In-Body CAR-T therapy takes aim at Hard-to-Treat blood cancer
NCT ID NCT07586709
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
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About 18 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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May 2026
An estimate. Start dates often move.
- Expected to finish
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Mar 2029
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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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
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
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More trials for these conditions
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