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UNKNOWNPHASE1

A Study of BCMA-directed CAR-T Cells Treatment in Subjects With r/r Multiple Myeloma

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

NCT03815383•The First Affiliated Hospital with Nanjing Medical University

View on ClinicalTrials.gov

Summary

This is a single-center, non-randomized and dose-escalation 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.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Volunteered to participate in this study and signed informed consent.
•2. Age 18-75 years old, male or female.
•3. Meet the internationally accepted Criteria for the diagnosis of multiple myeloma (IMWG diagnostic criteria 2014).
•4. Patients with relapsed or refractory multiple myeloma.
•5. 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
•6. Bone marrow sample is confirmed as BCMA-positive by flow cytometry or pathological examination.
•7. At least 2 weeks from monoclonal antibody therapy prior to CAR T cell therapy.
+6 more criteria

Exclusion Criteria

•1. Have a history of allergy to cellular products.
•2. 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.
•3. Subjects with the clinically significant cardiovascular diseases.
•4. A history of craniocerebral trauma, consciousness disorder, epilepsy, severe cerebral ischemia or hemorrhagic disease.
•5. Use any anticoagulant (except aspirin).
•6. Patients requiring urgent treatment due to tumor progression or spinal cord compression.
•7. Patients with active CNS involvement or clinical syndrome of MM meningeal involvement.
•8. After allogeneic hematopoietic stem cell transplantation.
•9. Plasma cell leukemia.
•10. Subjects with any autoimmune disease or any immune deficiency disease or other disease in need of immunosuppressive therapy.
+7 more criteria

Locations (1)

the First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

Key Dates

Start Date

April 11, 2019

Primary Completion Date

January 1, 2021

Completion Date

April 1, 2021

Last Updated

July 5, 2019

Enrollment

ESTIMATED participants

Conditions

Relapsed or Refractory Multiple Myeloma

Interventions

C-CAR088

BIOLOGICAL

Contacts

Jianyong Li, PhD

CONTACT

025-83718836,83714511 lijianyonglm@126.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 5, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study of BCMA-directed CAR-T Cells Treatment in Subjects With r/r Multiple Myeloma

Inclusion Criteria

Exclusion Criteria

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