CD19/CD22 CAR-T Cells in Adults With R/R ALL or NHL
A Preliminary Study to Evaluate the Safety, Tolerability, Preliminary Efficacy and Pharmacokinetic Profile of KQ-2002 (CD19/CD22 CAR-T) in Adults With Recurrent or Refractory Acute Lymphoblastic Leukemia or Non-Hodgkin's Lymphoma
Rong Tao
48 participants
May 31, 2024
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria11
- Male or female,≥18 years old;
- Histologically confirmed diagnosis of B-ALL or B-NHL(meeting one of the following conditions):
- (B-NHL)
- Second or greater relapse (CD20 regimens must be included) OR
- Refractory to first-line chemotherapy or relapse within 1 year OR
- Relapse within 1 year of auto-HSCT.
- 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 Criteria9
- 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 .
Interventions
CD19/CD22 cells will be infused on Day1 after induction chemotherapy regimen. Lymphodepleting chemotherapy:3 days of IV chemotherapy with fludarabine and cyclophosphamide. Fludarabine 30 mg/m2/day IV x 4 days (days -5 through -3) Cyclophosphamide 500 mg/m2/day IV x 2 days (days -5 and-3)
Locations(2)
View Full Details on ClinicalTrials.gov
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NCT06445803