Patient ringing bell after chemo treatment

An Off-the-Shelf BCMA CAR-T Trial for Relapsed and Refractory Multiple Myeloma

To refer a patient for trial eligibility, please submit a referral form or contact the Moffitt clinical trial coordinator for MCC24384.

Submit a Referral Contact Coordinator

Key Highlights

First-in-human off-the-shelf allogeneic BCMA CAR-T
No patient-specific manufacturing required
Single AZD4045 infusion after lymphodepletion
Intended for heavily pretreated RRMM

Designed for patients who have received at least 3 prior lines, including PI, IMiD, anti-CD38, and BCMA-directed therapy.

Off-the-Shelf CAR-T Therapy Clinical Trial #24384

Refer eligible patients for a Phase I/II study evaluating AZD4045 as an off-the-shelf CAR-T therapy targeting B Cell Maturation Antigen (BCMA).

A Readily Available Next Step for Unresponsive Myeloma Patients

Patients with RRMM often face limited options. AZD4045 is designed to:

Target BCMA on myeloma cells using an allogeneic CAR-T product
Use healthy donor-derived, gene-edited T cells engineered for off-the-shelf availability
Avoid delays associated with autologous CAR-T manufacturing

Which Patients May Be Eligible?

Inclusion Criteria Summary:

Age ≥18
RRMM
Measurable disease
ECOG 0–1
≥3 prior treatment classes including PI, IMiD, anti-CD38

Exclusion Criteria Summary:

Prior allogeneic transplant
Recent CAR-T / CAR-NK / TCE / BCMA therapy
Active uncontrolled infection
Significant neurologic disease or prior severe CAR-T toxicity

Review full clinical trial details

Not sure if your patient qualifies? Contact the Clinical Research Coordinator for rapid eligibility review: emily.merritt@moffitt.org

What does trial participation look like for patients?

Submit referral request and send patient records to Moffitt
Patients will be pre-screened for basic eligibility by the clinical research coordinator
Initial appointment with Dr. Freeman
Workup and clinical screening appointments
Following enrollment in the trial, patient will be placed in an appropriate cohort:

Cohort A — AZD4045 monotherapy
Screening → cyclophosphamide + fludarabine, Days -5 through -3 → Day 1, single AZD4045 infusion → close monitoring, within one hour of the treatment center, caregiver for the first 28 days.

Cohort B — AZD4045 + daratumumab + aldesleukin
Screening → cyclophosphamide + fludarabine, Days -5 through -3, plus daratumumab Day -3 → Day 1, AZD4045 followed by aldesleukin, which may continue daily through Day 14 → second daratumumab dose Day 5 → within one hour of the treatment center, caregiver for 28 days after infusion.

Location: Moffitt Magnolia main campus
Stay near campus: approx. 5 weeks, or until Day +28 after the AZD4045 infusion
Caregiver: required starting at lymphodepletion, not at infusion

Expenses Reimbursed

Travel, lodging and meals expenses are covered by the trial sponsor from the first visit/screening through the 2 year follow up period via reimbursement
Follow-up Care

There are 2 years of active follow-up care. This is followed up by care visits every 6 months until 15 years post therapy.

Partner with Moffitt

A referral for a clinical trial means we will work together to give your patient the best chance at beating their cancer.

For patients with RRMM who have exhausted standard options, this off-the-shelf CAR-T approach represents a promising next step sooner than other CAR-T options.

Ciara Freeman, MD

Principal Investigator

Have a patient you think would be a candidate for this clinical trial?

We are here to help, you can start a referral by submitting this online form.

If you have questions for the Research Coordinator about the trial, please contact emily.merritt@moffitt.org.

For questions about referring your patient or to learn more about Moffitt you can speak with a Physician Liaison:

Contact Your Physician Liaison

We're here to help. Complete the online form to refer your patient directly to Dr. Freeman.

Refer a Patient

World Leader in CAR T Therapy

As the first cancer center worldwide to treat over 2,000 patients with CAR T therapy, Moffitt is a world leader in CAR T, pioneering next-generation cell therapies and TILs to harness the power of the immune system.

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