Trial Title:
Human BCMA Targeted T Cells Injection（BCMA CAR-T）for Subjects With R/R MM
NCT ID:
NCT05594797
Condition:
Multiple Myeloma
Conditions: Official terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Conditions: Keywords:
BCMA
CAR-T
Relapsed/Refractory
Multiple Myeloma
Study type:
Interventional
Study phase:
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:
Human BCMA Targeted T Cells Injection
Description:
A single dose of predetermined level CAR-positive T cells will be infused.
Arm group label:
Human BCMA Targeted T Cells Injection
Other name:
BCMA CAR-T
Summary:
A Phase Ⅱ Clinical Study Evaluating the Efficacy and Safety of Human BCMA Targeted T
Cells Injection（BCMA CAR-T） Therapy for R/R MM.
Patients will be given a conditioning chemotherapy regimen of fludarabine and
cyclophosphamide followed by a single infusion of BCMA CAR+ T cells.
Detailed description:
Participants with relapsed/refractory multiple myeloma can participate if all eligibility
criteria are met. Tests required to determine eligibility include disease assessments, a
physical exam, Electrocardiograph, Computedtomography （CT）/Magnetic Resonance
Imaging(MRI)/Positron Emission Tomography（PET）, and blood draws. Participants receive
chemotherapy prior to the infusion of BCMA CAR+ T cells. After the infusion, participants
will be followed for side effects and effect of BCMA CAR+ T cells. Study procedures may
be performed while hospitalized.
Criteria for eligibility:
Criteria:
Inclusion Criteria:Subjects must meet all of the following criteria to be enrolled:
- Subjects volunteer to participate in clinical trails, understand and inform the
trials and sign informed consent form, be willing to complete all the trial
procedures;
- 18 to 75 years old (including cut-off value)，gender is not limited;
- Expected survival > 12 weeks;
- Previously diagnosed as multiple myeloma by the International Myeloma Working
Group（IMWG） updated criteria;
- One of the following indicators is satisfied:
1. Serum M protein ≥ 5 g/L;
2. Urine M protein ≥ 200 mg/24h;
3. Affected serum free light chain ≥ 100 mg/L and Serum free light chain ratio is
abnormal ;
- Patients with relapsed/refractory multiple myeloma, satisfying:
1. Patients have received at least 3 prior MM treatment regimens containing at
least one proteasome inhibitor and one immunomodulator;
2. Progress is documented within 12 months of the most recent antimyeloma
treatment, or efficacy assessment does not reach minimal response(MR) or above
or progression within 60 days of the most recent antimyeloma treatment;
- ECOG score 0-2;
- Autologous hematopoietic stem cell transplantation is not possible or relapses after
autologous hematopoietic stem cell transplantation, but requires further treatment
at the investigator's discretion；
- Liver, kidney and cardiopulmonary functions meet the following requirements:
1. Creatinine clearance rate (estimated by CockcroftGault formula)≥40mL/min;
2. Total bilirubin≤2×ULN; Alanine aminotransferase (ALT) ≤2.5×ULN and aspartate
aminotransferase (AST)≤2.5×ULN;
3. Left ventricular ejection fraction >50%;
4. Baseline peripheral oxygen saturation>95%;
- The venous access required for collection can be established, no contraindications
to leukocyte collection, and leukepheresis can be carried according to the judgement
of investigators, satisfying hemoglobin≥70g/L,platelets ≥50×10^9 / L, neutrophils
≥1.0×10^9/L.
Exclusion Criteria:Any one of the following conditions cannot be selected as a subject：
- Subjects have a history of central nervous system (CNS) diseases such as seizures,
paralysis, aphasia, stroke, severe brain injury, dementia, Parkinson's disease,
psychosis; known or history of active central nervous system (CNS) involvement or
presentation of multiple myeloma meninge/meningeal involvement;
- Subjects with plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS syndrome,
or primary light chain amyloidosis;
- Accompanied by other uncontrolled malignancies, in addition to adequately treated
cervical carcinoma in situ, basal cell or squamous cell skin cancer, localized
prostate cancer after radical resection, ductal carcinoma in situ after radical
resection and thyroid cancer after radical resection ;
- Any uncontrollable active infection, including but not limited to active
tuberculosis; fungal, bacterial, viral, or other infections that are uncontrollable
or require systemic intravenous therapy are present or suspected within 14 days
prior to enrollment;
- Subjects with positive Hepatitis B surface antigen(HBsAg) or Hepatitis B core
antibody (HBcAb) and hepatitis B virus (HBV) DNA titers higher than the lower limit
of the normal range of the investigative site); Hepatitis C virus (HCV) antibody
positive and peripheral blood HCV RNA positive; Human Immunodeficiency Viral (HIV)
antibody positive; syphilis positive;
- Any uncontrolled systemic diseases, including but not limited to unstable angina
pectoris, cerebrovascular accident, or transient cerebral ischemic (within 6 months
prior to screening), myocardial infarction (within 6 months prior to screening),
congestive heart failure (New York heart association (NYHA) classification ≥ Ⅲ),
uncontrolled diabetes mellitus (glycosylated hemoglobin HbAlc >8% at
screening)，severe arrhythmia, liver, kidney, or metabolic diseases that are poorly
controlled by medications;
- Subjects who have a history of pacemaker and brain pacemaker implantation;
- Subjects who have received CAR-T treatment or other genetically modified cell
therapies, as well as other BCMA-targeting drugs;
- Subjects with any hematopoietic stem cell transplant performed within the first two
months of screening, or any immunosuppressive therapy due to graft-versus-host
disease performed during the screening period;
- Subjects who were receiving systemic steroid treatment within 14 days before the
screening period and who were judged by the investigator to require long-term use of
systemic steroid therapy during treatment (except inhalation or topical use); or
subjects who received any systemic anti-tumor therapy ( except for local anti-tumor
therapy) ;
- Subjects who have received live attenuated vaccine within 4 weeks prior to
apheresis;
- In the past two years, the terminal organ was damaged due to autoimmune diseases
(such as Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus), or
the systemic use of immunosuppressive or other systemic disease control drugs was
required;
- Pregnant or lactating woman, or planned pregnancy during treatment or within 1 year
after treatment, or male subject whose partner plans to have a pregnancy within 1
year after cell transfusion; except participants of childbearing age are willing to
use a very effective and reliable method of contraception for 1 year after study
treatment;
- Subjects who have a disease that affects the signing of written informed consent or
who are unable to comply with research procedures; or who are unwilling or unable to
comply with research requirements;
- Subjects who have had severe immediate hypersensitivity reactions to any drugs used
in this research;
- Subjects who are considered unsuitable to participate in this trial by the
investigator.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Shanghai Changzheng Hospital
Address:
City:
Shanghai
Zip:
200003
Country:
China
Status:
Recruiting
Contact:
Last name:
Juan Du, Ph.D.
Phone:
021-81885423
Email:
juan_du@live.com
Facility:
Name:
The First Affiliated Hospital of Wenzhou Medical University
Address:
City:
Wenzhou
Zip:
325000
Country:
China
Status:
Recruiting
Contact:
Last name:
Songfu Jiang, Professor
Phone:
+8615305770033
Email:
Jiangsongfu@189.cn
Start date:
July 12, 2022
Completion date:
July 31, 2027
Lead sponsor:
Agency:
Hrain Biotechnology Co., Ltd.
Agency class:
Industry
Collaborator:
Agency:
Shanghai Changzheng Hospital
Agency class:
Other
Collaborator:
Agency:
First Affiliated Hospital of Wenzhou Medical University
Agency class:
Other
Source:
Hrain Biotechnology Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05594797
