Engineered immune cells target Hard-to-Treat myeloma with kidney issues
NCT ID NCT07489534
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a new treatment called PD-1Ab21-BCMA CAR-T cells for people with multiple myeloma who also have kidney problems. The treatment uses a patient's own immune cells, modified in a lab to better find and attack cancer cells. The goal is to see if this therapy can keep the cancer from coming back for at least one year. About 25 participants will receive this therapy as part of their first treatment plan.
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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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 25 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2025
- Expected to finish
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Jul 2027
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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14 years and older
- 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. Age: Over 14 years old 2. Diagnosed with multiple myeloma accompanied by renal dysfunction, received ≥ 2 courses of clinical first-line treatment, evaluated efficacy above PR, and predicted survival of more than three months. 3. The hospital examination meets the following indicators: 1. ECOG physical status score 0-2 or KPS score\>80 points 2. Having sufficient venous access for single or intravenous blood collection, and no other blood cells Separation contraindications 3. WBC≥1×109/L,LY≥0.3×109/L, 4. ALT and AST ≤ 2.5 ULN 5. Serum total bilirubin ≤ 2.0mg/dL (34.2 μmol/L) 6. PT:INR\<1.7 or PT prolonged by\<4s compared to normal value Exclusion Criteria: 1. Pregnant or lactating women (the safety of this treatment for unborn babies is unknown, and the assessment of pregnancy status for female participants is negative in serum or urine pregnancy tests within 48 hours prior to infusion); 2. Any uncontrollable active infection; 3. Presence of active hepatitis B or C virus infection; 4. HIV/AIDS infection; 5. Has neurological disorders; 6. Within 2 weeks prior to signing the informed consent form, systemic use of steroid drugs (inhalable steroids may be used); 7. Allergies to immunotherapy and related drugs; 8. Currently, there are patients with heart disease or poorly controlled hypertension who require treatment; 9. Currently, patients with unstable or active ulcers or gastrointestinal bleeding; 10. Patients with a history of organ transplantation or waiting for organ transplantation; 11. Hyponatremia, blood sodium\<125mmol/L; 12. Baseline blood potassium\<3.5mmol/L (potassium can be supplemented before participating in the study to restore blood potassium levels above this level); 13. The patient needs anticoagulant therapy (such as warfarin or heparin); 14. The patient requires long-term antiplatelet therapy (aspirin, dose\>300mg/d); Clopidogrel, dose\>75mg/d). Additionally, 1. Patients currently participating in other clinical trials; 2. Researchers believe that other reasons are not suitable for clinical trial participants.
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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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Chinese PLA General Hospital
RECRUITINGBeijing, Beijing Municipality, 100853, 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?