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Longterm Follow-up of Subjects Treated With bb2121

NCT02786511 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2020-01-22

No results posted yet for this study

Summary

This is a multi-center, non-randomized, open label, longterm safety and efficacy follow-up study for subjects who have been treated with bb2121 in the Phase 1 clinical parent study, that evaluated the safety and efficacy of bb2121 in subjects with relapsed or refractory B cell maturation antigen (BCMA)-expressing multiple myeloma.

bb2121 is defined as autologous T lymphocytes (T cells) transduced ex vivo with anti-BCMA02 CAR lentiviral vector encoding the chimeric antigen receptor (CAR) targeted to human BCMA suspended in cryopreservative solution. bb2121 is administered in subjects 1 time (or retreated if retreatment criteria are met) in parent clinical study. No investigational treatment will be administered in this study.

After completing the parent study, eligible subjects will be followed for up to 15 years after their last bb2121 infusion in the parent study.

Conditions

Interventions

DRUG

Safety and efficacy assessments

Vector copy number (VCN) measurement, safety evaluations, disease-specific assessments, and assessments to monitor for long-term implications of autologous transplant

Sponsors & Collaborators

  • Celgene

    lead INDUSTRY

Principal Investigators

  • Kristen Hege · Celgene Corporation

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-04-28
Primary Completion
2019-10-11
Completion
2019-10-11

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02786511 on ClinicalTrials.gov