Skip to content
Triangle logo TriangleGet started
← Full study record

NCT03288493 · OUTCOME

Phase 1: Maximum Tolerated Dose of P-BCMA-101

P-BCMA-101 Tscm CAR-T Cells in the Treatment of Patients With Multiple Myeloma (MM) · Source last updated 2024-03-28

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
Baseline through Day 28

What was measured

Rate of dose limiting toxicities (DLT)

Groups in this outcome

Phase 1: P-BCMA-101 CAR-T Cells

Single administration dose cohorts, given in a single intravenous infusion of CAR-T cells. Rimiducid may be administered as indicated.

Phase 1 P-BCMA-101 CAR-T Cells (Cohort A)

Single dose given across two intravenous infusions of CAR-T cells. Rimiducid may be administered as indicated.

Phase 1 P-BCMA-101 CAR-T Cells (Cohort B)

Single dose given across three intravenous infusions of CAR-T cells. Rimiducid may be administered as indicated.

Phase 1 P-BCMA-101 CAR-T Cells With Comb.Therapy (Cohort R)

Single intravenous infusion of CAR-T cells, with combination therapy, beginning one week before CAR-T infusion. Rimiducid may be administered as indicated.

Phase 1 P-BCMA-101 CAR-T Cells With Comb.Therapy (Cohort RP)

Single intravenous infusion of CAR-T cells, with combination therapy, beginning one week before apheresis. Rimiducid may be administered as indicated.

Phase 1 P-BCMA-101 CAR-T Cells With Comb.Therapy (Cohort RIT)

Single intravenous infusion of CAR-T cells, with combination therapy, beginning one week before CAR-T infusion. Rimiducid may be administered as indicated.

Phase 2: P-BCMA-101 CAR-T Cells

CAR-T cells administered via intravenous infusion as a total dose

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

Analysis denominator · Participants

GroupSource count
Phase 1: P-BCMA-101 CAR-T Cells69
Phase 1 P-BCMA-101 CAR-T Cells (Cohort A)3
Phase 1 P-BCMA-101 CAR-T Cells (Cohort B)1
Phase 1 P-BCMA-101 CAR-T Cells With Comb.Therapy (Cohort R)8
Phase 1 P-BCMA-101 CAR-T Cells With Comb.Therapy (Cohort RP)5
Phase 1 P-BCMA-101 CAR-T Cells With Comb.Therapy (Cohort RIT)16
Phase 2: P-BCMA-101 CAR-T Cells3

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 1: P-BCMA-101 CAR-T Cells0Not reportedNot reportedNot reportedNot reported
Phase 1 P-BCMA-101 CAR-T Cells (Cohort A)0Not reportedNot reportedNot reportedNot reported
Phase 1 P-BCMA-101 CAR-T Cells (Cohort B)0Not reportedNot reportedNot reportedNot reported
Phase 1 P-BCMA-101 CAR-T Cells With Comb.Therapy (Cohort R)0Not reportedNot reportedNot reportedNot reported
Phase 1 P-BCMA-101 CAR-T Cells With Comb.Therapy (Cohort RP)0Not reportedNot reportedNot reportedNot reported
Phase 1 P-BCMA-101 CAR-T Cells With Comb.Therapy (Cohort RIT)0Not reportedNot reportedNot reportedNot reported
Phase 2: P-BCMA-101 CAR-T CellsNANot reportedNot reportedNot reportedDLT not applicable for Phase 2 participants
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
        0
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        0
      7. comment
        DLT not applicable for Phase 2 participants
        group Id
        OG006
        value
        NA
denoms
  1. counts
    1. group Id
      OG000
      value
      69
    2. group Id
      OG001
      value
      3
    3. group Id
      OG002
      value
      1
    4. group Id
      OG003
      value
      8
    5. group Id
      OG004
      value
      5
    6. group Id
      OG005
      value
      16
    7. group Id
      OG006
      value
      3
    units
    Participants
description
Rate of dose limiting toxicities (DLT)
groups
  1. description
    Single administration dose cohorts, given in a single intravenous infusion of CAR-T cells. Rimiducid may be administered as indicated.
    id
    OG000
    title
    Phase 1: P-BCMA-101 CAR-T Cells
  2. description
    Single dose given across two intravenous infusions of CAR-T cells. Rimiducid may be administered as indicated.
    id
    OG001
    title
    Phase 1 P-BCMA-101 CAR-T Cells (Cohort A)
  3. description
    Single dose given across three intravenous infusions of CAR-T cells. Rimiducid may be administered as indicated.
    id
    OG002
    title
    Phase 1 P-BCMA-101 CAR-T Cells (Cohort B)
  4. description
    Single intravenous infusion of CAR-T cells, with combination therapy, beginning one week before CAR-T infusion. Rimiducid may be administered as indicated.
    id
    OG003
    title
    Phase 1 P-BCMA-101 CAR-T Cells With Comb.Therapy (Cohort R)
  5. description
    Single intravenous infusion of CAR-T cells, with combination therapy, beginning one week before apheresis. Rimiducid may be administered as indicated.
    id
    OG004
    title
    Phase 1 P-BCMA-101 CAR-T Cells With Comb.Therapy (Cohort RP)
  6. description
    Single intravenous infusion of CAR-T cells, with combination therapy, beginning one week before CAR-T infusion. Rimiducid may be administered as indicated.
    id
    OG005
    title
    Phase 1 P-BCMA-101 CAR-T Cells With Comb.Therapy (Cohort RIT)
  7. description
    CAR-T cells administered via intravenous infusion as a total dose
    id
    OG006
    title
    Phase 2: P-BCMA-101 CAR-T Cells
param Type
COUNT_OF_PARTICIPANTS
reporting Status
POSTED
time Frame
Baseline through Day 28
title
Phase 1: Maximum Tolerated Dose of P-BCMA-101
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice