NCT02658929

Brief Summary

Study CRB-401 is a 2-part, non-randomized, open label, multi-site Phase 1 study of bb2121 in adults with relapsed/refractory multiple myeloma (MM).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
67

participants targeted

Target at P75+ for phase_1 multiple-myeloma

Timeline
Completed

Started Dec 2015

Longer than P75 for phase_1 multiple-myeloma

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 22, 2015

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

January 15, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 20, 2016

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 22, 2019

Completed
3.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 22, 2022

Completed
Last Updated

January 23, 2023

Status Verified

January 1, 2023

Enrollment Period

3.6 years

First QC Date

January 15, 2016

Last Update Submit

January 20, 2023

Conditions

Multiple Myeloma

Keywords

Multiple MyelomaEfficacy and Safetybb2121CAR T CellBCMA

Outcome Measures

Primary Outcomes (1)

  • Incidence of adverse events (AEs) and abnormal laboratory test results, including dose limiting toxicities (DLTs)

    Day 1 through Month 60

Secondary Outcomes (1)

  • Disease-specific response criteria including: overall response rate (ORR), complete response (CR), very good partial response (VGPR), and partial response (PR) according to the International Myeloma Working Group (IMWG) Uniform Response Criteria for MM.

    Day 1 through Month 60

Study Arms (1)

bb2121

EXPERIMENTAL

bb2121 autologous CAR T cells will be infused at a dose ranging from 150 - 450 x 10\^6 CAR+ T cells after receiving lymphodepleting chemotherapy

Biological: bb2121

Interventions

bb2121BIOLOGICAL

bb2121

bb2121

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age at the time of signing informed consent
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  • Subjects must have measurable disease including at least one of the criteria below:
  • Serum M-protein greater or equal to 0.5 g/dL Urine M-protein greater or equal to 200 mg/24 h Serum free light chain (FLC) assay: involved FLC level greater or equal to 10 mg/dL (100 mg/L) provided serum FLC ratio is abnormal -Women of child-bearing potential (WCBP) must have a negative serum pregnancy test prior to treatment and refrain from tissue donation including egg donation or any other tissue/blood/organ donations, for at least 1 year following bb2121 infusion. All sexually active WCBP and all sexually active male subjects must agree to use effective methods of birth control throughout the study. All sexually active males subjects must refrain from tissue donation including egg donation or any other tissue/blood/organ donations, for at least 1 year following bb2121 infusion.
  • Part A:
  • Diagnosis of MM with relapsed or refractory disease and have had at least 3 different prior lines of therapy including proteasome inhibitor (e.g., bortezomib or carfilzomib) and immunomodulatory therapy (IMiD; e.g., lenalidomide or pomalidomide), or have "double refractory" disease to a proteasome inhibitor and IMiD, defined as progression on or within 60 days of treatment with these agents
  • \- Part B: Diagnosis of MM with relapsed or refractory disease with previous exposure to PI (e.g., bortezomib or carfilzomib), IMiDs (e.g., lenalidomide or pomalidomide), and daratumumab, and refractory (based on IMWG criteria) to their last line of therapy

You may not qualify if:

  • Subjects with known central nervous system disease
  • Inadequate hepatic function
  • Inadequate renal function
  • Inadequate bone marrow function
  • Presence of active infection within 72 hours
  • Significant co-morbid condition or disease which in the judgment of the Investigator would place the subject at undue risk or interfere with the study; examples include, but are not limited to, cirrhotic liver disease, sepsis, recent significant traumatic injury, and other conditions
  • Subjects with second malignancies in addition to myeloma if the second malignancy has required therapy in the last 3 years or is not in complete remission
  • Subjects with a history of class III or IV congestive heart failure or non-ischemic cardiomyopathy, unstable angina, myocardial infarction, or ventricular arrhythmia requiring medication or mechanical control within the previous 6 months
  • Known human immunodeficiency virus (HIV) positivity
  • Subjects who have plasma cell leukemia or clinically significant amyloidosis
  • Pregnant or lactating women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Stanford Cancer Center

Stanford, California, 94305, United States

Location

National Cancer Institute

Bethesda, Maryland, 20892, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

Mt. Sinai Medical Center Division of Hematology/Oncology

New York, New York, 10029, United States

Location

Sarah Cannon Research Inst

Nashville, Tennessee, 37203, United States

Location

Related Publications (2)

  • Raje N, Berdeja J, Lin Y, Siegel D, Jagannath S, Madduri D, Liedtke M, Rosenblatt J, Maus MV, Turka A, Lam LP, Morgan RA, Friedman K, Massaro M, Wang J, Russotti G, Yang Z, Campbell T, Hege K, Petrocca F, Quigley MT, Munshi N, Kochenderfer JN. Anti-BCMA CAR T-Cell Therapy bb2121 in Relapsed or Refractory Multiple Myeloma. N Engl J Med. 2019 May 2;380(18):1726-1737. doi: 10.1056/NEJMoa1817226.

    PMID: 31042825BACKGROUND

  • Lin Y, Raje NS, Berdeja JG, Siegel DS, Jagannath S, Madduri D, Liedtke M, Rosenblatt J, Maus MV, Massaro M, Petrocca F, Yeri A, Finney O, Caia A, Yang Z, Martin N, Campbell TB, Rytlewski J, Fuller J, Hege K, Munshi NC, Kochenderfer JN. Idecabtagene vicleucel for relapsed and refractory multiple myeloma: post hoc 18-month follow-up of a phase 1 trial. Nat Med. 2023 Sep;29(9):2286-2294. doi: 10.1038/s41591-023-02496-0. Epub 2023 Aug 17.

    PMID: 37592106DERIVED

Related Links

MeSH Terms

Conditions

Multiple Myeloma

Interventions

idecabtagene vicleucel

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Kristen Hege, MD

    Celgene Corporation

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 15, 2016

First Posted

January 20, 2016

Study Start

December 22, 2015

Primary Completion

July 22, 2019

Study Completion

September 22, 2022

Last Updated

January 23, 2023

Record last verified: 2023-01

Locations

US(9)