New universal cell therapy shows promise for Hard-to-Treat blood cancer
NCT ID NCT05498545
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage study tested a new type of cell therapy called LUCAR-B68 in 8 adults with multiple myeloma that had come back or stopped responding to treatment. The therapy targets a protein called BCMA on cancer cells and is designed to be used without needing to match the patient's own cells. The main goals were to check safety, find the right dose, and see if it helps control the disease.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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8 people
The number who actually took part.
- Started
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Nov 2022
- Finished
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May 2025
- 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 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. The subject voluntarily participates in the clinical study; Fully understand and be Informed of the study and sign the Informed consent (Informed Consent Form, ICF); Willing to follow and able to complete all test procedures; Informed consent must be obtained before initiating any tests or procedures related to the study that are not part of the standard treatment of the subject's disease; 2. Subjects ≥ 18 years of age. 3. Eastern Cooperative Oncology Group performance status score of 0, 1, or 2; 4. Documented initial diagnosis of MM according to IMWG diagnostic criteria. 5. Presence of measurable disease at screening. 6. Received a PI and an IMiD (except thalidomide). 7. Received at least 3 prior lines of therapy for multiple myeloma, undergone at least 1 complete cycle of treatment for each line, unless progressive disease (PD) was documented by IMWG criteria as the best response to the regimen. Also, subjects refractory or intolerant to any PI and any IMiD in their previous treatment afterwards are eligible. 8. Expected survival ≥ 3 months. 9. Clinical laboratory values meet screening visit criteria 10. Fertile women must be negative using a highly sensitive serum pregnancy test (β human chorionic gonadotropin \[β -HCG\]) at screening time and before initial treatment with cyclophosphamide and fludarabine; Exclusion Criteria: 1. No response to prior BCMA-targeted CAR-T therapy (except in subjects who relapsed after CR to prior CAR-T treatment); 2. Prior treatment with any antibody targeting BCMA; 3. Known active, or prior history of central nervous system (CNS) involvement, or clinical signs of membrane/spinal membrane involvement of multiple myeloma; 4. Serious underlying medical conditions 5. Positive of any hepatitis B surface antigen (HBsAg), hepatitis B virus deoxyribonucleic acid (HBV DNA), hepatitis C antibody (HCV-Ab), hepatitis C virus ribonucleic acid (HCV RNA), human immunodeficiency virus antibody (HIV-Ab) at the time of screening; 6. Male subjects who have a birth plan during the study period or within 1 year after the study treatment 7. Female subjects who are pregnant, breast-feeding, or plan to become pregnant during the study period or within 1 year after the study treatment 8. The investigator considered that the subjects were not suitable for any conditions of participation in the study
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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.
Contacts and locations
Locations
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Second Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710000, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- 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?
- A pre-treatment pill may supercharge cancer-fighting immune cells