Phase I Clinical Study of CBG002 CAR-T Cell in Treatment of Relapsed/refractory Multiple Myeloma

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Multiple Myeloma
• Intervention / Treatment: Drug: CBG002 CAR-T Cell Suspension

• Study Type: Interventional
• Enrollment (Estimated): 38
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Jie Jin; Phone Number: 0571-87236898; Email: jiej0503@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CBG002 CAR-T Cell Suspension; Single dose of CAR+ T cells will be infused, and classic "3+3" dose escalation will be applied.	Drug: CBG002 CAR-T Cell Suspension; Single dose of CAR+ T cells will be infused, and classic "3+3" dose escalation will be applied.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AEs.	The severity and incidence of treatment-emergent adverse events (TEAEs), treatment-related adverse events (TRAEs), and serious adverse events (SAEs).	2 years post infusion
DLT	The Dose Limiting Toxicities (DLTs) are based on drug related adverse events and are specifically defined in study protocol.	28 days post infusion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Response Rate (ORR)	ORR at 3 months post infusion as evaluated by the Investigator	3 months post infusion
Progression free survival (PFS)	The time from cell infusion to the first assessment of tumor progression or death from any cause	2 years post infusion
Overall survival (OS)	The time from cell infusion to death due to any cause	2 years post infusion
Duration of remission (DOR)	The time from the first assessment of the tumor for complete response and above efficacy to the first assessment of disease progression or death of any cause	2 years post infusion

Collaborators and Investigators

• Sponsor: Carbiogene Therapeutics Co. Ltd.
• Investigators: Principal Investigator: Jie Jin, Zhejiang University

Study record dates

Study Major Dates

• Study Start (Estimated): December 26, 2024
• Primary Completion (Estimated): October 25, 2027
• Study Completion (Estimated): February 22, 2028

Study Registration Dates

• First Submitted: October 23, 2024
• First Submitted That Met QC Criteria: November 22, 2024
• First Posted (Estimated): November 26, 2024

Study Record Updates

• Last Update Posted (Estimated): November 26, 2024
• Last Update Submitted That Met QC Criteria: November 22, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Hematologic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders; Multiple Myeloma; Neoplasms, Plasma Cell
• Other Study ID Numbers: CRKBY-102c

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No