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NCT03330197 · OUTCOME

Measure Immune Response of Ad-RTS-hIL-12 and Veledimex by a Quantitative Multiplex Immunoassay for Determination of IL-12 and IFNg Levels

A Study of Ad-RTS-hIL-12 + Veledimex in Pediatric Subjects With Brain Tumors Including DIPG · Source last updated 2025-08-12

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
MEAN
Unit
pg/mL
Interval / dispersion
Standard Deviation
Time frame
Day 0, Day 3, Day 7, Day 14, and Day 28

What was measured

Samples for serum cytokine analysis were collected on Days 0, 3, 7, 14, and 28. For the results, participants who had samples analyzed were included in the "number analyzed" counts; however, values that were below the limit of quantitation (BLQ) were excluded from the calculation of mean and standard deviation.

Analysis population: The Biomarker Evaluation Population (BEP) includes all subjects who received Ad-RTS-hIL-12 + at least one dose of their cohort-specific dose of veledimex who have adequate biomarker sample(s) at screening (baseline) and at least one non-missing follow-up biomarker assessment, excluding the disqualified assessments. All biomarker related data presentation will be based on the BEP unless specified otherwise. Note: In Arm 2, only 1 subject met this criteria.

Groups in this outcome

Arm 1 - Closed

Intratumoral Ad-RTS-hIL-12 freehand injection after tumor resection and oral veledimex (activator ligand) in pediatric patients with brain tumors. Ad-RTS-hIL-12: 2.0 x 10\^11 viral particles (vp) per injection, one intratumoral injection of Ad-RTS-hIL-12 Oral Veledimex - Arm 1 (Pediatric Brain Tumor): * Planned: 1 dose level (10mg/day) 15 oral daily doses of veledimex * Actual: All patients received 1 dose level (10 mg/day veledimex)

Arm 2 - Closed

Intratumoral Ad-RTS-hIL-12 stereotactic injection and oral veledimex (activator ligand) in pediatric patients with DIPG. Ad-RTS-hIL-12: 2.0 x 10\^11 viral particles (vp) per injection, one intratumoral injection of Ad-RTS-hIL-12 Oral Veledimex - Arm 2 (DIPG): * Planned:2 dose levels (10mg/day, 20mg/day) * Actual: 1 patient received 5 mg/day veledimex. The other patient did not receive veledimex due to SAE.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Arm 1 - Closed3
Arm 2 - Closed1

Reported measurements

Serum IFN-gamma - Day 0

Analysis denominator · Participants

GroupSource count
Arm 1 - Closed3
Arm 2 - Closed1
Values in pg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Arm 1 - ClosedNANANot reportedNot reportedAll subjects had BLQ values at this time point. BLQ was reported as \<2.4 pg/mL.
Arm 2 - ClosedNANANot reportedNot reportedSubject's result was BLQ at this time point. BLQ was reported as \<2.4 pg/mL.
Serum IFN-gamma - Day 3

Analysis denominator · Participants

GroupSource count
Arm 1 - Closed2
Arm 2 - Closed1
Values in pg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Arm 1 - Closed4.40Not reportedNot reportedNot reported
Arm 2 - Closed11.40Not reportedNot reportedNot reported
Serum IFN-gamma - Day 7

Analysis denominator · Participants

GroupSource count
Arm 1 - Closed3
Arm 2 - Closed1
Values in pg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Arm 1 - Closed6.40Not reportedNot reportedNot reported
Arm 2 - ClosedNANANot reportedNot reportedSubject's result was BLQ at this time point. BLQ was reported as \<2.4 pg/mL.
Serum IFN-gamma - Day 14

Analysis denominator · Participants

GroupSource count
Arm 1 - Closed2
Arm 2 - Closed1
Values in pg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Arm 1 - ClosedNANANot reportedNot reportedTwo subjects had BLQ values at this time point. BLQ was reported as \<2.4 pg/mL.
Arm 2 - ClosedNANANot reportedNot reportedSubject's result was BLQ at this time point. BLQ was reported as \<2.4 pg/mL.
Serum IFN-gamma - Day 28

Analysis denominator · Participants

GroupSource count
Arm 1 - Closed2
Arm 2 - Closed1
Values in pg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Arm 1 - ClosedNANANot reportedNot reportedTwo subjects had BLQ values at this time point. BLQ was reported as \<2.4 pg/mL.
Arm 2 - ClosedNANANot reportedNot reportedSubject's result was BLQ at this time point. BLQ was reported as \<2.4 pg/mL.
Serum IL-12 - Day 0

Analysis denominator · Participants

GroupSource count
Arm 1 - Closed3
Arm 2 - Closed1
Values in pg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Arm 1 - Closed120Not reportedNot reportedNot reported
Arm 2 - ClosedNANANot reportedNot reportedSubject's result was BLQ at this time point. BLQ was reported as \<1.6 pg/mL.
1.6Serum IL-12 - Day 3

Analysis denominator · Participants

GroupSource count
Arm 1 - Closed2
Arm 2 - Closed1
Values in pg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Arm 1 - Closed11.12.1Not reportedNot reportedNot reported
Arm 2 - ClosedNANANot reportedNot reportedSubject's result was BLQ at this time point. BLQ was reported as \<1.6 pg/mL.
Serum IL-12 - Day 7

Analysis denominator · Participants

GroupSource count
Arm 1 - Closed3
Arm 2 - Closed1
Values in pg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Arm 1 - Closed6.64.7Not reportedNot reportedNot reported
Arm 2 - ClosedNANANot reportedNot reportedSubject's result was BLQ at this time point. BLQ was reported as \<1.6 pg/mL.
Serum IL-12 - Day 14

Analysis denominator · Participants

GroupSource count
Arm 1 - Closed2
Arm 2 - Closed1
Values in pg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Arm 1 - ClosedNANANot reportedNot reportedTwo subjects had BLQ values at this time point. BLQ was reported as \<2.4 pg/mL.
Arm 2 - ClosedNANANot reportedNot reportedSubject's result was BLQ at this time point. BLQ was reported as \<1.6 pg/mL.
Serum IL-12 - Day 28

Analysis denominator · Participants

GroupSource count
Arm 1 - Closed2
Arm 2 - Closed1
Values in pg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Arm 1 - Closed1.60Not reportedNot reportedNot reported
Arm 2 - ClosedNANANot reportedNot reportedSubject's result was BLQ at this time point. BLQ was reported as \<1.6 pg/mL.
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        All subjects had BLQ values at this time point. BLQ was reported as \<2.4 pg/mL.
        group Id
        OG000
        spread
        NA
        value
        NA
      2. comment
        Subject's result was BLQ at this time point. BLQ was reported as \<2.4 pg/mL.
        group Id
        OG001
        spread
        NA
        value
        NA
    denoms
    1. counts
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        1
      units
      Participants
    title
    Serum IFN-gamma - Day 0
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        0
        value
        4.4
      2. group Id
        OG001
        spread
        0
        value
        11.4
    denoms
    1. counts
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        1
      units
      Participants
    title
    Serum IFN-gamma - Day 3
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        0
        value
        6.4
      2. comment
        Subject's result was BLQ at this time point. BLQ was reported as \<2.4 pg/mL.
        group Id
        OG001
        spread
        NA
        value
        NA
    denoms
    1. counts
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        1
      units
      Participants
    title
    Serum IFN-gamma - Day 7
  4. categories
    1. measurements
      1. comment
        Two subjects had BLQ values at this time point. BLQ was reported as \<2.4 pg/mL.
        group Id
        OG000
        spread
        NA
        value
        NA
      2. comment
        Subject's result was BLQ at this time point. BLQ was reported as \<2.4 pg/mL.
        group Id
        OG001
        spread
        NA
        value
        NA
    denoms
    1. counts
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        1
      units
      Participants
    title
    Serum IFN-gamma - Day 14
  5. categories
    1. measurements
      1. comment
        Two subjects had BLQ values at this time point. BLQ was reported as \<2.4 pg/mL.
        group Id
        OG000
        spread
        NA
        value
        NA
      2. comment
        Subject's result was BLQ at this time point. BLQ was reported as \<2.4 pg/mL.
        group Id
        OG001
        spread
        NA
        value
        NA
    denoms
    1. counts
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        1
      units
      Participants
    title
    Serum IFN-gamma - Day 28
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        0
        value
        12
      2. comment
        Subject's result was BLQ at this time point. BLQ was reported as \<1.6 pg/mL.
        group Id
        OG001
        spread
        NA
        value
        NA
    denoms
    1. counts
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        1
      units
      Participants
    title
    Serum IL-12 - Day 0
  7. categories
    1. measurements
      1. group Id
        OG000
        spread
        2.1
        value
        11.1
      2. comment
        Subject's result was BLQ at this time point. BLQ was reported as \<1.6 pg/mL.
        group Id
        OG001
        spread
        NA
        value
        NA
    denoms
    1. counts
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        1
      units
      Participants
    title
    1.6Serum IL-12 - Day 3
  8. categories
    1. measurements
      1. group Id
        OG000
        spread
        4.7
        value
        6.6
      2. comment
        Subject's result was BLQ at this time point. BLQ was reported as \<1.6 pg/mL.
        group Id
        OG001
        spread
        NA
        value
        NA
    denoms
    1. counts
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        1
      units
      Participants
    title
    Serum IL-12 - Day 7
  9. categories
    1. measurements
      1. comment
        Two subjects had BLQ values at this time point. BLQ was reported as \<2.4 pg/mL.
        group Id
        OG000
        spread
        NA
        value
        NA
      2. comment
        Subject's result was BLQ at this time point. BLQ was reported as \<1.6 pg/mL.
        group Id
        OG001
        spread
        NA
        value
        NA
    denoms
    1. counts
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        1
      units
      Participants
    title
    Serum IL-12 - Day 14
  10. categories
    1. measurements
      1. group Id
        OG000
        spread
        0
        value
        1.6
      2. comment
        Subject's result was BLQ at this time point. BLQ was reported as \<1.6 pg/mL.
        group Id
        OG001
        spread
        NA
        value
        NA
    denoms
    1. counts
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        1
      units
      Participants
    title
    Serum IL-12 - Day 28
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    2. group Id
      OG001
      value
      1
    units
    Participants
description
Samples for serum cytokine analysis were collected on Days 0, 3, 7, 14, and 28. For the results, participants who had samples analyzed were included in the "number analyzed" counts; however, values that were below the limit of quantitation (BLQ) were excluded from the calculation of mean and standard deviation.
dispersion Type
Standard Deviation
groups
  1. description
    Intratumoral Ad-RTS-hIL-12 freehand injection after tumor resection and oral veledimex (activator ligand) in pediatric patients with brain tumors. Ad-RTS-hIL-12: 2.0 x 10\^11 viral particles (vp) per injection, one intratumoral injection of Ad-RTS-hIL-12 Oral Veledimex - Arm 1 (Pediatric Brain Tumor): * Planned: 1 dose level (10mg/day) 15 oral daily doses of veledimex * Actual: All patients received 1 dose level (10 mg/day veledimex)
    id
    OG000
    title
    Arm 1 - Closed
  2. description
    Intratumoral Ad-RTS-hIL-12 stereotactic injection and oral veledimex (activator ligand) in pediatric patients with DIPG. Ad-RTS-hIL-12: 2.0 x 10\^11 viral particles (vp) per injection, one intratumoral injection of Ad-RTS-hIL-12 Oral Veledimex - Arm 2 (DIPG): * Planned:2 dose levels (10mg/day, 20mg/day) * Actual: 1 patient received 5 mg/day veledimex. The other patient did not receive veledimex due to SAE.
    id
    OG001
    title
    Arm 2 - Closed
param Type
MEAN
population Description
The Biomarker Evaluation Population (BEP) includes all subjects who received Ad-RTS-hIL-12 + at least one dose of their cohort-specific dose of veledimex who have adequate biomarker sample(s) at screening (baseline) and at least one non-missing follow-up biomarker assessment, excluding the disqualified assessments. All biomarker related data presentation will be based on the BEP unless specified otherwise. Note: In Arm 2, only 1 subject met this criteria.
reporting Status
POSTED
time Frame
Day 0, Day 3, Day 7, Day 14, and Day 28
title
Measure Immune Response of Ad-RTS-hIL-12 and Veledimex by a Quantitative Multiplex Immunoassay for Determination of IL-12 and IFNg Levels
type
SECONDARY
unit Of Measure
pg/mL

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Preserved source evidence · Not medical advice