Study of Dual Targeted CD19/BCMA FASTCART GC012F in Relapsed/ Refractory Multiple Myeloma

NCT05412329 | Unknown Phase 1

• 1 other identifier: GC012F-31
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single-arm, non-randomized, open-label study to confirm the RP2D (recommended phase 2 dose) of GC012F injection in patients with Relapsed/Refractory multiple myeloma (RRMM).

Conditions

Multiple Myeloma

Outcome Measures

Primary Outcomes (2)

• Dose limitinged toxicity（DLT）after GC012F infusion

  Incidence of dose-limiting toxicities within 21 days after GC012F infusion.

  Up to 21 days after patients infused with GC012F injectiom

• Adverse Events (AE) after infusion

  Incidence of adverse events within 48 weeks after GC012F infusion

  Up to 48 weeks after patients infused with GC012F injectiom

Secondary Outcomes (3)

• Overall Response Rate(ORR)

  Up to 24 weeks after patients infused with GC012F injectiom

• Progression-free survival (PFS), Overall Survival (OS), Duration Of Response (DOR)

  Up to 1/3/6/9/12 months after patients infused with GC012F injectiom

• CAR-T cell counts and number of CAR gene copies

  Up to 48 weeks after patients infused with GC012F injectiom

Study Arms (1)

GC012F treatment

EXPERIMENTAL

R/R multiple myeloma patients be treated with a single dose of GC012F cells.

Biological: GC012F injection

Interventions

GC012F injection BIOLOGICAL

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

GC012F treatment

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Eligible patients should meet all the following criteria:
• Age of 18-70 years at the time of signing informed consent (contains critical values)；
• Documented diagnosis at initial of active multiple myeloma according to IMWG criteria, and 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 κ/λ ratio
• Have had at least 3 different prior lines of therapy or primary refractory and PD within 12 months of their last line of therapy (patient should undergo at least 1 complete cycle of treatment in each line of therapy) defined by Consensus recommendations for the uniform reporting of clinical trials: report of the International Myeloma Workshop Consensus Panel 1; or patients have had at least 2 different prior lines of therapy and refractory to both IMiD and PI;
• Estimated life expectancy ≥3 months;
• ECOG: 0 or 1;
• Hemoglobin ≥ 7.0 g/dL (without prior RBC transfusion within 7 days before screening; recombinant human erythropoietin use is permitted);
• Absolute neutrophil count ≥ 1×109/L (without recombinant human granulocyte colony-stimulating factor within 7 days before screening and without pegylated G-CSF within 14 days of the laboratory test);
• Platelet count ≥50×109/L(without prior platelet transfusion within 7 days before the laboratory test)
• Absolute lymphocyte count ≥ 0.1×109/L;
• Adequate functional reserve of organs:
• ALT/AST ≤ 2.5× UNL (upper normal limit);

You may not qualify if:

• Patients should be excluded if they meet any one of the following criteria:
• Patients should be excluded if they meet any one of the following criteria:
• Presence of plasma cell leukemia (absolute number of peripheral plasma cells \>2.0×109/L), Waldenstrom's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein disease, skin changes) or primary amyloidosis (AL) at screening;
• Patients have other aggressive malignancies (except patients with disease free survival for more than 5 years from non-melanoma skin cancer and cervical carcinoma in situ, bladder cancer, or breast cancer);
• Any situations not benefit for subjects to accept or tolerated to planned therapy or understand informed consent; or any situation in which investigators believe that participation in this study is not in the subject's best interests (e.g., harm to health), or any situation that may prevent, limit or confuse the assessment;
• Patients with prior history of seizures or stroke within 6 months before signing ICF;
• Patients following cardic condition:
• New York Heart Association (NYHA) III or IV heart failure;
• Myocardial infarction or coronary artery bypass graft (CABG) ≤ 6 months prior to signing ICF;
• History of clinically significant ventricular arrhythmia or unexplained syncope, not believed to be vasovagal in nature or due to dehydration;
• History of severe non-ischemic cardiomyopathy;
• Impaired cardiac function (left ventricular ejection fraction \[LVEF\] \< 45%) as assessed by echocardiography or multiple gated acquisition scanning, or other heart diseases with clinically significant symptoms in 6 months prior to enrollment;
• Patients have known active, or history of central nervous system involvement or exhibit clinical signs of meningeal involvement in multiple myeloma;
• Patients positive for any of the following tests:
• HIV antibody;

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: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: June 4, 2022
• First Posted: June 9, 2022
• Study Start: June 13, 2022
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2024
• Last Updated: July 26, 2022

Record last verified: 2022-07

Locations

CN (1)