Descartes-11 in Multiple Myeloma

Cartesian Therapeutics

Status and phase: Terminated; Phase 1

Conditions: Multiple Myeloma

Treatments: Drug: Cyclophosphamide; Biological: Descartes-11; Drug: Fludarabine

Study type: Interventional

Funder types: Industry

Identifiers

NCT03994705

DC11A

Details and patient eligibility

About

This Phase I study will test the safety and anti-myeloma activity of ascending doses of Descartes-11 (autologous CD8+ T-cells expressing an anti-BCMA chimeric antigen receptor) in eligible patients with active multiple myeloma.

Enrollment: 25 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Active multiple myeloma that is refractory after at least 2 prior lines of therapy;
• measurable disease;
• adequate vital organ function; and
• no active infection.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

Dose-Escalation

Experimental group

Treatment:

Drug: Fludarabine

Biological: Descartes-11

Drug: Cyclophosphamide