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CAR T therapy targeting CD19 and BCMA for relapsed/refractory multiple myeloma

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)

Phase1; Phase2 Interventional AstraZeneca · NCT05850234

This study is testing a new CAR T-cell therapy for adults with tough-to-treat multiple myeloma to see if it’s safe and effective.

Quick facts

PhasePhase1; Phase2
Study typeInterventional
Enrollment182 (estimated)
Ages18 Years and up
SexAll
SponsorAstraZeneca Industry-sponsored
Drugs / interventionsCAR T
Locations36 sites (Birmingham, Alabama and 35 other locations)
Trial IDNCT05850234 on ClinicalTrials.gov

What this trial studies

This is a phase 1b/2, open-label, multicenter clinical trial evaluating GC012F (AZD0120), a dual CAR T-cell therapy targeting CD19 and BCMA, in adults with relapsed or refractory multiple myeloma. The study aims to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of the treatment in the first phase, while the second phase focuses on evaluating its efficacy and further characterizing safety and quality of life changes. Participants will receive the treatment after meeting specific eligibility criteria, including prior therapies and measurable disease.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with relapsed or refractory multiple myeloma who have received at least three prior lines of therapy.

Not a fit: Patients with invasive malignancies or those who do not meet the specific eligibility criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this therapy could provide a new treatment option for patients with relapsed or refractory multiple myeloma.

How similar studies have performed: Other studies have shown promise with CAR T-cell therapies in treating multiple myeloma, indicating a potential for success with this novel approach.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Birmingham, Alabama and 35 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Relapsed/Refractory Multiple MyelomaMultiple Myeloma, BCMA, CAR T, CD19, AZD0120
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.