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

Launched by RONG TAO · Jun 1, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment using specially modified immune cells, called CAR-T cells, to help adults with certain types of blood cancers, specifically relapsed or refractory acute lymphoblastic leukemia (ALL) and non-Hodgkin lymphoma (NHL). The aim is to find out if this treatment is safe, tolerable, and effective in fighting these cancers. Eligible participants are adults aged 18 and older who have had their cancer return after treatment or have not responded to standard therapies. Important health criteria include having good overall health and functioning organs, as well as a predicted survival time of at least 12 weeks.

Participants in the trial can expect to receive the CAR-T cell treatment, which is made on-site, and will be monitored closely for safety and effectiveness. It's important to note that individuals with certain health issues, recent treatments, or conditions like active infections or autoimmune diseases may not be eligible for this study. The trial is currently recruiting participants, so those interested should discuss this option with their healthcare provider to see if they qualify.

Gender

ALL

Eligibility criteria

• 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 .