FDA Allows iMMagine-1 Study to Continue for Patients With RRMM


Prior suspicions about a patient death in iMMagine-1 had been cleared up and the trial will continue with the permission of the FDA.

  • The iMMagine-1 study protocol was modified after the partial clinical hold.

  • iMMagine-1 was also expanded to include bridging therapies that may help with toxicity.

  • Data from the phase 1 iMMagine-1 study willl be announced in the second half of 2024.

The FDA has lifted the partial clinical hold placed on the CART-ddBCMA for the treatment of patients with relapsed or refractory multiple myeloma (RRMM).1

The partial clinical hold was placed by the FDA in June 2023, after a suspicious patient death. It was uncovered that the patient was treated with CART-ddBCMA even though they were ineligible to receive the investigational therapy, per the study’s protocol. Working with the FDA, developer of CART-ddBCMA, Arcellx, Inc has since modified the study protocol. It is believed that these changes will prevent or help to better manage adverse events (AEs) that occur in the study.

About the Phase 2 iMMagine-1 Study

Trial Name: A Phase II Study of CART-ddBCMA for the Treatment of Patients With Relapsed or Refractory Multiple Myeloma

ClinicalTrials.gov Identifier: NCT05396885

Sponsor: Arcellx, Inc

Recruitment Contact: 240-327-0379, clinical@arcellx.com

Completion Date: May 31, 2025

“We have worked closely with FDA to expeditiously resolve the clinical hold and we thank them for their collaboration and dialogue throughout this process," said Rami Elghandour, chairman and chief executive officer of Arcellx, Inc, in a press release.

iMMagine-1 is a pivotal, open-label, multicenter study, which will include up to 110 patients with RRMM. Patients in the study will be treated with a single dose of CART-ddBCMA 115±10 x 10-6 CAR-positive CART-ddBCMA cells via intravenous infusion.2

The study’s primary end point is overall response rate, and the secondary end points include stringent complete response rate, duration of response, very good partial response, time to initial response, progression-free survival, overall survival, the safety profile of CART-ddBCMA as determined by AEs, pharmacokinetics, anti-CART-ddBCMA antibodies, and health-related quality-of-life.

Patients are eligible for inclusion in the study if they are 18 years of age or older with RRMM and documented measurable disease. Patients are required to have a ECOG performance status of 0 to 1, a life expectancy of at least 12 weeks, and adequate organ function. Prior to receiving CART-ddBCMA in the study, any AEs from prior treatment must be resolved to at least grade 1.

Those excluded from the study are patients who were previously treated with prior systemic therapy for multiple myeloma within 14 days of starting study treatment; high-dose systemic therapy or immunosuppressives therapy within 14 days; or previous treatment with a gene-modified cellular immune therapy, BCMA-directed therapy, or autologous stem cell transplantation within 3 months. The study also does not allow certain patients based on their disease history or comorbidities that may interfere with the effectiveness of treatment.

Resulting from meetings with the FDA about the previous partial clinical hold, the FDA has agreed to an expansion of the iMMagine study.1

“During the review process, we updated our trial protocol, and were pleased that [the] FDA allowed for expanded bridging therapies, which better aligns our protocol with current clinical practice. As a key step to enhancing protocol adherence related to the prevention and management of the risk of adverse events, we retrained clinical sites. Importantly, during the partial clinical hold, [the] FDA approved dosing of all 17 patients who had been enrolled but not yet dosed prior to the hold, minimizing treatment disruption for patients and clinicians. We and our partners at Kite remain confident in CART-ddBCMA's potential as a best-in-class therapy for the treatment of patients with RRMM given the totality of data to date across our studies,” Elghandour stated.

The company plans to report its phase 1 data from iMMagine-1 in the second half of 2024 and to file a biologics license application in 2026.


1. Arcellx announces partial clinical hold lifted on iMMagine-1 phase 2 clinical program and reports second quarter financial results. News release. Arcellx, Inc. August 14, 2023. Accessed August 15, 2023. https://www.prnewswire.com/news-releases/arcellx-announces-partial-clinical-hold-lifted-on-immagine-1-phase-2-clinical-program-and-reports-second-quarter-financial-results-301900055.html#:~:text=On%20August%2014%2C%202023%2C%20Arcellx,adverse%20events%20within%20the%20trial.

Study of CART-ddBMCA in relapsed or refractory multiple myeloma 2. (iMMagine-1). ClinicalTrials.gov. Updated March 22, 2023. Accessed August 14, 2023. https://clinicaltrials.gov/ct2/show/NCT05396885?term=iMMagine-1&draw=2&rank=1

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