Clinical trial · Interventional
A Study of BCMA CAR-T Cell Therapy for Newly Diagnosed Multiple Myeloma
Clinical Trial for the Safety and Efficacy of BCMA CAR-T Cell Therapy for Newly Diagnosed Multiple Myeloma
NCT05712083CI-TRIAL-00064067unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- 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)
Clinical Trial for the Safety and Efficacy of BCMA CAR-T Cell Therapy for Newly Diagnosed Multiple Myeloma
Conditions
Conditions (2)
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 |
| New Diagnosis Tumor | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BCMA CAR-T cells | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment Group
- description
- This is a single arm clinical trial.
- interventionNames
- Drug: BCMA CAR-T cells
Primary outcomes (2)
- measure
- Dose-limiting toxicity (DLT)
- timeFrame
- Baseline up to 28 days after BCMA CAR T-cells infusion
- description
- Adverse events assessed according to NCI-CTCAE v5.0 criteria
- measure
- Incidence of treatment-emergent adverse events (TEAEs)
- timeFrame
- Baseline up to 2 years after BCMA CAR T-cells infusion
- description
- Incidence of treatment-emergent adverse events \[Safety and Tolerability\]
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * 1.Age and gender unlimited; * 2.According to the IMWG2014 standard, diagnosis as multiple myeloma; * 3.According to the MSMART 3.0 standard, it is defined as a high-risk multiple myeloma; * 4.Abnormal plasmocyte BCMA expression positive; * 5.Echocardiography shows the left ventricular ejection score (LVEF) ≥50%; * 6.The subject has no lung activity infection; * 7.Expected life time is more than 3 months; * 8.ECOG score 0-2 score; * 9.Voluntarily participate in the trial and sign the informed consent form. Exclusion Criteria: * 1.Patients with the history of epilepsy or other CNS disease; * 2.Patients with prolonged QT interval time or severe heart disease; * 3.Pregnant or breastfeeding; * 4.Active infection with no cure; * 5.Patients with active hepatitis B or C infection; * 6.Previously treated with any genetic therapy; * 7.The proiferation rate is less than 5 times response to CD3/CD28 co-stimulation signal; * 8.Serum creatinine \> 2.5mg/dl or ALT / AST \> 3 times ULN or bilirubin \> 2.0mg/dl; * 9.Those who suffer from other uncontrolled diseases are not suitable to join the study; * 10.HIV infection; * 11.Any situation that the researchers believe may increase the risk of patients or interfere with the test results.
References
Publications (0)
Data not yet available
No reference posted for this study.