Clinical Study to Evaluate the Safety and Efficacy of CAR-T in the Treatment of Relapsed or Refractory Multiple Myeloma

NCT06068400 | Terminated

• 1 other identifier: BG-CT-22-008
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single arm, single center clinical study evaluating the safety and efficacy of CAR-T treatment for relapsed or refractory multiple myeloma.

Conditions

Relapsed or Refractory Multiple Myeloma

Keywords

Multiple Myeloma; BCMA; GPRC5D

Outcome Measures

Primary Outcomes (2)

• Evaluation of Safety

  Count the Incidence of adverse events

  Up to 2 years after BCMA/GPRC5D dual CAR-T infusion

• Changes in cytokine level

  Calculate the change of cytokine level in peripheral blood by flow cytometry after BCMA/GPRC5D dual CAR-T infusion. Cytokines include IL-2、IL-6、IL-10、IFN-γ

  Up to 2 years after BCMA/GPRC5D dual CAR-T infusion

Secondary Outcomes (6)

• Complete response rate(CR)

  Up to 2 years after BCMA/GPRC5D dual CAR-T infusion

• Strict complete response rate(SCR)

  Up to 2 years after BCMA/GPRC5D dual CAR-T infusion

• Very good partial response rate(VGPR)

  Up to 2 years after BCMA/GPRC5D dual CAR-T infusion

• Partial response(PR)

  Up to 2 years after BCMA/GPRC5D dual CAR-T infusion

• Minimal response(MR)

  Up to 2 years after BCMA/GPRC5D dual CAR-T infusion

Study Arms (1)

BCMA/GPRC5D dual CAR-T

EXPERIMENTAL

The study plans to enroll 40 subjects, with a sample size based on actual occurrence and a dosage of 3 × 106/kg ± 20%\~1 × 107/kg ± 20% CAR positive T cells

Biological: BCMA/GPRC5D dual CAR-T

Interventions

BCMA/GPRC5D dual CAR-T BIOLOGICAL

BCMA/GPRC5D dual CAR-T is a new type CAR-T cells therapy for patients with Relapsed or Refractory Multiple Myeloma.

BCMA/GPRC5D dual CAR-T

Eligibility Criteria

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

You may qualify if:

• \. Patients or their guardians understand and voluntarily sign an informed consent form and are expected to complete the follow-up examinations and treatments related to the study.
• \. Aged 18-75 years, any gender.
• \. Diagnosed with multiple myeloma according to IMWG diagnostic criteria.
• \. Documented evidence that the patient's multiple myeloma is refractory or relapsed, defined as:
• a) Refractory: No response to salvage therapy (no response defined as no achievement of minimal response \[MR\] or disease progression during treatment), or disease progression within 60 days of the last treatment, or patients who achieved MR or higher but experienced disease progression.
• b) Relapsed: No response to any treatment, including no achievement of MR or higher in any prior treatment, but with minimal changes in M-protein without clinical progression or relapse as per the progression definition.
• \. Measurable disease at screening based on any of the following criteria: serum monoclonal paraprotein (M-protein) level ≥1.0 g/dL or urine M-protein level ≥200 mg/24 hours, or diagnosed with light-chain multiple myeloma in the absence of measurable disease in serum or urine: serum immunoglobulin free light chain ≥10 mg/dL and an abnormal κ/γ free light chain ratio, extramedullary measurable lesions, or presence of tumor cells in bone marrow biopsy.
• \. Patients have recovered from toxicity of prior treatment, with CTCAE toxicity grade ≤2 (unless the abnormality is related to the tumor or is deemed stable by the investigator with no significant impact on safety or efficacy).
• \. ECOG performance status score of 0-2 and an expected survival of more than 3 months.
• \. Adequate organ function, including:
• ALT (alanine transaminase) ≤3 times the upper limit of normal (ULN).
• AST (aspartate transaminase) ≤3 times ULN.
• Total bilirubin ≤1.5 times ULN.
• Serum creatinine ≤1.5 times ULN or creatinine clearance ≥30 mL/min (calculated by Cockcroft-Gault formula).
• Oxygen saturation ≥92%.

You may not qualify if:

• \. Diagnosis or treatment of invasive malignancies other than multiple myeloma within 3 years, unless the malignancy has been curatively treated and there is no known active disease within 3 years before enrollment, or unless the patient has been fully treated for non-melanoma skin cancer with no evidence of disease.
• \. Prior treatment with the following anti-cancer therapies (before leukapheresis for CAR-T cell production): received targeted therapy, epigenetic therapy, or investigational drug treatment within 14 days or at least 5 half-lives (whichever is shorter); received monoclonal antibody therapy within 21 days; received proteasome inhibitor therapy within 14 days; received immunomodulatory drug therapy within 7 days; received radiation therapy within 14 days (excluding bone marrow radiation ≤5% of bone marrow reserve).
• \. Underwent hematopoietic stem cell transplantation within 2 months prior to screening.
• \. History of central nervous system disorders.
• \. Clinical signs of active central nervous system (CNS) involvement or manifestations of multiple myeloma meningeal involvement.
• \. Diagnosed with Waldenström's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes), or primary AL amyloidosis.
• \. Positive for hepatitis B surface antigen (HBsAg) or positive for hepatitis B core antibody (HBcAb) with peripheral blood HBV DNA quantification, positive for hepatitis C virus (HCV) antibody, human immunodeficiency virus (HIV) antibody, cytomegalovirus (CMV) DNA, syphilis test, or Epstein-Barr virus DNA.
• \. History of severe allergies (defined as Grade 2 or higher reactions) or known hypersensitivity to any active ingredients, excipients, mouse-derived products, or heterologous proteins included in this trial, including the conditioning regimen.
• \. Severe cardiac diseases, including but not limited to severe arrhythmias, unstable angina, extensive myocardial infarction, New York Heart Association class III or IV heart failure, myocardial infarction within ≤6 months prior to screening, coronary artery bypass grafting (CABG) performed, except for non-vascular vagal syncope or dehydration, severe non-ischemic cardiomyopathy, and resistant hypertension.
• \. Unstable systemic diseases, as judged by the investigator, including but not limited to severe liver, kidney, or metabolic diseases requiring drug treatment.
• \. Had acute or chronic graft-versus-host disease (GVHD) within 6 months prior to screening or required immunosuppressive treatment for GVHD.
• \. Active autoimmune or inflammatory neurological diseases (e.g., Guillain-Barré syndrome, amyotrophic lateral sclerosis) and clinically significant active cerebrovascular diseases (e.g., cerebral edema, posterior reversible encephalopathy syndrome) at screening.
• \. Requires emergency treatment for tumor emergencies at screening (e.g., spinal cord compression, intestinal obstruction, leukostasis, tumor lysis syndrome).
• \. Has uncontrollable bacterial, fungal, viral, or other infections requiring antibiotic treatment.
• \. Received blood transfusions or hematopoietic cytokine drugs affecting the patient's blood counts within 2 weeks prior to screening for planned CAR-T cell production, as determined by the investigator to affect cell preparation.

Sponsors & Collaborators

• Guangzhou Bio-gene Technology Co., Ltd: lead
• Shenzhen Qianhai Shekou Free Trade Zone Hospital: collaborator

Study Sites (1)

Shenzhen Qianhai Shekou Free Trade Zone Hospital

Shenzhen, Guangdong, 518000, China

Location

Related Publications (1)

• Wei L, Xiao X, Jing X, Zheng Y, Sun X, Bai W, Li M, Luo M, Xiao Y. Case Report: Summary of multiple CAR-T expansions in anti-BCMA/GPRC5D bispecific CAR-T cell therapy for multiple myeloma. Front Immunol. 2025 Jun 6;16:1607778. doi: 10.3389/fimmu.2025.1607778. eCollection 2025.

  PMID: 40547010 DERIVED

MeSH Terms

Conditions

Recurrence; Multiple Myeloma

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; 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

• Yang Xiao, MD

  Shenzhen Qianhai Shekou Free Trade Zone Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2023
• First Posted: October 5, 2023
• Study Start: September 21, 2023
• Primary Completion: February 2, 2024
• Study Completion: February 2, 2024
• Last Updated: March 17, 2026

Record last verified: 2026-03

Locations

CN (1)