Actively Recruiting
Clinical Trial of CNCT19 Cell Injection in the Treatment of Relapsed or Refractory Acute Lymphoblastic Leukemia
Led by Juventas Cell Therapy Ltd. · Updated on 2025-08-08
100
Participants Needed
11
Research Sites
314 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The study is a Phase II, single-arm, open-label, single-dose clinical trial, and its primary objective is to evaluate the efficacy and safety of CNCT19 Cell Injection in the treatment of CD19 positive Relapsed or Refractory acute lymphoblastic leukemia.
CONDITIONS
Official Title
Clinical Trial of CNCT19 Cell Injection in the Treatment of Relapsed or Refractory Acute Lymphoblastic Leukemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent
- Age 18 to 65 years
- Diagnosed with relapsed or refractory acute lymphoblastic leukemia (ALL) with specific relapse or remission criteria
- CD19 tumor expression confirmed in bone marrow or peripheral blood within 3 months
- Philadelphia chromosome positive ALL patients intolerant to or failing second-generation tyrosine kinase inhibitors, excluding those with T315I mutation
- Bone marrow with at least 5% lymphoblasts at screening
- ECOG performance status of 0 to 1
- Adequate organ function including liver enzymes, bilirubin, creatinine, pulmonary reserve, and blood clotting tests
- Suitable vascular access for apheresis
- Women of childbearing potential must have negative pregnancy tests and use effective contraception; all males must use contraception during and for at least two years after treatment
You will not qualify if you...
- Active central nervous system involvement by malignancy
- Isolated extra-medullary disease relapse
- Chemotherapy within 2 weeks before CNCT19 infusion, except specified exceptions
- Radiotherapy within specified time frames before CNCT19 infusion
- Use of therapeutic systemic steroids within 72 hours before infusion, except low-dose physiological replacements
- Prior anthracycline/anthraquinone treatment exceeding recommended cumulative doses
- Previous treatment with any CAR-T therapy
- Acute or moderate-to-severe chronic graft-versus-host disease within 4 weeks before screening
- Systemic vasculitis
- Positive for certain hepatitis, syphilis, EBV, or CMV markers with active infection
- Prior malignancy unless cured >5 years or low relapse risk
- Significant heart conditions including low ejection fraction, severe arrhythmias, uncontrolled hypertension, recent heart surgery, or other unsuitable heart diseases
- Clinically significant pleural effusion
- History of epilepsy, cerebrovascular disease, or other active CNS diseases
- Recent deep vein thrombosis or pulmonary embolism
- Hypersensitivity to drug ingredients
- Live vaccine within 6 weeks prior to screening
- Active infections during screening
- Life expectancy less than 3 months
- Participation in other interventional clinical studies or recent use of investigational drugs
- Any other condition making the patient unsuitable for cell therapy as judged by the investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 11 locations
1
Beijing Boren Hospital
Beijing, Beijing Municipality, China, 100000
Actively Recruiting
2
Xinqiao Hospital of TMMU
Chongqing, Chongqing Municipality, China, 400000
Actively Recruiting
3
Nanfang Hospital
Guangzhou, Guangdong, China
Actively Recruiting
4
Yanda hospital, Hebei medical university
Sanhe, Hebei, China, 065200
Not Yet Recruiting
5
Henan Cancer Hospital
Zhengzhou, Henan, China, 450000
Actively Recruiting
6
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, China
Actively Recruiting
7
The affiliated hospital of Xuzhou medical university
Xuzhou, Jiangsu, China, 221006
Actively Recruiting
8
Tongji Hospital of Tongji University
Shanghai, Shanghai Municipality, China, 200000
Actively Recruiting
9
West China Hospital，Sichuan University
Chengdu, Sichuan, China, 610000
Actively Recruiting
10
Institute of Hematology & Blood Diseases Hospital
Tianjin, Tianjin Municipality, China, 300020
Actively Recruiting
11
The First Affiliated Hospital, Zhejiang University school of Medicine
Hangzhou, Zhejiang, China, 310000
Actively Recruiting
Research Team
Y
Yan Zhou
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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