BCMA/GPRC5D CAR-T Therapy for Multiple Myeloma

NCT07196124 | Not Yet Recruiting Early Phase 1

• 1 other identifier: YD-005
• Study Type: interventional
• Target: 12
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study is a single-arm, multicenter clinical trial of dose escalation and dose expansion.

Conditions

Multiple Myeloma Refractory

Keywords

CAR-T

Outcome Measures

Primary Outcomes (2)

• Dose Limited Toxicity Rate

  After the infusion of CAR-T, subjects still experienced adverse events, meeting the DLT definition, related to or possibly related to CAR-T infusion after optimal supportive treatment.

  Up to 28 days after CAR-T infusion.

• Incidence of Treatment-Emergent Adverse Events

  Count the Incidence of adverse events.

  Up to 24 months.

Secondary Outcomes (3)

• Concentration of CAR-T cells after Infusion (PK)

  Up to 24 months.

• Concentration of Cytokine after Infusion (PD)

  Up to 24 months.

• overall response rate, ORR

  Up to 24 months.

Study Arms (1)

BCMA/GPRC5D CAR-T cell injection

EXPERIMENTAL

Dose escalation: Three dose levels were designed, and if the maximum tolerated dose (MTD) was not found at the highest level, no further dose escalation was to be performed. Approximately 12-18 subjects were planned to be enrolled in the dose-escalation phase to evaluate the safety and tolerability of CAR-T injection and to determine the MTD and/or the recommended phase II dose (RP2D). Dose Expansion: During or after the dose escalation process, if a certain dose group is determined to have preliminary anti-tumor effects and controllable safety, it can be extended at this dose level to further evaluate the tolerance and safety of CAR-T injection, and to preliminarily evaluate its effectiveness.

Biological: BCMA/GPRC5D CAR-T

Interventions

BCMA/GPRC5D CAR-T BIOLOGICAL

A single infusion of BCMA/GPRC5D CAR-T Injection administered intravenously.

BCMA/GPRC5D CAR-T cell injection

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The patient or their guardian understands and voluntarily signs the informed consent form and expects to complete the follow-up examinations and treatments of the research protocol；
• Age 18-85 years old (inclusive), gender unrestricted;
• In accordance with the standards for the recurrence of multiple myeloma in the 'Chinese Guidelines for the Diagnosis and Treatment of Multiple Myeloma (Revised 2022)';
• Determine the presence of measurable lesions during screening based on any of the following criteria: serum monoclonal protein (M-protein) level ≥ 1.0 g/dL or urine M protein level ≥ 200 mg/24 hours; or diagnosed with light chain multiple myeloma without measurable lesions in serum or urine: serum immunoglobulin free light chain ≥ 10 mg/dL and serum immunoglobulin κ/γ free light chain ratio abnormal;
• Has previously received at least first-line or higher treatment for multiple myeloma.
• Patients with lymphoma must have at least one measurable lesion from baseline according to the revised IWG criteria for assessing the efficacy of malignant lymphoma；
• The organ functions well；
• ECOG performance status score 0-3 and estimated survival time greater than 3 months.

You may not qualify if:

• Diagnosed with or treated for other invasive malignant tumors, excluding multiple myeloma, within 3 years;
• Previous anti-tumor treatments (before the collection and preparation of CAR-T blood): received targeted therapy, epigenetic therapy, or experimental drug treatment within 14 days or within at least 5 half-lives (whichever is shorter), or used invasive experimental medical devices; received monoclonal antibody treatment for multiple myeloma within 21 days; received cytotoxic treatment within 14 days; received proteasome inhibitor treatment within 14 days; received immunomodulator treatment within 7 days; received radiotherapy within 14 days (except when the irradiated field covers ≤5% of the bone marrow reserve);
• During screening, individuals with Waldenström's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes), or primary AL amyloidosis;
• Hepatitis B surface antigen (HBsAg) positive, hepatitis B core antibody (HBcAb) positive and peripheral blood HBV-DNA higher than the detection limit; Hepatitis C virus (HCV) antibody positive; Persons with human immunodeficiency virus (HIV) antibody positive; Cytomegalovirus (CMV) DNA positive cases; EBV-DNA positive patients; The syphilis antibody was positive.
• Those with a history of anaphylaxis \[A history of anaphylaxis was defined as an allergic reaction of grade 2 or higher, in which any of the following clinical manifestations occurred: Airway obstruction (rhinorrhea, cough, stridor, dyspnea), Tachycardia, Hypotension, Arrhythmia, Gastrointestinal symptoms (nausea, vomiting), Incontinence, Laryngeal edema, Bronchospasm, Cyanosis, Shock, Respiratory, cardiac arrest\] or known to be allergic to any of the drug active ingredients, excipents, or mouse-derived products or xenoproteins included in this trial (including the lymphatic cells clearance protocol).
• Have severe cardiac disease, including but not limited to severe arrhythmia, unstable angina, massive myocardial infarction, New York Heart Association class III or IV cardiac dysfunction, and refractory hypertension.
• Screen for patients who have had acute/chronic graft-versus-host disease (GVHD) within the past 6 months, or who require immunosuppressive treatment for GVHD;
• Active autoimmune or inflammatory diseases (e.g., Guillain-Barre syndrome (GBS), amyotrophic lateral sclerosis (ALS)) and clinically significant active cerebrovascular diseases (e.g., cerebral edema, posterior reversible encephalopathy syndrome (PRES)).
• Patients with cancer emergencies (such as spinal cord compression, intestinal obstruction, leukostasis, tumor lysis syndrome, etc.) requiring emergency treatment before screening or reinfusion.
• Presence of uncontrolled bacterial, fungal, viral, or other infection requiring antibiotic treatment.
• Patients who had undergone major surgery (excluding diagnostic surgery and biopsy) within 4 weeks before lymphatic cells clearance or planned to undergo major surgery during the study period, or who had not fully healed the surgical wound before enrollment.
• Persons with severe mental illness.
• Within 1 week before the collection of peripheral blood mononuclear cells (PBMC), patients who use granulocyte colony-stimulating factor (G-CSF), granulocyte macrophage colony-stimulating factor (GM-CSF) and other hematopoietic cytokine drugs that have an impact on the patient's blood picture (if it is a long-acting preparation, it is 2 weeks) and have an impact on cell preparation as judged by the investigator .
• Within 2 weeks before PBMC collection, patients were receiving hormonal or immunosuppressive drugs that were judged by the investigator to have an effect on cell production.
• hormone: subjects who were receiving systemic steroid therapy within 2 weeks before PBMC collection and who required long-term systemic steroid therapy (except inhaled or topical use) as judged by the investigator during the treatment.

Sponsors & Collaborators

• Guangzhou Bio-gene Technology Co., Ltd: lead

Central Study Contacts

Min LUO

CONTACT

+862032030437; mluo@gzbiogene.com

Study Design

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

Study Record Dates

• First Submitted: September 19, 2025
• First Posted: September 29, 2025
• Study Start: October 10, 2025
• Primary Completion (Estimated): October 9, 2028
• Study Completion (Estimated): December 9, 2028
• Last Updated: September 29, 2025

Record last verified: 2025-09