CAR-T Injection in Transplant In-Eligible Newly Diagnosed Multiple Myeloma Patients

Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Early Phase 1
SUMMARY

This is a single-arm, single-center, open-label clinical study to evaluate the safety and efficacy of CAR-T in patients with NDMM.

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

• Age ≥18 when signing informed consent form(ICF)

• Documented evidence of multiple myeloma at diagnosis as defined by IMWG guidelines ,monoclonal plasma cells in the bone marrow ≥10% and/or serum M protein ≥ 3 g/dL and/or 24h urine light chain ≥ 500 mg and/or presence of a biopsy proven plasmacytomas, not meet evidence of Smoldering Myeloma with SLiM/CRAB syptoms, and meet at least 2 of a-c or meet d of the following criteria at screening:

∙ Serum M protein ≥ 2 g/dL;

‣ Serum involved / uninvolved free light chain ratio ≥ 20;

‣ Bone marrow involved with monoclonal plasma cells ≥20% ;

‣ With Cytogenetic high-risk markers.

• Or documented evidence of multiple myeloma at diagnosis as defined by IMWG guidelines CRAB (calcium elevation, renal insufficiency, anemia, and bone abnormalities)/SLiM criteria, monoclonal plasma cells in the bone marrow ≥10% or presence of a biopsy proven plasmacytomas, and measurable secretory disease according to IMWG criteria meet one or more of the following criteria at screening:

∙ Serum M protein ≥ 1 g/dL;

‣ Urine M protein ≥ 200 mg/24h;

‣ Serum free light chain sFLC ≥ 10 mg/dL with abnormal serum immunoglobulin κ/λ free light chain ratio.

• ECOG score was 0-3 at screen;

• Estimated life expectancy ≥3 months;

• Absolute neutrophil count (ANC) ≥ 1.5×10\^9/L without use of growth factors;

• Platelet count ≥ 50×10\^9/L without transfusion support within 7 days before the screen;

• Hemoglobin≥ 60 g/L;

• Adequate functional reserve of organs:

∙ ALT/AST ≤ 2.5× ULN(Upper Limit of Normal);

‣ Creatinine clearance ≥ 15mL/min;

‣ Serum total bilirubin ≤ 1.5×ULN, except in subjects with congenital bilirubinemia,then direct bilirubin ≤ 1.5×ULN;

‣ The left ventricular ejection fraction (LVEF)≥50%, and no clinically significant ECG abnormalities were found;

‣ Basic oxygen saturation in natural indoor air: SPO2\>92%.

⁃ Adequate venous access for apheresis collection, and no other contraindications to apheresis;

⁃ Subjects and sexual partner with fertility are willing to use effective and reliable method of contraception for at least 1 year after CAR-T cell infusion, serum HCG should be negative in females with fertility both at screening and baseline;

⁃ Subjects must sign a written informed consent.

Locations
Other Locations
China
Shanghai Changzheng Hospital
RECRUITING
Shanghai
Contact Information
Primary
Juan Du, MD
changzheng_pg@163.com
+86-21 -81885423
Time Frame
Start Date: 2023-05-04
Estimated Completion Date: 2025-09-30
Participants
Target number of participants: 18
Treatments
Experimental: GC012F treatment
CAR-T will be infused at a dose of 0.6,1.5,3 x 10\^5 CAR-T cells/kg after receiving lymphodepleting chemotherapy. Lenalidomide maintenance therapy will be given post month 6 at physicians' choice.
Related Therapeutic Areas
Sponsors
Leads: Shanghai Changzheng Hospital
Collaborators: Gracell Biotechnologies (Shanghai) Co., Ltd.

This content was sourced from clinicaltrials.gov