A Phase Ⅱ Clinical Study Evaluating the Efficacy and Safety of Human BCMA Targeted T Cells Injection Therapy for Relapsed/Refractory Multiple Myeloma

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

A Phase Ⅱ Clinical Study Evaluating the Efficacy and Safety of Human BCMA Targeted T Cells Injection(BCMA CAR-T) Therapy for R/R MM. Patients will be given a conditioning chemotherapy regimen of fludarabine and cyclophosphamide followed by a single infusion of BCMA CAR+ T cells.

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

• Subjects volunteer to participate in clinical trails, understand and inform the trials and sign informed consent form, be willing to complete all the trial procedures;

• 18 to 75 years old (including cut-off value),gender is not limited;

• Expected survival \> 12 weeks;

• Previously diagnosed as multiple myeloma by the International Myeloma Working Group(IMWG) updated criteria;

• One of the following indicators is satisfied:

‣ Serum M protein ≥ 5 g/L;

⁃ Urine M protein ≥ 200 mg/24h;

⁃ Affected serum free light chain ≥ 100 mg/L and Serum free light chain ratio is abnormal ;

• Patients with relapsed/refractory multiple myeloma, satisfying:

‣ Patients have received at least 3 prior MM treatment regimens containing at least one proteasome inhibitor and one immunomodulator;

⁃ Progress is documented within 12 months of the most recent antimyeloma treatment, or efficacy assessment does not reach minimal response(MR) or above or progression within 60 days of the most recent antimyeloma treatment;

• ECOG score 0-2;

• Autologous hematopoietic stem cell transplantation is not possible or relapses after autologous hematopoietic stem cell transplantation, but requires further treatment at the investigator's discretion;

• Liver, kidney and cardiopulmonary functions meet the following requirements:

‣ Creatinine clearance rate (estimated by CockcroftGault formula)≥40mL/min;

⁃ Total bilirubin≤2×ULN; Alanine aminotransferase (ALT) ≤2.5×ULN and aspartate aminotransferase (AST)≤2.5×ULN;

⁃ Left ventricular ejection fraction \>50%;

⁃ Baseline peripheral oxygen saturation\>95%;

• The venous access required for collection can be established, no contraindications to leukocyte collection, and leukepheresis can be carried according to the judgement of investigators, satisfying hemoglobin≥70g/L,platelets ≥50×10\^9 / L, neutrophils ≥1.0×10\^9/L.

Locations
Other Locations
China
Shanghai Changzheng Hospital
RECRUITING
Shanghai
The First Affiliated Hospital of Wenzhou Medical University
RECRUITING
Wenzhou
Contact Information
Primary
Xuedong Sun, M.D.
sunxuedong@dashengbio.com
+8615811287219
Time Frame
Start Date: 2022-07-12
Estimated Completion Date: 2027-07-31
Participants
Target number of participants: 100
Treatments
Experimental: Human BCMA Targeted T Cells Injection
Single administration:6.0×10\^6 CAR+T/kg
Related Therapeutic Areas
Sponsors
Leads: Hrain Biotechnology Co., Ltd.
Collaborators: First Affiliated Hospital of Wenzhou Medical University, Shanghai Changzheng Hospital

This content was sourced from clinicaltrials.gov