CAR T Therapy for Multiple Myeloma

Recruiting at 7 trial locations

Overseen By AstraZeneca Clinical Study Information Center

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: AstraZeneca

Must be taking: Proteasome inhibitors, Immunomodulatory drugs

Disqualifiers: CNS involvement, Plasma cell leukemia, HIV, Hepatitis B, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 4 weeks

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called AZD0120 (also known as GC012F, a type of CAR T therapy) to determine its safety and tolerability for people with multiple myeloma, a type of blood cancer. The study targets patients recently diagnosed with this condition or whose cancer has returned after initial treatments. Participants should have experienced multiple myeloma and may have faced treatment failure or relapse. The trial involves a single infusion of the treatment. For those who have had multiple myeloma and have not yet tried CAR T therapy, this trial might be suitable. As a Phase 1 trial, the research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new therapy.

Do I need to stop my current medications to join the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that AZD0120, also known as GC012F, has been tested in earlier studies. These studies found the treatment to be generally safe. In one study with 22 patients, 27% experienced only mild to moderate side effects, indicating that most people tolerate the treatment well.

Although the treatment remains in the early testing stages, it is encouraging that other trials have not reported any severe side effects. The current study focuses on understanding the safety and tolerability of the treatment, so researchers closely monitor any side effects. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for multiple myeloma, which often involve chemotherapy, stem cell transplants, and immunomodulatory drugs, AZD0120 is a CAR T-cell therapy. This innovative treatment works by genetically engineering a patient's own T cells to better recognize and attack cancer cells. Researchers are particularly excited about AZD0120 because it offers a personalized approach that could provide more effective and long-lasting responses compared to traditional therapies. Additionally, since it involves a single infusion, it may offer convenience and reduce the need for ongoing treatments.

What evidence suggests that this treatment might be an effective treatment for multiple myeloma?

Research has shown that GC012F (AZD0120), the treatment under study in this trial, could effectively treat multiple myeloma, a type of blood cancer. This CAR T-cell therapy targets specific proteins, BCMA and CD19, on cancer cells, leading to strong and lasting responses. In patients whose multiple myeloma has returned or is difficult to treat, GC012F has been associated with high rates of MRD negativity, meaning no cancer cells are detected. This suggests it might help patients achieve deep remission. Additionally, early research indicates it is a safe treatment option with positive health outcomes. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

This trial is for adults with Multiple Myeloma who have measurable disease, progressive disease within a year of treatment or within 6 months after the last therapy. They must have had 1-2 prior treatments including a proteasome inhibitor and immunomodulatory drug, be in good physical condition (ECOG 0 or 1), and have proper organ function. Not eligible if they've had CNS involvement by myeloma, recent stroke/seizure, HIV, previous CAR T therapy, plasma cell leukemia at screening time, active hepatitis B/C infection or serious medical conditions like uncontrolled infections or active autoimmune diseases.

Inclusion Criteria

Subjects must have measurable disease per IMWG criteria, defined as: Serum monoclonal paraprotein (M-protein) ≥1.0 g/dL (10 g/L), Urine M-protein ≥200 mg/24 h, Serum free light chain (FLC) assay: involved FLC level is ≥10 mg/dL (100 mg/L) and serum kappa lambda FLC ratio is abnormal

My myeloma has worsened within 1 year after or 6 months before my last treatment.

I am 18 years old or older.

Exclusion Criteria

Stroke or seizure within 6 months of signing informed consent

Seropositive for human immunodeficiency virus (HIV)

My multiple myeloma has affected or is affecting my brain or spinal cord.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

GC012F (AZD0120) is administered in one infusion to evaluate safety, tolerability, and efficacy

4 weeks

1 visit (in-person)

Follow-up

Participants are monitored for safety, pharmacokinetics, and pharmacodynamics over an extended period

2 years

What Are the Treatments Tested in This Trial?

Interventions

• GC012F (AZD0120)

Trial Overview The study tests GC012F (AZD0120), an experimental dual-targeting CAR T-cell therapy aimed at CD19/BCMA in early-line treatment for Multiple Myeloma patients. It's an initial phase trial to evaluate safety and how well it works. The intervention involves genetically modifying patient's T-cells to fight cancer.

How Is the Trial Designed?

Group I: AZD0120 Experimental Treatment 1 Intervention

AZD0120 will be administrated in one infusion

Who Is Running the Clinical Trial?

AstraZeneca

Lead Sponsor

Trials

4,491

Recruited

290,540,000+

Sir Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Dr. Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05850234

NCT05850234 | A Study of GC012F (AZD0120), a CAR T ... This trial is a phase 1b/2, open-label, multicenter study of GC012F (AZD0120), a CD19/BCMA dual CART-cell therapy, in adult subjects with relapsed/refractory ...

2. ashpublications.org ashpublications.org/blood/article/142/Supplement%201/1022/502612/Updated-Results-of-a-Phase-I-Open-Label-Single-Arm

Updated Results of a Phase I Open-Label Single-Arm Study of ... The promising preliminary results achieved with GC012F demonstrate potential of CAR-T therapy in newly-diagnosed MM pts. Further research with ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10431165/

P869: UPDATED RESULTS OF A PHASE I, OPEN-LABEL ... The updated results showed GC012F continues to provide deep and durable responses, and a very high MRD negativity rate in RRMM pts.

4. jamanetwork.com jamanetwork.com/journals/jamaoncology/fullarticle/2821602

B-Cell Maturation Antigen/CD19 Dual-Targeting ... The BCMA/CD19 dual-targeting CAR T-cell therapy, GC012F, is a safe treatment associated with positive health and survival outcomes for patients with high-risk ...

5. astrazenecaclinicaltrials.com astrazenecaclinicaltrials.com/study/D8310C00001

A Phase Ib/II Study of AZD0120, Dual-Targeting CAR-T ... 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 ...

6. ascopubs.org ascopubs.org/doi/10.1200/JCO.2023.41.16_suppl.8005

Updated results of a phase I, open-label study of BCMA ... The updated results showed GC012F continues to provide deep and durable responses, and a very high MRD negativity ratein RRMM pts.