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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Research Site
  Birmingham, Alabama, United States Recruiting
• Research Site
  Phoenix, Arizona, United States Recruiting
• Research Site
  La Jolla, California, United States Recruiting
• Research Site
  Los Angeles, California, United States Recruiting
• Research Site
  San Francisco, California, United States Recruiting
• Research Site
  Aurora, Colorado, United States Recruiting

Study contacts

• Study coordinator: AstraZeneca Clinical Study Information Center
• Email: information.center@astrazeneca.com
• Phone: 1-877-240-9479

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• In Vivo CD19/CD20 CAR T-Cell Therapy for Relapsed or Refractory B-Cell Lymphoma

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  Recruiting Phase 1 Chinese PLA General Hospital · Beijing · NCT07775508

• CT0596 CAR-T in relapsed/refractory multiple myeloma: a phased dose-find and efficacy study

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• IL-15–armored CAR-T for relapsed or refractory multiple myeloma and plasma cell leukemia

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  Recruiting Phase 2 The First Hospital of Jilin University · Changchun, Jilin · NCT07509086

• CD5 CAR T-cell therapy for relapsed or refractory T-cell lymphoma

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• Glofitamab plus obinutuzumab for mantle cell lymphoma after CAR‑T

  This trial tests whether the antibody drug glofitamab given with obinutuzumab can shrink or control mantle cell lymphoma that returned or didn't respond after CD19 CAR‑T therapy in adults.

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• CD7 CAR T-Cell Therapy for T-Cell Lymphomas

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  Recruiting at 4 sites Phase 1/2 Beijing GoBroad Hospital · Beijing, Beijing Municipality and 3 other locations · NCT06925464

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.