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

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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.
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

Inclusion Criteria:


  1. ≥18 years of age at the time of consent.
  2. ECOG performance status of 0 or 1.
  3. Documented diagnosis of MM per IMWG diagnostic criteria.
  4. 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.
  5. Have documented evidence of progressive disease per IMWG criteria.
  6. Participant must have measurable disease at screening.
  7. Participant must have adequate bone marrow and organ function (hematological, hepatic and renal) demonstrated at screening.

EXCLUSION CRITERIA

Exclusion Criteria :


  1. Participant has a history of significant toxicity during prior CAR T-cell therapy and T-cell engaging therapy.
  2. 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.
  3. Participant has significant cardiac, neurological, or psychiatric conditions.
  4. Any other significant medical conditions such as:

  1. Serious active or uncontrolled infection
  2. Active autoimmune disease or a history of autoimmune disease within 2 years
  3. Active plasma cell leukemia at the time of screening
  4. Clinical evidence of dementia or altered mental status, or stroke, intracranial haemorrhage, or seizure within 6 months before signing informed consent form (ICF).
  5. 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.


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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.
Phone iconCall 713-231-8670Email iconEmail Study Center

Study Details


Contition
Relapsed/Refractory Multiple Myeloma
Age
18+
Phase
PHASE1/PHASE2
Participants Needed
182
Est. Completion Date
Nov 14, 2028
Treatment Type
INTERVENTIONAL

Sponsor
AstraZeneca
ClinicalTrials.gov NCT Identifier
NCT05850234
Study Number
GC012F-CD19/BCMA-001

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