A Phase Ⅰ Study Evaluating Safety and Efficacy of C-CAR088 Treatment in Subjects With Relapsed or Refractory Multiple Myeloma

Hebei Yanda Ludaopei Hospital1 site in 1 country10 target enrollmentJanuary 8, 2019

ConditionsRelapsed or Refractory Multiple Myeloma

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Relapsed or Refractory Multiple Myeloma
Sponsor: Hebei Yanda Ludaopei Hospital
Enrollment: 10
Locations: 1
Primary Endpoint: Safety: The incidence of treatment-emergent adverse events (TEAEs)
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This is a single-center, non-randomized study to evaluate the safety and efficacy of C-CAR088 in relapsed or refractory multiple myeloma patient.

Detailed Description

The study will include the following sequential phases: Screening, Pre-Treatment (Cell Product Preparation, Lymphodepleting Chemotherapy), C-CAR088 infusion and Follow-up.

Registry

clinicaltrials.gov

Start Date

January 8, 2019

End Date

October 30, 2020

Last Updated

6 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Hebei Yanda Ludaopei Hospital

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Volunteered to participate in this study and signed informed consent.
•Age 18-70 years old, male or female.
•Meet the internationally accepted Criteria for the diagnosis of multiple myeloma (IMWG diagnostic criteria 2014).
•Patients with relapsed or refractory multiple myeloma who meet at least one of the following conditions:
•Subjects must have received at least two therapy regimens (including proteasome inhibitor or immune-modulator therapy, disease progress or relapse after the last therapy).
•Subjects have received only one therapy regimen, but the investigators judge that patients have unmet treatment needs or can't get benefit from current treatment options.
•Subjects have one or more measurable multiple myeloma lesion, must include one of the following conditions:
•Serum M protein≥1 g/dl(10g/L)
•Urine M protein≥200 mg/24h
•Serum free light chain(sFLC): κ/λ ratio abnormal and ≥10 mg/dl

Exclusion Criteria

•Have a history of allergy to cellular products.
•Any kind of these laboratory testing: including but not limited to,serum total bilirubin≧1.5mg/dl, serum ALT, AST≧2.5×ULN, serum creatinine≧2.0mg/dl, Hb (hemoglobin)\<80g/L, neutrophils\<1000/mm\^3, platelets≦50000/mm\^3 or platelet count maintained by transfusion.
•Subjects with the following clinically significant cardiovascular diseases.
•A history of craniocerebral trauma, consciousness disorder, epilepsy, severe cerebral ischemia or hemorrhagic disease.
•Use any anticoagulant (except aspirin).
•Patients requiring urgent treatment due to tumor progression or spinal cord compression.
•Patients with CNS metastasis or symptoms of CNS involvement.
•The investigators judge that any increase in the risk of the subject or interference with the results of the trial.
•After allogeneic hematopoietic stem cell transplantation.
•Plasma cell leukemia.