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BCMA Nano Antibody CAR-T Cells for Patients With Refractory and Relapsed Multiple Myeloma (BCMA CAR-T)

Primary Purpose

Relapsed and Refractory Multiple Myeloma

Status
Unknown status
Phase
Early Phase 1
Locations
China
Study Type
Interventional
Intervention
BCMA CAR-T Cells
Sponsored by
The Pregene (ShenZhen) Biotechnology Company, Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

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

Eligibility Criteria

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

Inclusion Criteria:

  • 18-75 years, the expected survival time is greater than 3 months;
  • Active MM was diagnosed, BCMA positive;
  • At present, there is no effective treatment, such as chemotherapy or recurrence after hematopoietic stem cell transplantation, or patients voluntarily choose to infuse anti-BCMA nano-antibody CAR-T cells as the first treatment;
  • ECOG : 0-2 points;
  • Cardiac function: no heart disease or coronary heart disease, cardiac function 1-2;
  • Liver function: TBIL < 3 ULN, AST < 2.5 ULN, ALT < 2.5 ULN;
  • Renal function: Cr < 1.25 ULN;
  • Patients with smooth peripheral venous access can meet the needs of intravenous drip;
  • There are no other serious diseases (such as autoimmune diseases, immunodeficiency and organ transplantation) that are inconsistent with this protocol;
  • There was no history of malignancy;
  • Women of childbearing age must be tested for negative blood pregnancy tests within 7 days, and subjects of childbearing age must use appropriate contraceptive measures during the trial and within 3 months after the trial;
  • Patients agreed to participate in the clinical study and signed the informed consent form.

Exclusion Criteria:

  • Pregnant women or lactating women (women of childbearing age need to have a pregnancy check);
  • Severe infectious diseases were found in the first 4 weeks of admission;
  • Active hepatitis B or C viral hepatitis;
  • HIV infected patients;
  • Suffering from severe autoimmune or immunodeficiency diseases;
  • Severe allergic constitution;
  • Severe mental disorders;
  • Systematic overuse of glucocorticoids within the first four weeks of admission (except for inhaled corticosteroids);
  • Suffering from severe heart, liver, renal insufficiency, diabetes and other diseases;
  • In the past 3 months, he participated in other clinical studies or previous treatment of other gene products.

Sites / Locations

  • Pregene Shenzhen Biotechnology Co., Ltd.Recruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

single arm

Arm Description

This clinical study, "BCMA nano-antibody CAR-T cells in the treatment of refractory recurrent multiple myeloma clinical research," is a single center, single arm, open design. The aim is to study the safety and efficacy of BCMA nano antibody CAR-T in the treatment of MM. In this study, a 3 + 3 dose gradient climbing design was used. Three dosage groups, 5x106 / kg, 1x107 / kg and 1.5x107 / kg, were divided into three groups.

Outcomes

Primary Outcome Measures

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Any adverse events associated with BCMA nanoscale CAR-T cell therapy during the trial period

Secondary Outcome Measures

Full Information

First Posted
September 3, 2018
Last Updated
September 6, 2018
Sponsor
The Pregene (ShenZhen) Biotechnology Company, Ltd.
Collaborators
Henan Cancer Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03661554
Brief Title
BCMA Nano Antibody CAR-T Cells for Patients With Refractory and Relapsed Multiple Myeloma
Acronym
BCMA CAR-T
Official Title
BCMA Nano Antibody CAR-T Cells for the Treatment of Refractory Relapsed Multiple ,Single Center, Single Arm and Open Clinical Study of Myeloma
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Unknown status
Study Start Date
April 10, 2018 (Actual)
Primary Completion Date
October 30, 2018 (Anticipated)
Study Completion Date
November 30, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Pregene (ShenZhen) Biotechnology Company, Ltd.
Collaborators
Henan Cancer Hospital

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 clinical study is an exploratory study, mainly to study the safety and efficacy of BCMA nano-antibody CAR-T in the treatment of MM. In this study, a 3 + 3 dose gradient climbing design was used. Three dosage groups, 5 x 106 / kg, 7.5 x 106 / kg and 1.5 x 107 / kg, were divided into three groups. Patients were enrolled in the sequence from low to high doses. When each dose group was completed, the next dose group could be enrolled if there was no more than 3-level toxicity or unpredictable severe toxicity. If the dose group had more than 3-level toxicity or unpredictable severe toxicity, two patients were enrolled to observe if there was any toxicity. Sexual occurrence, if two patients in each group developed grade 3 or more toxicity or unpredictable severe toxicity, the dose group was the dose-limiting group, and the dose group in front of the group was the maximum tolerated dose, at which the initial efficacy was observed. Nine patients were enrolled in the hill climbing test, and six patients were enrolled in the follow-up preliminary efficacy study, with an estimated 15 enrolled.
Detailed Description
The aim of this study is to study the safety and efficacy of BCMA nanoantibody CAR-T in the treatment of MM. BCMA CAR is composed of BCMA nano-antibody, CD8 strand region, transmembrane region and 4-1BB costimulatory domain, and CD3-_T cell activation domain. BCMA nano-antibody CAR-T cells were prepared by lentivirus infection of T cells. In this study, a 3 + 3 dose gradient climbing design was used. Three dosage groups, 5x106 / kg, 1x107 / kg and 1.5x107 / kg, were divided into three groups. Patients were enrolled in the sequence from low to high doses. When each dose group was completed, the next dose group could be enrolled if there was no more than 3-level toxicity or unpredictable severe toxicity. If the dose group had more than 3-level toxicity or unpredictable severe toxicity, two patients were enrolled to observe if there was any toxicity. Sexual occurrence, if two patients in each group developed grade 3 or more toxicity or unpredictable severe toxicity, the dose group was the dose-limiting group, and the dose group in front of the group was the maximum tolerated dose, at which the initial efficacy was observed. Nine patients were enrolled in the hill climbing test, and six patients were enrolled in the follow-up preliminary efficacy study, with an estimated 15 enrolled. After transfusion, adverse events were closely monitored and therapeutic effects were evaluated on the 28th day after transfusion. Follow-up was conducted every 6 weeks within 6 months and every 10 weeks after 6 months. To evaluate the safety and efficacy of BCMA nano antibody CAR-T in the treatment of refractory and relapsed MM.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Model Description
In this study, a 3 + 3 dose gradient climbing design was used. Three dosage groups, 5 x 106 / kg, 1 x 107 / kg and 1.5 x 107 / kg, were divided into three groups.
Masking
None (Open Label)
Masking Description
Clinical study of BCMA nano-antibody CAR-T cells in the treatment of refractory recurrent multiple myeloma (single center, single arm, open clinical study)
Allocation
N/A
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
single arm
Arm Type
Experimental
Arm Description
This clinical study, "BCMA nano-antibody CAR-T cells in the treatment of refractory recurrent multiple myeloma clinical research," is a single center, single arm, open design. The aim is to study the safety and efficacy of BCMA nano antibody CAR-T in the treatment of MM. In this study, a 3 + 3 dose gradient climbing design was used. Three dosage groups, 5x106 / kg, 1x107 / kg and 1.5x107 / kg, were divided into three groups.
Intervention Type
Biological
Intervention Name(s)
BCMA CAR-T Cells
Intervention Description
The Chinese name of CAR-T cells is chimeric antigen receptor T cells. It is through gene transfection technology, so that patients with T lymphocytes can carry B cell-specific antigens, so that T lymphocytes can selectively kill B lymphocyte-derived tumor cells.
Primary Outcome Measure Information:
Title
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Description
Any adverse events associated with BCMA nanoscale CAR-T cell therapy during the trial period
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
No
Eligibility Criteria
Inclusion Criteria: 18-75 years, the expected survival time is greater than 3 months; Active MM was diagnosed, BCMA positive; At present, there is no effective treatment, such as chemotherapy or recurrence after hematopoietic stem cell transplantation, or patients voluntarily choose to infuse anti-BCMA nano-antibody CAR-T cells as the first treatment; ECOG : 0-2 points; Cardiac function: no heart disease or coronary heart disease, cardiac function 1-2; Liver function: TBIL < 3 ULN, AST < 2.5 ULN, ALT < 2.5 ULN; Renal function: Cr < 1.25 ULN; Patients with smooth peripheral venous access can meet the needs of intravenous drip; There are no other serious diseases (such as autoimmune diseases, immunodeficiency and organ transplantation) that are inconsistent with this protocol; There was no history of malignancy; Women of childbearing age must be tested for negative blood pregnancy tests within 7 days, and subjects of childbearing age must use appropriate contraceptive measures during the trial and within 3 months after the trial; Patients agreed to participate in the clinical study and signed the informed consent form. Exclusion Criteria: Pregnant women or lactating women (women of childbearing age need to have a pregnancy check); Severe infectious diseases were found in the first 4 weeks of admission; Active hepatitis B or C viral hepatitis; HIV infected patients; Suffering from severe autoimmune or immunodeficiency diseases; Severe allergic constitution; Severe mental disorders; Systematic overuse of glucocorticoids within the first four weeks of admission (except for inhaled corticosteroids); Suffering from severe heart, liver, renal insufficiency, diabetes and other diseases; In the past 3 months, he participated in other clinical studies or previous treatment of other gene products.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
jishuai zhang, doctor
Phone
13661255147
Email
zhangjs@pregene.com
Facility Information:
Facility Name
Pregene Shenzhen Biotechnology Co., Ltd.
City
Shenzhen
State/Province
Guangdong
ZIP/Postal Code
518000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
jishuai zhang
Phone
13661255147
Ext
13661255147
Email
zhangjs@pregene.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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BCMA Nano Antibody CAR-T Cells for Patients With Refractory and Relapsed Multiple Myeloma

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