Status:
RECRUITING
Nanobody-based Biepitope CAR-T Cells Targeting BCMA in the Treatment of R/RMM
Lead Sponsor:
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Collaborating Sponsors:
Hebei Taihe Chunyu Biotechnology Co., Ltd
Huazhong University of Science and Technology Union Shenzhen Hospital
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
PHASE2
Brief Summary
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 center...
Detailed Description
This study is a multicenter, open-label, prospective, single-arm clinical study with patients with relapsed/refractory multiple myeloma as the test subjects, in order to evaluate the safety and effica...
Eligibility Criteria
Inclusion
- 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:
- Serum creatinine ≤ 1.5× ULN or creatinine clearance (Cockcroft-Gault) \>30 ml/min；
- Left ventricular ejection fraction (LVEF) ≥50%,
- Baseline peripheral oxygen saturation \> 90%;
- Total bilirubin ≤ 1.5×ULN; ALT and AST ≤2.5×ULN.
Exclusion
- 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.
Key Trial Info
Start Date :
April 23 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 18 2026
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06503107
Start Date
April 23 2024
End Date
October 18 2026
Last Update
July 16 2024
Active Locations (1)
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1
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430022