Trial Title:
LCAR-M61S and LCAR-M61D in Treatment of Relapsed/Refractory Multiple Myeloma
NCT ID:
NCT06472479
Condition:
Relapsed/Refractory Multiple Myeloma
Conditions: Official terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Vidarabine
Cyclophosphamide
Fludarabine
Fludarabine phosphate
Conditions: Keywords:
Multiple myeloma
Relapsed/Refractory multiple myeloma
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
Single Group Assignment & Two-cohort; LCAR-M61S and LCAR-M61D cells preparation
intravenous infusion; Pretreatment of cyclophosphamide and fludarabine.
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
LCAR-M61S cells preparation
Description:
Biological:
LCAR-M61S or LCAR-M61D cells intravenous infusion; Prior to infusion of the LCAR-M61S and
LCAR-M61D cell preparation, Subjects will receive a conditioning premedication regimen
consisting of cyclophosphamide and fludarabine.
Arm group label:
LCAR-M61S and LCAR-M61D
Other name:
Cyclophosphamide
Other name:
Fludarabine
Intervention type:
Biological
Intervention name:
LCAR-M61D cells preparation
Description:
Biological:
LCAR-M61S or LCAR-M61D cells intravenous infusion; Prior to infusion of the LCAR-M61S and
LCAR-M61D cell preparation, Subjects will receive a conditioning premedication regimen
consisting of cyclophosphamide and fludarabine.
Arm group label:
LCAR-M61S and LCAR-M61D
Other name:
Cyclophosphamide
Other name:
Fludarabine
Summary:
A prospective, two-cohort, open-label dose-exploration and expansion study to evaluate
the safety, tolerability, pharmacokinetics, and antitumor efficacy characteristics of
LCAR-M61S and LCAR-M61D in patients with relapsed/refractory multiple myeloma.
Detailed description:
This study was a prospective, two-cohort, open-label clinical study to evaluate the
safety, tolerability, pharmacokinetics, and antitumor efficacy characteristics of
LCAR-M61S and LCAR-M61D in patients with relapsed/refractory multiple myeloma. All
subjects who meet the eligibility criteria will receive intravenous injection of
LCAR-M61S or LCAR-M61D cell injection. The study will include the following sequential
phases: screening, apheresis, pre-treatment (lymphodepleting chemotherapy), treatment,
and follow-up.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Subjects voluntarily participate in clinical research;
- Age ≥18 years old;
- Eastern Cooperative Oncology Group (ECOG) score 0-2;
- Examination evidence of initial diagnosis of MM according to IMWG diagnostic
criteria;
- Measurable lesions were present;
- Subjects have received at least three previous lines of multiple myeloma therapy,
each with at least one complete therapy cycle, unless the best response to the
therapeutic regimen was documented as disease progression (PD confirmed according to
IMWG criteria);
- Expected survival ≥3 months;
- Clinical laboratory values in the screening period meet criteria;
Exclusion Criteria:
- Received previous therapy targeting GPRC5D and/or CD19 targets;
- Prior antineoplastic therapy and meet exclusion criteria (before apheresis);
- Subjects had Waldenstrom macroglobulinemia, POEMS syndrome, or primary AL
amyloidosis at the time of screening.
- Subjects who were positive for any of HBsAg, HBV DNA, HCV-Ab, HCV RNA, and HIV-Ab;
- Life-threatening allergic reactions, hypersensitivity reactions, or intolerance to
CAR-T cell formulations or their excipients, including DMSO, are known.
- Serious underlying diseases were present;
- Female subjects who were pregnant, breastfeeding, or planning to become pregnant
while participating in this study or within 1 year of receiving study treatment.
- Also enrolled in other clinical studies.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Anhui Cancer Hospital
Address:
City:
Hefei
Zip:
230031
Country:
China
Contact:
Last name:
Kaiyang Ding
Phone:
13966672170
Email:
dingky@126.com
Facility:
Name:
Henan Cancer Hospital
Address:
City:
Zhengzhou
Zip:
450003
Country:
China
Contact:
Last name:
Xudong Wei
Phone:
13837169301
Email:
weixudong63@126.com
Facility:
Name:
Jiangsu Province Hospital
Address:
City:
Nanjing
Zip:
210029
Country:
China
Contact:
Last name:
Lijuan Chen
Phone:
15850521836
Email:
chenljb@126.com
Facility:
Name:
Beijing Gobroad Hospital
Address:
City:
Beijing
Zip:
102206
Country:
China
Contact:
Last name:
Kai Hu
Phone:
15010390336
Email:
huk@gobroadhealthcare.com
Start date:
July 1, 2024
Completion date:
October 12, 2029
Lead sponsor:
Agency:
The First Affiliated Hospital with Nanjing Medical University
Agency class:
Other
Collaborator:
Agency:
Nanjing Legend Biotech Co.
Agency class:
Industry
Source:
The First Affiliated Hospital with Nanjing Medical University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06472479
