Actively Recruiting
CD19/CD22 CAR-T Cells in Adults With R/R ALL or NHL
Led by Rong Tao · Updated on 2024-06-06
48
Participants Needed
2
Research Sites
130 weeks
Total Duration
On this page
Sponsors
R
Rong Tao
Lead Sponsor
N
Novatim Immune Therapeutics (Zhejiang) Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
This study examines the safety, tolerability and preliminary efficacy of anti-CD19 /CD22 CAR T cells (KQ-2002)manufactured on-site in adults with relapsed or refractory CD19+ B cell acute lymphoblastic leukemia or CD19+ B cell non Hodgkin lymphoma.
CONDITIONS
Official Title
CD19/CD22 CAR-T Cells in Adults With R/R ALL or NHL
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female, at least 18 years old
- Confirmed diagnosis of B-cell acute lymphoblastic leukemia or B-cell non-Hodgkin lymphoma
- For B-NHL: second or greater relapse including CD20 regimens, refractory to first-line chemotherapy or relapse within 1 year, relapse within 1 year of auto-HSCT, or measurable lesions for dose expansion cohort
- For B-ALL: relapse within 12 months of first complete remission, relapse after second-line treatment, relapse after auto-HSCT, failure to achieve remission after induction therapy, or intolerance/refractory to at least two tyrosine kinase inhibitors
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
- Estimated survival of at least 12 weeks
- Adequate function of main tissues and organs
You will not qualify if you...
- Prior treatment with bendamustine-containing or fludarabine regimens
- Anti-T-cell monoclonal antibody, donor lymphocyte infusion, or CNS radiotherapy within 8 weeks
- Chemotherapy, lenalidomide, bortezomib within 2 weeks
- Vincristine within 1 week
- Use of prednisone 7.5 mg/day or equivalent glucocorticoids within 72 hours
- Active or latent hepatitis B, active hepatitis C, or any uncontrolled infection
- Uncontrolled symptomatic illness including angina, stroke or transient ischemia within 6 months, recent myocardial infarction, severe heart failure (NYHA Class III or higher), severe arrhythmia, hepatic, renal, or metabolic disorders, and uncontrolled hypertension
- Active bleeding or venous thromboembolic events
- Autoimmune diseases causing end-organ damage or requiring systemic immunosuppressive drugs
- Central nervous system disease or symptoms of CNS involvement
- Pregnant or nursing women
- Grade 2 or higher non-hematologic toxicity except alopecia and grade 2 neuropathy
- Any other condition deemed inappropriate by the principal investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
The First Affiliated Hospital of Nanchang University;
Nanchang, Jiangxi, China, 360000
Actively Recruiting
2
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
Research Team
W
Weijing Zhang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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