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Recruiting Phase 1

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

NCT06445803 · tracked via the Priya Life Science China tracker
Sponsor
Phase
Phase 1
Started
2024-05-31
Last updated
2024-06-06

Condition(s) studied

Acute Lymphoblastic Leukemia, in RelapseAcute Lymphoblastic Leukemia With Failed RemissionB-cell Lymphoma RefractoryB-cell Lymphoma Recurrent

Investigational drug(s) / intervention(s)

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

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

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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 .

Primary outcome measure(s)

  • Incidence of Dose-limiting toxicity — Up to 28 days
    Will be recorded and graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
  • Incidence and severity of adverse events — Up to 15 years
    Will be recorded and graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0

Trial sites (2)

FacilityCityRegionStatus
The First Affiliated Hospital of Nanchang University; Nanchang Jiangxi Recruiting
Fudan University Shanghai Cancer Center Shanghai Shanghai Municipality Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06445803 on ClinicalTrials.gov ↗ ← All trials in China