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Study of T Cells Targeting CD138/BCMA/CD19/More Antigens (CART-138/BCMA/19/More) for Chemotherapy Refractory and Relapsed Multiple Myeloma

Primary Purpose

Multiple Myeloma

Status

Recruiting

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

CART-138/BCMA/19/more

About this trial

This is an interventional treatment trial for Multiple Myeloma

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

CD138 or BCMA antigen positive multiple myeloma in patients with no available curative treatment options (such as autologous or allogeneic SCT).
Relapsed and/or refractory multiple myeloma.
Relapsed after prior autologous or allogenic SCT.
Expected survival ≥ 3 months
Creatinine < 2.0 mg/dl
Blood coagulation function: PT and APTT < 2x normal
Arterial blood oxygen saturation > 92%
Alanine Aminotransferase (ALT)/Aspartate Aminotransferase (AST) < 3x normal
Karnofsky scores ≥ 60 and ECOG score ≤ 2
Adequate venous access for apheresis, and no other contraindications for leukapheresis
Patients should not take system chemotherapy in one month and 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

CART-138/BCMA/19/more

Arm Description

Outcomes

Primary Outcome Measures

Determine if there is grade 3 to 5 cytokine release syndrome

Number of Patients With Grade 3 Through Grade 5 Cytokine Release Syndrome(CRS) That Are Related to Study Intervening Measures, Graded According to NCI CTCAE Version 4.0

Secondary Outcome Measures

Investigators try to assess major reaction rate (MRR, PR+VGPR+CR) at the end of the research.

Number of Patients achieved major reaction rate (MRR;PR+VGPR+CR) According to IMWG response criteria at the end of the research.

Full Information

NCT ID

NCT03196414

First Posted

October 19, 2016

Last Updated

April 30, 2019

Sponsor

The First Affiliated Hospital of Soochow University

1. Study Identification

Unique Protocol Identification Number

NCT03196414

Brief Title

Study of T Cells Targeting CD138/BCMA/CD19/More Antigens (CART-138/BCMA/19/More) for Chemotherapy Refractory and Relapsed Multiple Myeloma

Official Title

Study of T Cells Targeting CD138/BCMA/CD19/More Antigens (CART-138/BCMA/19/More) for Chemotherapy Refractory and Relapsed Multiple Myeloma

Study Type

Interventional

2. Study Status

Record Verification Date

September 2016

Overall Recruitment Status

Recruiting

Study Start Date

September 2016 (undefined)

Primary Completion Date

September 2026 (Anticipated)

Study Completion Date

December 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

The First Affiliated Hospital of Soochow University

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

Placing a tumor antigen chimeric receptor that has been created in the laboratory into patient autologous or donor-derived T cells may make the body build immune response to kill cancer cells. Genetically engineered lymphocyte (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 multiple myeloma.To test the safety and efficacy of giving targeting CD138 or B-cell maturation antigen or CD19 or more antigens T cells in treating patients with multiple myeloma that is refractory to further chemotherapy or relapsed(after stem cell transplantation or intensive chemotherapy).

Detailed Description

Adults ages 18-75 with Relapsed and/or Chemotherapy Refractory Multiple Myelomas. Design: Participants may be screened with: Medical history Physical exam Blood and urine tests Heart tests Bone marrow sample Multiple scans and X-rays Lymphocytes are collected by apheresis from the enrolled patient or a healthy donor. Blood is removed through a needle in an arm. 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 2 chemotherapy drugs over 5 days. Two days later, participants will get an intravenous (IV) catheter in an arm. They will get the split doses CART cells on day0, day1, day2 through the IV in 1 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 at 1, 2, 3, 6, 9 and 12 months after the infusion, then every 6 months until two years after infusion. 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

Multiple Myeloma

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

10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

CART-138/BCMA/19/more

Arm Type

Experimental

Intervention Type

Biological

Intervention Name(s)

CART-138/BCMA/19/more

Intervention Description

Cyclophosphamide，Fludarabine，CART-138/BCMA /19/more cells Cyclophosphamide: 300 mg/m2 IV over 30 minutes on days -5 , -4,and -3; Fludarabine: 30 mg/m2 IV over 30 minutes immediately following the cyclophosphamide on day -5, -4, and -3 Biological: Anti-CD138/BCMA/CD19/more total CART cells 5x106- 100x106 CAR+ T cells per kg of recipient bodyweight

Primary Outcome Measure Information:

Title

Determine if there is grade 3 to 5 cytokine release syndrome

Description

Number of Patients With Grade 3 Through Grade 5 Cytokine Release Syndrome(CRS) That Are Related to Study Intervening Measures, Graded According to NCI CTCAE Version 4.0

Time Frame

2 weeks-12 months after initial dose

Secondary Outcome Measure Information:

Title

Investigators try to assess major reaction rate (MRR, PR+VGPR+CR) at the end of the research.

Description

Number of Patients achieved major reaction rate (MRR;PR+VGPR+CR) According to IMWG response criteria at the end of the research.

Time Frame

up to 24 weeks

Other Pre-specified Outcome Measures:

Title

Investigators try to test CART 138 cells copies in vivo.

Description

CART Cell survival time by testing CART-138/BCMA cells copies in vivo through PCR Method.

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: CD138 or BCMA antigen positive multiple myeloma in patients with no available curative treatment options (such as autologous or allogeneic SCT). Relapsed and/or refractory multiple myeloma. Relapsed after prior autologous or allogenic SCT. Expected survival ≥ 3 months Creatinine < 2.0 mg/dl Blood coagulation function: PT and APTT < 2x normal Arterial blood oxygen saturation > 92% Alanine Aminotransferase (ALT)/Aspartate Aminotransferase (AST) < 3x normal Karnofsky scores ≥ 60 and ECOG score ≤ 2 Adequate venous access for apheresis, and no other contraindications for leukapheresis Patients should not take system chemotherapy in one month and 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

Ling zhi Yan, PhD

Phone

13584821140

yanlingzhi@suda.edu.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Fu cheng cheng, PhD

Organizational Affiliation

First Affiliated Hospital,Soochow University

Official's Role

Principal Investigator

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

Ling zhi Yan, Phd

Phone

13584821140

yanlingzhi@suda.edu.cn

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

33717057

Citation

Zhang Y, Zhang C, Zhou J, Zhang J, Chen X, Chen J, Wang P, Sun X, Lou X, Qi W, Kang L, Yu L, Wu D, Li C. Case Report: Reversible Neurotoxicity and a Clinical Response Induced by BCMA-Directed Chimeric Antigen Receptor T Cells Against Multiple Myeloma With Central Nervous System Involvement. Front Immunol. 2021 Feb 25;12:552429. doi: 10.3389/fimmu.2021.552429. eCollection 2021.

Results Reference

derived

Learn more about this trial

Study of T Cells Targeting CD138/BCMA/CD19/More Antigens (CART-138/BCMA/19/More) for Chemotherapy Refractory and Relapsed Multiple Myeloma

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