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

NCT03751293 | Unknown Phase 1 DMC

• 1 other identifier: 0203-006
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Relapsed or Refractory 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

Biological: C-CAR088

Interventions

C-CAR088 BIOLOGICAL

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

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

C-CAR088

Eligibility Criteria

• Age: 18 Years - 70 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 18-70 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
• 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.

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 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.
• One week before leukapheresis and one week before CART cell infusion, treated with more than 5mg/d prednisone (or equal amount of other corticosteroids).
• 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.

Sponsors & Collaborators

• Hebei Yanda Ludaopei Hospital: lead

Study Sites (1)

Hebei Yanda Ludaopei Hospital

Sanhe, Hebei, 065200, 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

Peihua Lu, PhD&MD

CONTACT

+86-0316-3306393; peihua_lu@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: November 15, 2018
• First Posted: November 23, 2018
• Study Start: January 8, 2019
• Primary Completion: October 30, 2019
• Study Completion: October 30, 2020
• Last Updated: May 15, 2019

Record last verified: 2019-05

Locations

CN (1)