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Study of T Cells Targeting CD19/BCMA (CART-19/BCMA) for High Risk Multiple Myeloma Followed With Auto-HSCT

Primary Purpose

Safety and Efficacy

Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
anti-CD19 and anti-BCMA CAR
Immunomodulatory drugs
Sponsored by
The First Affiliated Hospital of Soochow University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Safety and Efficacy

Eligibility Criteria

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

Inclusion Criteria:

  • Multiple myeloma patients eligible for auto-HSCT.
  • High risk multiple myeloma (R-ISS III stage or with extramedullary infiltration or with del(17p), t(4;14), t(14;16), t(14;20), 1q21+ or disease progression during treatment).
  • Expected survival ≥ 3 months.
  • Creatinine < 2.0 mg/dl.
  • Blood coagulation function: PT and APTT <2x normal.
  • Arterial blood oxygen saturation>92%.
  • ALT(alanine aminotransferase)/AST (aspartate aminotransferase)< 3x normal
  • Karnofsky scores ≥ 60 and ECOG score≤2.
  • Adequate venous access for apheresis, and no other contraindications for leukapheresis.
  • Patients should not take immunotherapy in three months prior to CART cells infusion.
  • Voluntary informed consent is given.

Exclusion Criteria:

  • Pregnant or lactating women.
  • Uncontrolled active infection.
  • Active hepatitis B or hepatitis C infection.
  • Concurrent use of systemic steroids. Recent or current use of inhaled steroids is not exclusionary.
  • Previously treatment with any gene therapy products.
  • Any uncontrolled active medical disorder that would preclude participation as outlined.
  • HIV infection.
  • History of myocardial infarction and severe arrhythmia in half a year.
  • Any form of primary immunodeficiency (such as Severe Combined Immunodeficiency Disease).
  • Patients with fever of unknown origin (T>38℃).

Sites / Locations

  • First Affiliated Hospital, Soochow UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

anti-CD19 and anti-BCMA CAR

Arm Description

Participants will get auto-HSCT. Hematopoietic reconstitution after auto-HSCT, participants will get the anti-CD19 CAR T cells (on d0) and anti-BCMA CAR T cells as split-dose (40% on d1 and 60% on d2)

Outcomes

Primary Outcome Measures

Incidence and severity of adverse events
Proportion of subjects with adverse events overall and by severity grade
PFS
Is defined as time from first induction date to first documentation of PD, or death due to any cause, whichever occurs first.
OS
Is defined as time from first induction date to time of death due to any cause

Secondary Outcome Measures

Duration of best response
According to IMWG response criteria at the end of the research.
MRD negative conversion ratio and persistence
MRD negative by flow cytometry
Proportion of subjects who achieved Complete Response (CR) Rate
Percentage of subjects who achieved CR or stringent CR according to IMWG Uniform Response Criteria for Multiple Myeloma
Pharmacokinetics - Cmax
Maximum transgene level
Pharmacokinetics - Tmax
Time to peak transgene level
Pharmacokinetics - AUC
Area under the curve of the transgene level
Duration of persistence of CAR T cells in the blood
Duration of persistence of CAR T cells in the blood

Full Information

First Posted
February 19, 2018
Last Updated
May 17, 2021
Sponsor
The First Affiliated Hospital of Soochow University
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1. Study Identification

Unique Protocol Identification Number
NCT03455972
Brief Title
Study of T Cells Targeting CD19/BCMA (CART-19/BCMA) for High Risk Multiple Myeloma Followed With Auto-HSCT
Official Title
Study of T Cells Targeting CD19/BCMA (CART-19/BCMA) for High Risk Multiple Myeloma Followed With Auto-HSCT
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Recruiting
Study Start Date
February 20, 2018 (Actual)
Primary Completion Date
December 2021 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The First Affiliated Hospital of Soochow 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
CART therapy has showed good safety and efficacy in treatment of lymphoma and acute lymphoblastic leukemia. Researchers want to see if this helps people with high risk multiple myeloma after auto-HSCT.To test the safety and efficacy of giving targeting CD19 and BCMA T cells in treating high risk multiple myeloma followed with auto-HSCT.
Detailed Description
Adults ages 18-75 with high risk Multiple Myelomas (R-ISS III stage or with extramedullary infiltration or with del(17p), t(4;14), t(14;16), t(14;20), 1q21+ or disease progression during treatment). Design: Participants may be screened with: Medical history Physical exam Blood and urine tests Heart tests Bone marrow sample Multiple scans and X-rays Participants will have apheresis. Blood is removed through a needle in an arm. T cells are removed. The rest of the blood is returned through a needle in the other arm. The cells will be changed in a laboratory. Participants will get auto-HSCT. Hematopoietic reconstitution after auto-HSCT, participants will get the T cells through the IV within 3 days. Maintenance therapy with IMiDs was received after combined CAR T infusion. After this, participants will stay in the hospital for at least 9 days and stay nearby for 2 weeks. Then they will have blood tests and see a doctor. Participants will visit the clinic 1, 2, 3, 6, 9 and 12 months after the infusion, then every 3 months until disease progression. A bone marrow sample will be taken at the 3-month visit.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Safety and Efficacy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
anti-CD19 and anti-BCMA CAR
Arm Type
Experimental
Arm Description
Participants will get auto-HSCT. Hematopoietic reconstitution after auto-HSCT, participants will get the anti-CD19 CAR T cells (on d0) and anti-BCMA CAR T cells as split-dose (40% on d1 and 60% on d2)
Intervention Type
Biological
Intervention Name(s)
anti-CD19 and anti-BCMA CAR
Intervention Description
Participants will get auto-HSCT. Hematopoietic reconstitution after auto-HSCT, participants will get the anti-CD19 CAR T cells (1×10e+7/kg on d0) and anti-BCMA CAR T cells as split-dose (total 5×10e+7/kg, 40% on d1 and 60% on d2)
Intervention Type
Drug
Intervention Name(s)
Immunomodulatory drugs
Other Intervention Name(s)
IMiDs
Intervention Description
Maintenance therapy
Primary Outcome Measure Information:
Title
Incidence and severity of adverse events
Description
Proportion of subjects with adverse events overall and by severity grade
Time Frame
Approximately 3 years
Title
PFS
Description
Is defined as time from first induction date to first documentation of PD, or death due to any cause, whichever occurs first.
Time Frame
Minimum of 2 years after first induction
Title
OS
Description
Is defined as time from first induction date to time of death due to any cause
Time Frame
Minimum of 2 years after first induction
Secondary Outcome Measure Information:
Title
Duration of best response
Description
According to IMWG response criteria at the end of the research.
Time Frame
Minimum of 2 years
Title
MRD negative conversion ratio and persistence
Description
MRD negative by flow cytometry
Time Frame
Minimum of 2 years
Title
Proportion of subjects who achieved Complete Response (CR) Rate
Description
Percentage of subjects who achieved CR or stringent CR according to IMWG Uniform Response Criteria for Multiple Myeloma
Time Frame
Minimum of 2 years
Title
Pharmacokinetics - Cmax
Description
Maximum transgene level
Time Frame
Approximately 2.5 years after first CAR infused
Title
Pharmacokinetics - Tmax
Description
Time to peak transgene level
Time Frame
Approximately 2.5 years after first CAR infused
Title
Pharmacokinetics - AUC
Description
Area under the curve of the transgene level
Time Frame
Approximately 2.5 years after first CAR infused
Title
Duration of persistence of CAR T cells in the blood
Description
Duration of persistence of CAR T cells in the blood
Time Frame
Approximately 2.5 years after first CAR infused

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: Multiple myeloma patients eligible for auto-HSCT. High risk multiple myeloma (R-ISS III stage or with extramedullary infiltration or with del(17p), t(4;14), t(14;16), t(14;20), 1q21+ or disease progression during treatment). Expected survival ≥ 3 months. Creatinine < 2.0 mg/dl. Blood coagulation function: PT and APTT <2x normal. Arterial blood oxygen saturation>92%. ALT(alanine aminotransferase)/AST (aspartate aminotransferase)< 3x normal Karnofsky scores ≥ 60 and ECOG score≤2. Adequate venous access for apheresis, and no other contraindications for leukapheresis. Patients should not take immunotherapy in three months prior to CART cells infusion. Voluntary informed consent is given. Exclusion Criteria: Pregnant or lactating women. Uncontrolled active infection. Active hepatitis B or hepatitis C infection. Concurrent use of systemic steroids. Recent or current use of inhaled steroids is not exclusionary. Previously treatment with any gene therapy products. Any uncontrolled active medical disorder that would preclude participation as outlined. HIV infection. History of myocardial infarction and severe arrhythmia in half a year. Any form of primary immunodeficiency (such as Severe Combined Immunodeficiency Disease). Patients with fever of unknown origin (T>38℃).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
chengcheng fu
Phone
0086-0512-67781856
Email
fuzhengzheng@suda.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
depei wu
Organizational Affiliation
The First Affiliated Hospital of Soochow University
Official's Role
Study Chair
Facility Information:
Facility Name
First Affiliated Hospital, Soochow University
City
Suzhou
State/Province
Jiangsu
ZIP/Postal Code
215000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fu chengcheng, Phd
Phone
13962191404
Email
fuzhengzheng@suda.edu.cn
First Name & Middle Initial & Last Name & Degree
Shi xiaolan, Phd
Email
shixiaolan@suda.edu.cn

12. IPD Sharing Statement

Learn more about this trial

Study of T Cells Targeting CD19/BCMA (CART-19/BCMA) for High Risk Multiple Myeloma Followed With Auto-HSCT

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