Descartes-11 in Multiple Myeloma

Sponsor

Cartesian Therapeutics (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT03994705

Collaborator

(none)

Enrollment

Locations

Arm

40.5

Anticipated Duration (Months)

12.5

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This Phase I/2 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.

Condition or Disease	Intervention/Treatment	Phase
Multiple Myeloma	Biological: Descartes-11 Drug: Fludarabine Drug: Cyclophosphamide	Phase 1/Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

25 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Phase I Safety Study of Descartes-11 in Patients With Relapsed/Refractory Multiple Myeloma

Actual Study Start Date :

Aug 6, 2019

Anticipated Primary Completion Date :

Aug 6, 2022

Anticipated Study Completion Date :

Dec 20, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Dose-Escalation	Biological: Descartes-11 CAR T-Cells Drug: Fludarabine Pre-conditioning chemotherapy Drug: Cyclophosphamide Pre-conditioning therapy

Arm

Intervention/Treatment

Experimental: Dose-Escalation

Biological: Descartes-11

CAR T-Cells

Drug: Fludarabine

Pre-conditioning chemotherapy

Drug: Cyclophosphamide

Pre-conditioning therapy

Outcome Measures

Primary Outcome Measures

Incidence (number) of Treatment-Emergent Adverse Events [14 Days]
Safety and Tolerability

Secondary Outcome Measures

Treatment Response [Time Frame: 1, 3, 6, 9 and 12 months]
IMWG treatment response criteria

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.