Clinical trial · Interventional
BCMA Chimeric Antigen Receptor Expressing T Cells in Multiple Myeloma
A Phase I Clinical Trial of T-Cells Targeting B-Cell Maturation Antigen for Subjects With BCMA-positive Multiple Myeloma
NCT03093168CI-TRIAL-00037310unknownPhase 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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Anti-BCMA CAR-T cells | Biological | — | UNRESOLVED |
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Fludarabine | Drug | Fludarabine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- anti-BCMA CAR-T
- description
- Administration of anti-BCMA:TCRζ-4-1-BB CAR-T cells to patients with multiple myeloma
- interventionNames
- Biological: Anti-BCMA CAR-T cells
- Drug: Fludarabine
- Drug: Cyclophosphamide
Primary outcomes (1)
- measure
- Safety measured by occurrence of study related adverse effects defined by NCI CTCAE 4.0
- timeFrame
- 6 months
- description
- Safety measured by occurrence of study related adverse effects defined by NCI CTCAE 4.0
Secondary outcomes (3)
- measure
- Overall complete remission rate defined by the standard response criteria for malignant lymphoma for each arm
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 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 * Clinical performance status of ECOG score 0-4 * 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 (1)
- DERIVEDZhou L, Fu W, Wu S, Xu K, Qiu L, Xu Y, Yan X, Zhang Q, Zhang M, Wang L, Hong R, Chang AH, Yu J, Fu S, Kong D, Li L, Wang Y, Li Z, Jiang H, Huang J, Liu Z, Su N, Wei G, Hu Y, Huang H. Derivation and validation of a novel score for early prediction of severe CRS after CAR-T therapy in haematological malignancy patients: A multi-centre study. Br J Haematol. 2023 Aug;202(3):517-524. doi: 10.1111/bjh.18873. Epub 2023 May 16. PMID 37192741