Clinical trial · Interventional
Study of T Cells Targeting CD19/BCMA (CART-19/BCMA) for High Risk Multiple Myeloma Followed With Auto-HSCT
NCT03455972CI-TRIAL-00105712active not recruitingPhase 1 / Phase 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)
CART therapy has showed good safety and efficacy in treatment of lymphoma and acute lymphoblastic leukemia. Researchers want to see if this helps people with high risk multiple myeloma after auto-HSCT.To test the safety and efficacy of giving targeting CD19 and BCMA T cells in treating high risk multiple myeloma followed with auto-HSCT.
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 |
|---|---|---|---|
| Safety and Efficacy | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| anti-CD19 and anti-BCMA CAR | Biological | — | UNRESOLVED |
| Immunomodulatory drugs | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- anti-CD19 and anti-BCMA CAR
- description
- Participants will get auto-HSCT. Hematopoietic reconstitution after auto-HSCT, participants will get the anti-CD19 CAR T cells (on d0) and anti-BCMA CAR T cells as split-dose (40% on d1 and 60% on d2)
- interventionNames
- Biological: anti-CD19 and anti-BCMA CAR
- Drug: Immunomodulatory drugs
Primary outcomes (3)
- measure
- Incidence and severity of adverse events
- timeFrame
- Approximately 2 years
- description
- Proportion of subjects with adverse events overall and by severity grade
- measure
- PFS, response
- timeFrame
- every 6 months after first induction
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Multiple myeloma patients eligible for auto-HSCT. * High risk multiple myeloma (R-ISS III stage or with extramedullary infiltration or with del(17p), t(4;14), t(14;16), t(14;20), 1q21+ or disease progression during treatment). * Expected survival ≥ 3 months. * Creatinine \< 2.0 mg/dl. * Blood coagulation function: PT and APTT \<2x normal. * Arterial blood oxygen saturation\>92%. * ALT(alanine aminotransferase)/AST (aspartate aminotransferase)\< 3x normal * Karnofsky scores ≥ 60 and ECOG score≤2. * Adequate venous access for apheresis, and no other contraindications for leukapheresis. * Patients should not take immunotherapy in three months prior to CART cells infusion. * Voluntary informed consent is given. Exclusion Criteria: * Pregnant or lactating women. * Uncontrolled active infection. * Active hepatitis B or hepatitis C infection. * Concurrent use of systemic steroids. Recent or current use of inhaled steroids is not exclusionary. * Previously treatment with any gene therapy products. * Any uncontrolled active medical disorder that would preclude participation as outlined. * HIV infection. * History of myocardial infarction and severe arrhythmia in half a year. * Any form of primary immunodeficiency (such as Severe Combined Immunodeficiency Disease). * Patients with fever of unknown origin (T\>38℃).
References
Publications (0)
Data not yet available
No reference posted for this study.