Clinical trial · Interventional
A Feasibility and Safety Study of Dual Specificity CD38 and BCMA CAR-T Cell Immunotherapy for Relapsed or Refractory Multiple Myeloma
Phase I/II Study to Evaluate Treatment of Relapsed or Refractory Multiple Myeloma With Dual CAR-T Cells Targeting CD38 and BCMA
- 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)
CAR-T cell therapy has shown promising results for the treatment of relapsed or refractory Multiple Myeloma,however, a subset of patients relapse due to the loss of target in tumor cells.Dual Specificity CD38 and BCMA CAR-T cells can recognize and kill the malignant cells through recognition of CD38 or BCMA. This is a phase 1/2 study designed to determine the safety of dual specificity CD38 and BCMA CAR-T cells and the feasibility of making enough to treat patients with relapsed or refractory 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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dual Specificity CD38 and bcma CAR-T Cells | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (3)
- measure
- Number of Participants with Severe/Adverse Events as a Measure of Safety and Tolerability
- timeFrame
- 24weeks
- measure
- MTD of dual specificity CD38 and BCMA CAR-T cells
- timeFrame
- 4 weeks
- description
- The highest dose of dual specificity CD38 and BCMA CAR-T cells that is estimated to result in defined Dose Limiting Toxicity (DLT) with the exception of allowable 'expected' AEs associated with the intravenous infusion of dual specificity CD38 and BCMA CAR-T cells
- measure
- Copies numbers of CAR in peripheral blood(PB), bone marrow(BM)and lymph nodes
- timeFrame
- 24 weeks
Secondary outcomes (3)
- measure
- Six-month Objective response rate of complete remission and partial remission
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 12 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Male or female participant 2. 12 Years to 70 Years (Child, Adult, Senior) 3. Patient with relapsed or refractory Multiple Myeloma,multiple myeloma cell express CD38(over 50%) and BCMA (over 50%) 4. Estimated life expectancy ≥ 12 weeks (according to investigator's judgement) 5. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1 6. Adequate organ function Exclusion Criteria: 1. Prior malignancy, except carcinoma in situ of the skin or cervix treated with curative intent and with no evidence of active disease 2. Diagnosis of Burkitt's leukemia/lymphoma according to WHO classification or chronic myelogenous leukemia lymphoid blast crisis 3. Richter's syndrome 4. Presence of Grade II-IV (Glucksberg) or B-D (IBMTR) acute or extensive chronic GVHD at the time of screening 5. Subjects with any autoimmune disease or any immune deficiency disease or other disease in need of immunosuppressive therapy 6. Severe active infection (uncomplicated urinary tract infections, bacterial pharyngitis is allowed), Prophylactic antibiotic, antiviral and antifungal treatment is permissible 7. Active hepatitis B, active hepatitis C, or any human immunodeficiency virus (HIV) infection at the time of screening 8. Patient has an investigational medicinal product within the last 30 days prior to screening 9. Previous treatment with investigational gene or cell therapy medicine products 10. Concurrent use of systemic steroids. Recent or current use of inhaled steroids is not exclusionary 11. Pregnant or nursing women
References
Publications (0)
Data not yet available