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Longterm Follow-up of Subjects Treated With bb2121

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Celgene

Status

Completed

Conditions

Multiple Myeloma

Treatments

Drug: Safety and efficacy assessments

Study type

Observational

Funder types

Industry

Identifiers

NCT02786511
LTF-305

Details and patient eligibility

About

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.

Full description

The LTF-305 study has completed enrollment and is scheduled to be closed. All patients participating in this study have discontinued from follow-up or have been transferred into the GC-LTFU-001 study for further observation (similar to time frames established in the LTF-305).

Enrollment

50 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Provision of written informed consent for this study by subjects
  • Were administered bb2121 in the parent clinical study
  • Able to comply with the study requirements

Exclusion criteria

  • Subject has disease progression AND subject has undetectable VCN (<0.0003 vector copies per diploid genome) in peripheral blood cells for 2 consecutive measurements at least 1 month apart, at least 12 months after drug product infusion

Trial design

50 participants in 1 patient group

Subjects with multiple myeloma
Description:
Subjects treated with ex vivo gene therapy in a bluebird bio sponsored trial who agree to participate in this study.
Treatment:
Drug: Safety and efficacy assessments

Trial contacts and locations

9

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Data sourced from clinicaltrials.gov

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