Clinical trial · Interventional
BCMA-CAR-T in Relapsed/Refractory Multiple Myeloma
a Single-center, One Arm, Open Clinical Study of BCMA Nanobody CAR-T Cell in Refractory/Relapsed Myeloma
NCT03664661CI-TRIAL-00034782unknownPhase 1ClinicalTrials.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)
Evaluation of the safety and efficacy of BCMA nanobody CAR-T cells in relapsed/refractory myeloma
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 |
|---|---|---|---|
| Relapsed/Refractory Myeloma | Plasma Cell Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BCMA nanobody CAR-T cells | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- experimental group
- description
- BCMA nanobody CAR-T cells
- interventionNames
- Drug: BCMA nanobody CAR-T cells
Primary outcomes (1)
- measure
- occurrence of study related adverse events
- timeFrame
- 4 weeks
- description
- safety of CAR-T cells
Secondary outcomes (2)
- measure
- Treatment response rate
- timeFrame
- 3 months and 6 months
- description
- response rate according to IMWG criteria
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * 18 and ≤70 years old and the expected lifetime \>3 months * Active myeloma according to IMWG criteria, and BCMA positive by immunohistochemistry or flow cytometry * No effective treatment option available * ECOG score 0-2 * Sufficient heart, liver, kidney function (heart: no heart disease or coronary heart disease, patient heart function NYHA grade 1-2; liver: TBIL ≤ 3ULN, AST ≤ 2.5ULN, ALT ≤ 2.5ULN; kidney: Cr≤ 1.25ULN); * smoothly peripheral superficial veins * No other serious diseases that conflict with this protocol (eg, autoimmune diseases, immunodeficiency, organ transplantation) * No history of other malignancies * Women of childbearing age must be negative for blood pregnancy test within 7 days and must take appropriated contraceptive measures during and 3 months after the study * The patient himself agrees to participate in this clinical study and signed the "informed consent" Exclusion Criteria: * Severe infectious 4 weeks before enrollment * Active hepatitis B or C viral hepatitis, HIV, * Severe autoimmune disease or immunodeficiency disease * Severe allergies * Severe mental disorder * Patients who used high-dose glucocorticoids within 1 week * Participation in other clinical studies in the past 3 months or having been treated with other gene products
References
Publications (0)
Data not yet available
No reference posted for this study.