Safety and Efficacy of Anti-BCMA-GPRC5D CAR-T Cells Therapy in the Treatment of r/r MM

NCT06515262 | Recruiting

• 1 other identifier: BG-CT-23-015
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single-center, open-label, single-arm study to evaluate the safety and efficacy of bispecific BCMA-GPRC5D CAR-T cells in patients with relapsed or refractory multiple myeloma who received three or more lines of therapy.

Conditions

Relapsed/Refractory Multiple Myeloma

Keywords

BCMA-GPRC5D CAR-T

Outcome Measures

Primary Outcomes (1)

• Incidence of adverse events(AE) after infusion

  The frequency, severity, and laboratory findings of all adverse events/serious adverse events are included.Cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome are graded by American Society for Transplantation and Cellular Therapy (ASTCT) criteria.

  within 2 years after infusion

Secondary Outcomes (4)

• Overall Response Rate (ORR)

  within 2 years after infusion

• Concentration of CAR-T cells

  Days 1,4, 7, 10, 14 ,21,28and months 2, 3, 6, 9, 12,18,24 after infusion

• Progression-free survival(PFS)

  within 2 years after infusion

• Overall survival(OS)

  within 2 years after infusion

Study Arms (1)

Anti-BCMA CAR-T

EXPERIMENTAL

BCMA-GPRC5D CAR-T is a novel CAR cell therapy for the treatment of relapsed/refractory multiple myeloma.

Biological: Anti-BCMA-GPRC5D CAR-T cells infusion

Interventions

Anti-BCMA-GPRC5D CAR-T cells infusion BIOLOGICAL

Subiects who meet the enrollment conditions will receive intravenous infusion of anti-BCMA-GPRC5D CAR-T Cells after lymphodepleting therapy.

Anti-BCMA 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:

• The patient or his/her guardian understands and voluntarily signs the informed consent, and is expected to complete the follow-up examination and treatment of the study procedure;
• Age 18-75 years old, gender unlimited;
• Diagnosed as Multiple Myeloma (MM) according to the international standard for multiple myeloma (IMWG);
• The presence of measurable disease at screening meets one of the following criteria:Serum M-protein ≥ 1.0 g/dL or Urine M-protein ≥ 200 mg/24h or diagnosed as Light-chain MM without measurable disease in serum and urine; Serum free light chain ≥ 10 mg/dL with an abnormal κ/λ ratio;
• Patients must relapse or be refractory after three or more lines of therapy, which at least include: one Proteasome Inhibitor (PI), one Immunomodulatory Drug (IMiD), and one anti-CD38 monoclonal antibody;
• diagnosed as relapsed/refractory disease or primary refractory disease;
• The last treatment is ineffective, or the disease progresses within 60 days after the end of the last therapy;
• The patient has recovered from the toxicity of the prior treatment, i.e., CTCAE toxicity grade \< 2 (unless the abnormality is related to the tumor or is stable as judged by the investigator and has little impact on safety or efficacy);
• ECOG score 1-2 points and the expected survival period ≥ 3 months;
• Liver, kidney and cardiopulmonary functions meet the following requirements:
• Total bilirubin ≤ 1.5×ULN, alanine aminotransferase (ALT) ≤ 3 × ULN and aspartate aminotransferase (AST) ≤ 3 × ULN;
• Serum creatinine ≤ 1.5×ULN, or creatinine clearance ≥ 60 mL/min;
• Hemoglobin (Hb) ≥ 50 g/L without prior blood transfusion within 7 days;
• Baseline peripheral oxygen saturation \> 92%;
• Corrected serum calcium ≤ 12.5 mg/dL (≤ 3.1 mmol/L) or free (ionized, ionic) calcium ≤ 6.5 mg/dL (≤ 1.6 mmol/L);

You may not qualify if:

• Have been diagnosed with or treated for aggressive malignancies other than multiple myeloma;
• Prior antitumor therapy (prior to blood collection for CAR-T preparation) : targeted therapy, epigenetic therapy, or investigational drug therapy within 14 days or at least 5 half-lives, whichever is shorter;
• It is suspected that MM has involved the central nervous system or meninges and has been confirmed by MRI or CT, or there are other active central nervous system diseases;
• Patients with Fahrenheit macroglobulinemia, POEMS syndrome, or primary AL, amyloidosis;
• Subjects with positive HBsAg or HBcAb positive and peripheral blood HBV DNA titer is higher than the lower limit of detection of the research institution; HCV antibody positive; HIV antibody positive; CMV DNA titer is higher than the lower limit of detection of the research institution; EBV DNA titer is higher than the lower limit of detection of the research institution;
• Patients have a severe allergic history;
• Any unstable systemic disease: including but not limited to unstable angina, cerebrovascular accident or transient cerebral ischemia (within 6 months before screening), myocardial infarction (within 6 months before screening), congestive heart failure \[New York Heart Association (NYHA) classification ≥ grade III\];
• Systemic diseases judged by researchers to be unstable: including but not limited to severe liver, kidney or metabolic diseases requiring drug treatment;
• Patients with acute/chronic graft-versus-host disease (GVHD) or requiring immunosuppressive therapy for GVHD within 6 months prior to screening;
• Active autoimmune or inflammatory diseases of the nervous system;
• Patients develop oncology emergencies and need to be treated before screening or infusion;
• Uncontrolled infections that need antibiotics treatment;
• Exposure to hematopoietic growth factor of cells within 1-2 weeks before apheresis;
• Exposure to Corticosteriods or immunosuppressive agents within 2 weeks before apheresis;
• Patients receive a major surgical operation within 4 weeks before lymphodepletion or do not recover completely before the enrollment; or plan to receive a major surgical operation during the study period;

Sponsors & Collaborators

• 920th Hospital of Joint Logistics Support Force of People's Liberation Army of China: lead
• Guangzhou Bio-gene Technology Co., Ltd: collaborator

Study Sites (1)

Sanbin Wang

Kunming, Kunming, Yunnan, 650100, China

RECRUITING

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

• Sanbin Wang

  920th Hospital of Joint Logistics Support Force of People's Liberation Army of China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sanbin Wang, MD

CONTACT

13187424131; Sanbin1011@163.com

Sanbin Wang, MD

CONTACT

Study Design

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

Study Record Dates

• First Submitted: July 17, 2024
• First Posted: July 23, 2024
• Study Start: July 1, 2024
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: July 23, 2024

Record last verified: 2024-07

Locations

CN (1)