Descartes-11 in Patients With Relapsed/Refractory Multiple Myeloma

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-01

Study Completion Date

2021-06-11

Brief Summary

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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.

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Detailed Description

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Conditions

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Multiple Myeloma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Dose Level 1

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

Group Type EXPERIMENTAL

Descartes-11

Intervention Type BIOLOGICAL

CAR T-Cells

Fludarabine

Intervention Type DRUG

Pre-conditioning chemotherapy

Cyclophosphamide

Intervention Type DRUG

Pre-conditioning therapy

Dose Level 2

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

Group Type EXPERIMENTAL

Descartes-11

Intervention Type BIOLOGICAL

CAR T-Cells

Fludarabine

Intervention Type DRUG

Pre-conditioning chemotherapy

Cyclophosphamide

Intervention Type DRUG

Pre-conditioning therapy

Dose Level 3

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

Group Type EXPERIMENTAL

Descartes-11

Intervention Type BIOLOGICAL

CAR T-Cells

Fludarabine

Intervention Type DRUG

Pre-conditioning chemotherapy

Cyclophosphamide

Intervention Type DRUG

Pre-conditioning therapy

Dose Level 4 A

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

Group Type EXPERIMENTAL

Descartes-11

Intervention Type BIOLOGICAL

CAR T-Cells

Fludarabine

Intervention Type DRUG

Pre-conditioning chemotherapy

Cyclophosphamide

Intervention Type DRUG

Pre-conditioning therapy

Dose Level 4B

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

Group Type EXPERIMENTAL

Descartes-11

Intervention Type BIOLOGICAL

CAR T-Cells

Fludarabine

Intervention Type DRUG

Pre-conditioning chemotherapy

Cyclophosphamide

Intervention Type DRUG

Pre-conditioning therapy

Dose Level 4C

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

Group Type EXPERIMENTAL

Descartes-11

Intervention Type BIOLOGICAL

CAR T-Cells

Interventions

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Descartes-11

CAR T-Cells

Intervention Type BIOLOGICAL

Fludarabine

Pre-conditioning chemotherapy

Intervention Type DRUG

Cyclophosphamide

Pre-conditioning therapy

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No