Autologous CD8+ T-cells Expressing an Anti-BCMA CAR in Patients With Myeloma

Multiple Myeloma Clinical Trial

Official title:

Combined Phase I-Phase II Study of Autologous CD8+ T-cells Transiently Expressing a Chimeric Antigen Receptor Directed to B-Cell Maturation Antigen in Patients With Multiple Myeloma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03448978
• Other study ID #: 241-59-88
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: February 26, 2018
• Est. completion date: December 31, 2021

Study information

• Verified date: March 2022
• Source: Cartesian Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This Phase I/II study will test the safety and anti-myeloma activity of ascending doses of Descartes-08 (autologous CD8+ T-cells expressing an anti-BCMA chimeric antigen receptor) in eligible patients with active multiple myeloma.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: December 31, 2021
• Est. primary completion date: December 26, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria (condensed):

• Multiple myeloma that is double-refractory to a proteasome inhibitor (PI) and an immunomodulatory drug (IMiD) after at least 2 prior lines of therapy OR have failed at least 3 prior lines of therapy

• Measurable disease activity as indicated by serum or urine M-protein, serum free light chain, biopsy-proven plasmacytoma, >5% bone marrow plasma cells.

• Adequate vital organ function as indicated by ANC (>1000/uL), platelet count (>50,000/uL), hemoglobin (>8 g/dL), serum ALT and AST (each <3.0 x upper limit of normal), total bilirubin (<2 mg/dL), creatinine clearance (>30 mL/min), and cardiac ejection fraction (>45%)

Exclusion Criteria (condensed):

NOTE: Prior anti-BCMA or CAR-T therapy is NOT exclusionary

• Active plasma cell leukemia

• Pregnant or lactating

• Active, uncontrolled infection

• Active and severe auto-immune disease

• Active arrhythmia, or obstructive or restrictive pulmonary disease

• Central nervous system disease

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Biological:
• Descartes-08
autologous CD8+ T-cells transiently expressing an anti-BCMA chimeric antigen receptor

Drug:
• Fludarabine
intravenous fludarabine
• Cyclophosphamide
intravenous cyclophosphamide

Locations

Country	Name	City	State
United States	The Center for Cancer and Blood Disorders	Bethesda	Maryland
United States	Virgina Cancer Specialists	Fairfax	Virginia
United States	University of Oklahoma Health Sciences Center	Oklahoma City	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
Cartesian Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence (number) of Treatment-Emergent Adverse Events [Safety and Tolerability]	Incidence (number) of Treatment-Emergent Adverse Events [Safety and Tolerability]. Descriptive statistics by incidence rate, body system classification, severity, and causality [per protocol definitions]	2 weeks
Secondary	Treatment response	IMWG treatment response criteria	1, 3, 6, 9 and 12 months