RECRUITINGPhase 1 / Phase 2INTERVENTIONAL
Nanobody-based Biepitope CAR-T Cells Targeting BCMA in the Treatment of R/RMM
A Multicenter Clinical Study on the Safety and Efficacy of Nanobody-based Biepitope CAR-T Cells Targeting BCMA in the Treatment of Relapsed/Refractory Multiple Myeloma
About This Trial
To explore the safety and efficacy of nanobody-based BCMA-targeting biepitope CAR-T cells in the treatment of relapsed/refractory multiple myeloma，this study will be conducted in multiple study centers, with 60 patients openly enrolled to receive CAR-T cell therapy. Patients participating in clinical trials will be tested and evaluated for treatment safety, efficacy, duration of response, and long-term survival.
Who May Be Eligible (Plain English)
Who May Qualify:
- Patient or his or her legal guardian voluntarily participates in and signs an willing to sign a consent form form.
- Aged ≥ 18 years and ≤ 75 years.
- Diagnosed as Multiple Myeloma (MM) according to the international standard for multiple myeloma (IMWG 2014).
- Diagnosed as relapsed/refractory disease or primary refractory disease; relapse is defined as disease progression within 60 days of the most recent treatment with three or more lines of therapy with different mechanisms of action; refractory is defined as failure to achieve MR or above efficacy with prior treatment and disease progression with recent treatment, or disease progression within 60 days of treatment.
- Flow cytometry or immunohistochemistry showed positive BCMA expression in myeloma cells.
- Have not been treated with antibody-based drugs within 2 weeks prior to cell therapy.
- ECOG score 0-2 points.
- HGB≥70g/L，PLT≥30×10\^9/L.
- Liver, kidney and cardiopulmonary functions meet the following requirements:
1. Serum creatinine ≤ 1.5× ULN or creatinine clearance (Cockcroft-Gault) \>30 ml/min；
2. Left ventricular ejection fraction (LVEF) ≥50%,
3. Baseline peripheral oxygen saturation \> 90%;
4. Total bilirubin ≤ 1.5×ULN; ALT and AST ≤2.5×ULN.
Who Should NOT Join This Trial:
- Previous diagnosis and treatment of other malignancies within 3 years;
- Presence of one of the following cardiac criteria: atrial fibrillation; Myocardial infarction within the last 12 months; Prolonged QT syndrome or secondary QT prolongation, as judged by the investigator. Echocardiogram LVSF \<30% or LVEF \<50%; Clinically significant pericardial effusion; Cardiac insufficiency NYHA (New York Heart Association) III or IV (absence of this symptom confirmed by echocardiography within 12 months of treatment);
- Patients with active GVHD;
- Patients with a history of severe pulmonary impairment disease;
- Combined with other malignant tumors in the advanced stage;
...See full criteria on ClinicalTrials.gov
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
Inclusion Criteria:
* Patient or his or her legal guardian voluntarily participates in and signs an informed consent form.
* Aged ≥ 18 years and ≤ 75 years.
* Diagnosed as Multiple Myeloma (MM) according to the international standard for multiple myeloma (IMWG 2014).
* Diagnosed as relapsed/refractory disease or primary refractory disease; relapse is defined as disease progression within 60 days of the most recent treatment with three or more lines of therapy with different mechanisms of action; refractory is defined as failure to achieve MR or above efficacy with prior treatment and disease progression with recent treatment, or disease progression within 60 days of treatment.
* Flow cytometry or immunohistochemistry showed positive BCMA expression in myeloma cells.
* Have not been treated with antibody-based drugs within 2 weeks prior to cell therapy.
* ECOG score 0-2 points.
* HGB≥70g/L，PLT≥30×10\^9/L.
* Liver, kidney and cardiopulmonary functions meet the following requirements:
1. Serum creatinine ≤ 1.5× ULN or creatinine clearance (Cockcroft-Gault) \>30 ml/min；
2. Left ventricular ejection fraction (LVEF) ≥50%,
3. Baseline peripheral oxygen saturation \> 90%;
4. Total bilirubin ≤ 1.5×ULN; ALT and AST ≤2.5×ULN.
Exclusion Criteria:
* Previous diagnosis and treatment of other malignancies within 3 years;
* Presence of one of the following cardiac criteria: atrial fibrillation; Myocardial infarction within the last 12 months; Prolonged QT syndrome or secondary QT prolongation, as judged by the investigator. Echocardiogram LVSF \<30% or LVEF \<50%; Clinically significant pericardial effusion; Cardiac insufficiency NYHA (New York Heart Association) III or IV (absence of this symptom confirmed by echocardiography within 12 months of treatment);
* Patients with active GVHD;
* Patients with a history of severe pulmonary impairment disease;
* Combined with other malignant tumors in the advanced stage;
* Co-infection with severe or persistent infection that cannot be effectively controlled;
* Combined with severe autoimmune disease or congenital immunodeficiency;
* Active hepatitis (hepatitis B virus deoxyribonucleic acid \[HBV-DNA ≥ 500 IU/ml and abnormal liver function\] or hepatitis C antibody \[HCV-Ab\] positive, HCV-RNA above the lower limit of detection of the analytical method and abnormal liver function);
* Human immunodeficiency virus (HIV) infection or syphilis infection;
* Patients with a history of severe allergy to biological products (including antibiotics);
* Patients with central nervous system disorders such as uncontrolled epilepsy, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, etc;
* Pregnant or Lactating Women; Patients and his or her spouses have a fertility plan within 12 months after CAR-T cell infusion;
* Other conditions considered inappropriate by the researcher.
Treatments Being Tested
DRUG
Nanobody-based biepitope BCMA-targeting CAR-T cells
Each patient will receive nanobody-based biepitope BCMA-targeting CAR-T cell by intravenous infusion on day 0.
Locations (1)
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China