Clinical trial · Interventional
Universal CAR-T Cells Targeting Multiple Myeloma
Universal CAR-T Cells for the Treatment of Multiple Myeloma
NCT06006741CI-TRIAL-00123862not yet recruitingPhase 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 aim of this study is to assess the feasibility, safety and efficacy of universal CAR T cells targeting multiple myeloma. Another goal of the study is to learn more about the persistence and function of the universal 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 in Remission | Multiple Myeloma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MM-specific universal CAR T cells | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Universal CART cells to treat MM
- interventionNames
- Biological: MM-specific universal CAR T cells
Primary outcomes (1)
- measure
- Percentage of patients with treatment related adverse effect
- timeFrame
- 6 months
- description
- percentage of participants with treatment-related adverse events, as assessed by physical examination, vital signs, standard clinical lab tests.
Secondary outcomes (2)
- measure
- Anti-tumor activity of the universal 4SCAR-T cells after infusion
- timeFrame
- 3 months
- description
- CART cells in the peripheral blood of patients will be measured by qPCR on Day 7, 14, 21, 28, 60 and 90 after infusion.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients with confirmed multiple myeloma failed curative treatment options (including autologous or allogeneic SCT). 2. Complete remission (CR) cannot be achieved after at least 2 prior therapy regimens. 3. High risk MM in CR1 or CR2 and not eligible for SCT because of age or comorbid diseases. 4. Less than 1 year between last chemotherapy and progression (i.e. most recent progression free interval \< 1 year). 5. Relapsed after prior autologous or allogenic SCT with residual disease after at least 1 prior therapy and not eligible for allogeneic SCT. 6. Residual disease after primary therapy and not eligible for ASCT 7. Expected survival \> 12 weeks• Creatinine \< 2.5 mg/dl• ALT (alanine aminotransferase)/AST (aspartate aminotransferase) \< 3x normal 8. Bilirubin \< 2.0 mg/dl 9. Any relapse after prior SCT is eligible regardless of other prior therapy 10. Adequate venous access for apheresis, and no other contraindications for leukapheresis 11. Voluntary informed consent is signed Exclusion Criteria: 1. Pregnant or lactating women 2. Uncontrolled active infection 3. Active hepatitis B or hepatitis C infection 4. Concurrent use of systemic steroids. Recent or current use of inhaled steroids is not exclusionary. 5. Previous related CAR-T cell therapy 6. Any uncontrolled active medical disorder that would preclude participation 7. HIV infection
References
Publications (0)
Data not yet available
No reference posted for this study.