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

NCT06705725 | Not Yet Recruiting Phase 1

• 1 other identifier: CRKBY-102c
• Study Type: interventional
• Target: 38
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Multiple Myeloma

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Overall Response Rate (ORR)

  3 months post infusion

• Progression free survival (PFS)

  2 years post infusion

• Overall survival (OS)

  2 years post infusion

• Duration of remission (DOR)

  2 years post infusion

Study Arms (1)

CBG002 CAR-T Cell Suspension

EXPERIMENTAL

Single dose of CAR+ T cells will be infused, and classic "3+3" dose escalation will be applied.

Drug: CBG002 CAR-T Cell Suspension

Interventions

CBG002 CAR-T Cell Suspension DRUG

Single dose of CAR+ T cells will be infused, and classic "3+3" dose escalation will be applied.

CBG002 CAR-T Cell Suspension

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Carbiogene Therapeutics Co. Ltd.: lead

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Jie Jin

  Zhejiang University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jie Jin

CONTACT

0571-87236898; jiej0503@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2024
• First Posted: November 26, 2024
• Study Start: December 26, 2024
• Primary Completion (Estimated): October 25, 2027
• Study Completion (Estimated): February 22, 2028
• Last Updated: November 26, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share