New cell therapy takes on Hard-to-Treat myeloma

NCT ID NCT07100067

Disease control Sponsor: Nanjing Legend Biotech Co. Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests a new cell therapy called LCAR-F33S in 35 people with multiple myeloma that has come back or stopped responding to other treatments. The therapy uses a patient's own immune cells, which are modified in a lab to attack the cancer. The main goals are to check safety, find the right dose, and see if it shrinks tumors.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: LCAR-F33S cells (a type of CAR T-cell therapy made from the patient's own immune cells)
What this could lead to: If it works, this could offer a new treatment option for people with multiple myeloma that has stopped responding to standard therapies.
What could go wrong: This is a very early, small study (35 people) focused on safety and dosing. The treatment may not work, and there are risks of serious side effects like cytokine release syndrome.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 35 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2025

Expected to finish

Nov 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Subjects voluntarily participate in clinical research. * Age ≥18 years old. * Eastern Cooperative Oncology Group (ECOG) score 0-2. * Examination evidence of initial diagnosis of MM according to IMWG diagnostic criteria. * Measurable lesions were present. * Subjects have received treatment with one PI, one IMiD and a CD38 monoclonal antibody. * Subjects have received at least three previous lines of multiple myeloma therapy, each with at least one complete therapy cycle, unless the best response to the therapeutic regimen was documented as disease progression (PD confirmed according to IMWG criteria). * Expected survival ≥3 months. * Clinical laboratory values in the screening period meet criteria. Exclusion Criteria: * Received previous therapy targeting FcRH5 targets. * Prior antineoplastic therapy and meet exclusion criteria (before apheresis); * Subjects had Plasma cell leukemia, Waldenstrom macroglobulinemia, POEMS syndrome, or primary AL amyloidosis at the time of screening. * Subjects who were positive for any of HBsAg, HBV DNA, HCV-Ab, HCV RNA, and HIV-Ab; * Life-threatening allergic reactions, hypersensitivity reactions, or intolerance to CAR-T cell formulations or their excipients, including DMSO, are known. * Serious underlying diseases were present. * Female subjects who were pregnant, breastfeeding, or planning to become pregnant while participating in this study or within 1 year of receiving study treatment. * Also enrolled in other clinical studies.

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Conditions

The condition(s) this trial relates to.

plasma cell myeloma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Relapsed/refractory multiple myeloma (MM)

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

4 sites. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

Open the record ↗
A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

New cell therapy takes on Hard-to-Treat myeloma

What the study statuses mean