Descartes-11 in Patients With Relapsed/Refractory Multiple Myeloma

Cartesian Therapeutics

Status and phase: Terminated; Phase 1

Conditions: Multiple Myeloma

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

Study type: Interventional

Funder types: Industry; NIH

Identifiers

NCT03994705

5R44CA221432-03 (U.S. NIH Grant/Contract)

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: 20 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: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 6 patient groups

Dose Level 1

Experimental group

Description:

Participants were administered Cyclophosphamide and Fludarabine for preconditioning on Days 1,2,3 Participants were administered 10 million cells of Descartes-11 via intravenous catheter on Days 7,14

Treatment:

Drug: Fludarabine

Drug: Cyclophosphamide

Biological: Descartes-11

Dose Level 2

Experimental group

Description:

Participants were administered Cyclophosphamide and Fludarabine for preconditioning on Days 1,2,3 Participants were administered 32 million cells of Descartes-11 via intravenous catheter on Days 7,14

Treatment:

Drug: Fludarabine

Drug: Cyclophosphamide

Biological: Descartes-11

Dose Level 3

Experimental group

Description:

Participants were administered Cyclophosphamide and Fludarabine for preconditioning on Days 1,2,3 Participants were administered 100 million cells of Descartes-11 via intravenous catheter on Days 7,14

Treatment:

Drug: Fludarabine

Drug: Cyclophosphamide

Biological: Descartes-11

Dose Level 4 A

Experimental group

Description:

Participants were administered Cyclophosphamide and Fludarabine for preconditioning on Days 1,2,3 Participants were administered 150 million cells of Descartes-11 via intravenous catheter on Days 7,14,21

Treatment:

Drug: Fludarabine

Drug: Cyclophosphamide

Biological: Descartes-11

Dose Level 4B

Experimental group

Description:

Participants were administered Cyclophosphamide and Fludarabine for preconditioning on Days 1,2,3 Participants were administered 150 million cells of Descartes-11 via intravenous catheter on Days 7,10,14,21

Treatment:

Drug: Fludarabine

Drug: Cyclophosphamide

Biological: Descartes-11

Dose Level 4C

Experimental group

Description:

Participants were not administered Cyclophosphamide and Fludarabine for preconditioning on Days 1,2,3 Participants were administered 150 million cells of Descartes-11 via intravenous catheter on Days 1,4, 7,10,14,21

Treatment:

Biological: Descartes-11