Autologous Transplantation Combined With BCMA CAR-T in the Treatment of UHR-MM

ConditionsUltra High Risk mm (uhr-mm), 18-70 Years Old, Suitable for ASCT. And Meet Any of the Following uhr-mm Definitions Cytogenetics Ultra High Risk Primary Refractory Early Progression Plasma Cell Leukemia Non Paraosseous Extramedullary Infiltration R2-ISS-IV /MPSS-IV

Trial statusRecruiting

Trial phasePhase 1, Phase 2

Trial typeInterventional

Biological sexAll

Age18-70

SponsorInstitute of Hematology & Blood Diseases Hospital, China

About this trial

To evaluate the safety and efficacy of autologous hematopoietic stem cell transplantation (ASCT) combined with BCMA-CART in the treatment of UHR-MM.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

The subjects voluntarily participated in the study and signed the informed consent form (ICF) by themselves or their legal guardians;

Disqualifiers

Have a history of allergy to any component in cell products;

History of autologous / allogeneic hematopoietic stem cell transplantation;

Stroke or seizure within 6 months before signing ICF;

Have autoimmune disease, immune deficiency or other diseases requiring immunosuppressant treatment;

Trial design

Design model

Single group

Treatments tested in this trial

BCMA CART
Drug
Bcma-cart was reinfused at a dose of 1.0-2.0 × 10 \^ 6 / kg on day +3 (± 1 day) after autologous hematopoietic stem cell reinfusion.

Treatment groups

50 Participants

are divided into 1 treatment group

Group A: BCMA CARTExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

MRD negative rate at 3 month after treatment of ASCT+CAR-T

Time frame

3 month

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Institute of Hematology & Blood Diseases Hospital, China

Lead sponsor

Hebei Taihe Chunyu Biotechnology Co., Ltd

Collaborator

Source ClinicalTrials.gov

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