Clinical trial · Interventional
Multi-CAR T Cell Therapy in the Treatment of Multiple Myeloma
Multiple Antigen-specific CAR T Cells For the Treatment of Multiple Myeloma
NCT03271632CI-TRIAL-00124143not yet 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)
The aim of this clinical trial is to assess the feasibility, safety and efficacy of autologous CAR T cell immunotherapy targeting multiple cancer cell surface antigens in relapsed and refractory multiple myeloma patients. Another goal of the study is to learn more about the persistence and function of CAR T cells in the body.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CAR T cells | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Single arm
- description
- CAR T cells to treat MM
- interventionNames
- Biological: CAR T cells
Primary outcomes (1)
- measure
- Percentage of patients with treatment related adverse effect
- timeFrame
- 1 month
- description
- percentage of participants with treatment-related adverse events, as assessed by physical exam, vital signs, standard clinical lab tests.
Secondary outcomes (2)
- measure
- Anti-tumor activity of fourth generation multiple CAR-T cells after infusion
- timeFrame
- 1 year
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Male and female subjects with surface antigen confirmed multiple myeloma with no available curative treatment options (including autologous or allogeneic SCT). * Complete remission (CR) cannot be achieved after at least 4 prior combination therapy regimens. * MM in CR2 or CR3 and not eligible for allogeneic SCT because of age, comorbid diseases, or lack of available donor. * Less than 1 year between last chemotherapy and progression (i.e. most recent progression free interval \< 1 year). * Relapsed after prior autologous or allogenic SCT MM patients with relapsed or residual disease after at least 1 prior therapy and not eligible for allogeneic SCT. * Residual disease after primary therapy and not eligible for ASCT * Expected survival \> 12 weeks * Creatinine \< 2.5 mg/dl * ALT (alanine aminotransferase)/AST (aspartate aminotransferase) \< 3x normal * Bilirubin \< 2.0 mg/dl * Any relapse after prior SCT is eligible regardless of other prior therapy * Adequate venous access for apheresis, and no other contraindications for leukapheresis * 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. * Previous related CAR-T cell therapy Any uncontrolled active medical disorder that would preclude participation * HIV infection
References
Publications (0)
Data not yet available
No reference posted for this study.