Skip to content
Triangle logo TriangleGet started
← Full study record

NCT03958656 · OUTCOME

Number of Participants That Had Any Grade ≤2, and 3, 4 and 5 Adverse Events Following Administration of T Cells Expressing Anti- Signaling Lymphocytic Activation Molecule F7 (SLAMF7) Chimeric Antigen Receptor (CAR)

T-cells Expressing an Anti-SLAMF7 CAR for Treating Multiple Myeloma · Source last updated 2021-09-09

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
Date treatment consent signed to date off study, approximately 3 months and 27 days for Level 1, 3 months and 18 days for Level 2, 5 months and 23 days for Level 3, and 1 month and 29 days for Level 4.

What was measured

Adverse Events were assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). Grade1 is mild, Grade 2 is moderate, Grade 3 is severe, Grade 4 is life-threatening or disabling, and Grade 5 is fatal.

Analysis population: 3/13 participants enrolled on Level 2 (n=1) and Level 3 (n=2) were not treated,

Groups in this outcome

LEVEL 1 - 0.66x10^6 Per Kilogram (kg)

0.66x10\^6 Anti-Signaling lymphocytic activation molecule F7 (SLAMF7) - Chimeric antigen receptor (CAR) + T cells per kg of recipient bodyweight

LEVEL 2 - 2.0x10^6 Per kg

2.0x10\^6 Anti-Signaling lymphocytic activation molecule F7 (SLAMF7) - Chimeric antigen receptor (CAR) + T cells per kg of recipient bodyweight

LEVEL 3 - 6.0x10^6 Per kg

6.0x10\^6 Anti-Signaling lymphocytic activation molecule F7 (SLAMF7) - Chimeric antigen receptor (CAR) + T cells per kg of recipient bodyweight

LEVEL 4 - 12.0x10^6 Per kg

12.0x10\^6 Chimeric antigen receptor (CAR) + T cells per kg of recipient bodyweight

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

Analysis denominator · Participants

GroupSource count
LEVEL 1 - 0.66x10^6 Per Kilogram (kg)3
LEVEL 2 - 2.0x10^6 Per kg3
LEVEL 3 - 6.0x10^6 Per kg3
LEVEL 4 - 12.0x10^6 Per kg1

Reported measurements

< Grade 2
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
LEVEL 1 - 0.66x10^6 Per Kilogram (kg)0Not reportedNot reportedNot reportedNot reported
LEVEL 2 - 2.0x10^6 Per kg0Not reportedNot reportedNot reportedNot reported
LEVEL 3 - 6.0x10^6 Per kg1Not reportedNot reportedNot reportedNot reported
LEVEL 4 - 12.0x10^6 Per kg0Not reportedNot reportedNot reportedNot reported
Grade 2
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
LEVEL 1 - 0.66x10^6 Per Kilogram (kg)3Not reportedNot reportedNot reportedNot reported
LEVEL 2 - 2.0x10^6 Per kg3Not reportedNot reportedNot reportedNot reported
LEVEL 3 - 6.0x10^6 Per kg3Not reportedNot reportedNot reportedNot reported
LEVEL 4 - 12.0x10^6 Per kg1Not reportedNot reportedNot reportedNot reported
Grade 3
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
LEVEL 1 - 0.66x10^6 Per Kilogram (kg)3Not reportedNot reportedNot reportedNot reported
LEVEL 2 - 2.0x10^6 Per kg3Not reportedNot reportedNot reportedNot reported
LEVEL 3 - 6.0x10^6 Per kg3Not reportedNot reportedNot reportedNot reported
LEVEL 4 - 12.0x10^6 Per kg1Not reportedNot reportedNot reportedNot reported
Grade 4
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
LEVEL 1 - 0.66x10^6 Per Kilogram (kg)3Not reportedNot reportedNot reportedNot reported
LEVEL 2 - 2.0x10^6 Per kg3Not reportedNot reportedNot reportedNot reported
LEVEL 3 - 6.0x10^6 Per kg3Not reportedNot reportedNot reportedNot reported
LEVEL 4 - 12.0x10^6 Per kg1Not reportedNot reportedNot reportedNot reported
Grade 5
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
LEVEL 1 - 0.66x10^6 Per Kilogram (kg)0Not reportedNot reportedNot reportedNot reported
LEVEL 2 - 2.0x10^6 Per kg0Not reportedNot reportedNot reportedNot reported
LEVEL 3 - 6.0x10^6 Per kg0Not reportedNot reportedNot reportedNot reported
LEVEL 4 - 12.0x10^6 Per kg0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        1
      4. group Id
        OG003
        value
        0
    title
    < Grade 2
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        3
      3. group Id
        OG002
        value
        3
      4. group Id
        OG003
        value
        1
    title
    Grade 2
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        3
      3. group Id
        OG002
        value
        3
      4. group Id
        OG003
        value
        1
    title
    Grade 3
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        3
      3. group Id
        OG002
        value
        3
      4. group Id
        OG003
        value
        1
    title
    Grade 4
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
    title
    Grade 5
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    2. group Id
      OG001
      value
      3
    3. group Id
      OG002
      value
      3
    4. group Id
      OG003
      value
      1
    units
    Participants
description
Adverse Events were assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). Grade1 is mild, Grade 2 is moderate, Grade 3 is severe, Grade 4 is life-threatening or disabling, and Grade 5 is fatal.
groups
  1. description
    0.66x10\^6 Anti-Signaling lymphocytic activation molecule F7 (SLAMF7) - Chimeric antigen receptor (CAR) + T cells per kg of recipient bodyweight
    id
    OG000
    title
    LEVEL 1 - 0.66x10^6 Per Kilogram (kg)
  2. description
    2.0x10\^6 Anti-Signaling lymphocytic activation molecule F7 (SLAMF7) - Chimeric antigen receptor (CAR) + T cells per kg of recipient bodyweight
    id
    OG001
    title
    LEVEL 2 - 2.0x10^6 Per kg
  3. description
    6.0x10\^6 Anti-Signaling lymphocytic activation molecule F7 (SLAMF7) - Chimeric antigen receptor (CAR) + T cells per kg of recipient bodyweight
    id
    OG002
    title
    LEVEL 3 - 6.0x10^6 Per kg
  4. description
    12.0x10\^6 Chimeric antigen receptor (CAR) + T cells per kg of recipient bodyweight
    id
    OG003
    title
    LEVEL 4 - 12.0x10^6 Per kg
param Type
COUNT_OF_PARTICIPANTS
population Description
3/13 participants enrolled on Level 2 (n=1) and Level 3 (n=2) were not treated,
reporting Status
POSTED
time Frame
Date treatment consent signed to date off study, approximately 3 months and 27 days for Level 1, 3 months and 18 days for Level 2, 5 months and 23 days for Level 3, and 1 month and 29 days for Level 4.
title
Number of Participants That Had Any Grade ≤2, and 3, 4 and 5 Adverse Events Following Administration of T Cells Expressing Anti- Signaling Lymphocytic Activation Molecule F7 (SLAMF7) Chimeric Antigen Receptor (CAR)
type
PRIMARY
unit Of Measure
Participants

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice