A Single-Arm, Single-Center Clinical Study to Evaluate the Safety and Efficacy of CAR-T in the Treatment of Multiple Myeloma

Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

This is a single arm, single center clinical study evaluating the safety and efficacy of CAR-T treatment for multiple myeloma.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
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• 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.

Locations
Other Locations
China
Shenzhen Qianhai Shekou Free Trade Zone Hospital
RECRUITING
Shenzhen
Contact Information
Primary
Yang Xiao, MD
jdxiao111@163.com
13902213175
Backup
Liya Wei, MD
45000674@qq.com
18824309836
Time Frame
Start Date: 2023-09-13
Estimated Completion Date: 2029-05-31
Participants
Target number of participants: 40
Treatments
Experimental: BCMA/GPRC5D double CAR-T
The study plans to enroll 40 subjects, with a sample size based on actual occurrence and a dosage of 3 × 106/kg ± 20%\~1 × 107/kg ± 20% CAR positive T cells
Related Therapeutic Areas
Sponsors
Leads: Guangzhou Bio-gene Technology Co., Ltd

This content was sourced from clinicaltrials.gov