Clinical trial NCT06705725: Phase I Clinical Study of CBG002 CAR-T Cell in Treatment of Relapsed/refractory Multiple Myeloma
Official title: Phase I Clinical Study of CBG002 CAR-T Cell in Treatment of Relapsed/refractory Multiple Myeloma
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Multiple Myeloma
Lead sponsor: Carbiogene Therapeutics Co. Ltd.
Sponsor class: INDUSTRY
First posted: 2024-11-26
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a single arm study to evaluate the efficacy and safety of BCMA-targeted CAR-T cells therapy for patients with relapsed/refractory Multiple Myeloma.


Eligibility criteria: Inclusion Criteria:

* 18 years old≤ subjects \< 75 years old, all genders;
* Patients volunteered to participate in the study, and they or their legal guardians signed informed consent form (ICF);
* According to the diagnostic criteria of the "The Guidelines for Diagnosis and Treatment of Multiple Myeloma in China (2022)", patients with multiple myeloma are clearly diagnosed;
* Patients without indications for hematopoietic stem cell transplantation；
* Meet the definition criteria of relapsed or refractory multiple myeloma. Patients failed at least 3-line of anti-multiple myeloma therapy have at least 2 complete treatment cycles per line, unless the best response to the therapy was recorded as disease progression; Must have a record of disease progression during or within 12 months after the last treatment;
* Applicable only in the dose expansion phase: the surface BCMA positive percentage of plasma cells of bone marrow samples by flow cytometry is ≥ 50 %;
* Patient has one or more measurable multiple myeloma lesions；
* Patients must have appropriate organ function;
* Patients had no contraindications to peripheral blood mononuclear cell collection;
* ECOG score 0-2;
* Expected survival ≥ 12 weeks;
* Female subjects of childbearing potential must have a negative blood pregnancy test within 7 days prior to cell therapy and not be lactating.

Exclusion Criteria:

* Have a history of allergies to cyclophosphamide, fludarabine, or any component of the cell product;
* Severe cardiovascular and cerebrovascular diseases;
* Severe comorbidities or diseases that the researchers believe will put the patients at inappropriate risk or interfere with the study;
* Have a history of allogeneic hematopoietic stem cell transplantation, or received autologous hematopoietic stem cell transplantation (ASCT) within 12 weeks prior to signing the ICF;
* Central nervous system (CNS) involvement or symptoms of CNS involvement or CNS metastases;
* Stroke or seizure occurred within 6 months prior to signing the ICF;
* Previous plasma cell leukemia;
* Multiple myeloma with extramedullary lesions;
* Previous or screening examination showing amyloidosis;
* Malignant tumor cells with T cell origin revealed by previous pathological examination;
* Having autoimmune disease, immunodeficiency or other disease that requires immunosuppressant therapy;
* Within 5 years prior to signing the ICF, patients with malignancies other than multiple myeloma;
* Uncontrolled active infection;
* Systemic disease judged by the investigator to be unstable;
* More than 5 mg/day of prednisone (or equivalent amounts of other corticosteroids) within 1 week prior to apheresis;
* Have used any CAR-T cell products or other genetically modified T cell therapies;
* Previously received anti-tumor therapy against BCMA targets, including but not limited to antibodies, ADCs or CAR-T;
* History of live vaccination (including live attenuated vaccines) within 4 weeks prior to signing the ICF;
* Any non-hematologic toxicity due to prior therapy that cannot be restored to Grade ≤1 or baseline;
* Patients with grade ≥2 acute graft-versus-host disease (GVHD) (Glucksberg criteria) or extensive chronic GVHD (Seattle criteria) requiring treatment within 4 weeks prior to enrollment, or those who may need to receive anti-GVHD treatment during the trial as judged by the investigator;
* History of alcoholism, drug abuse or mental illness requiring drug intervention within 1 year prior to signing the ICF, which may affect the safety evaluation or compliance as judged by the investigator;
* Other conditions that are considered inappropriate by the investigator to participate in this study.

Primary outcomes:
measure: AEs.
timeFrame: 2 years post infusion
measure: DLT
timeFrame: 28 days post infusion
Secondary outcomes:
measure: Overall Response Rate (ORR)
timeFrame: 3 months post infusion
measure: Progression free survival (PFS)
timeFrame: 2 years post infusion
measure: Overall survival (OS)
timeFrame: 2 years post infusion
measure: Duration of remission (DOR)
timeFrame: 2 years post infusion
Other outcomes:
Locations:
Study officials:
affiliation: Zhejiang University
name: Jie Jin
role: PRINCIPAL_INVESTIGATOR
References: