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Multiple MyelomaPhase 1/2DURGA-3NCT06235229

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

A Phase 1/2 study testing GC012F in people with Multiple Myeloma, run by Gracell Biotechnologies (Shanghai) Co., Ltd. at 10 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Multiple Myeloma
What is being tested?
GC012F
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
110 participants
Where
10 sitesChina
Study dates
26 Dec 2023to 2 Mar 2026
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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;
  • ALT/AST ≤ 3× ULN (upper limit of normal); Total bilirubin ≤ 2× ULN (in subjects with Gilbert syndrome, direct bilirubin ≤ 1.5× ULN is required);
  • Creatinine clearance ≥ 40 mL/min, calculated by Cockcroft-Gault;
  • Left ventricular ejection fraction (LVEF) ≥ 45% with no evidence of pericardial effusion as diagnosed by echocardiography; No clinically significant electrocardiogram abnormality observed;
  • Baseline oxygen saturation ≥ 95% on room air; No clinically significant pleural effusion observed.
  • Female subjects with fertility must:
  • Have a negative serum beta-human chorionic gonadotropin (β-hCG) pregnancy test confirmed by investigators during screening and before undergoing lymphodepletion with cyclophosphamide and fludarabine.
  • Agree and be able to use effective contraception continuously from screening to at least 1 year after GC012F infusion. Contraception must include one highly effective and one additional effective (barrier) method, initiated from screening until at least 1 year after GC012F infusion or until two consecutive flow cytometry tests show the absence of CAR-T cells (whichever occurs later).
  • Agree to avoid breastfeeding during the study period until at least 1 year after GC012F infusion or until two consecutive flow cytometry tests show the absence of CAR-T cells (whichever occurs later).
  • Male subjects must agree to use condoms during sexual contact with pregnant females or females with fertility for at least 2 year after GC012F infusion, even if a successful vasectomy has been performed.
  • Sufficient venous access for leukapheresis collection, and no other contraindications to leukapheresis.

Who cannot join

  • 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);
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  • 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.
  • Patients with clinically significant bleeding symptoms or definite bleeding tendencies (e.g., gastrointestinal bleeding, bleeding gastric ulcers, etc.), hereditary or acquired bleeding and thrombotic tendencies (e.g., hemophilia, coagulation disorders, hypersplenism, etc.) within 90 days prior to screening; have experienced arteriovenous thrombotic events (e.g., cerebrovascular diseases (including cerebral hemorrhage, cerebral infarction, etc.), deep vein thrombosis, and/or pulmonary embolism) within 180 days prior to screening.
  • Accompanied by other uncontrolled malignancies. The following are excluded: early-stage tumors that have received radical treatment (carcinoma in situ or grade 1 tumors, or non-ulcerated primary melanoma with a depth < 1 mm and no involvement of lymph nodes), basal cell skin cancer, squamous cell skin cancer, cervical carcinoma in situ, or breast carcinoma in situ that has received potential radical treatment.
  • Have received any of the following treatments:
  • Received an allogeneic hematopoietic stem cell transplantation (allo-HSCT) within 6 months prior to leukapheresis. Patients undergoing allo-HSCT who have discontinued all immunosuppressive drugs for 6 weeks prior to leukapheresis and have no manifestations of graft-versus-host disease (GVHD) may be enrolled.
  • Received an autologous hematopoietic stem cell transplantation (auto-HSCT) within ≤ 12 weeks prior to leukapheresis.
  • Severe underlying medical conditions, such as:
  • Evidence of active viral or bacterial infection (requiring systemic antimicrobial therapy) or uncontrolled systemic fungal infection;
  • Active autoimmune diseases or a history of autoimmune disease within the past 3 years;
  • Significant clinical evidence of dementia or altered mental status;
  • History of any central nervous system (CNS) or neurodegenerative diseases, (e.g., epilepsy, seizures, paralysis, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, psychiatric disorders).
  • Patients have CNS metastases or CNS involvement (including cranial neuropathies or mass lesions and leptomeningeal disease).
  • Positive results in any of the following tests:
  • HIV antibody positive;
  • HBsAg positive; or HBcAb positive, with HBV DNA titer higher than the lower limit of detection;
  • HCV antibody positive, with HCV RNA titer higher than the lower limit detection; or known history of Hepatitis C, but did not complete antiviral treatment for ≥24 weeks;
  • Syphilis antibody positive.
  • Accompanied by plasma cell leukemia (peripheral blood plasma cells > 2.0×10^9/L), Waldenstrom macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy of undetermined significance, skin changes), or primary amyloidosis.
  • Patients have a history of severe hypersensitivity or allergy.
  • Contraindication or hypersensitivity to fludarabine, cyclophosphamide, and any component of experimental product.
  • Surgery plan within 2 weeks prior to leukapheresis or during the study (except for local anesthesia surgery, but not performed within 2 weeks after CAR-T infusion).
  • Pregnant or lactating, or planning to have a pregnancy during or within 2 year after treatment.
  • Acute toxicities (except for hematological toxicities and alopecia) caused by previous treatments have not recovered to ≤ grade 1.
  • Participated in other clinical trials within 4 weeks prior to ICF signing, or ICF signing date is within 5 half-lives of the drug from the last medication in the last drug clinical trial (whichever is longer).
  • Any situation in which investigators believe that participation in this study is not in the subject's best interests, or any situation that may hinder patients' participation in the entire trial or confuse the assessment.

Trial locations and contacts

10 sites in 1 country. Contact the study team or a site near you to ask about taking part.

He Huang, MD contact

0571-88208277

hehuangyu@126.com

Juan Du, MD contact

021-81885423

juan_du@live.com

10 sites in 1 country

China10 sites, 8 recruiting

  • Research Site

    Beijing, 100024

    Active, not recruiting

  • Research Site

    Beijing, 102200

    Recruiting

  • Research Site

    Hangzhou, 310003

    Recruiting

  • Research Site

    Jinan, 250117

    Recruiting

  • Research Site

    Shanghai, 200003

    Recruiting

  • Research Site

    Shanghai, 201210

    Recruiting

  • Research Site

    Shenyang, 110134

    Recruiting

  • Research Site

    Wenzhou, 325000

    Recruiting

  • Research Site

    Wuhan, 430030

    Recruiting

  • Research Site

    Xi'an, 710004

    Active, not recruiting

Other trials in China

About this study

Official title: A Phase I/II Clinical Study of Chimeric Antigen Receptor T-cell Therapy Targeting CD19 and BCMA (GC012F) in Patients With Relapsed/Refractory Multiple Myeloma

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.

Read the detailed description

A leukapheresis procedure will be performed on eligible subjects to manufacture GC012F.Subjects will receive an infusion of GC012F at specified doses after three consecutive days of lymphodepletion consisting of fludarabine and cyclophosphamide. Bridging therapy is allowed between leukapheresis and lymphodepletion.

Being tested
GC012F
Keywords
Relapsed/Refractory Multiple Myeloma, Chimeric Antigen Receptor - T(CAR-T), Dual Targets, B-cell Maturation Antigen(BCMA), Cluster of Differentiation - 19(CD19)
Medical subject headings
Multiple Myeloma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GC012FBiological

    GC012F is a BCMA/CD19 dual CAR product

Study groups in NCT06235229
Study groupRoleWhat they receive
GC012FExperimentalGC012F will be administered by infusion
Receives: Biological: GC012F

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Phase 1: Dose-limiting toxicities

    The incidence of DLT within 28 days post infusion

    Measured: 28 days post GC012F infusion

  2. Phase 2: Overall response rate

    Overall response rate according to IMWG 2016

    Measured: Minimum of 2 year post GC012F infusion

Secondary outcomes (7)

  1. Adverse events

    The incidence and severity of adverse events

    Measured: Minimum of 2 year post GC012F infusion

  2. Pharmacokinetics: Cmax

    The maximum trangsgene level at Tmax

    Measured: Minimum of 2 year post GC012F infusion

  3. Pharmacokinetics: Tmax

    Time to peak transgene level

    Measured: Minimum of 2 year post GC012F infusion

  4. Overall survival (OS)

    Time from GC012F infusion to the date of death due to any cause

    Measured: Minimum of 2 year post GC012F infusion

  5. Duration of response (DOR)

    Time from initial response to the date of disease progression

    Measured: Minimum of 2 year post GC012F infusion

  6. Progression-free survival (PFS)

    Time from GC012F infusion to the date of disease progression

    Measured: Minimum of 2 year post GC012F infusion

  7. Minimal residual disease (MRD)

    Proportion of subjects who achieved MRD negative

    Measured: Minimum of 2 year post GC012F infusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Jan 2024
  2. Study start26 Dec 2023
  3. Primary completion2 Mar 2026 (estimated)
  4. Study completion2 Mar 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
110 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06235229
Sponsor's protocol ID
D8315C00001
Other IDs
GBF-311
Acronym
DURGA-3
Status last verified
Feb 2026
First submitted
23 Jan 2024
Last updated
25 Feb 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing GC012F in people with Multiple Myeloma, run by Gracell Biotechnologies (Shanghai) Co., Ltd. at 10 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 25 inclusion and 39 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 25 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact He Huang, MD (0571-88208277, hehuangyu@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phase 1: Dose-limiting toxicities (time frame: 28 days post GC012F infusion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06235229.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2026.

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