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Trial Title:
Nanobody-based Biepitope CAR-T Cells Targeting BCMA in the Treatment of R/RMM
NCT ID:
NCT06503107
Condition:
Multiple Myeloma
Conditions: Official terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Conditions: Keywords:
CAR-T
BCMA
Relapsed / Refractory multiple myeloma
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Nanobody-based biepitope BCMA-targeting CAR-T cells
Description:
Each patient will receive nanobody-based biepitope BCMA-targeting CAR-T cell by
intravenous infusion on day 0.
Arm group label:
Effective of nanobody-based biepitope BCMA-targeting CAR-T cells
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 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.
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 efficacy of nanobody-based biepitope CAR-T cells targeting BCMA
in the treatment of R/RMM, and to collect CAR-T PK/PD indicators. The structure of BCMA
target CAR-T is designed to identify two different epitopes of BCMA protein with two
recognition domains, in order to killig MM cells without secreting more pro-inflammatory
factors and avoiding escape caused by the limitations of single BCMA antigen recognition.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Address:
City:
Wuhan
Zip:
430022
Country:
China
Status:
Recruiting
Contact:
Last name:
Heng Mei, M.D., Ph.D
Phone:
027-8572600
Email:
hmei@hust.edu.cn
Investigator:
Last name:
Heng Mei, M.D., Ph.D
Email:
Principal Investigator
Start date:
April 23, 2024
Completion date:
October 18, 2026
Lead sponsor:
Agency:
Wuhan Union Hospital, China
Agency class:
Other
Collaborator:
Agency:
Hebei Taihe Chunyu Biotechnology Co., LTD
Agency class:
Other
Collaborator:
Agency:
Huazhong University of Science and Technology Union Shenzhen Hospital
Agency class:
Other
Collaborator:
Agency:
The Seventh Affiliated Hospital of Sun Yat-sen University
Agency class:
Other
Source:
Wuhan Union Hospital, China
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06503107
