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
281 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
Researchers are evaluating CTA101 UCAR-T cell injection in patients who have relapsed or refractory CD19+ B-line hematological malignancies, including B-cell acute lymphoblastic leukemia (B-ALL) and B-cell non-Hodgkin lymphoma (B-NHL). This early phase 1, single-arm, open-label study aims primarily to explore the safety of the treatment, focusing especially on dose-related safety concerns. The study will enroll 72 patients divided into two groups of 36, with dosing levels guided by previous clinical trials of similar products. Participants will receive CTA101 UCAR-T cells via intravenous infusion. The study uses a standard 3+3 dose escalation design with two dose levels to determine safe dosing. This single-center study does not include a control group and monitors patients closely following infusion. Treatment-emergent adverse events will be tracked for up to 2 years to assess safety. During the study, participants will undergo regular assessments including monitoring for dose-limiting toxicities within 28 days after infusion and tracking adverse events over 2 years. Researchers will also measure response outcomes such as minimal residual disease negative overall response rate, event-free survival, overall response rate, and overall survival at various time points up to 24 months. Additional evaluations for tumor control in B-NHL patients will be conducted. Eligibility includes lab tests, heart function evaluation, infection status, and performance status. The total study duration extends to at least 2 years after treatment infusion.
CONDITIONS
Brief 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 3 to less than 70 years old for B-ALL; aged 18 to less than 70 years old for NHL
- Confirmed diagnosis of CD19+ B-ALL or B-NHL according to recognized guidelines
- Relapsed or refractory disease meeting specific criteria for treatment response or recurrence
- For B-ALL, bone marrow lymphoblasts greater than 5% by morphology or greater than 1% by flow cytometry
- Philadelphia-chromosome negative or positive patients unable to tolerate or respond to TKI treatments for B-ALL
- For NHL, at least one evaluable tumor lesion per Lugano 2014 criteria
- No HLA donor specific antibodies or negative HLA antibodies
- Liver and kidney function within specified limits
- Left ventricular ejection fraction of 50% or greater
- No active lung infection and blood oxygen saturation of at least 92%
- Estimated survival time of at least 3 months
- ECOG performance status between 0 and 2
- Willingness to participate and provide informed consent
You will not qualify if you...
- Presence of extramedullary lesions except controlled CNS lymphoma for ALL patients
- Diagnosed lymphoblastic crisis of chronic myeloid leukemia or Burkitt's leukemia/lymphoma for ALL
- Hereditary bone marrow failure syndromes for ALL
- Intracranial extralateral lesions or extensive gastrointestinal involvement for NHL
- Radiotherapy, chemotherapy, or monoclonal antibody treatment within 1 week before screening
- Allergy to components of cell products
- Prior CAR T cell or genetically-modified T cell therapy
- Severe cardiac conditions including NYHA class III or IV heart failure
- Recent serious cardiac events within 12 months
- Severe hypertension grade 3 or above
- Abnormal ECG findings such as prolonged QT or severe arrhythmias
- History of brain trauma, seizures, or cerebrovascular diseases
- Severe active infections excluding simple urinary or bacterial pharyngitis
- Presence of indwelling catheters except specific allowed types
- History of other primary cancers except certain cured or localized types
- Autoimmune diseases requiring treatment or immunodeficiency
- Graft-versus-host disease
- Recent live vaccinations within 4 weeks
- History of alcoholism, drug abuse, or mental illness
- Active hepatitis B or certain infections
- Recent systemic steroid use except inhaled steroids
- Participation in other clinical studies within 2 weeks
- Pregnancy, breastfeeding, or inability to use contraception
- Any other condition increasing risk or interfering with study results as judged by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 28 days after CTA101 infusion
Participants receive CTA101 UCAR-T cell injection by intravenous infusion to treat relapsed or refractory CD19+ B-line hematological malignancy.
1 treatment visit (in-person) with monitoring up to 28 days
Duration - Up to 2 years after CTA101 infusion
Participants are monitored for safety and response to treatment after the CTA101 infusion.
Visits at weeks 4, 12, and months 6, 12, 18, and 24
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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