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NCT03338972 · OUTCOME

Duration of Persistence of Adoptively Transferred BCMA CAR-T Cells

Immunotherapy With BCMA CAR-T Cells in Treating Patients With BCMA Positive Relapsed or Refractory Multiple Myeloma · Source last updated 2023-09-08

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

Measure
MEDIAN
Unit
Days
Interval / dispersion
Inter-Quartile Range
Time frame
Assessed from Baseline up to a maximum of 537 days

What was measured

Persistence of CART cells is tested by qPCR in PBMC.

Groups in this outcome

Treatment (Chemotherapy, BCMA CAR-T Cells) at Dose Level 1

Patients undergo leukapheresis. Patients then receive cyclophosphamide and fludarabine on days -4 to -2. Beginning to 36-96 days after chemotherapy, patients receive BCMA-specific CAR-expressing T lymphocytes IV over 20-30 minutes on day 0. Patients may receive a second dose of BCMA-specific CAR-expressing T lymphocytes IV with or without additional cytoreductive chemotherapy at the discretion of the principal investigator or their designee (sub-investigator). Arm 1 contains patients treated as dose level 1 (50 x 10\^6 EGFRt cells) Autologous Anti-BCMA-CAR-expressing CD4+/CD8+ T-lymphocytes FCARH143: Given IV Cyclophosphamide: Given IV Fludarabine: Given IV Leukapheresis: Undergo leukapheresis

Treatment (Chemotherapy, BCMA CAR-T Cells) at Dose Level 2

Patients undergo leukapheresis. Patients then receive cyclophosphamide and fludarabine on days -4 to -2. Beginning to 36-96 days after chemotherapy, patients receive BCMA-specific CAR-expressing T lymphocytes IV over 20-30 minutes on day 0. Patients may receive a second dose of BCMA-specific CAR-expressing T lymphocytes IV with or without additional cytoreductive chemotherapy at the discretion of the principal investigator or their designee (sub-investigator). Arm 2 contains patients treated as dose level 2 (150 x 10\^6 EGFRt cells) Autologous Anti-BCMA-CAR-expressing CD4+/CD8+ T-lymphocytes FCARH143: Given IV Cyclophosphamide: Given IV Fludarabine: Given IV Leukapheresis: Undergo leukapheresis

Treatment (Chemotherapy, BCMA CAR-T Cells) at Dose Level 3

Patients undergo leukapheresis. Patients then receive cyclophosphamide and fludarabine on days -4 to -2. Beginning to 36-96 days after chemotherapy, patients receive BCMA-specific CAR-expressing T lymphocytes IV over 20-30 minutes on day 0. Patients may receive a second dose of BCMA-specific CAR-expressing T lymphocytes IV with or without additional cytoreductive chemotherapy at the discretion of the principal investigator or their designee (sub-investigator). Arm 3 contains patients treated as dose level 3 (300 x 10\^6 EGFRt cells) Autologous Anti-BCMA-CAR-expressing CD4+/CD8+ T-lymphocytes FCARH143: Given IV Cyclophosphamide: Given IV Fludarabine: Given IV Leukapheresis: Undergo leukapheresis

Treatment (Chemotherapy, BCMA CAR-T Cells) at Dose Level 4

Patients undergo leukapheresis. Patients then receive cyclophosphamide and fludarabine on days -4 to -2. Beginning to 36-96 days after chemotherapy, patients receive BCMA-specific CAR-expressing T lymphocytes IV over 20-30 minutes on day 0. Patients may receive a second dose of BCMA-specific CAR-expressing T lymphocytes IV with or without additional cytoreductive chemotherapy at the discretion of the principal investigator or their designee (sub-investigator). Arm 4 contains patients treated as dose level 4 (450 x 10\^6 EGFRt cells) Autologous Anti-BCMA-CAR-expressing CD4+/CD8+ T-lymphocytes FCARH143: Given IV Cyclophosphamide: Given IV Fludarabine: Given IV Leukapheresis: Undergo leukapheresis

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

Analysis denominator · Participants

GroupSource count
Treatment (Chemotherapy, BCMA CAR-T Cells) at Dose Level 17
Treatment (Chemotherapy, BCMA CAR-T Cells) at Dose Level 28
Treatment (Chemotherapy, BCMA CAR-T Cells) at Dose Level 37
Treatment (Chemotherapy, BCMA CAR-T Cells) at Dose Level 43

Reported measurements

Source class 1
Values in Days · Interval/dispersion: Inter-Quartile Range
GroupValueSpreadLowerUpperComment
Treatment (Chemotherapy, BCMA CAR-T Cells) at Dose Level 1134Not reported104182Not reported
Treatment (Chemotherapy, BCMA CAR-T Cells) at Dose Level 2110Not reported64169Not reported
Treatment (Chemotherapy, BCMA CAR-T Cells) at Dose Level 3386Not reported282537Not reported
Treatment (Chemotherapy, BCMA CAR-T Cells) at Dose Level 4236Not reported133309Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        104
        upper Limit
        182
        value
        134
      2. group Id
        OG001
        lower Limit
        64
        upper Limit
        169
        value
        110
      3. group Id
        OG002
        lower Limit
        282
        upper Limit
        537
        value
        386
      4. group Id
        OG003
        lower Limit
        133
        upper Limit
        309
        value
        236
denoms
  1. counts
    1. group Id
      OG000
      value
      7
    2. group Id
      OG001
      value
      8
    3. group Id
      OG002
      value
      7
    4. group Id
      OG003
      value
      3
    units
    Participants
description
Persistence of CART cells is tested by qPCR in PBMC.
dispersion Type
Inter-Quartile Range
groups
  1. description
    Patients undergo leukapheresis. Patients then receive cyclophosphamide and fludarabine on days -4 to -2. Beginning to 36-96 days after chemotherapy, patients receive BCMA-specific CAR-expressing T lymphocytes IV over 20-30 minutes on day 0. Patients may receive a second dose of BCMA-specific CAR-expressing T lymphocytes IV with or without additional cytoreductive chemotherapy at the discretion of the principal investigator or their designee (sub-investigator). Arm 1 contains patients treated as dose level 1 (50 x 10\^6 EGFRt cells) Autologous Anti-BCMA-CAR-expressing CD4+/CD8+ T-lymphocytes FCARH143: Given IV Cyclophosphamide: Given IV Fludarabine: Given IV Leukapheresis: Undergo leukapheresis
    id
    OG000
    title
    Treatment (Chemotherapy, BCMA CAR-T Cells) at Dose Level 1
  2. description
    Patients undergo leukapheresis. Patients then receive cyclophosphamide and fludarabine on days -4 to -2. Beginning to 36-96 days after chemotherapy, patients receive BCMA-specific CAR-expressing T lymphocytes IV over 20-30 minutes on day 0. Patients may receive a second dose of BCMA-specific CAR-expressing T lymphocytes IV with or without additional cytoreductive chemotherapy at the discretion of the principal investigator or their designee (sub-investigator). Arm 2 contains patients treated as dose level 2 (150 x 10\^6 EGFRt cells) Autologous Anti-BCMA-CAR-expressing CD4+/CD8+ T-lymphocytes FCARH143: Given IV Cyclophosphamide: Given IV Fludarabine: Given IV Leukapheresis: Undergo leukapheresis
    id
    OG001
    title
    Treatment (Chemotherapy, BCMA CAR-T Cells) at Dose Level 2
  3. description
    Patients undergo leukapheresis. Patients then receive cyclophosphamide and fludarabine on days -4 to -2. Beginning to 36-96 days after chemotherapy, patients receive BCMA-specific CAR-expressing T lymphocytes IV over 20-30 minutes on day 0. Patients may receive a second dose of BCMA-specific CAR-expressing T lymphocytes IV with or without additional cytoreductive chemotherapy at the discretion of the principal investigator or their designee (sub-investigator). Arm 3 contains patients treated as dose level 3 (300 x 10\^6 EGFRt cells) Autologous Anti-BCMA-CAR-expressing CD4+/CD8+ T-lymphocytes FCARH143: Given IV Cyclophosphamide: Given IV Fludarabine: Given IV Leukapheresis: Undergo leukapheresis
    id
    OG002
    title
    Treatment (Chemotherapy, BCMA CAR-T Cells) at Dose Level 3
  4. description
    Patients undergo leukapheresis. Patients then receive cyclophosphamide and fludarabine on days -4 to -2. Beginning to 36-96 days after chemotherapy, patients receive BCMA-specific CAR-expressing T lymphocytes IV over 20-30 minutes on day 0. Patients may receive a second dose of BCMA-specific CAR-expressing T lymphocytes IV with or without additional cytoreductive chemotherapy at the discretion of the principal investigator or their designee (sub-investigator). Arm 4 contains patients treated as dose level 4 (450 x 10\^6 EGFRt cells) Autologous Anti-BCMA-CAR-expressing CD4+/CD8+ T-lymphocytes FCARH143: Given IV Cyclophosphamide: Given IV Fludarabine: Given IV Leukapheresis: Undergo leukapheresis
    id
    OG003
    title
    Treatment (Chemotherapy, BCMA CAR-T Cells) at Dose Level 4
param Type
MEDIAN
reporting Status
POSTED
time Frame
Assessed from Baseline up to a maximum of 537 days
title
Duration of Persistence of Adoptively Transferred BCMA CAR-T Cells
type
SECONDARY
unit Of Measure
Days

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

Preserved source evidence · Not medical advice