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

NCT03661554 | Unknown Early Phase 1

• 1 other identifier: PRG 1801
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Relapsed and Refractory Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

• 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

  2 years

Study Arms (1)

single arm

EXPERIMENTAL

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.

Biological: BCMA CAR-T Cells

Interventions

BCMA CAR-T Cells BIOLOGICAL

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.

single arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Pregene (ShenZhen) Biotechnology Company, Ltd.: lead
• Henan Cancer Hospital: collaborator

Study Sites (1)

Pregene Shenzhen Biotechnology Co., Ltd.

Shenzhen, Guangdong, 518000, China

RECRUITING

MeSH Terms

Conditions

Recurrence; Multiple Myeloma

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Central Study Contacts

jishuai zhang, doctor

CONTACT

13661255147; zhangjs@pregene.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Masking Details: Clinical study of BCMA nano-antibody CAR-T cells in the treatment of refractory recurrent multiple myeloma (single center, single arm, open clinical study)
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 3, 2018
• First Posted: September 7, 2018
• Study Start: April 10, 2018
• Primary Completion: October 30, 2018
• Study Completion: November 30, 2018
• Last Updated: September 10, 2018

Record last verified: 2018-09

Locations

CN (1)