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

NCT04322292 | Completed Phase 1

• 1 other identifier: QT2019007
• Study Type: interventional
• Target: 9
• 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

Multiple Myeloma

Keywords

Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

• Safety: The incidence of treatment-emergent adverse events (TEAEs)

  The incidence of treatment-emergent adverse events (TEAEs)

  30 days

Secondary Outcomes (4)

• Overall response rate (ORR)

  12 months

• Progression free survival (PFS)

  6 months、12 months

• The CART cell duration in vivo

  12 months

• The soluble BCMA changes in peripheral blood

  12 months

Study Arms (1)

C-CAR088

EXPERIMENTAL

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

Drug: C-CAR088

Interventions

C-CAR088 DRUG

Autologous BCMA-directed CAR-T cells, single infusion intravenously at a target dose of 1.0-9.0 x 10\^6 anti-BCMA CAR+T cells/kg. Other Name: 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:

• Age 18-75 years old, male or female;
• The patient volunteered to participate in the study, and he or his legal guardian signed the Informed Consent;
• Meet the internationally accepted Criteria for the diagnosis of multiple myeloma (IMWG diagnostic criteria 2014);
• Patients with a clear diagnosis of relapsed or refractory multiple myeloma；
• The patient have one or more measurable multiple myeloma lesion, must include one of the following conditions:
• Serum M protein≥1.0 g/dL(10g/L)
• Urine M protein≥200 mg/24h
• Serum free light chain(sFLC): κ/λ FLC ratio is abnormal and affected FLC ≥10mg / dL
• Bone marrow sample is confirmed as BCMA-positive by flow cytometry or pathological examination;
• ECOG scores 0 - 1;
• Echocardiography showed normal diastolic function, left ventricular ejection fraction (LVEF) ≥50%, and no severe arrhythmia;
• No active pulmonary infections, normal pulmonary function and oxygen saturation ≥ 92% on room air.
• Absolute neutrophil count ≥1.0 × 109 / L, platelet count ≥50 × 109 / L; total serum bilirubin ≤1.5mg / dl; serum ALT or AST less than 2.5 times the upper limit of normal; serum creatinine ≤2.0mg / dl;
• No contraindications of peripheral blood apheresis;
• Expected survival time \> 12 weeks;.

You may not qualify if:

• Have a history of allergy to cellular products;
• Presence of clinically significant cardiovascular disease;
• A history of craniocerebral trauma, consciousness disorder, epilepsy, severe cerebral ischemia or hemorrhagic disease;
• Need to 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;
• After allogeneic hematopoietic stem cell transplantation;
• Plasma cell leukemia;
• Received systemic anti-tumor treatment within 2 weeks before apheresis, and within 1 week before apheresis, prednisone (or equivalent amount of other corticosteroids) was applied in excess of 5 mg/d ;
• Patients with autoimmune diseases, immunodeficiency, or other immunosuppressive agents;
• Uncontrolled active infection;
• Have used any CAR T cell products or other genetically modified T cell therapy before;
• 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;
• Participated in any other clinical trial within 1 months;

Sponsors & Collaborators

• Institute of Hematology & Blood Diseases Hospital, China: lead

Study Sites (1)

InstituteHBDH

Tianjin, 300000, China

Location

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

Multiple Myeloma

Condition Hierarchy (Ancestors)

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

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: March 24, 2020
• First Posted: March 26, 2020
• Study Start: September 12, 2019
• Primary Completion: September 22, 2022
• Study Completion: September 22, 2022
• Last Updated: February 11, 2026

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)