BCMA-CAR-T in Relapsed/Refractory Multiple Myeloma

Phase 1

• Conditions: Relapsed/Refractory Myeloma
• Interventions: Drug: BCMA nanobody CAR-T cells

• Registration Number: NCT03664661
• Lead Sponsor: Henan Cancer Hospital

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2018-04-11
• Status Verified: 2018-09
• Study First Submitted: 2018-09-06
• Study First Submitted QC: 2018-09-07
• Last Update Submitted: 2018-09-07
• Study First Posted: 2018-09-10
• Last Update Posted: 2018-09-10
• Primary Completion: 2019-04-10
• Study Completion: 2020-04-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
experimental group	BCMA nanobody CAR-T cells	BCMA nanobody CAR-T cells

Primary Outcome Measures

Name	Time	Method
occurrence of study related adverse events	4 weeks	safety of CAR-T cells

Secondary Outcome Measures

Name	Time	Method
Treatment response rate	3 months and 6 months	response rate according to IMWG criteria
copy number of CAR-T cells	one year	copy number of CAR-T cells

Trial Locations

Locations (1)

Cancer Hospital Affiliate to Zhengzhou University & Henan Cancer Hospital; 🇨🇳 Zhengzhou, Henan, China