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AZD0120 in Relapsed/Refractory Multiple Myeloma (DURGA-1)

RecruitingPhase 1/2

A Phase Ib/II Study of AZD0120, Dual-Targeting Autologous Chimeric Antigen Receptor T-cell (CAR T) Therapy Directed Against CD19 and B-cell Maturation Antigen (BCMA) in Participants With Relapsed/Refractory Multiple Myeloma (DURGA-1)

Who can join

Ages 18 and older · All sexes

Full eligibility criteria
Inclusion Criteria:

* ≥18 years of age at the time of consent.
* ECOG performance status of 0 or 1.
* Documented diagnosis of MM per IMWG diagnostic criteria.
* Participant must have received at least 3 prior lines of therapy, which include a proteasome inhibitor (PI), an immunomodulatory drug (IMiD), and an anti-CD38 antibody.
* Have documented evidence of progressive disease per IMWG criteria.
* Participant must have measurable disease at screening.
* Participant must have adequate bone marrow and organ function (hematological, hepatic and renal) demonstrated at screening.

Exclusion Criteria :

* Participant has a history of significant toxicity during prior CAR T-cell therapy and T-cell engaging therapy.
* Participant has a history of a prior non-hematologic malignancy, unless the participant has been disease-free with no evidence of recurrence for ≥ 2 years. Some exceptions may apply.
* Participant has significant cardiac, neurological, or psychiatric conditions.
* Any other significant medical conditions such as:

  * Serious active or uncontrolled infection
  * Active autoimmune disease or a history of autoimmune disease within 2 years
  * Active plasma cell leukemia at the time of screening
  * Clinical evidence of dementia or altered mental status, or stroke, intracranial haemorrhage, or seizure within 6 months before signing informed consent form (ICF).
* Known active or prior history of central nervous system involvement or exhibits clinical signs of meningeal involvement of MM.

Other protocol-defined Inclusion/Exclusion criteria apply.

About the study

This trial is a Phase 1b/2, open-label, multicenter study of AZD0120, a CD19/BCMA dual CAR T-cell therapy, in adult subjects with relapsed/refractory multiple myeloma.

What is being tested

Sponsor: AstraZeneca · Participants: 232 · Started: Jul 20, 2023

Contact the study team

Official record on ClinicalTrials.gov — NCT05850234

Locations in the U.S.

AlabamaResearch Site, Birmingham
ArizonaResearch Site, Phoenix
CaliforniaResearch Site, La Jolla
Research Site, Los Angeles
Research Site, San Francisco
ColoradoResearch Site, Aurora
Research Site, Denver
FloridaResearch Site, Jacksonville
Research Site, Miami
Research Site, Tampa
GeorgiaResearch Site, Atlanta
IllinoisResearch Site, Chicago
IowaResearch Site, Iowa City
MassachusettsResearch Site, Boston
Research Site, Boston
MichiganResearch Site, Ann Arbor
Research Site, Detroit
MinnesotaResearch Site, Minneapolis
Research Site, Rochester
New YorkResearch Site, Buffalo (Not yet recruiting)
Research Site, New York
Research Site, Stony Brook
North CarolinaResearch Site, Charlotte
Research Site, Durham
TennesseeResearch Site, Nashville
Research Site, Nashville
TexasResearch Site, Austin
Research Site, Dallas
Research Site, Houston
UtahResearch Site, Salt Lake City
VirginiaResearch Site, Charlottesville
WashingtonResearch Site, Edmonds
Research Site, Seattle
WisconsinResearch Site, Milwaukee

Conditions

From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.