI-621) 2.0 mg/kg | 11 |
| Part 4: Ontorpacept (PF-07901800/TTI-621) Q2W / 2.0 mg/kg | 4 |
Reported measurements
ADA Positive: Overall Incidence
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 4: Ontorpacept (PF-07901800/TTI-621) 0.5 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 4: Ontorpacept (PF-07901800/TTI-621) 0.7 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 4: Ontorpacept (PF-07901800/TTI-621) 1.0 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 4: Ontorpacept (PF-07901800/TTI-621) 1.4 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 4: Ontorpacept (PF-07901800/TTI-621) 2.0 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 4: Ontorpacept (PF-07901800/TTI-621) Q2W / 2.0 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
NAb Positive: Overall Incidence
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 4: Ontorpacept (PF-07901800/TTI-621) 0.5 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 4: Ontorpacept (PF-07901800/TTI-621) 0.7 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 4: Ontorpacept (PF-07901800/TTI-621) 1.0 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 4: Ontorpacept (PF-07901800/TTI-621) 1.4 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 4: Ontorpacept (PF-07901800/TTI-621) 2.0 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 4: Ontorpacept (PF-07901800/TTI-621) Q2W / 2.0 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- title
- ADA Positive: Overall Incidence
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- title
- NAb Positive: Overall Incidence
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 6
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 11
- group Id
- OG005
- value
- 4
- units
- Participants
- description
- A participant was ADA (or NAb) positive if: (1) baseline titer is missing or negative and participants had \>1 post-treatment positive titer (treatment-induced), or (2) positive titer at baseline and had a \> \[4-fold dilution increase\] in titer from baseline in \> 1 post-treatment sample (treatment-boosted).
- groups
- description
- Participants with relapsed or refractory CTCL received TTI-621 0.5 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
- id
- OG000
- title
- Part 4: Ontorpacept (PF-07901800/TTI-621) 0.5 mg/kg
- description
- Participants with relapsed or refractory CTCL received TTI-621 0.7 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
- id
- OG001
- title
- Part 4: Ontorpacept (PF-07901800/TTI-621) 0.7 mg/kg
- description
- Participants with relapsed or refractory CTCL received TTI-621 1.0 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
- id
- OG002
- title
- Part 4: Ontorpacept (PF-07901800/TTI-621) 1.0 mg/kg
- description
- Participants with relapsed or refractory CTCL received TTI-621 1.4 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
- id
- OG003
- title
- Part 4: Ontorpacept (PF-07901800/TTI-621) 1.4 mg/kg
- description
- Participants with relapsed or refractory CTCL received TTI-621 2.0 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
- id
- OG004
- title
- Part 4: Ontorpacept (PF-07901800/TTI-621) 2.0 mg/kg
- description
- Participants with relapsed or refractory CTCL received a 2.0 mg/kg TTI-621 infusion once every 2 weeks until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
- id
- OG005
- title
- Part 4: Ontorpacept (PF-07901800/TTI-621) Q2W / 2.0 mg/kg
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Immunogenicity analysis population includes all treated participants with at least one (ADA) Anti-Drug Antibody sample (pre-dose or post-treatment) analyzed. Here, "Number of Participants Analyzed" refers to participants evaluable for this outcome measure.
- reporting Status
- POSTED
- time Frame
- Part 4: From pre-infusion on day 1 up to end of study treatment (maximum treatment exposure for Part 4 was 667 days)
- title
- Part 4: Number of Participants With Positive Anti-Drug Antibody (ADA) and Neutralizing Antibodies (NAb)
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice