NCT03338972 · OUTCOME

Number of Participants With Detectable BCMA CART Cell Migration to Primary Disease Site (Bone Marrow) at Day 28

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: COUNT_OF_PARTICIPANTS
Unit: Participants
Interval / dispersion: Not reported
Time frame: Baseline up to Day 28

Analysis population: CART cell migration to bone marrow was identified in all patients for whom a Day 28 bone marrow biopsy specimen was available (19 out of 19). In 6 cases, biopsy was not performed due to patient clinical status or bone marrow biopsy was attempted but no aspirate could be collected.

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

Group	Source count
Treatment (Chemotherapy, BCMA CAR-T Cells) at Dose Level 1	5
Treatment (Chemotherapy, BCMA CAR-T Cells) at Dose Level 2	7
Treatment (Chemotherapy, BCMA CAR-T Cells) at Dose Level 3	5
Treatment (Chemotherapy, BCMA CAR-T Cells) at Dose Level 4	2

Reported measurements

Source class 1

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment (Chemotherapy, BCMA CAR-T Cells) at Dose Level 1	5	Not reported	Not reported	Not reported	Not reported
Treatment (Chemotherapy, BCMA CAR-T Cells) at Dose Level 2	7	Not reported	Not reported	Not reported	Not reported
Treatment (Chemotherapy, BCMA CAR-T Cells) at Dose Level 3	5	Not reported	Not reported	Not reported	Not reported
Treatment (Chemotherapy, BCMA CAR-T Cells) at Dose Level 4	2	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
5
group Id
OG001
value
7
group Id
OG002
value
5
group Id
OG003
value
2

denoms

counts
group Id
OG000
value
5
group Id
OG001
value
7
group Id
OG002
value
5
group Id
OG003
value
2
units
Participants

groups

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
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
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
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

COUNT_OF_PARTICIPANTS

population Description

CART cell migration to bone marrow was identified in all patients for whom a Day 28 bone marrow biopsy specimen was available (19 out of 19). In 6 cases, biopsy was not performed due to patient clinical status or bone marrow biopsy was attempted but no aspirate could be collected.

reporting Status

POSTED

time Frame

Baseline up to Day 28

title

Number of Participants With Detectable BCMA CART Cell Migration to Primary Disease Site (Bone Marrow) at Day 28

type

SECONDARY

unit Of Measure

Participants

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

Preserved source evidence · Not medical advice