New dual-target CAR-T therapy takes on hard-to-treat blood cancers
NCT ID NCT06986434
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-phase study tests a new treatment called CAR19-BCMA CAR-T for people with certain blood cancers (plasma cell neoplasms or lymphomas/leukemias) that have returned or not responded to at least three prior treatments. The therapy uses a patient's own immune cells, modified to target two markers (CD19 and BCMA) on cancer cells. The main goals are to check safety and find the best dose, with 20 participants enrolled.
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
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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 20 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Apr 2026
An estimate. Start dates often move.
- Expected to finish
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Aug 2028
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.
Show the full entry requirements Hide 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: 1. Relapsed/refractory CD19BCMA positive plasma cell neoplasms and lymphomas/leukemias with plasmacytic differentiation must be assured and meet all of the following conditions: * Confirmation for either BCMA or CD19 positivity using immunohistochemistry or flow cytometry * Patients with multiple myeloma, plasma cell carcinoma, plasma cell leukemia and lymphomas/leukemias with plasmacytic differentiation who have received at least three 3 lines treatment (including anti-CD38 monoclonal antibodies, protease inhibitors, immunosuppressants, etc.) but have failed or experienced relapse * Patients with system light chain amyloidosis who have received at least 2 lines treatments in the past \[anti-CD38 monoclonal antibody, proteasome inhibitor (PI), or immunomodulatory drug (IMiD)\], but have failed or experienced relapse 2. Age 18-80 years, no gender restrictions 3. ECOG score ≤ 2 points 4. Expected survival period is not less than 3 months 5. HGB≥60g/L 6. Liver function and cardiopulmonary function meet the following requirements: * left ventricular ejection fraction≥50% * Oxygen saturation \>90% * Total bilirubin ≤1.5×ULN, ALT and AST≤2.5×ULN 7. Participants agreed to use contraception from the time of informed consent until 1 year after CAR-T cell infusion Exclusion Criteria: * Severe heart failure with left ventricular ejection fraction \<50% * A history of severe lung function impairment * Combined with other advanced malignant tumors * Complicated with severe infection that could not be effectively controlled * Severe autoimmune disease or congenital immune deficiency * Active hepatitis (hepatitis B virus DNA \[HBV-DNA\] or hepatitis C virus RNA \[HCV-RNA\] test results above the lower limit of detection) * Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS), or syphilis infection * History of severe allergy to biological products (including antibiotics) * Patients with other serious physical or mental illnesses or laboratory abnormalities that could increase the risk of participating in the study or interfere with the results of the study, and those who were deemed by the investigator to be unsuitable for participation in the study * Female patients (those with fertility) are in pregnancy or lactation
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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 places running it
1 site. The list below names each one and where it is.
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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
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.
Contacts and locations
Locations
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the Fifth Medical Center of Chinese People's Liberation Army General Hospital
Beijing, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Banking blood and bone marrow to decode plasma cell disorders
- Can engineered cells beat blood cancers that Won't quit?
- Can a tropical tea shrink blood cancers?
- Engineered immune cells take aim at Hard-to-Treat myeloma
- Can engineered immune cells outsmart Treatment-Resistant myeloma?
- Can a lower dose of a myeloma drug keep the disease in check with fewer side effects?