Clinical Study of the Safety and Efficacy of BCMA CAR-NK

Launched by SHENZHEN PREGENE BIOPHARMA CO., LTD. · Dec 14, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called BCMA CAR-NK cell therapy for patients with multiple myeloma, a type of blood cancer that has come back after treatment or hasn’t responded to previous therapies. The main goals of the study are to see how safe this treatment is and to find out the highest dose that patients can tolerate. Researchers will also look at how well this therapy works, how long the cells last in the body, and how different factors, like the donor's and patient's genetic match, might affect safety and effectiveness.

To be eligible for this trial, participants must be at least 18 years old and have tried multiple treatments for their myeloma without success. They should have measurable signs of the disease and other specific health criteria. If enrolled, patients will first receive a treatment to clear their lymphocytes (a type of immune cell), followed by the infusion of the BCMA CAR-NK cells. After the treatment, participants will be monitored for any side effects and how well the therapy works over time. It's important to note that this study is currently recruiting patients, so there is an opportunity for eligible individuals to participate in this promising research.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age 18 years or above, no gender preference.
• • Patients who have received at least 3 prior lines of treatment for multiple myeloma and have failed at least proteasome inhibitor and immunomodulator therapy; Each line has at least 1 complete treatment cycle unless the best remission status for that treatment is documented as progressive disease (PD) (as per the IMWG efficacy evaluation criteria published in 2016, Appendix 4); PD must be documented during or within 12 months after receiving the last treatment.
• * Presence of measurable lesions at screening, which are defined as any of the following situations:
• • Serum M protein≥1 g/dL (≥10 g/L) Urinary M protein≥200 mg/24 hours Serum free light chain (FLC): abnormal serum FLC ratio (\<0.26 or \>1.65) and involved FLC≥10 mg/dL (100 mg/L)
• • ECOG score (Appendix 1): 0\~1.
• • Expected survival≥3 months.
• * The following test values within 7 days prior to lymphocyte clearance meet the following criteria:
• • Hematology Absolute lymphocyte count:≥0.5×109/L\[Granulocyte colony-stimulating factor (G-CSF) is allowed, but subjects should not have received this supportive therapy within 7 days prior to laboratory test during the screening period\] Absolute neutrophil count:≥1.0×10\^9 /L\[Granulocyte colony-stimulating factor (G-CSF) is allowed, but subjects should not have received this supportive therapy within 7 days prior to laboratory test during the screening period\].
• • Platelets:Subjects platelet count ≥50 x 10\^9/L (subjects must not receive transfusion support within 7 days prior to laboratory test during the screening period) Hemoglobin:≥8.0 g/dL (recombinant human erythropoietin is allowed) \[subjects have not received a red blood cell (RBC) transfusion within 7 days prior to laboratory test during the screening period\].
• • Liver Total bilirubin (serum) :Total bilirubin (serum) ≤1.5 × ULN AST and ALT:≤3× ULN
• • Peripheral venous pathway meets the requirements of intravenous drip.
• • Subjects agree to use reliable methods for contraception from the time of signing the informed consent till 1 year after the transfusion.
• • Voluntary participation in the clinical trial and signing of the informed consent form.
• Exclusion Criteria:
• • Subjects who have had a severe anaphylactic reaction.
• • Subjects who received the following anti-MM therapy within a specific time prior to lymphocyte clearance.
• • Small molecule targeted therapy within 2 weeks or 5 half-lives (whichever is longer).
• • Large-molecule drug within 4 weeks or 2 half-lives (whichever is longer). Cytotoxic drugs, modern Chinese medicine preparations with antitumor effects within 2 weeks.
• • Immunomodulators therapy within 1 week.
• • Subjects who have received a live or attenuated vaccine within 4 weeks prior to lymphocyte clearance.
• * Subjects who have received the following therapy within 7 days prior to lymphocyte clearance, or that requires long-term treatment during the study period according to the investigators:
• • Systemic steroid therapy (except for inhaled one or topical use). Immunosuppressive therapy. Treatment of graft-versus-host response.
• • Subjects presenting with incomplete recovery or stabilization to grade 1 (NCI-CTCAE v5.0) of toxicity (including peripheral neuropathy) caused by prior treatments.
• • Cardiac disease: episode of myocardial infarction≤6 months prior to lymphocyte clearance; episode of unstable angina, severe arrhythmia as judged by the investigators, or coronary artery bypass graft≤3 months prior to lymphocyte clearance.
• • Women who are pregnant or breastfeeding.
• • Subjects who, in the opinion of the investigators, have any clinical or laboratory test abnormalities or other reasons that make them ineligible to participate in this clinical study.