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Recruiting Phase 1

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

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About this study

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.

Condition
Acute Lymphoblastic Leukemia, in Relapse, Acute Lymphoblastic Leukemia With Failed Remission, B-cell Lymphoma Refractory, B-cell Lymphoma Recurrent
Tested
KQ-2002 CAR-T cells （CD19/CD22 CAR T-Cells）
Sponsor
Rong Tao

Who can join

Age
18 years and older
Sex
All sexes
Healthy volunteers
Not accepted

Inclusion 13

  • Minimum age: 18 years
  • Study condition: Acute Lymphoblastic Leukemia, in Relapse, Acute Lymphoblastic Leukemia With Failed Remission, B-cell Lymphoma Refractory, B-cell Lymphoma Recurrent
  • 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 10

  • 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 .

Where

2 sites, 2 recruiting

The First Affiliated Hospital of Nanchang University;

Nanchang, Jiangxi, China

Recruiting

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Recruiting

Contact

Potential match only. Final eligibility is determined by the study team.