Trial Title:
Study of CT071 Injection in High Risk Newly Diagnosed Multiple Myeloma
NCT ID:
NCT06407947
Condition:
Multiple Myeloma
Conditions: Official terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Conditions: Keywords:
Multiple Myeloma
Chimeric antigen receptor modified T cells
Study type:
Interventional
Study phase:
Early Phase 1
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:
Chimeric antigen receptor modified T cells Infusion
Description:
chimeric antigen receptor T cells
Arm group label:
Chimeric antigen receptor modified T cells Infusion
Other name:
Single Group Assignment
Summary:
This trial is a single-arm, single-center, open-label clinical trial to evaluate the
safety, efficacy, and metabolism kinetics of CT071 in patients with high-risk newly
diagnosed multiple myeloma.
Detailed description:
This trial is a single-arm, single-center, open-label clinical trial to evaluate the
safety, efficacy, and metabolism kinetics of CT071 in patients with high-risk newly
diagnosed multiple myeloma (HRNDMM).
Criteria for eligibility:
Criteria:
Inclusion Criteria:
Participants must meet all of the following criteria to be enrolled:
1.Volunteer to participate in the clinical trial; the participants themselves fully
understand and are informed of this study, and sign the informed consent form and are
willing to follow and able to complete all trial procedures;
2.Age ≥ 18 years, male or female;
3.Participants must have newly diagnosed with multiple myeloma according to International
Myeloma Working Group diagnostic criteria 2014 ;
4.Measurable disease based on at least one of the following parameters (International
Myeloma Working Group consensus criteria for response and minimal residual disease
assessment in multiple myeloma 2016); the values for these parameters obtained up to 60
days prior to signing the Informed Consent Form including the results at the time of
diagnosis may be used.
1. Serum M-protein ≥ 1.0 g/dL;
2. Urine M-protein ≥ 200 mg/24 hr;
3. Serum free light chain (FLC): involved FLC level ≥ 10 mg/dL (100 mg/L) provided
serum FLC ratio is abnormal.
5.Known to have the following high risk factors, i.e. At least one of the following
conditions is met:
1)Meet any one or more of the cytogenetic criteria: del (17p); t (4; 14); t (14;
16); t (14; 20); 1q21 amplification ≥ 4 copies; 2)R-ISS stage 3; R2-ISS stages 3 and
4; 3)Presence of soft tissue extramedullary plasmacytoma 4)2%-5% in peripheral
plasma cells;
6.Eastern Cooperative Oncology Group (ECOG) score 0-2;
7.Participants should meet the following test results (repeat tests are allowed):
1)Hematology: Absolute neutrophil (ANC) count ≥ 1.0 × 109/L; Platelet (PLT) ≥ 50 ×
109/L; Hemoglobin (Hb) ≥ 7.5 g/dL; 2)Blood chemistry: Endogenous creatinine
clearance ≥ 40 mL/min (see Appendix 1 using the Cockcroft-Gault formula); Alanine
aminotransferase (ALT) ≤ 2.5 × upper limit of normal (ULN), aspartate
aminotransferase (AST) ≤ 2.5 × ULN, total bilirubin ≤ 1.5 × ULN; 3)International
normalized ratio (INR), or activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN.
8.Venous access required for collection can be established and there is no
contraindication for cell collection.
9.Females of childbearing potential (WOCBP) must have a negative serum pregnancy
test at screening and must be willing to use effective and reliable contraception
for at least 12 months after CT071 infusion.
10.A male participant, if sexually active with a female of childbearing potential,
is willing to use a highly effective and reliable method of contraception for 1 year
after receiving trial treatment. All male participants absolutely refrain from
donating sperm during the trial and for 1 year after receiving trial treatment.
Exclusion Criteria:
Participants were not enrolled in the trial if they met any of the following
criteria:
1. Patients with non-secretory MM.
2. Prior treatment for MM other than up to 2 cycles of (bortezomib, lenalidomide,
dexamethasone) for induction, including but not limited to cytotoxic therapy,
proteasome inhibitors, immunomodulators, targeted therapy, radiotherapy
(patients are eligible for this trial if the radiation field covers ≤ 5% bone
marrow reserve regardless of the end date of radiotherapy), epigenetic therapy,
etc.
3. Pregnant or lactating females.
4. Patients with severe mental disorders or altered mental status, history of
central nervous system disease, such as epilepsy, intracranial hemorrhage,
paralysis, aphasia, stroke, severe brain injury, dementia, Parkinson's disease,
cerebellar disease, memory impairment, spinal cord compression, psychiatric
disease or any disease involving the central nervous system, or suspected
central nervous system (CNS) metastasis, or any autoimmune disease involving
the CNS, with or suspected CNS infiltration.
5. Participants had other malignancies, including the following that were
considered to have been successfully treated: non-metastatic basal cell or
squamous cell skin cancer, non-metastatic prostate cancer, carcinoma in situ of
the breast or cervix, and non-muscle invasive bladder cancer.
6. Active autoimmune disease that results in end organ damage or requires systemic
immunosuppressive/systemic disease modifying drugs, including but not limited
to Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus and
other patients requiring long-term immunosuppressive therapy.
7. Have any uncontrolled active infection (defined as exhibiting persistent signs
or symptoms associated with infection that do not improve despite appropriate
anti-infective therapy), or other serious active viral, bacterial, or
uncontrolled systemic fungal infection. I
8. Positive test results for biomarkers of any of the following pathogenic
microorganisms: human immunodeficiency virus (HIV) antibody, Treponema pallidum
antibody (TPPA), hepatitis C virus (HCV) antibody, hepatitis B virus (HBV)
surface antigen (HBsAg) (core antigen [HBcAb] positive must have DNA copies
below the lower limit of normal).
9. Vaccination with live attenuated vaccine or mRNA vaccine within 8 weeks and
inactivated vaccine within 4 weeks prior to screening.
10. Patients who are allergic or intolerant to lymphodpletion drugs, tocilizumab,
or allergic to the ingredients of CT071 cell infusion preparation (DMSO); Or
previous history of other severe allergies, such as anaphylactic shock.
11. Clinically significant cardiac abnormalities, including but not limited to:
1)Uncontrolled congestive heart failure (New York Heart Association Class III or IV
heart failure, see Appendix 3); 2)Myocardial infarction, coronary artery bypass
grafting or unstable angina within 6 months prior to apheresis; 3)History of
clinically significant uncontrolled cardiac arrhythmias such as ventricular
arrhythmias; 4)History of severe non-ischemic cardiomyopathy; 5)Left ventricular
ejection fraction (LVEF) < 50%, diagnosed by echocardiography, without clinically
significant ECG abnormalities; 6)Other heart disease that, in the opinion of the
investigator, may jeopardize the health of the participant when participating in
this clinical trial.
12.Participants with known or suspected chronic obstructive pulmonary disease (COPD)
with a forced expiratory volume in 1 second (FEV1) < 50% of the predicted normal
value of spirometry, or other lung disease that, in the judgment of the
investigator, significantly affects lung function or affects the safety of the
participant, such as asthma, interstitial lung disease, diffuse lung disease,
pulmonary infection, pulmonary embolism, etc.
13.No need for supplemental oxygen for maintenance and oxygen saturation < 92% in
room air.
14.Participant has a history of stroke or seizure within 6 months prior to the
screening period.
15.Has had major surgery before screening, or is planned to undergo major surgery
after the trial treatment (excluding cataract and other surgery under local
anesthesia). The investigator must discuss with the sponsor to determine whether a
surgery is major surgery before enrolling the participant in the trial.
16.The participant has not recovered to Common Terminology Criteria for Adverse
Events (CTCAE) v5.0 ≤ Grade 1 from toxicities attributable to previous treatments,
except for alopecia, peripheral neuropathy, and other events that, in the judgment
of the investigator, are unlikely to result in lymphodepletion or cumulative
toxicities of CT071 treatment; 17.Other conditions considered inappropriate for
participation in this clinical trial by the investigator.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Juan Du
Address:
City:
Shanghai
Zip:
200000
Country:
China
Status:
Recruiting
Contact:
Last name:
Juan Du
Phone:
15800706091
Email:
juan_du@live.com
Investigator:
Last name:
Juan Du, PhD
Email:
Principal Investigator
Start date:
June 6, 2024
Completion date:
June 3, 2027
Lead sponsor:
Agency:
Shanghai Changzheng Hospital
Agency class:
Other
Collaborator:
Agency:
CARsgen Therapeutics Co., Ltd.
Agency class:
Industry
Source:
Shanghai Changzheng Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06407947
