A Study of GC012F in Patients With Relapsed/Refractory Multiple Myeloma

NCT06235229 | Recruiting Phase 1

• 2 other identifiers: D8315C00001GBF-311
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 10

Brief Summary

This study is a single-arm, open-lable, phase I/II study to evaluate the efficacy and safety of GC012F in subjects with relapsed/refractory multiple myeloma.

Conditions

Multiple Myeloma

Keywords

Relapsed/Refractory Multiple Myeloma; Chimeric Antigen Receptor - T(CAR-T); Dual Targets; B-cell Maturation Antigen(BCMA); Cluster of Differentiation - 19(CD19)

Outcome Measures

Primary Outcomes (2)

• Phase 1: Dose-limiting toxicities

  The incidence of DLT within 28 days post infusion

  28 days post GC012F infusion

• Phase 2: Overall response rate

  Overall response rate according to IMWG 2016

  Minimum of 2 year post GC012F infusion

Secondary Outcomes (7)

• Adverse events

  Minimum of 2 year post GC012F infusion

• Pharmacokinetics: Cmax

  Minimum of 2 year post GC012F infusion

• Pharmacokinetics: Tmax

  Minimum of 2 year post GC012F infusion

• Overall survival (OS)

  Minimum of 2 year post GC012F infusion

• Duration of response (DOR)

  Minimum of 2 year post GC012F infusion

Study Arms (1)

GC012F

EXPERIMENTAL

GC012F will be administered by infusion

Biological: GC012F

Interventions

GC012F BIOLOGICAL

GC012F is a BCMA/CD19 dual CAR product

GC012F

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 must have a diagnosis of active multiple myeloma as defined by the updated IMWG (International Myeloma Working Group) criteria, and meet one or more of the following criteria:
• Serum M protein ≥ 1 g/dL；
• Urine M protein ≥ 200 mg/24hrs;
• Serum free light chain (sFLC) ≥ 10 mg/dL with abnormal sFLC κ/λ ratio.
• Have received at least 3 prior lines of therapy for multiple myeloma. Note: According to IMWG guidelines, a single line of therapy includes a full course of monotherapy, combination therapy with multiple drugs, or sequential treatment with multiple regimens (e.g., the use of a 3-6 cycle regimen of bortezomib combined with dexamethasone, followed by stem cell transplantation, consolidation therapy, and lenalidomide maintenance therapy, is considered a single line of therapy). Unless the best response was documented as progressive disease (PD) or the subject was intolerant to the therapy.
• Prior therapy should include proteasome inhibitors (PIs), immunomodulatory drugs (IMiDs), and anti-CD38 antibodies.
• Evaluated by investigator based on IMWG standards, subjects have a confirmed (through testing at a central or local laboratory) PD during or within 12 months following the most recent anti-myeloma treatment.
• Voluntarily signed a written informed consent form (ICF).
• The signing of ICF complies with the requirements of GCP and relevant national laws and regulations.
• Males or females, aged 18-75 years old (including the thresholds).
• Subjects should be willing and able to comply with the study visit schedule and other protocol requirements.
• ECOG (Eastern Cooperative Oncology Group) performance score 0-1.
• Estimated life expectancy ≥ 3 months.
• Adequate functional reserve of organs:
• Neutrophil count ≥ 0.75×10\^9/L (growth factor support is allowed, but no supportive treatment is allowed within 7 days prior to screening); Hemoglobin ≥ 8.0 g/dL (no red blood cell transfusion within 7 days prior to screening, recombinant human erythropoietin is allowed); Platelet count ≥ 50×10\^9/L (no platelet transfusion within 7 days prior to screening); Lymphocyte count ≥ 0.3×10\^9/L;

You may not qualify if:

• Prior treatment with CAR-T products for any target.
• Have any of the following concomitant treatment history:
• Received a total of ≥ 70 mg of prednisone or an equivalent dose of other corticosteroids within 7 days prior to leukapheresis;
• Investigators believe that patients has comorbidities requiring the systemic use of corticosteroids (a total of ≥ 70 mg of prednisone or an equivalent dose of other corticosteroids) or other immunosuppressive drugs within 12 weeks after the start of the study treatment;
• Received a live-attenuated vaccine within 4 weeks prior to leukapheresis or lymphodepletion;
• Received any anticancer therapy, including but not limited to radiation therapy, cytotoxic therapy, PIs, IMiDs, targeted therapy, epigenetic therapy, or experimental drug treatment, within 14 days prior to leukapheresis (if radiation field covers ≤ 5% of bone marrow, subjects can be enrolled regardless of the end date of radiation therapy);
• Received monoclonal antibody for treating multiple myeloma within 21 days prior to leukapheresis.
• Patients' corticosteroid maintenance doses are greater than physiological replacement doses (i.e., prednisone ≥ 7.5 mg/day or hydrocortisone ≥ 12 mg/m\^2/day).
• Patients with any of the following heart diseases:
• Congestive heart failure (NYHA classification ≥ III);
• Experienced myocardial infarction or underwent coronary artery bypass grafting (CABG) within 6 months prior to screening;
• Clinically significant ventricular arrhythmias or a history of unexplained syncope not due to vasovagal reaction or dehydration; or a QTc interval \> 480 ms during screening;
• History of severe non-ischemic cardiomyopathy.
• Patients requiring assisted oxygenation or mechanical ventilation or with oxygen saturation \<95% on room air (patients with oxygen saturation \<95%, but with lung function test results showing carbon monoxide diffusing capacity and forced expiratory volume in 1 second \> 45% of predicted value, may be enrolled).
• Patients with hypertension that is uncontrolled by drug therapy.

Sponsors & Collaborators

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

Study Sites (10)

Research Site

Beijing, 100024, China

ACTIVE NOT RECRUITING

Research Site

Beijing, 102200, China

RECRUITING

Research Site

Hangzhou, 310003, China

RECRUITING

Research Site

Jinan, 250117, China

RECRUITING

Research Site

Shanghai, 200003, China

RECRUITING

Research Site

Shanghai, 201210, China

RECRUITING

Research Site

Shenyang, 110134, China

RECRUITING

Research Site

Wenzhou, 325000, China

RECRUITING

Research Site

Wuhan, 430030, China

RECRUITING

Research Site

Xi'an, 710004, China

ACTIVE NOT 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

Central Study Contacts

He Huang, MD

CONTACT

0571-88208277; hehuangyu@126.com

Juan Du, MD

CONTACT

021-81885423; juan_du@live.com

Study Design

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

Study Record Dates

• First Submitted: January 23, 2024
• First Posted: January 31, 2024
• Study Start: December 26, 2023
• Primary Completion: March 2, 2026
• Study Completion: March 2, 2026
• Last Updated: February 25, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• Access Criteria: When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

Locations

CN (10)