Actively Recruiting
A Study of GC012F in Patients With Relapsed/Refractory Multiple Myeloma
Led by Gracell Biotechnologies (Shanghai) Co., Ltd. · Updated on 2026-02-25
110
Participants Needed
10
Research Sites
113 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
A Study of GC012F in Patients With Relapsed/Refractory Multiple Myeloma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of active multiple myeloma by updated IMWG criteria with one or more of the following: serum M protein 1 g/dL, urine M protein 200 mg/24 hours, or serum free light chain 10 mg/dL with abnormal ratio
- Received at least 3 prior lines of therapy for multiple myeloma, including proteasome inhibitors, immunomodulatory drugs, and anti-CD38 antibodies
- Confirmed progressive disease during or within 12 months after most recent treatment
- Signed informed consent complying with GCP and relevant laws
- Age between 18 and 75 years inclusive
- Willing and able to comply with study visits and protocol requirements
- ECOG performance score of 0 or 1
- Estimated life expectancy of at least 3 months
- Adequate organ function including neutrophil count 0.75x10^9/L, hemoglobin 8.0 g/dL, platelet count 50x10^9/L, lymphocyte count 0.3x10^9/L
- Liver enzymes ALT/AST 3 times upper limit of normal, bilirubin 2 times upper limit, creatinine clearance 40 mL/min
- Left ventricular ejection fraction 45% with no pericardial effusion
- Baseline oxygen saturation 95% on room air
- Female subjects with fertility must have negative pregnancy test, agree to effective contraception until 1 year post infusion, and avoid breastfeeding
- Male subjects must agree to use condoms during sexual contact with fertile females for 2 years post infusion
- Sufficient venous access for leukapheresis and no contraindications
You will not qualify if you...
- Prior treatment with any CAR-T products
- Recent use of high-dose corticosteroids or immunosuppressive drugs within specified timeframes
- Recent live-attenuated vaccine within 4 weeks prior to leukapheresis or lymphodepletion
- Recent anticancer therapies within 14 to 21 days prior to leukapheresis depending on treatment type
- Corticosteroid maintenance dose above physiological replacement levels
- Significant heart diseases including severe heart failure, recent myocardial infarction, serious arrhythmias, or severe non-ischemic cardiomyopathy
- Need for assisted oxygen or mechanical ventilation or oxygen saturation below 95% on room air unless lung function tests permit
- Uncontrolled hypertension
- Clinically significant bleeding disorders or recent thrombotic events
- Other uncontrolled malignancies except specified early-stage treated tumors
- Recent hematopoietic stem cell transplantation within specified timeframes
- Severe underlying medical conditions such as active infections, autoimmune diseases, dementia, or neurodegenerative diseases
- CNS metastases or involvement
- Positive tests for HIV, hepatitis B or C, or syphilis
- Specific plasma cell disorders such as plasma cell leukemia or POEMS syndrome
- History of severe allergies or hypersensitivity to study drugs
- Planned surgery within 2 weeks prior or during study except local anesthesia surgery
- Pregnant or lactating women or planning pregnancy during or within 2 years after treatment
- Unresolved acute toxicities from prior treatments above grade 1
- Participation in other clinical trials within 4 weeks prior to consent or within 5 half-lives of prior study drugs
- Any condition that investigators judge would interfere with participation or assessment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 10 locations
1
Research Site
Beijing, China, 100024
Active, Not Recruiting
2
Research Site
Beijing, China, 102200
Actively Recruiting
3
Research Site
Hangzhou, China, 310003
Actively Recruiting
4
Research Site
Jinan, China, 250117
Actively Recruiting
5
Research Site
Shanghai, China, 200003
Actively Recruiting
6
Research Site
Shanghai, China, 201210
Actively Recruiting
7
Research Site
Shenyang, China, 110134
Actively Recruiting
8
Research Site
Wenzhou, China, 325000
Actively Recruiting
9
Research Site
Wuhan, China, 430030
Actively Recruiting
10
Research Site
Xi'an, China, 710004
Active, Not Recruiting
Research Team
H
He Huang, MD
CONTACT
J
Juan Du, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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