Clinical trial · Interventional
BCMA Chimeric Antigen Receptor Expressing T Cells Therapy for Relapsed/Refractory Multiple Myeloma
A Phase I Clinical Trial of T-Cells Targeting B-Cell Maturation Antigen for Subjects With Relapsed/Refractory Multiple Myeloma
NCT03943472CI-TRIAL-00053597unknownEarly Phase 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)
The goal of this clinical trial is to study the feasibility and efficacy of anti-B-Cell Maturation Antigen (BCMA) expressing T cells in treating patients with multiple 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 |
|---|---|---|---|
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Anti-BCMA CAR-T cells | Biological | — | UNRESOLVED |
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Fludarabine | Drug | Fludarabine | ALIAS |
| Immune inhibitors | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- anti-BCMA CAR-T
- description
- Administration of anti-BCMA CAR-T cells to patients with multiple myeloma
- interventionNames
- Biological: Anti-BCMA CAR-T cells
- Drug: Fludarabine
- Drug: Cyclophosphamide
- type
- EXPERIMENTAL
- label
- anti-BCMA CAR-T+ Immune inhibitors
- description
- Administration of anti-BCMA CAR-T cells + Immune inhibitors to patients with multiple myeloma
- interventionNames
- Biological: Anti-BCMA CAR-T cells
- Drug: Fludarabine
- Drug: Cyclophosphamide
- Drug: Immune inhibitors
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Expected survival \> 12 weeks * Diagnosis of Multiple Myeloma by MWG criteria 20 * Patients previously received at least 3 different prior treatment regimens for multiple myeloma, including alkylating agent, protein inhibitors, and immunomodulator, and have disease progression in the past 60 days * Important organs function enough to tolerate this therapy * At least 90 days after stem cell transplantation * Accessible to intravenous injection, and no white blood cell collection contraindications * Sexually active patients must be willing to utilize one of the more effective birth control methods for 30 days after the CTL infusion. Male partner should use a condom * Able to understand and sign the Informed Consent Document. Exclusion Criteria: * Patients with symptoms of central nervous system * Patients with second malignancies in addition to multiple myeloma * Active hepatitis B or C, HIV infections * Any other active diseases could affect the enrollment of this trial * Suffering severe cardiovascular or respiratory disease * Poorly controlled hypertension * Long term use of immunosuppressive agents after organ transplantation, except currently receiving or recently received glucocorticoid treatment * A history of mental illness and poorly controlled * Screening showing target cell transduction efficacy is lower than 30%, or T cell proliferation is not enough for infusion (less than 5 fold) * Occurrence of unstable pulmonary embolism, deep vein thrombosis, or other major arterial/venous thromboembolic events 30 days prior to assignment * Women of child-bearing potential who are pregnant or breastfeeding during therapy, or have a planned pregnancy with 2 months after therapy * Women of child-bearing potential who are not willing to practice birth control from the time of enrollment on this study and for 2 months after receiving the preparative regimen. Women of child bearing potential must have a negative serum or urine pregnancy test performed within 48 hours before infusion * Active systemic infections or uncontrolled infection within 14 days prior enrollment * Subjects suffering disease affects the understanding of informed consent or complying with study protocol.
References
Publications (0)
Data not yet available
No reference posted for this study.