Status:
RECRUITING
Clinical Study to Evaluate the Safety and Efficacy of CAR-T in the Treatment of Multiple Myeloma
Lead Sponsor:
Guangzhou Bio-gene Technology Co., Ltd
Conditions:
Multiple Myeloma in Relapse
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
This is a single arm, single center clinical study evaluating the safety and efficacy of CAR-T treatment for multiple myeloma.
Detailed Description
This study is a single arm, single center study targeting patients with recurrent/refractory multiple myeloma (r/rMM). The study plans to enroll 40 subjects, with a sample size based on actual occurre...
Eligibility Criteria
Inclusion
- Patients or their guardians understand and voluntarily sign the informed consent form, and are expected to complete the follow-up examination and treatment of study procedures;
- Aged 18-75 years, male or female;
- According to IMWG diagnostic criteria, diagnosed with multiple myeloma;
- Patients with documented multiple myeloma disease as relapsed refractory or primary refractory, defined as: a) relapsed refractory: no response to salvage therapy (no response defined as failure to achieve minimal response \[MR\] or disease progression on treatment), or disease progression within 60 days of the last treatment, or disease progression in patients who have achieved MR or above remission; b) primary refractory: never achieved MR or above response to any treatment, including never achieved MR or above remission, but M protein changes are not large, patients without evidence of clinical progression and patients who have primary refractory, progressed, and met the definition of progression.
- the presence of measurable disease at screening as determined by any of the following criteria: serum monoclonal paraprotein (M-protein) level ≥ 1.0 g/dL or urine M-protein level ≥ 200 mg/24 hours; or diagnosis of light chain multiple myeloma without measurable disease in serum or urine: serum immunoglobulin free light chain ≥ 10 mg/dL and abnormal serum immunoglobulin κ/γ free light chain ratio; extramedullary measurable disease; the presence of tumor cells in the bone marrow as detected;
- the patient has recovered from the toxicity of previous treatment, that is, CTCAE toxicity grade \< 2 (unless the abnormality is tumor-related or judged by the investigator to be stable, it has little effect on safety or efficacy);
- ECOG performance status score 0 to 2 and expected survival greater than 3 months;
- Appropriate organ function:
- alanine aminotransferase (ALT) ≤ 3 times the upper limit of normal (ULN); aspartate aminotransferase (AST) ≤ 3 times the ULN; total bilirubin ≤ 1.5 times the ULN; Serum creatinine ≤ 1.5 times ULN, or creatinine clearance ≥ 30 mL/min (calculated by Cockcroft-Gault formula); Intraventricular oxygen saturation ≥ 92%; Left ventricular ejection fraction (LVEF) ≥ 45%, no pericardial effusion confirmed by echocardiography, no clinically significant electrocardiographic findings; no clinically significant pleural effusion; 9. venous access for collection can be established, no contraindications for leukocyte collection.
Exclusion
- Diagnosis or treatment of another invasive malignancy other than multiple myeloma within 3 years, with the following exceptions: malignancy treated with curative intent and no known active disease ≥ 3 years prior to enrollment; or adequately treated non-melanoma skin cancer with no evidence of disease;
- previous anticancer therapy (prior to blood collection for CAR-T preparation) as follows: targeted therapy, epigenetic therapy, or investigational agent within 14 days or at least 5 half-lives (whichever is shorter), or invasive investigational medical devices; monoclonal antibody therapy within 21 days; proteasome inhibitor therapy within 14 days; immunomodulator therapy within 7 days; and radiotherapy within 14 days (except for bone marrow reserve with ≤ 5% field coverage);
- Any hematopoietic stem cell transplantation within 2 months before screening;
- History of central nervous system diseases;
- known active central nervous system (CNS) involvement or clinical signs of meningeal involvement in multiple myeloma;
- Waldenström macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal proteinopathy, and skin changes) or primary AL amyloidosis at screening;
- Hepatitis B surface antigen (HBsAg) positive, or hepatitis B core antibody (HBcAb) positive and peripheral blood HBV DNA quantitative detection positive; hepatitis C virus (HCV) antibody positive; human immunodeficiency virus (HIV) antibody positive; cytomegalovirus (CMV) DNA detection positive; syphilis detection positive; Epstein-Barr virus DNA detection positive;
- Patients with a history of severe allergy \[a history of severe allergy is defined as a secondary or above allergic reaction, any of the following clinical manifestations occur when allergic reactions occur: airway obstruction (runny nose, cough, wheezing, dyspnea), tachycardia, hypotension, arrhythmia, gastrointestinal symptoms (nausea, vomiting), incontinence, laryngeal edema, bronchospasm, cyanosis, shock, respiratory, cardiac arrest\] or known allergy to any of the active ingredients, excipients or murine products and xenogeneic proteins contained in this trial (including Qinglin regimen);
- Patients with severe heart disease, including but not limited to severe arrhythmia, unstable angina pectoris, massive myocardial infarction, New York Heart Association class III or IV cardiac insufficiency, myocardial infarction ≤ 6 months before screening or coronary artery bypass grafting (CABG), a history of unexplained syncope and non-vasovagal or dehydration caused by, a history of severe non-ischemic cardiomyopathy, refractory hypertension (refractory hypertension is defined as: the use of reasonable tolerable adequate doses of ≥ 3 antihypertensive drugs (including diuretics) on the basis of lifestyle improvement for \> 1 month of blood pressure is still not up to standard or taking ≥ 4 antihypertensive drugs blood pressure can be effectively controlled);
- unstable systemic diseases judged by the investigator: including but not limited to severe liver, kidney or metabolic diseases requiring drug treatment;
- Patients with acute/chronic graft-versus-host disease (GVHD) within 6 months before screening, or need to receive immunosuppressive agents for GVHD;
- Patients with active autoimmune or inflammatory diseases of the nervous system (e.g., Guillain-Barre syndrome (GBS), amyotrophic lateral sclerosis (ALS)) and clinically significant active cerebrovascular disease (e.g., cerebral edema, posterior reversible encephalopathy syndrome (PRES));
- Neoplastic emergencies (such as spinal cord compression, intestinal obstruction, leukostasis, tumor lysis syndrome, etc.) requiring emergency treatment before screening or reinfusion;
- presence of uncontrollable bacterial, fungal, viral, or other infections requiring antibiotic therapy;
- Hematopoietic cytokine drugs that have been transfused or have an effect on the hemogram of patients such as erythropoietin (EPO), granulocyte colony-stimulating factor (G-CSF), and granulocyte-macrophage colony-stimulating factor (GM-CSF) within 2 weeks of blood collection scheduled for CAR-T preparation at screening, and have an effect on cell preparation as judged by the investigator.
- Receiving hormonal or immunosuppressive agents at screening within 2 weeks of blood collection scheduled for CAR-T preparation and having an effect on cell preparation as judged by the investigator.
- 1\) Corticosteroids: subjects who are receiving systemic steroid therapy within 2 weeks of blood collection scheduled for CAR-T at screening and require chronic systemic steroid therapy during treatment as judged by the investigator (except for inhaled or topical use); and subjects who are receiving systemic steroid therapy within 72 hours before cell reinfusion (except for inhaled or topical use); 2) Immunosuppressants: subjects who are receiving immunosuppressive agents within 2 weeks of blood collection scheduled for CAR-T at screening; 17. Patients who have undergone major surgery (except diagnostic surgery and biopsy) within 4 weeks before Qinglin or plan to undergo major surgery during the study period, or whose surgical wounds have not completely healed before enrollment; 18. Patients who have received (attenuated) live viral vaccines within 4 weeks before screening; 19. patients with severe mental illness; 20. Alcoholics or those who have a history of drug abuse; 21. Pregnant or lactating women, and female subjects who plan to become pregnant within 2 years after cell reinfusion or male subjects whose partners plan to become pregnant within 2 years after cell reinfusion; 22. patients who have contraindications to any study procedure or have other medical conditions that may place them at unacceptable risk according to the investigator 's judgment and/or clinical criteria.
Key Trial Info
Start Date :
September 13 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 31 2029
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06068400
Start Date
September 13 2023
End Date
May 31 2029
Last Update
October 5 2023
Active Locations (1)
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1
Shenzhen Qianhai Shekou Free Trade Zone Hospital
Shenzhen, Guangdong, China, 518000