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New dual-target CAR-T therapy takes on hard-to-treat blood cancers

NCT ID NCT06986434

What the study statuses mean

This study's is highlighted.

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 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

Early phase 1

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

Participants

About 20 people

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

Expected to start

Apr 2026

An estimate. Start dates often move.

Expected to finish

Aug 2028

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: 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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. 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 ↗

  3. 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

  • 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.