Back to resultsHumanized CAR-T Cells of Anti-BCAM and Anti-CD19 Against Relapsed and Refractory Multiple Myeloma
Primary Purpose
Relapsed or Refractory Multiple Myeloma
Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Autologous BCMA CAR-T cells and CD19 CAR-T cells
Sponsored by
About this trial
This is an interventional treatment trial for Relapsed or Refractory Multiple Myeloma focused on measuring Relapsed and refractory multiple myeloma; CAR-T
Eligibility Criteria
Inclusion Criteria:
- Male or female aged 18-70 years old
- Estimated Survival time > 12 weeks
- Relapsed and refractory multiple myeloma were confirmed by physical examination, pathological examination, laboratory examination and imaging
- Chemotherapy failure or recurrent multiple myeloma
- Glutamic-pyruvic transaminase, glutamic oxalacetic transaminase< 3 fold of normal level
- Bilirubin<2.0mg/dl
- Karnofsky Performance Status>50% at the time of screening
- Adequate pulmonary, renal, hepatic, and cardiac function
- Fail in autologous haemopoietic stem cell transplantation
- Not suitable for stem cell transplantation conditions or abandoned due to conditions
- Free of leukocytes removal contraindications
- Voluntarily join CAR-T clinical trial ,Understand and sign written informed consent
Exclusion Criteria:
- The patient is a pregnant or breastfeeding woman, or is a woman with a pregnancy plan within six months
- Patients have infectious diseases (such as HIV, active tuberculosis, etc.)
- The patient is an active hepatitis B or hepatitis C infection
- Feasibility assessment proves that the efficiency of transduction of lymphocyte is below 10% or the lymphocyte cannot be propagated
- Abnormal vital signs
- Subjects with mental or psychological illness who cannot be combined with treatment and efficacy evaluation.
- Highly allergic constitution or history of severe allergies, especially allergy to interleukin-2
- General infection or local severe infection, or other infection that is not controlled
- Dysfunction in lung, heart, kidney and brain
- Severe autoimmune diseases
- Other symptoms that are not applicable for CAR-T
Sites / Locations
- The First Affiliated Hospital of Nangchang UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Mixed BCMA/CD19 CAR-T Transfer
Arm Description
Subjects with BCMA/CD19+ multiple myeloma will be infused with CD19-targeting CAR T Cells and BCMA-targeting CAR T Cells in one time or in parts
Outcomes
Primary Outcome Measures
Overall response rate (ORR)
Assessment of ORR (ORR = sCR+CR+VGPR+PR ) at 1 months of treatment
minimal residual disease（MRD）
Assessment of MRD negative overall response rate at 3 months of treatment
Progression-free survival (PFS)
Assessment of Progression-free survival (PFS) at 6 months of treatment
Overall survival (OS)
Assessment of overall survival (OS) at 6 months of treatment
Secondary Outcome Measures
Safety (incidence of adverse events defined as dose-limited toxicity)
Occurrence of study related adverse events defined as NCI CTCAE 4.0 > grade 3 possibly, probably, or definitely related to study treatment.
Expression of CD19 CART cells
Expression of CD19 CART cells in blood, bone marrow by Quantitative Polymerase Chain Reaction (q-PCR) and by flow cytometry.
Full Information
NCT ID
NCT04194931
First Posted
December 9, 2019
Last Updated
December 10, 2019
Sponsor
The First Affiliated Hospital of Nanchang University
1. Study Identification
Unique Protocol Identification Number
NCT04194931
Brief Title
Humanized CAR-T Cells of Anti-BCAM and Anti-CD19 Against Relapsed and Refractory Multiple Myeloma
Official Title
Study Evaluating the Safety and Efficacy With Sequential Infusion of Humanized CAR-T Cells of Anti-BCAM and Anti-CD19 Against Relapsed and Refractory Multiple Myeloma
Study Type
Interventional
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Unknown status
Study Start Date
December 1, 2019 (Anticipated)
Primary Completion Date
December 31, 2020 (Anticipated)
Study Completion Date
December 31, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The First Affiliated Hospital of Nanchang University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This is a single arm, open-label, single center study to evaluate the safety and efficacy of BCMA/CD19 CAR-T cells in patients with BCMA+，CD19+ relapsed or refractory multiple myeloma.
Detailed Description
CD19 has been extensively evaluated as a therapeutic target for relapsed or refractory multiple myeloma by chimeric antigen receptor T cell therapy,this is a single arm, open-label, single center study to preliminary explore the safety, tolerability and cellular pharmacokinetics of Anti-BCMA and Anti-CD19 CAR-T cells in the treatment of relapsed or refractory multiple myeloma.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Relapsed or Refractory Multiple Myeloma
Keywords
Relapsed and refractory multiple myeloma; CAR-T
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Mixed BCMA/CD19 CAR-T Transfer
Arm Type
Experimental
Arm Description
Subjects with BCMA/CD19+ multiple myeloma will be infused with CD19-targeting CAR T Cells and BCMA-targeting CAR T Cells in one time or in parts
Intervention Type
Biological
Intervention Name(s)
Autologous BCMA CAR-T cells and CD19 CAR-T cells
Intervention Description
Autologous BCMA CAR-T cells and CD19 CAR-T cells with average 1-5*10^6 cells/kg body weight,separately.
Primary Outcome Measure Information:
Title
Overall response rate (ORR)
Description
Assessment of ORR (ORR = sCR+CR+VGPR+PR ) at 1 months of treatment
Time Frame
2 year
Title
minimal residual disease（MRD）
Description
Assessment of MRD negative overall response rate at 3 months of treatment
Time Frame
2 year
Title
Progression-free survival (PFS)
Description
Assessment of Progression-free survival (PFS) at 6 months of treatment
Time Frame
2 year
Title
Overall survival (OS)
Description
Assessment of overall survival (OS) at 6 months of treatment
Time Frame
2 year
Secondary Outcome Measure Information:
Title
Safety (incidence of adverse events defined as dose-limited toxicity)
Description
Occurrence of study related adverse events defined as NCI CTCAE 4.0 > grade 3 possibly, probably, or definitely related to study treatment.
Time Frame
Study treatment until Week 24
Title
Expression of CD19 CART cells
Description
Expression of CD19 CART cells in blood, bone marrow by Quantitative Polymerase Chain Reaction (q-PCR) and by flow cytometry.
Time Frame
2 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female aged 18-70 years old
Estimated Survival time > 12 weeks
Relapsed and refractory multiple myeloma were confirmed by physical examination, pathological examination, laboratory examination and imaging
Chemotherapy failure or recurrent multiple myeloma
Glutamic-pyruvic transaminase, glutamic oxalacetic transaminase< 3 fold of normal level
Bilirubin<2.0mg/dl
Karnofsky Performance Status>50% at the time of screening
Adequate pulmonary, renal, hepatic, and cardiac function
Fail in autologous haemopoietic stem cell transplantation
Not suitable for stem cell transplantation conditions or abandoned due to conditions
Free of leukocytes removal contraindications
Voluntarily join CAR-T clinical trial ,Understand and sign written informed consent
Exclusion Criteria:
The patient is a pregnant or breastfeeding woman, or is a woman with a pregnancy plan within six months
Patients have infectious diseases (such as HIV, active tuberculosis, etc.)
The patient is an active hepatitis B or hepatitis C infection
Feasibility assessment proves that the efficiency of transduction of lymphocyte is below 10% or the lymphocyte cannot be propagated
Abnormal vital signs
Subjects with mental or psychological illness who cannot be combined with treatment and efficacy evaluation.
Highly allergic constitution or history of severe allergies, especially allergy to interleukin-2
General infection or local severe infection, or other infection that is not controlled
Dysfunction in lung, heart, kidney and brain
Severe autoimmune diseases
Other symptoms that are not applicable for CAR-T
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fei LI, M.D.;Ph.D.
Phone
+86-139-7003-8386
Email
yx021021@sina.com
Facility Information:
Facility Name
The First Affiliated Hospital of Nangchang University
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330006
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fei LI, M.D., Ph.D.
Phone
+86-139-7003-8386
Email
yx021021@sina.com
12. IPD Sharing Statement
Learn more about this trial
Humanized CAR-T Cells of Anti-BCAM and Anti-CD19 Against Relapsed and Refractory Multiple Myeloma
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