BCMA-CAR-T in Relapsed/Refractory Multiple Myeloma

Relapsed/Refractory Myeloma Clinical Trial

Official title:

a Single-center, One Arm, Open Clinical Study of BCMA Nanobody CAR-T Cell in Refractory/Relapsed Myeloma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03664661
• Other study ID #: HenanCH CAR 2-2
• Status: Recruiting
• Phase: Phase 1
• Start date: April 11, 2018
• Est. completion date: April 30, 2020

Study information

• Verified date: September 2018
• Source: Henan Cancer Hospital
• Contact: Yongping Song, M.D
• Phone: +86-371-65587199
• Email: songyongping2018[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Evaluation of the safety and efficacy of BCMA nanobody CAR-T cells in relapsed/refractory myeloma

Description:

There are no effective regimens for relapsed/refractory myeloma. BCMA express extensively in mature B cells and plasma cells. Myeloma cells express BCMA universally. BCMA signal pathway can induce plasma cell proliferation and survival, down-regulation of BCMA could control the progression of myeloma. The BCMA CAR used in this study consists of BCMA nanobody, CD8 hinge, transmembrane region and 4-1bb co-stimulation domain.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: April 30, 2020
• Est. primary completion date: April 10, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• 18 and =70 years old and the expected lifetime >3 months

• Active myeloma according to IMWG criteria, and BCMA positive by immunohistochemistry or flow cytometry

• No effective treatment option available

• ECOG score 0-2

• Sufficient heart, liver, kidney function (heart: no heart disease or coronary heart disease, patient heart function NYHA grade 1-2; liver: TBIL = 3ULN, AST = 2.5ULN, ALT = 2.5ULN; kidney: Cr= 1.25ULN);

• smoothly peripheral superficial veins

• No other serious diseases that conflict with this protocol (eg, autoimmune diseases, immunodeficiency, organ transplantation)

• No history of other malignancies

• Women of childbearing age must be negative for blood pregnancy test within 7 days and must take appropriated contraceptive measures during and 3 months after the study

• The patient himself agrees to participate in this clinical study and signed the "informed consent"

Exclusion Criteria:

• Severe infectious 4 weeks before enrollment

• Active hepatitis B or C viral hepatitis, HIV,

• Severe autoimmune disease or immunodeficiency disease

• Severe allergies

• Severe mental disorder

• Patients who used high-dose glucocorticoids within 1 week

• Participation in other clinical studies in the past 3 months or having been treated with other gene products

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell
• Relapsed/Refractory Myeloma

Intervention

Drug:
• BCMA nanobody CAR-T cells
step 1: Collect 50-100ml of peripheral blood for culture of BCMA nanobody CAR- T cells. step 2. After 72 hours, pretreated with FC regimen, details as follow Cyclophosphamide 600-800mg/m2 for 2 days Fludarabine 25-30mg/m2 for 3 days. step 3: After another 48 hours transfusion the cells back to the patients the numbers of infused CAR T cells are 5x106 /kg for the first 3 patients, 1.5x107 /kg for the second 3 patients and 4.5x107 /kg for the third 3 patients. After finishing this, another 6 patients will be enrolled for observation of efficacy.

Locations

Country	Name	City	State
China	Cancer Hospital Affiliate to Zhengzhou University & Henan Cancer Hospital	Zhengzhou	Henan

Sponsors (2)

Lead Sponsor	Collaborator
Henan Cancer Hospital	The Pregene (ShenZhen) Biotechnology Company, Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	occurrence of study related adverse events	safety of CAR-T cells	4 weeks
Secondary	Treatment response rate	response rate according to IMWG criteria	3 months and 6 months
Secondary	copy number of CAR-T cells	copy number of CAR-T cells	one year