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CD19/CD22 CAR-T Cells in Adults With R/R ALL or NHL

RecruitingPhase 1Ages 18 Years - anyAllRong Tao
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: * Male or female,≥18 years old; * Histologically confirmed diagnosis of B-ALL or B-NHL(meeting one of the following conditions): (B-NHL) 1. Second or greater relapse (CD20 regimens must be included) OR 2. Refractory to first-line chemotherapy or relapse within 1 year OR 3. Relapse within 1 year of auto-HSCT. 4. With measurable or evaluable lesions(Dose expansion cohort) (B-ALL) a. Relapse within 12 months of complete remission on first treatment OR b. Relapse after second-line treatment OR c. Relapse after auto HST OR d. Failure to achieve CR/CRi at the end of induction therapy OR e. Ph+ ALL intolerance to TKI or refractory or relapse after treatment with at least two and more TKIs. * ECOG 0\~2 * Estimated survival time ≥ 12 weeks; * Main tissues and organs function well. Exclusion Criteria: * Subjects will be excluded related to the following prior therapy criteria:Prior treatment with bendamustine-containing or fludarabine;Anti-T-cell monoclonal antibody, donor lymphocyte infusion, and CNS radiotherapy within 8 weeks; Chemotherapy, lenalidomide, bortezomib within 2 weeks; vincristine within 1 week; glucocorticoids (prednisone ≥7.5 mg/d or equivalent) within 72 h * Active or latent hepatitis B or active hepatitis C (test within 8 weeks of screening), or any uncontrolled infection at screening * Uncontrolled, symptomatic, intercurrent illness including but not limited to angina pectoris, cerebrovascular accident or transient ischemia (within 6 months prior to screening), myocardial infarction (within 6 months prior to screening), New York Heart Association (NYHA) classification of ≥ Class III congestive heart failure, severe arrhythmia poorly controlled by medications, hepatic, renal, or metabolic disorders, and hypertension that is uncontrolled by standard therapy; * active bleeding, or venous thromboembolic event * Autoimmune diseases (e.g., Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus, etc.) that result in end-organ damage or require systemic application of immunosuppressive drugs * Central nervous system (CNS) disease or symptoms of CNS involvement * Pregnant or nursing (lactating) women * Presence of Grade 2 or above non-hematologic toxicity , alopecia and grade 2 neuropathy excluded * Any Iinappropriate conditions in the opinion of the PI .
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What it tests

  • KQ-2002 CAR-T cells (CD19/CD22 CAR T-Cells)
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Where

2 sites
The First Affiliated Hospital of Nanchang University;
Nanchang, China
Fudan University Shanghai Cancer Center
Shanghai, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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