Actively Recruiting
A Study of CTA101 UCAR-T Cell Injection in Patients With Relapsed or Refractory CD19+ B-line Hematological Malignancy
Led by He Huang · Updated on 2020-12-28
72
Participants Needed
1
Research Sites
385 weeks
Total Duration
On this page
Sponsors
H
He Huang
Lead Sponsor
N
Nanjing Bioheng Biotech Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
A study of CTA101 UCAR-T cell injection in patients with relapsed or refractory CD19+ B-line hematological malignancy
CONDITIONS
Official Title
A Study of CTA101 UCAR-T Cell Injection in Patients With Relapsed or Refractory CD19+ B-line Hematological Malignancy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 2 3 and <70 years old for ALL, or 2 18 and <70 years old for NHL
- Histologically confirmed diagnosis of CD19+ B-ALL according to NCCN guidelines or NHL according to WHO classification
- Relapsed or refractory disease meeting specified criteria for B-ALL or NHL
- Bone marrow lymphoblast or prolymphocyte count >5% (morphology) and/or >1% (flow cytometry) for ALL
- Philadelphia-chromosome-negative or patients intolerant or nonresponsive to 2 TKI treatments for ALL
- At least one evaluable tumor lesion according to Lugano 2014 for NHL
- HLA antibody negative or HLA antibody positive with donor specific antibody negative
- Total bilirubin 2 51umol/L, ALT and AST 2 3 times upper limit of normal, creatinine 2 176.8umol/L
- Left ventricular ejection fraction 2 50% by echocardiogram
- No active lung infection, blood oxygen saturation 2 92%
- Estimated survival time 2 3 months
- ECOG performance status 0 to 2
- Patient or legal guardian agrees to participate and signs informed consent
You will not qualify if you...
- Extramedullary lesions except controlled CNSL (ALL only)
- Diagnosis of lymphoblastic crisis of chronic myeloid leukemia or Burkitt's leukemia/lymphoma (ALL only)
- Hereditary syndromes such as Fanconi anemia, Kostmann syndrome, Shwachman syndrome, or other bone marrow failure syndromes (ALL only)
- Intracranial extralateral lesions or extensive gastrointestinal lymphoma involvement (NHL only)
- Radiotherapy, chemotherapy, or monoclonal antibody treatment within 1 week before screening
- Allergy to any components of the cell products
- Prior CAR T cell or genetically modified T cell therapy
- NYHA cardiac function class III or IV
- Severe cardiac diseases or events within 12 months prior
- Severe hypertension grade 3 or above
- Prolonged QT interval or severe arrhythmia history
- History of serious neurological conditions including trauma, epilepsy, or cerebrovascular disease
- Severe active infections excluding simple urinary tract infection or bacterial pharyngitis
- Indwelling catheters except certain central venous access catheters
- History of other primary cancers except cured non-melanoma or certain localized cancers with disease-free survival 2 years
- Autoimmune diseases requiring treatment or immunodeficiency
- Graft-versus-host disease
- Live vaccine within 4 weeks before screening
- History of alcoholism, drug abuse, or mental illness
- Active hepatitis B with high viral load or other specified infections
- Systemic steroid therapy within 1 week before screening (except inhaled steroids)
- Participation in other clinical trials within 2 weeks before screening
- Pregnant or breastfeeding women or those unable to use effective contraception
- Any condition increasing risk or interfering with study results as judged by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The First Hospital of Zhejiang Medical Colleage Zhejiang University
Hangzhou, Zhejiang, China, 310003
Actively Recruiting
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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