Study of BCMA CAR-T in Multiple Myeloma

Multiple Myeloma Clinical Trial

Official title:

A Study of BCMA CAR-T Cells for Patients With Relapse and Refractory Multiple Myeloma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03322735
• Other study ID #: HenanCH284
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: October 19, 2017
• Last updated: December 28, 2017
• Start date: December 8, 2017
• Est. completion date: December 2019

Study information

• Verified date: October 2017
• Source: Henan Cancer Hospital
• Contact: Yongping Song
• Phone: +86-13521186987
• Email: ph200811[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to infusion BCMA CAR-T cells to the patients with relapsed and refractory multiple myeloma(MM), to assess the safety and feasibility of this strategy. The CAR enables the T cell to recognize and kill the MM cells through the recognition of BCMA, a protein expressed of the surface of the malignant plasma cells in MM patients.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: December 2019
• Est. primary completion date: October 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• 1. 18 years to 70 years, expected survival > 3 months;

• 2. Confirmed diagnosis of active MM as defined by IMWG. BCMA expression of the malignant cells must be detected by immunohistochemistry or by flow cytometry.

• 3. BCMA-expressing B cell malignancy must be assured and must be relapsed or refractory disease.;

• 4. ECOG performance status of 0-2;

• 5. Cardiac function: 1-2 levels; Liver: TBIL=3ULN,AST =2.5ULN,ALT =2.5ULN; kidney:

Cr=1.25ULN;

• 6. No serious allergic constitution;

• 7. No other serous diseases that conflicts with the clinical program;

• 8. No other cancer history;

• 9. female participants of reproductive potential must have a negative serum pregnancy test;

• 10. Subjects must have signed written, informed consent.

Exclusion Criteria:

• 1. Pregnant or lactating women;

• 2. Uncontrolled active infection, HIV infection, syphilis serology reaction positive;

• 3. Active hepatitis B or hepatitis C infection;

• 4. Recent or current use of glucocorticoid or other immunosuppressor;

• 5. serious mental disorder;

• 6. With severe cardiac, liver, renal insufficiency, diabetes and other diseases;

• 7. Participate in other clinical research in the past three months; previously treatment with any gene therapy products;

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Drug:
• Fludarabine
25-30mg/m2/day IV for 3 days
• Cyclophosphamide
cyclophosphamide 0.6-0.8g/m2/day IV for 2 days

Biological:
• BCMA CAR-T
BCMA CAR-T cells will be administered after completion of the chemotherapy.

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	Incidence of Treatment-Emergent Adverse Events	number of participants with adverse events	1 year
Secondary	Persistence of the BCMA CAR+ T cells	determine duration of in vivo survival of BCMA CAR-T cells	1 year
Secondary	anti-tumor responses of BCMA CAR-T cells		1 year