Not yet recruiting NCT06705725
Phase I Clinical Study of CBG002 CAR-T Cell in Treatment of Relapsed/refractory Multiple Myeloma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: CBG002 CAR-T Cell Suspension.
- Who it may be relevant to
- Registry conditions: Multiple Myeloma. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Drug CBG002 CAR-T Cell Suspension
Single dose of CAR+ T cells will be infused, and classic "3+3" dose escalation will be applied.
Primary outcome measures
- AEs. [Time frame: 2 years post infusion]
- DLT [Time frame: 28 days post infusion]
Secondary outcome measures (4)
- Overall Response Rate (ORR) [Time frame: 3 months post infusion]
- Progression free survival (PFS) [Time frame: 2 years post infusion]
- Overall survival (OS) [Time frame: 2 years post infusion]
- Duration of remission (DOR) [Time frame: 2 years post infusion]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06705725 · CRKBY-102c