A Study of CC-98633 BCMA-targeted Chimeric Antigen Receptor (CAR) T Cells in Subjects With Relapsed and/or Refractory Multiple Myeloma

STATUS

Recruiting
participants needed

80
sponsor

Juno Therapeutics, a Subsidiary of Celgene

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Updated on 19 February 2024

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measurable disease

multiple myeloma

bortezomib

lenalidomide

carfilzomib

daratumumab

thalidomide

refractory multiple myeloma

ixazomib

pomalidomide

proteasome inhibitor

bcma

immunotherapeutic agent

Summary

This is a Phase 1, multicenter, open-label study of CC-98633, BCMA-Targeted NEX-T Chimeric Antigen Receptor (CAR) T Cells, in subjects with relapsed and/or refractory multiple myeloma.

The study will consist of 2 parts: dose-escalation (Part A) and dose-expansion (Part B). The dose-escalation part (Part A) of the study is to evaluate the safety and tolerability of increasing dose levels of CC-98633 to establish a recommended Phase 2 dose (RP2D); and the dose-expansion part (Part B) of the study is to further evaluate the safety, pharmacokinetics/pharmacodynamics, and efficacy of CC-98633 at the RP2D.

Details

Condition	Multiple Myeloma, Multiple Myeloma, Lymphoproliferative Disorder
Age	18years - 100years
Treatment	CC-98633
Clinical Study Identifier	NCT04394650
Sponsor	Juno Therapeutics, a Subsidiary of Celgene
Last Modified on	19 February 2024

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Eligibility		Yes	No	Not Sure
Inclusion Criteria
	Age 18 years
	Signed written informed consent prior to any study procedure
	Relapsed and/or refractory multiple myeloma (MM). Subjects must have received at least 3 prior antimyeloma treatment regimens and be refractory to the last regimen prior to study entry. Subjects must have previously received all of the following therapies
	following therapies
	Autologous stem cell transplant
	A regimen that included an immunomodulatory agent (eg, thalidomide, lenalidomide, pomalidomide) and a proteasome inhibitor (eg, bortezomib, carfilzomib, ixazomib), either alone or combination
	Anti-CD38 (eg, daratumumab), either alone or combination
	Measurable disease
	Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
	Adequate organ function
Exclusion Criteria
	Known active or history of central nervous system (CNS) involvement of MM
	Active or history of plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, skin changes) syndrome, or clinically significant amyloidosis
	Prior treatment with CAR T-cell or another genetically modified T-cell therapy
	Prior treatment with investigational therapy directed at BCMA
	Uncontrolled or active infection
	Active autoimmune disease requiring immunosuppressive therapy
	History or presence of clinically significant CNS pathology such as seizure disorder, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis

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Study Definition

Wikipedia

A Study of CC-98633 BCMA-targeted Chimeric Antigen Receptor (CAR) T Cells in Subjects With Relapsed and/or Refractory Multiple Myeloma