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

Cartesian Therapeutics

Status and phase: Terminated; Phase 1

Conditions: Multiple Myeloma

Treatments: Biological: Descartes-08; Drug: Fludarabine; Drug: Cyclophosphamide

Study type: Interventional

Funder types: Industry

Identifiers

NCT03448978

241-59-88

Details and patient eligibility

About

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.

Enrollment: 32 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

32 participants in 1 patient group

Descartes-08 plus fludarabine/cyclophosphamide pretreat

Experimental group

Description:

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

Treatment:

Drug: Cyclophosphamide

Drug: Fludarabine

Biological: Descartes-08