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Trial Title:
Universal BCMA-targeted LUCAR-B68 Cells in Patients With Relapsed/Refractory Multiple Myeloma
NCT ID:
NCT05498545
Condition:
Relapsed/Refractory Multiple Myeloma
Conditions: Official terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
LUCAR-B68 cells product
Description:
Before treatment with LUCAR-B68 cells, subjects will receive a conditioning regimen
Arm group label:
LUCAR-B68 cells product
Summary:
A Clinical Study to Evaluate the Safety, Tolerability, and Efficacy of Universal
BCMA-targeted LUCAR-B68 Cells Product in Patients With Relapsed/Refractory Multiple
Myeloma
Detailed description:
This is a prospective, single-arm, open-label, dose-finding and dose-expansion study that
evaluates the safety, tolerability, PK, and anti-tumor efficacy of LUCAR-B68 cell
preparations in relapsed/refractory multiple myeloma subjects who received adequate
standard therapy
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Second Affiliated Hospital of Xi'an Jiaotong University
Address:
City:
Xi'an
Zip:
710000
Country:
China
Start date:
September 2022
Completion date:
March 2027
Lead sponsor:
Agency:
Second Affiliated Hospital of Xi'an Jiaotong University
Agency class:
Other
Collaborator:
Agency:
Nanjing Legend Biotech Co.
Agency class:
Industry
Source:
Second Affiliated Hospital of Xi'an Jiaotong University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05498545
