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

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

Status

Terminated

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03448978

Enrollment

Registered

2018-02-28

Start date

2018-03-08

Completion date

2021-06-03

Last updated

2024-07-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Myeloma

Keywords

Descartes-08, CAR T Cell, CART, CAR-T, CAR T-Cell, Multiple Myeloma, BCMA, B-cell maturation antigen, B cell maturation antigen

Brief summary

This Phase I 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.

Interventions

BIOLOGICALDescartes-08

autologous CD8+ T-cells transiently expressing an anti-BCMA chimeric antigen receptor

DRUGFludarabine

intravenous fludarabine

DRUGCyclophosphamide

intravenous cyclophosphamide

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Incidence (number) of Treatment-Emergent Adverse Events [Safety and Tolerability]	2 weeks	Incidence (number) of Treatment-Emergent Adverse Events \[Safety and Tolerability\]. Descriptive statistics by incidence rate, body system classification, severity, and causality \[per protocol definitions\]

Secondary

Measure	Time frame	Description
Treatment response	1, 3, 6, 9 and 12 months	IMWG treatment response criteria

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026