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

NCT03815383 | Unknown Phase 1

• 1 other identifier: 0203-008
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Relapsed or Refractory Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

• Safety:TEAEs

  The incidence of treatment-emergent adverse events (TEAEs)

  30 days

Secondary Outcomes (2)

• ORR

  12 months

• PFS

  6 months, 12 months

Study Arms (1)

C-CAR088

EXPERIMENTAL

Lymphocytes will be transduced with lentiviral vector containing CAR-BCMA gene

Biological: C-CAR088

Interventions

C-CAR088 BIOLOGICAL

Autologous BCMA-directed CAR-T cells by a single infusion intravenously will be given in escalating doses.

Also known as: CBM.BCMA Chimeric Antigen Receptor T cell

C-CAR088

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Volunteered to participate in this study and signed informed consent.
• Age 18-75 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.
• 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
• Bone marrow sample is confirmed as BCMA-positive by flow cytometry or pathological examination.
• At least 2 weeks from monoclonal antibody therapy prior to CAR T cell therapy.
• ECOG scores 0 - 1.
• Normal cardiac diastolic function, left ventricular ejection fraction (LVEF) ≥ 50% (detected by echocardiography), no serious arrhythmia.
• No active pulmonary infections, normal pulmonary function and oxygen saturation ≥ 92% on room air.
• No contraindications of leukapheresis.
• Expected survival \> 12 weeks.

You may not qualify if:

• 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 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 active CNS involvement or clinical syndrome of MM meningeal involvement.
• After allogeneic hematopoietic stem cell transplantation.
• Plasma cell leukemia.
• Subjects with any autoimmune disease or any immune deficiency disease or other disease in need of immunosuppressive therapy.
• Uncontrolled active infection.
• Prior treatment with CAR T therapy or any other genetically modified T cell therapy.
• Live vaccine inoculation within four weeks before enrollment.
• Hepatitis B or hepatitis C virus infection (including carriers), syphilis, as well as acquired, congenital immune deficiency diseases, including but not limited to HIV-infected persons.
• Have a history of alcoholism, drug addiction and mental illness.

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

Study Sites (1)

the First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210000, China

RECRUITING

Related Publications (1)

• Qu X, An G, Sui W, Wang T, Zhang X, Yang J, Zhang Y, Zhang L, Zhu D, Huang J, Zhu S, Yao X, Li J, Zheng C, Zhu K, Wei Y, Lv X, Lan L, Yao Y, Zhou D, Lu P, Qiu L, Li J. Phase 1 study of C-CAR088, a novel humanized anti-BCMA CAR T-cell therapy in relapsed/refractory multiple myeloma. J Immunother Cancer. 2022 Sep;10(9):e005145. doi: 10.1136/jitc-2022-005145.

  PMID: 36100310 DERIVED

MeSH Terms

Conditions

Recurrence; Multiple Myeloma

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Central Study Contacts

Jianyong Li, PhD

CONTACT

025-83718836,83714511; lijianyonglm@126.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2019
• First Posted: January 24, 2019
• Study Start: April 11, 2019
• Primary Completion: January 1, 2021
• Study Completion: April 1, 2021
• Last Updated: July 5, 2019

Record last verified: 2018-12

Locations

CN (1)