RecruitingPhase 2NCT06574126

Ciltacabtagene Autoleucel in High-Risk Smoldering Multiple Myeloma

Phase II Open-Label, Single Arm, Multicenter Study of Ciltacabtagene Autoleucel in High-Risk Smoldering Multiple Myeloma (GEM-CAR-HiRiSMM)

Sponsor

PETHEMA Foundation

Enrollment

20 participants

Start Date

Sep 30, 2024

Study Type

INTERVENTIONAL

Conditions

High Risk Smoldering Multiple Myeloma

Summary

This is an open-label, single arm, multicenter, interventional study with Dara-VRD followed by cilta-cel in high-risk smoldering multiple myeloma (SMM) patients. The primary objectives of this trial, related with efficafy and safety of the treatment, are i) to evaluate the proportion of high-risk SMM patients with undetectable minimal residual disease (MRD) at 6 months, 12 months, and thereafter every 12 months up to 5 years after cilta-cel administration as well as the sustained undetectable MRD rate in the intent-to-treat (ITT) population; ii) to annotate frequency and severity of adverse events (AE) and serious adverse events (SAE), as well as data from laboratory tests aslo related with safety such as Immunoglobulin (Ig) G levels, complete blood count (CBC) cytopenia adn T-cell populations. Secondary objectives are related with response to therapy and will measure different categories of response and survival.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a CAR-T cell therapy called ciltacabtagene autoleucel (cilta-cel) — a highly personalized treatment using your own modified immune cells — for people with high-risk smoldering multiple myeloma (SMM), a precancerous blood condition that is at high risk of progressing to full myeloma. The goal is to treat it early before it becomes active cancer. **You may be eligible if...** - You are 18 or older - You have been diagnosed with high-risk smoldering multiple myeloma (not yet active disease) - Your risk is classified as high-risk by specific criteria (e.g., high M-protein, high bone marrow plasma cells, or abnormal protein ratios) - Your performance status and organ function (kidneys, liver, heart, lungs) are adequate **You may NOT be eligible if...** - You already have active (symptomatic) multiple myeloma - You have received prior treatment for myeloma or SMM - You have serious organ problems, active infections, or other cancers - You are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGGroup 1: Dara-VRD followed by apheresis and cilta-cel infusion

In Group 1, 10 eligible participants will undergo a maximum of two 28-day induction cycles with Dara-VRD. Participants in Group 1 are considered enrolled as the date of signing the Informed Consent Form. This will be followed by apheresis according to institutional standards with the collection target and instructions for processing and shipping apheresis product provided in the Cell Therapy Investigational Product Procedures Manual. Cilta-cel will be generated from T cells selected from the apheresis. Participants for whom apheresis or manufacturing fails will be allowed a second attempt of apheresis. Between apheresis and cilta-cel infusion, participants will be allowed to have stem cell collection using GCSF+/-plerixafor. Cilta-cel will be manufactured by transduction of T cells with an LV vector expressing anti-BCMA CAR, followed by T cell expansion.

DRUGGroup 2: Apheresis followed by Dara-VRD and cilta-cel infusion

In Group 2, 10 eligible participants will undergo apheresis first, according to institutional standards with the collection target and instructions for processing and shipping apheresis product provided in the Cell Therapy Investigational Product Procedures Manual. Study enrollment is defined as the date of signing Informed Consent Form. The apheresis will be followed by a maximum of two 28-day induction cycles with DARA-VRD. Cilta-cel will be generated from T cells selected from the apheresis. Participants for whom the apheresis or manufacturing fails will be allowed a second attempt at apheresis. Between apheresis and cilta-cel infusion, participants will be allowed to have stem cell collection using GCSF+/-plerixafor. Cilta-cel will be manufactured by transduction of T cells with an LV vector expressing anti-BCMA CAR, followed by T cell expansion.

Locations(1)

Hospital Clinico Universitario Salamanca

Salamanca, Spain

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06574126