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In-Body CAR-T therapy takes aim at Hard-to-Treat blood cancer

NCT ID NCT07586709

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-phase study tests the safety of a new immunotherapy that creates cancer-fighting cells inside the body for people with relapsed or refractory plasma cell neoplasms, a type of blood cancer. The treatment targets two proteins (BCMA and GPRC5D) on cancer cells. Researchers will monitor side effects like cytokine release syndrome and nerve toxicity in 18 participants.

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

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

About 18 people

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

Expected to start

May 2026

An estimate. Start dates often move.

Expected to finish

Mar 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

18 to 75 years

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: * Voluntary signing of informed consent by the subject or legally authorized representative, with willingness and ability to comply with scheduled visits, study treatment, laboratory tests, and other study procedures. * Diagnosis of relapsed or refractory plasma cell neoplasms meeting the following criteria: 1. Clonal plasma cells confirmed to be BCMA and/or GPRC5D positive by flow cytometry or immunohistochemistry; 2. Previously treated with at least 2 lines of anti-plasma cell neoplasms therapy, with at least 1 complete treatment cycle for each line, and evidence of disease progression within 12 months after the most recent anti-plasma cell neoplasms treatment, or being refractory to both immunomodulatory drugs and proteasome inhibitors, with disease progression within 2 months after the most recent anti-plasma cell neoplasms treatment (according to the IMWG diagnostic criteria) * Age 18 to 75 years (inclusive), male or female. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2. * Life expectancy \> 3 months from the date of informed consent. * Hemoglobin (HGB) ≥ 60 g/L (transfusion allowed). * Adequate organ function (hepatic, renal, cardiac, and pulmonary): 1. Creatinine ≤ 2 × ULN; 2. Left ventricular ejection fraction (LVEF) ≥ 50%; 3. Oxygen saturation \> 90%; 4. Total bilirubin ≤ 1.5 × ULN; ALT and AST ≤ 2.5 × ULN. * Willingness to use highly effective contraception from signing of informed consent until 1 year after SL4903 infusion. Exclusion Criteria: * Severe cardiac dysfunction with left ventricular ejection fraction (LVEF) \< 50%. * History of severe pulmonary impairment. * Concurrent diagnosis of another active malignancy. * Uncontrolled active infection. * History of severe autoimmune disease or primary immunodeficiency. * Active hepatitis (defined as HBV DNA or HCV RNA above the lower limit of detection). * Human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS), or active syphilis. * History of severe hypersensitivity to biological products (including antibiotics). * Allogeneic hematopoietic stem cell transplant recipients with ongoing acute graft-versus-host disease (GVHD) despite discontinuation of immunosuppressive therapy for at least one month prior to screening. * Any other severe comorbidities or laboratory abnormalities that, in the investigator's opinion, would increase the risk to the subject or interfere with study results, rendering the subject unsuitable for participation. * Pregnant or breastfeeding women (including women of childbearing potential who are pregnant or lactating).

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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  1. The official record

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More trials for these conditions

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