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

Primary Purpose

Multiple Myeloma

Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
C-CAR088
Sponsored by
Peking Union Medical College Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Myeloma focused on measuring Multiple Myeloma

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age 18-75 years old, male or female;
  2. The patient volunteered to participate in the study, and he or his legal guardian signed the Informed Consent;
  3. Patients with a clear diagnosis of relapsed or refractory multiple myeloma
  4. 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
  5. Bone marrow sample is confirmed as BCMA-positive by flow cytometry or pathological examination;
  6. At least 2 weeks from monoclonal antibody therapy prior to CAR T cell therapy.
  7. ECOG scores 0 - 1;
  8. Good cardiac and pulmonary organ function;
  9. Expected survival time > 12 weeks;.
  10. Female subjects of childbearing age must have a negative urine / blood pregnancy test within 7 days before cell therapy and not be in lactation; female or male subjects of childbearing age need to take effective contraception throughout the study.

Exclusion Criteria:

  1. Have a history of allergy to cellular products;
  2. Laboratory testing occurs when: including but not limited to, serum total bilirubin ≥1.5mg / dl; serum ALT or AST is 2.5 times higher than the upper limit of normal value; serum creatinine ≥2.0mg / dl; hemoglobin <80g / L; absolute neutrophil count <1000 / mm3 or dependent on GCSF or Other growth factors can maintain the centriole count ≥1000 / mm²; platelet count <50000 / mm³ or the above level can be maintained due to platelet transfusion;
  3. Presence of clinically significant cardiovascular disease, such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or any heart function Grade 3 (moderate) or Grade 4 (severe) heart disease (according to the New York Heart Association Function Classification method: NYHA); patients with a history of myocardial infarction, cardiac angioplasty or stent implantation, unstable angina pectoris or other clinically significant heart disease within 12 months before enrollment;
  4. A history of craniocerebral trauma, consciousness disorder, epilepsy, severe cerebral ischemia or hemorrhagic disease;
  5. Need to use any anticoagulant (except aspirin);
  6. Patients requiring urgent treatment due to tumor progression or spinal cord compression;
  7. Patients with CNS metastasis or symptoms of CNS involvement;
  8. After allogeneic hematopoietic stem cell transplantation;
  9. Plasma cell leukemia;
  10. Patients with autoimmune diseases, immunodeficiency, or other immunosuppressive agents;
  11. Uncontrolled active infection;
  12. Have used any CAR T cell products or other genetically modified T cell therapy before;
  13. 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;
  14. Have a history of alcoholism, drug addiction and mental illness;
  15. Participated in any other clinical trial within 1 months;
  16. The investigators believe that there are other circumstances that are not suitable for the trial.

Sites / Locations

  • Peking Union Medical College HospitalRecruiting

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

The Incidence of adverse events (TEAEs) within 30 days after intravenous infusion of C-CAR088

Secondary Outcome Measures

Overall response rate (ORR)
ORR(including sCR / CR / VGPR / PR, based on IMWG 2016 efficacy evaluation criteria)
Progression free survival (PFS)
PFS(based on IMWG 2016 efficacy evaluation criteria)

Full Information

First Posted
March 2, 2020
Last Updated
March 2, 2020
Sponsor
Peking Union Medical College Hospital
Collaborators
Cellular Biomedicine Group Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT04295018
Brief Title
A Study of BCMA-directed CAR-T Cells Treatment in Subjects With r/r Multiple Myeloma
Official Title
A Phase # 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
October 2019
Overall Recruitment Status
Unknown status
Study Start Date
October 23, 2019 (Actual)
Primary Completion Date
September 2021 (Anticipated)
Study Completion Date
December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peking Union Medical College Hospital
Collaborators
Cellular Biomedicine Group Ltd.

4. Oversight

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

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
Keywords
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
10 (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
Drug
Intervention Name(s)
C-CAR088
Intervention Description
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.
Primary Outcome Measure Information:
Title
The Incidence of adverse events (TEAEs) within 30 days after intravenous infusion of C-CAR088
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Overall response rate (ORR)
Description
ORR(including sCR / CR / VGPR / PR, based on IMWG 2016 efficacy evaluation criteria)
Time Frame
12 months
Title
Progression free survival (PFS)
Description
PFS(based on IMWG 2016 efficacy evaluation criteria)
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: 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; 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; At least 2 weeks from monoclonal antibody therapy prior to CAR T cell therapy. ECOG scores 0 - 1; Good cardiac and pulmonary organ function; Expected survival time > 12 weeks;. Female subjects of childbearing age must have a negative urine / blood pregnancy test within 7 days before cell therapy and not be in lactation; female or male subjects of childbearing age need to take effective contraception throughout the study. Exclusion Criteria: Have a history of allergy to cellular products; Laboratory testing occurs when: including but not limited to, serum total bilirubin ≥1.5mg / dl; serum ALT or AST is 2.5 times higher than the upper limit of normal value; serum creatinine ≥2.0mg / dl; hemoglobin <80g / L; absolute neutrophil count <1000 / mm3 or dependent on GCSF or Other growth factors can maintain the centriole count ≥1000 / mm²; platelet count <50000 / mm³ or the above level can be maintained due to platelet transfusion; Presence of clinically significant cardiovascular disease, such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or any heart function Grade 3 (moderate) or Grade 4 (severe) heart disease (according to the New York Heart Association Function Classification method: NYHA); patients with a history of myocardial infarction, cardiac angioplasty or stent implantation, unstable angina pectoris or other clinically significant heart disease within 12 months before enrollment; 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; 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; 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
Daobin Zhou, PhD&MD
Phone
010-69155020
Email
zhoudb@pumch.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Lu Zhang
Phone
010-69155660
Email
pumczhanglu@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daobin Zhou
Organizational Affiliation
Peking Union Medical College Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking Union Medical College Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100010
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daobin Zhou, PhD&MD
Phone
010-69155020
Email
zhoudb@pumch.cn
First Name & Middle Initial & Last Name & Degree
Lu Zhang
Phone
010-69155660
Email
pumczhanglu@163.com

12. IPD Sharing Statement

Plan to Share IPD
No
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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