An Investigator-initiated Trial Evaluating the Efficacy and Safety of Anti-GPRC5D CAR-T Cells Therapy in the Treatment of Relapsed / Refractory(r/r) Multiple Myeloma(MM)

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY

It is a single-center, open-labeled, single-arm, non-randomized investigator-initiated trial evaluating the efficacy and safety of anti-GPRC5D CAR-T cells therapy for relapsed and refractory(r/r) multiple myeloma(MM).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• The patient or his/her guardian understands and voluntarily signs the informed consent, and is expected to complete the follow-up examination and treatment of the study procedure;

• Age 18-75 years old, gender unlimited;

• Patients diagnosed with multiple myeloma according to International Myeloma Working Group(IMWG) diagnostic criteria;

• Subjects who had failed treatment with at least 3 drugs of different mechanisms (including chemotherapy, proteasome inhibitors, immunomodulators, etc.), or had progressed or relapsed during the last treatment period or within 6 months after the end of treatment;

• The presence of measurable lesions at screening was determined according to any of the following criteria, defined as: (1) serum monoclonal immunoglobulin (M-protein) level ≥1.0 g/dL; (2) urine M protein level ≥200 mg/ 24h; (3) Light chain multiple myeloma diagnosed with no measurable lesion in serum or urine: serum immunoglobulin free light chain ≥10 mg/dL and serum immunoglobulin κ/γ free light chain ratio abnormal;

• The patient has recovered from the toxicity of the prior treatment, i.e., CTCAE toxicity grade \< 2 (unless the abnormality is related to the tumor or is stable as judged by the investigator and has little impact on safety or efficacy);

• Eastern cooperative oncology group (ECOG) score is 0-2;

• Survival is expected to be greater than 3 months;

• Adequate liver , kidney and cardiopulmonary function;

⁃ Willingness to complete the informed consent process and to comply with study procedures and visit schedule.

Locations
Other Locations
China
920th Hospital of Joint Logistics Support Force of People's Liberation Army of China
RECRUITING
Kunming
No.212 Daguan Road, Xishan District
RECRUITING
Kunming
Contact Information
Primary
Sanbin Wang, MD
Sanbin1011@163.com
13187424131
Backup
Sanbin Wang, MD
Time Frame
Start Date: 2023-02-07
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 18
Treatments
Experimental: Anti-GPRC5D CAR-T
Subjects who meet the enrollment conditions will receive intravenous infusion of anti--GPRC5D CAR-T Cells after lymphodepleting therapy.
Related Therapeutic Areas
Sponsors
Leads: 920th Hospital of Joint Logistics Support Force of People's Liberation Army of China

This content was sourced from clinicaltrials.gov