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CAR T-cell Therapy

Leukapheresis for Multiple Myeloma

Phase 1
Waitlist Available
Led By Damian J. Green
Research Sponsored by Fred Hutchinson Cancer Research Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline up to 3 months after cart infusion
Awards & highlights

Study Summary

This trial is testing a new cancer treatment that uses genetically modified T cells to target and kill cancer cells.

Eligible Conditions
  • Multiple Myeloma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 28 days after car t cell infusion
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 28 days after car t cell infusion for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Count of Patients That Experienced Adverse Events
Dose-limiting Toxicities (DLT) Rate
Secondary outcome measures
Duration of Persistence of Adoptively Transferred BCMA CAR-T Cells
Number of Participants With Detectable BCMA CART Cell Migration to Primary Disease Site (Bone Marrow) at Day 28
Objective Response Rate (ORR)
+2 more

Side effects data

From 2017 Phase 2 trial • 20 Patients • NCT01097057
10%
Hyperglycemia
5%
DVT
5%
Febrile Neutropenia
5%
Cellulitis
5%
Atrial Fibrillation
100%
80%
60%
40%
20%
0%
Study treatment Arm
Treatment (Rituximab, Etoposide, Carboplatin, Ifosfamide)

Trial Design

4Treatment groups
Experimental Treatment
Group I: Treatment (chemotherapy, BCMA CAR-T cells) at dose level 4Experimental Treatment4 Interventions
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)
Group II: Treatment (chemotherapy, BCMA CAR-T cells) at dose level 3Experimental Treatment4 Interventions
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)
Group III: Treatment (chemotherapy, BCMA CAR-T cells) at dose level 2Experimental Treatment4 Interventions
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)
Group IV: Treatment (chemotherapy, BCMA CAR-T cells) at dose level 1Experimental Treatment4 Interventions
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)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fludarabine
2012
Completed Phase 3
~1100
Autologous Anti-BCMA-CAR-expressing CD4+/CD8+ T-lymphocytes FCARH143
2017
Completed Phase 1
~30
Cyclophosphamide
1995
Completed Phase 3
~3780
Leukapheresis
2016
Completed Phase 2
~690

Find a Location

Who is running the clinical trial?

Juno Therapeutics, Inc., a Bristol-Myers Squibb CompanyIndustry Sponsor
14 Previous Clinical Trials
1,699 Total Patients Enrolled
5 Trials studying Multiple Myeloma
430 Patients Enrolled for Multiple Myeloma
Fred Hutchinson Cancer Research CenterLead Sponsor
443 Previous Clinical Trials
148,217 Total Patients Enrolled
64 Trials studying Multiple Myeloma
2,946 Patients Enrolled for Multiple Myeloma
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,932,295 Total Patients Enrolled
578 Trials studying Multiple Myeloma
188,702 Patients Enrolled for Multiple Myeloma

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Immunotherapy With BCMA CAR-T Cells in Treating Patients With BCMA Positive Relapsed or Refractory Multiple Myeloma
Damian Green 2017. "Immunotherapy With BCMA CAR-T Cells in Treating Patients With BCMA Positive Relapsed or Refractory Multiple Myeloma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03338972.
~4 spots leftby Apr 2025
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