Using stem cell transplantation with C-CAR088 to treat ultra high-risk multiple myeloma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase I/II clinical trial investigates the combination of autologous stem cell transplantation (ASCT) and C-CAR088, an autologous BCMA CAR-T cell therapy, for patients with ultra high-risk multiple myeloma. Participants will undergo leukapheresis, stem cell collection, conditioning, and receive a single dose of C-CAR088 three days after ASCT. The study will evaluate the safety and efficacy of this treatment approach over a period of 24 months, with close monitoring during the initial three months. The trial aims to provide a new therapeutic option for patients who have not responded adequately to standard treatments.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Transplantation eligible patients, male or female, aged 18 to 70 years
* Ultra high risk multiple myeloma, defined as failed or unsatisfied responses to front line VRD-based treatment with or without the presence of multiple high-risk cytogenetic features
* Adequate liver, renal, bone marrow, and heart function
* Eastern Cooperative Oncology Group (ECOG) Performance status 0-1.
* Male and female of reproductive potential must agree to use birth control during the study.

Exclusion Criteria:

* Known allergies to the components or excipients of the C-CAR088 cell product
* Prior allogenic HSCT, or ASCT
* CNS involvement
* Stroke or convulsion history within 6 months prior to signing ICF
* Autoimmune disease, immunodeficiency or disease requiring immunosuppressants treatment
* Uncontrolled active infection; active HBV, HCV infection; HIV or syphilis Infection
* Severe heart, liver, renal or metabolism disease
* Inadequate wash-out time for previous anti-tumor treatments prior to apheresis
* Previous CAR-T cell treatment, genetically modified T-cell therapies or BCMA-directed treatment history
* History or current evidence of any condition, therapy, or laboratory abnormality that, in the opinion of the investigator, might confound the results of the trial, interfere with the patient's safe participation and compliance in the trial

Where it's running

• Institute of Hematology & Blood Diseases Hospital
  Tianjin, Tianjin Municipality, China Recruiting

Study contacts

• Principal investigator: Dehui Zou, M.D., PH.D. — Institute of Hematology & Blood Diseases Hospital, China
• Study coordinator: Yan Xu, M.D., PH.D.
• Email: xuyan1@ihcams.ac.cn
• Phone: 86-022-23909171

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.