Clinical Study of T Cell Infusion Targeting BCMA Chimeric Antigen Receptor

Launched by PERSONGEN BIOTHERAPEUTICS (SUZHOU) CO., LTD. · Nov 25, 2020

Keywords

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Gender

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Eligibility criteria

• Inclusion Criteria:
• • 1. Subjects who voluntarily participated in the study and signed written informed consent;
• • 2. The age of signing informed consent is 14-65 years old;
• • 3. Patients with multiple myeloma were diagnosed according to the IMWG diagnostic criteria;
• • 4. The expression of BCMA was confirmed by flow cytometry or immunohistochemistry;
• • 5. The expected survival time was \> 12 weeks;
• • 6. The main researchers and attending physicians believe that there is no other feasible and effective alternative treatment, such as hematopoietic stem cell transplantation;
• • 7. Relapsed or refractory multiple myeloma (mm) A. At least one complete regimen including induction, consolidation and maintenance of proteasome inhibitors and / or immunomodulators was performed at least once, and the interval between the two regimens was more than 3 months; B. According to the criteria of IMWG, recurrence was considered; C. Refractory patients (disease progression during standard treatment; efficacy of proteasome inhibitor combined with immunomodulator less than PR; efficacy after autologous stem cell transplantation less than PR; disease progression within 6 months after transplantation; progression and recurrence within 1 year after initial treatment); D. Recurrence occurred after allogeneic SCT treatment;
• • 8. The main organ functions are sound, including: A. Renal function: serum creatinine clearance rate \> 40 ml / min / 1.73 m2, adjusted according to age / gender standard; B. Alanine transferase (ALT) was less than 2 times the normal maximum value of the same age; C. Bilirubin \< 2.0 mg / dl; D. Echocardiography or multi gated angiography (MUGA) showed left ventricular short axis shortening (LVSF) ≥ 28%, or left ventricular ejection fraction (LVEF) ≥ 45%;
• • 9. ECOG physical status (PS) ≤ 2;
• • 10. The pregnant test results of fertile female subjects within 48 hours before infusion were negative, and they were not in lactation period; all subjects with reproductive potential should take adequate contraceptive measures from the beginning of the study to one year after the end of the study.
• Exclusion Criteria:
• • 1. Pregnant or lactating female patients;
• • 2. Participate in another clinical trial within 4 weeks before enrollment (3 months in case of monoclonal antibody clinical trial) or intend to participate in another clinical trial during the whole study period;
• • 3. Other anti BCMA treatments have been used in the past;
• • 4. Uncontrolled active infection; for example, there is a known history of human immunodeficiency virus; active hepatitis B or hepatitis C infection; HBV-DNA detection exceeds normal, etc;
• • 5. There is grade 2-4 acute or systemic chronic GVHD or GVHD under treatment;
• • 6. Cns-3 disease progression, or the presence of central nervous system parenchymal lesions that may increase the central nervous system toxicity; patients with active central nervous system leukemia infiltration;
• • 7. The researchers think that they are not suitable to participate in this clinical trial due to various reasons.