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NCT03602612 · OUTCOME

Maximum Tolerated Dose (MTD) of Anti-B Cell Maturation Antigen (BCMA) - Chimeric Antigen Receptor (CAR)-T Cells

T Cells Expressing a Novel Fully-Human Anti-BCMA CAR for Treating Multiple Myeloma · Source last updated 2026-06-16

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

Measure
NUMBER
Unit
million CAR + T cells
Interval / dispersion
Not reported
Time frame
First 28 days of treatment

What was measured

The MTD is the dose at which a maximum of 1 of 6 patients has a DLT. A DLT is Grade 3 toxicities possibly or probably or definitely related to the Anti-B cell maturation antigen (BCMA) - chimeric antigen receptor (CAR)-expressing T-Cells lasting more than 9 days. Grade 4 toxicities possibly or probably or definitely related to the anti-BCMA CAR T cells. Grade 3 is severe, and Grade 4 is life-threatening.

Analysis population: 9/35 participants were enrolled but not treated.

Groups in this outcome

All Arm 1 Dose Escalation Dose Participants

All participants in Arm 1 Dose Escalation Group who received CAR+T cells, Cyclophosphamide and Fludarabine.

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

Analysis denominator · Participants

GroupSource count
All Arm 1 Dose Escalation Dose Participants18

Reported measurements

Source class 1
Values in million CAR + T cells · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Arm 1 Dose Escalation Dose Participants6Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        6
denoms
  1. counts
    1. group Id
      OG000
      value
      18
    units
    Participants
description
The MTD is the dose at which a maximum of 1 of 6 patients has a DLT. A DLT is Grade 3 toxicities possibly or probably or definitely related to the Anti-B cell maturation antigen (BCMA) - chimeric antigen receptor (CAR)-expressing T-Cells lasting more than 9 days. Grade 4 toxicities possibly or probably or definitely related to the anti-BCMA CAR T cells. Grade 3 is severe, and Grade 4 is life-threatening.
groups
  1. description
    All participants in Arm 1 Dose Escalation Group who received CAR+T cells, Cyclophosphamide and Fludarabine.
    id
    OG000
    title
    All Arm 1 Dose Escalation Dose Participants
param Type
NUMBER
population Description
9/35 participants were enrolled but not treated.
reporting Status
POSTED
time Frame
First 28 days of treatment
title
Maximum Tolerated Dose (MTD) of Anti-B Cell Maturation Antigen (BCMA) - Chimeric Antigen Receptor (CAR)-T Cells
type
PRIMARY
unit Of Measure
million CAR + T cells

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

Preserved source evidence · Not medical advice