Clinical trial · Interventional
An Clinical Study of NKG2D-CAR-NK Cells for the Treatment of Refractory Recurrent Multiple Myeloma
An Exploratory Clinical Study of the Safety and Efficacy of NKG2D Chimeric Antigen Receptor NK Cell Injections for the Treatment of Efractory Recurrent Multiple Myeloma
- 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)
Multiple myeloma (MM) is a malignant disease characterized by the abnormal proliferation of clonal plasma cells. However, multiple myeloma remains an incurable disease and requires the exploration of more effective treatment methods to improve the efficacy of relapsed refractory multiple myeloma and prolong survival time.Currently, clinical application of CAR-T is mostly based on autologous T cell preparation, while relapsed/refractory AML patients have undergone multiple chemotherapy treatments, resulting in impaired self-T cell function, which affects the efficacy and prognosis of CAR-T therapy. Therefore, it is necessary to find new alternative treatments. NK cells are important immune cells in the body and are an important component of innate immunity. Compared with CAR-T cell therapy, CAR-NK cells have unique advantages in adoptive cell therapy. NKG2D receptor is an activating receptor expressed on NK cells, which can recognize NKG2D ligands (NKG2DL) expressed on tumor cells, activating NK cell killing activity through NKG2D-NKG2DL interaction. Therefore, the investigators plan to treat relapsed multiple myeloma by infusing NKG2D-CAR-NK cells to evaluate its efficacy and safety.
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 |
|---|---|---|---|
| NKG2D Chimeric Antigen Receptor NK Cell Injection | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Low dose group
- description
- CAR-NK cell count 6x10\^8
- interventionNames
- Drug: NKG2D Chimeric Antigen Receptor NK Cell Injection
- type
- EXPERIMENTAL
- label
- Medium dose group
- description
- CAR-NK cell count 1x10\^9
- interventionNames
- Drug: NKG2D Chimeric Antigen Receptor NK Cell Injection
- type
- EXPERIMENTAL
- label
- High dose group
- description
- CAR-NK cell count 1.5x10\^9
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age range from 18 to 70 years old; 2. Expected survival time\>12 weeks; 3. Diagnosed as multiple myeloma through physical examination, pathological examination, laboratory examination, and imaging; 4. Difficult to treat multiple myeloma patients; 5. Patients with recurrent multiple myeloma; 6. ALT, AST\<3 times normal; Bilirubin\<2.0mg/dl; 7. Quality of Life Score (KPS)\>50%; 8. The patient has no serious diseases such as heart, liver, or kidney; 9. Recurrence or no remission of the disease after hematopoietic stem cell transplantation or cellular immunotherapy; 10. Inappropriate conditions for stem cell transplantation or abandonment of transplantation due to limitations in conditions; 11. Blood can be taken intravenously without any other contraindications for leukocyte removal surgery; 12. Can understand and voluntarily sign a written informed consent form. Exclusion Criteria: 1. Pregnant or lactating women, or women with pregnancy plans within six months; 2. Infectious diseases (such as HIV, active tuberculosis, etc.); 3. Active hepatitis B or hepatitis C infection; 4. Feasibility assessment screening proves that the transfection of targeted lymphocytes is less than 10% or the amplification is insufficient (\<5-fold) under the co stimulation of CD3/CD28; 5. Abnormal vital signs and inability to cooperate with the examination; 6. Individuals with mental or psychological disorders who cannot cooperate with treatment and efficacy evaluation; 7. Highly allergic constitution or a history of severe allergies, especially those who are allergic to IL-2; 8. Subjects with systemic or severe local infections requiring anti infection treatment; 9. Subjects with severe autoimmune diseases; 10. The doctor believes that there are other reasons why patients cannot be included in treatment.
References
Publications (0)
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