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

Primary Purpose

Relapsed or Refractory Multiple Myeloma

Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
C-CAR088
Sponsored by
The First Affiliated Hospital with Nanjing Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Relapsed or Refractory Multiple Myeloma

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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.
  8. ECOG scores 0 - 1.
  9. Normal cardiac diastolic function, left ventricular ejection fraction (LVEF) ≥ 50% (detected by echocardiography), no serious arrhythmia.
  10. No active pulmonary infections, normal pulmonary function and oxygen saturation ≥ 92% on room air.
  11. No contraindications of leukapheresis.
  12. Expected survival > 12 weeks.
  13. Female subjects in childbearing age, their serum or urine pregnancy test must be negative,until 7 days before cell therapy and all subjects must agree to take effective contraceptive measures during the trial.

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.
  11. Uncontrolled active infection.
  12. Prior treatment with CAR T therapy or any other genetically modified T cell therapy.
  13. Live vaccine inoculation within four weeks before enrollment.
  14. 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.
  15. Have a history of alcoholism, drug addiction and mental illness.
  16. Participated in any other clinical trial within one month.
  17. The investigators believe that there are other circumstances that are not suitable for the trial.

Sites / Locations

  • the First Affiliated Hospital of Nanjing Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

C-CAR088

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

ORR
Overall response rate
PFS
Progression free survival

Full Information

First Posted
January 22, 2019
Last Updated
July 1, 2019
Sponsor
The First Affiliated Hospital with Nanjing Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT03815383
Brief Title
A Study of BCMA-directed CAR-T Cells Treatment in Subjects With r/r Multiple Myeloma
Official Title
A Phase Ⅰ Study Evaluating Safety and Efficacy of C-CAR088 Treatment in Subjects With Relapsed or Refractory Multiple Myeloma
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Unknown status
Study Start Date
April 11, 2019 (Actual)
Primary Completion Date
January 2021 (Anticipated)
Study Completion Date
April 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The First Affiliated Hospital with Nanjing Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Relapsed or Refractory Multiple Myeloma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
C-CAR088
Arm Type
Experimental
Arm Description
Lymphocytes will be transduced with lentiviral vector containing CAR-BCMA gene
Intervention Type
Biological
Intervention Name(s)
C-CAR088
Other Intervention Name(s)
CBM.BCMA Chimeric Antigen Receptor T cell
Intervention Description
Autologous BCMA-directed CAR-T cells by a single infusion intravenously will be given in escalating doses.
Primary Outcome Measure Information:
Title
Safety:TEAEs
Description
The incidence of treatment-emergent adverse events (TEAEs)
Time Frame
30 days
Secondary Outcome Measure Information:
Title
ORR
Description
Overall response rate
Time Frame
12 months
Title
PFS
Description
Progression free survival
Time Frame
6 months, 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Female subjects in childbearing age, their serum or urine pregnancy test must be negative,until 7 days before cell therapy and all subjects must agree to take effective contraceptive measures during the trial. 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 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. Participated in any other clinical trial within one month. The investigators believe that there are other circumstances that are not suitable for the trial.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jianyong Li, PhD
Phone
025-83718836,83714511
Email
lijianyonglm@126.com
Facility Information:
Facility Name
the First Affiliated Hospital of Nanjing Medical University
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jianyong Li, PhD
Email
lijianyonglm@126.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
36100310
Citation
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.
Results Reference
derived

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

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