Experimental Dual-Target CAR-T therapy takes aim at Hard-to-Treat plasma cell cancers
NCT ID NCT07519187
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times
Summary
This early-phase trial is testing a new type of gene therapy called CAR 70-BCMA dual-target CAR-T for people with relapsed or refractory plasma cell neoplasms, including multiple myeloma. The therapy involves taking a patient's own immune cells, re-engineering them to recognize and attack cancer cells that carry two specific markers (CD70 and BCMA), and infusing them back. The study will enroll 20 participants to primarily evaluate safety and find the right dose, while also looking at how well the treatment works.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- CAR 70-BCMA dual-target CAR-T cells (a type of gene therapy that re-engineers a patient's own immune cells to attack cancer)
- What this could lead to
- If successful, this could point toward a new treatment option for patients with hard-to-treat plasma cell cancers like multiple myeloma.
- What could go wrong
- This is a very early, small trial (20 people) focused mainly on safety. The therapy may not work or could cause serious side effects, and it is not yet known if it will lead to long-term disease control.
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.
- Started
-
Apr 2026
- Expected to finish
-
Apr 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 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. The subject or their legally authorized representative has provided written informed consent and is willing and able to comply with scheduled visits, study treatment, laboratory tests, and other study procedures 2. Diagnosis of relapsed or refractory plasma cell neoplasms, defined as follows: * Clonal plasma cells positive for BCMA and/or CD70 expression as determined by flow cytometry or immunohistochemistry * Patients with multiple myeloma, plasmacytoma, or plasma cell leukemia who have received at least three prior lines of therapy, including a proteasome inhibitor (PI), an immunomodulatory agent (IMiD), and an anti-CD38 monoclonal antibody, and whose best response was less than partial response (PR) or who experienced disease progression after achieving at least PR * Patients with systemic light chain amyloidosis who have received at least two prior lines of therapy, including an anti-CD38 monoclonal antibody and either a proteasome inhibitor (PI) or an immunomodulatory agent (IMiD), and whose best response was less than partial response (PR) or who experienced disease progression after achieving at least PR 3. Aged 18 to 75 years (inclusive), male or female 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 5. Life expectancy greater than 3 months from the date of informed consent 6. Hemoglobin (HGB) ≥ 60 g/L (transfusion permitted) 7. Adequate hepatic, renal, cardiac, and pulmonary function meeting the following criteria: * Creatinine ≤ 2 × upper limit of normal (ULN) * Left ventricular ejection fraction (LVEF) ≥ 50% * Oxygen saturation \> 90% * Total bilirubin ≤ 1.5 × ULN; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN 8. The subject agrees to use contraceptive measures from the time of signing the informed consent form until 1 year after CAR-T cell infusion Exclusion Criteria: * Severe cardiac dysfunction with left ventricular ejection fraction (LVEF) \< 50% * History of severe pulmonary function impairment * Concurrent progressive malignancy * Concurrent severe infection that cannot be adequately controlled * Concurrent severe autoimmune disease or congenital immunodeficiency * Active hepatitis, defined as hepatitis B virus deoxyribonucleic acid (HBV-DNA) or hepatitis C virus ribonucleic acid (HCV-RNA) above the lower limit of detection * Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS), or syphilis infection * History of severe allergic reaction to biological products (including antibiotics) * Patients who have undergone allogeneic hematopoietic stem cell transplantation and still have acute graft-versus-host disease (GVHD) one month after discontinuation of immunosuppressive agents * Presence of any other serious physical or mental illness, or laboratory abnormality that may increase the risk of study participation, interfere with the interpretation of study results, or render the patient unsuitable for study enrollment in the opinion of the investigator * Female patients of childbearing potential who are pregnant or breastfeeding
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Multiple myeloma are added.
Genom att skicka in godkänner du våra Användarvillkor
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.
-
The places running it
1 site. 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.
-
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
-
General Hospital of Western Theater Command of PLA
RECRUITINGChengdu, Chengdu, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Cheap blood count ratios eyed as window into Myeloma's inflammatory grip
- Can a t-cell engager rescue myeloma that outsmarted CAR-T?
- Can myeloma treatment work without steroids?
- Double-Drug attack on Hard-to-Treat lymphomas
- Banking blood and bone marrow to decode plasma cell disorders
- Which scan sees hidden myeloma better: PET or MRI?