Universal BCMA-targeted LUCAR-B68 Cells in Patients With Relapsed/Refractory Multiple Myeloma

Launched by SECOND AFFILIATED HOSPITAL OF XI'AN JIAOTONG UNIVERSITY · Aug 10, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment for patients with relapsed or refractory multiple myeloma, a type of blood cancer that comes back after treatment or does not respond to treatment. The trial will test a special type of immune cell called LUCAR-B68, which targets a specific protein (BCMA) found on myeloma cells. The main goals are to see if this treatment is safe, how well it works, and if patients can tolerate it without serious side effects.

To be eligible for this study, participants need to be at least 18 years old and have previously been treated for multiple myeloma at least three times. They should have measurable signs of the disease and be willing to follow the study's procedures. Some health conditions may exclude individuals from participating, such as certain infections or serious medical issues. The trial is not yet recruiting participants, but once it starts, those who join can expect to receive close medical care and monitoring during the treatment process. This study is an important step in finding new options for patients who have not had success with standard therapies.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. The subject voluntarily participates in the clinical study; Fully understand and be Informed of the study and sign the Informed consent (Informed Consent Form, ICF); Willing to follow and able to complete all test procedures; Informed consent must be obtained before initiating any tests or procedures related to the study that are not part of the standard treatment of the subject's disease;
• • 2. Subjects ≥ 18 years of age.
• • 3. Eastern Cooperative Oncology Group performance status score of 0, 1, or 2;
• • 4. Documented initial diagnosis of MM according to IMWG diagnostic criteria.
• • 5. Presence of measurable disease at screening.
• • 6. Received a PI and an IMiD (except thalidomide).
• • 7. Received at least 3 prior lines of therapy for multiple myeloma, undergone at least 1 complete cycle of treatment for each line, unless progressive disease (PD) was documented by IMWG criteria as the best response to the regimen. Also, subjects refractory or intolerant to any PI and any IMiD in their previous treatment afterwards are eligible.
• • 8. Expected survival ≥ 3 months.
• • 9. Clinical laboratory values meet screening visit criteria
• • 10. Fertile women must be negative using a highly sensitive serum pregnancy test (β human chorionic gonadotropin \[β -HCG\]) at screening time and before initial treatment with cyclophosphamide and fludarabine;
• Exclusion Criteria:
• • 1. No response to prior BCMA-targeted CAR-T therapy (except in subjects who relapsed after CR to prior CAR-T treatment);
• • 2. Prior treatment with any antibody targeting BCMA;
• • 3. Known active, or prior history of central nervous system (CNS) involvement, or clinical signs of membrane/spinal membrane involvement of multiple myeloma;
• • 4. Serious underlying medical conditions
• • 5. Positive of any hepatitis B surface antigen (HBsAg), hepatitis B virus deoxyribonucleic acid (HBV DNA), hepatitis C antibody (HCV-Ab), hepatitis C virus ribonucleic acid (HCV RNA), human immunodeficiency virus antibody (HIV-Ab) at the time of screening;
• • 6. Male subjects who have a birth plan during the study period or within 1 year after the study treatment
• • 7. Female subjects who are pregnant, breast-feeding, or plan to become pregnant during the study period or within 1 year after the study treatment
• • 8. The investigator considered that the subjects were not suitable for any conditions of participation in the study