Study of FasT CAR-T GC012F Injection NDMM Patients

NCT05840107 | Recruiting Early Phase 1

• 1 other identifier: GC012F-322
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single-arm, single-center, open-label clinical study to evaluate the safety and efficacy of CAR-T in patients with NDMM.

Conditions

Multiple Myeloma

Outcome Measures

Primary Outcomes (6)

• Adverse Events (AE) after CAR-T infusion

  An assessment of severity grade will be made according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), with the exception of cytokine release syndrome (CRS), and immune effector cellassociated neurotoxicity syndrome (ICANS). CRS and ICANS should be evaluated according to the American Society for Transplantation and Cellular Therapy (ASTCT) consensus grading

  Up to 1 year after patients infused with CAR-T injection

• Percentage of patients with complete response (CR) and stringent complete response (sCR) after infusion

  Up to 2 years after patients infused with CAR-T injection

• overall response rate (ORR)

  ORR defined as proportion of patients achieving PR or better based on IMWG defined response criteria

  Up to 2 years after patients infused with CAR-T injection

• Percentage of patients with minimal residual disease (MRD) negative in CR/sCR patients at landmark analysis

  MRD negative rate

  Up to 2 years after patients infused with CAR-T injection

• Progress free survival (PFS)

  PFS is defined as the time interval from the initiation of induction therapy until disease progression or death (for any reason).

  Up to 2 years after patients infused with GC01 2F injection

• Duration of response (DOR) after CAR-T infusion

  DOR is defined as the time interval from the first assessment of sCR, CR, VGPR or PR to the first assessment of PD or death from any cause after CAR T infusion.

  Up to 2 years after patients infused with GC01 2F injection

Study Arms (1)

GC012F treatment

EXPERIMENTAL

CAR-T will be infused at a dose of 0.6,1.5,3 x 10\^5 CAR-T cells/kg after receiving lymphodepleting chemotherapy. Lenalidomide maintenance therapy will be given post month 6 at physicians' choice.

Biological: GC012F injection

Interventions

GC012F injection BIOLOGICAL

GC012F injection is an autologous dual CAR-T targeted BCMA and CD19. A single infusion of CAR-T cells will be administered intravenously

GC012F treatment

Eligibility Criteria

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

You may qualify if:

• Age ≥18 when signing informed consent form（ICF）
• Documented evidence of multiple myeloma at diagnosis as defined by IMWG guidelines ,monoclonal plasma cells in the bone marrow ≥10% and/or serum M protein ≥ 3 g/dL and/or 24h urine light chain ≥ 500 mg and/or presence of a biopsy proven plasmacytomas, not meet evidence of Smoldering Myeloma with SLiM/CRAB syptoms, and meet at least 2 of a-c or meet d of the following criteria at screening:
• Serum M protein ≥ 2 g/dL;
• Serum involved / uninvolved free light chain ratio ≥ 20;
• Bone marrow involved with monoclonal plasma cells ≥20% ;
• With Cytogenetic high-risk markers.
• Or documented evidence of multiple myeloma at diagnosis as defined by IMWG guidelines CRAB (calcium elevation, renal insufficiency, anemia, and bone abnormalities)/SLiM criteria, monoclonal plasma cells in the bone marrow ≥10% or presence of a biopsy proven plasmacytomas, and measurable secretory disease according to IMWG criteria meet one or more of the following criteria at screening:
• Serum M protein ≥ 1 g/dL;
• Urine M protein ≥ 200 mg/24h;
• Serum free light chain sFLC ≥ 10 mg/dL with abnormal serum immunoglobulin κ/λ free light chain ratio.
• ECOG score was 0-3 at screen;
• Estimated life expectancy ≥3 months;
• Absolute neutrophil count (ANC) ≥ 1.5×10\^9/L without use of growth factors;
• Platelet count ≥ 50×10\^9/L without transfusion support within 7 days before the screen;
• Hemoglobin≥ 60 g/L;

You may not qualify if:

• Patients who are transplant eligible high-risk patients and plan to adopt auto/allo-transplantation
• Subject has had radiation therapy within 14 days of screening;
• Subjects has plasma cell leukemia or POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes);
• Subjects has a diagnosis of primary amyloidosis, Waldenstroem's disease, monoclonal gammopathy of undetermined significance, or smoldering multiple myeloma;
• Having other tumors (excluding non-melanoma skin cancer and cervical cancer in situ bladder cancer and breast cancer that have been disease-free for more than 5 years);
• Evidence of serious mental disorders or changes in mental status, or the presence of central nervous system or diseases, such as seizures, cerebrovascular ischemia/hemorrhage, dementia, cerebellar diseases, or autoimmune diseases involving CNS;
• History of hereditary diseases such as Fanconi anemia, Schrader syndrome, Costerman syndrome, or any other known bone marrow failure syndrome;
• Clinically significant cardiac disease including: uncontrolled cardiac arrhythmia or clinically significant ECG abnormalities, grade III-IV heart failure or myocardial infarction cardiac angioplasty or stenting unstable angina or other clinically significant cardiac conditions within one year prior to enrollment;
• Presence of any indwelling catheter or drainage tube (e.g., percutaneous nephrostomy catheter indwelling catheter bile drainage tube or pleural/peritoneal/pericardial catheter) The use of a dedicated central venous catheter is permitted;
• Confirmed or suspected CNS involved;
• A positive virological result for any of the following: HIV, HCV, HBsAg（If HBcAg positive, DNA copies must below the LOQ）, TPPA;
• Other severe viral or bacterial infections or uncontrolled systemic fungal infections are present;
• Severe allergic history or allergic constitution;
• There is a history of an autoimmune disease (e.g., Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus) that has resulted in terminal organ damage or requires systemic immunosuppressive/disease modulating drugs in the past 2 years;
• Presence of lung disease (such as pulmonary fibrosis);

Sponsors & Collaborators

• Shanghai Changzheng Hospital: lead
• Gracell Biotechnologies (Shanghai) Co., Ltd.: collaborator

Study Sites (1)

Shanghai Changzheng Hospital

Shanghai, Shanghai Municipality, 200003, 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

• Juan Du, MD

  Shanghai Changzheng Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Juan Du, MD

CONTACT

+86-21 -81885423; changzheng_pg@163.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Hematology Department

Study Record Dates

• First Submitted: April 22, 2023
• First Posted: May 3, 2023
• Study Start: May 4, 2023
• Primary Completion: September 30, 2025
• Study Completion: September 30, 2025
• Last Updated: February 13, 2024

Record last verified: 2024-02

Locations

CN (1)