Clinical trial · Observational
Longterm Follow-up of Subjects Treated With bb2121
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Safety and efficacy assessments | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- 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.
- interventionNames
- Drug: Safety and efficacy assessments
Primary outcomes (6)
- measure
- Overall survival
- timeFrame
- 15 years post-drug product infusion
- measure
- Monitoring for all Adverse Events, including Serious Adverse Events, related to the drug product
- timeFrame
- 15 years post-drug product infusion
- measure
- Monitoring for all Serious Adverse Events including any new malignancy or new diagnosis of a neurologic, rheumatologic, or hematologic disorder that is clinically significant
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available