Clinical Trial of CNCT19 Cell Injection in the Treatment of Relapsed or Refractory Acute Lymphoblastic Leukemia

  • STATUS
    Recruiting
  • End date
    Mar 14, 2024
  • participants needed
    100
  • sponsor
    Juventas Cell Therapy Ltd.
Updated on 17 February 2021

Summary

The study is a Phase II, single-arm, open-label, single-dose clinical trial, and its primary objective is to evaluate the efficacy and safety of CNCT19 Cell Injection in the treatment of CD19 positive Relapsed or Refractory acute lymphoblastic leukemia.

Description

The study is a Phase II, single-arm, open-label, single-dose clinical trial, and its primary objective is to evaluate the efficacy and safety of CNCT19 Cell Injection in the treatment of CD19 positive Relapsed or Refractory acute lymphoblastic leukemia. The study consists of screening period (8 weeks), treatment period (4 weeks), and follow-up period (2 years at most).

Details
Condition Relapsed or Refractory Acute Lymphoblastic Leukemia
Treatment single dose of CNCT19
Clinical Study IdentifierNCT04684147
SponsorJuventas Cell Therapy Ltd.
Last Modified on17 February 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Informed consent is signed by the subject
Age 18 to 65
Relapsed or refractory acute lymphoblastic leukemia (ALL). (1) Relapse within 12 months of first remission; (2)a. Without remission after more than 6 weeks of induction chemotherapy or without remission after 2 cycles of induction chemotherapy regimen; c. 2nd or greater Bone Marrow (BM) relapse OR; d. First relapse after chemotherapy, without remission after at least 1 rescue treatment; e. Any BM relapse after autologous or allogeneic stem cell transplantation (SCT)
Documentation of CD19 tumor expression demonstrated in bone marrow or peripheral blood within 3 months of study entry
Patients with Philadelphia chromosome positive (Ph+) ALL are eligible if they are intolerant to or have failed 2 generation of tyrosine kinase inhibitor therapy (TKI); no TKI salvage treatments if the patient has a T315I mutation
Bone marrow with 5% lymphoblasts by morphologic assessment at screening
Eastern cooperative oncology group (ECOG) performance status of 0 to 1
Adequate organ function defined as
aspartate aminotransferase (AST) 3 upper limit of normal (ULN)
Serum alanine aminotransferase (ALT) 3 upper limit of normal (ULN)
Total bilirubin 2 ULN, except in individuals with Gilbert's syndrome; Note: Patients with Gilbert's syndrome that bilirubin 3 ULN and direct bilirubin 1.5 ULN will be eligible
A serum creatinine 1.5 ULN or Creatine removal rate 60mL/min (Cockcroft and Gault
Must have a minimum level of pulmonary reserve as Grade 1 dyspnea and oxygen saturation > 91% on room air
International normalized ratio (INR) 1.5 ULN and activated partial thromboplastin time (APTT) 1.5 ULN
Vascular conditions for apheresis
Women of childbearing age have a negative blood / urine pregnancy test within 3 days before apheresis and the CNCT19 infusion. Women of child-bearing potential and all male participants must use highly effective methods of contraception throughout the study and for a period of at least two years after the CNCT19 infusion

Exclusion Criteria

Active Central Nervous System (CNS) involvement by malignancy
Isolated extra-medullary disease relapse
Patients who received chemotherapy within 2 weeks before CNCT19 infusion. The following situations are excluded
Lymphodepleting Chemotherapy prescribed by the protocol
Tyrosine kinase inhibitors (TKI) and hydroxyurea must be stopped > 72 hours prior to CNCT19 infusion
The following drugs must be stopped > 1 week prior to CNCT19 infusion: 6-mercaptopurine, 6-thioguanine, methotrexate (<25 mg / m2), cytosine arabinoside (<100 mg / m2 / d), vincristine, asparaginase
CNS prophylaxis treatment must be stopped > 1 week prior to CNCT19 infusion
Pegylated-asparaginase must be stopped > 4 weeks prior to CNCT19 infusion
Radiotherapy before CNCT19 infusion
Non-CNS site of radiation completed < 2 weeks prior to CNCT19 Infusion; CNS
directed radiation completed < 8 weeks prior to CNCT19 infusion
\. Therapeutic systemic doses of steroids were stopped < 72 hours prior to
CNCT19 infusion. However, the following physiological replacement doses of
steroids are allowed: < 10 mg/day hydrocortisone or equivalent
\. Has received anthracycline/anthraquinone drug treatment exceeding the
maximum cumulative dose recommended by the guidelines, estimated by
investigators before screening, as follows
Doxorubicin: 550mg/m2 (radiotherapy or combined medication, <(radiotherapy or combined medication, <350~400 mg/m2)
Epirubicin: 900~1000 mg/m2 (Adriamycin used, <800 mg/m2)
Pirarubicin: 950 mg/m2
Daunorubicin: 550 mg/m2
Demethoxydaunorubicin: 290 mg/m2
Aclarithromycin: 2000 mg/m2 (Adriamycin used, <800 mg/m2)
Mitoxantrone: 160 mg/m2 (using doxorubicin, <120 mg/m2); 7. Has had treatment with any prior CAR-T therapy. 8. Patients with acute graft-versus-host disease (GVHD) or moderate-to-severe chronic GVHD within 4 weeks before screening; Patients who have received systemic drug therapy for GVHD within 4 weeks before CNCT19 infusion. 9. Patients with systemic vasculitis (such as Wegener granulomatosis, nodular polyarteritis, etc.), systemic lupus erythematosus; and active or uncontrolled autoimmune disease (such as Crohns' disease, rheumatoid arthritis, autoimmune hemolytic anemia, etc.), primary or secondary immunodeficiency (such as human immunodeficiency virus infection or severe infectious disease). 10. Patients complying with any of hepatitis B surface antigen (HBsAg) and/or hepatitis B e antigen (HBeAg) positive, hepatitis B e antibody (HBe-Ab) and/or hepatitis B core antibody (HBc-Ab) positive and HBV-DNA copies being more than the lower limit of detection, hepatitis C antibody (HCV-Ab) positive, anti-treponemia pallidum antibody (TP-Ab) positive, EBV-DNA, and CMV-DNA copies being more than the lower limit of detection. 11. Prior malignancy. Patients with Prior malignancy that has been cured for 5 years or has a low risk of relapse, judged by investigators are excluded. 12. a. Left Ventricular Ejection Fraction (LVEF) 45%; b. III/IV congestive heart failure (NYHA); c. Severe arrhythmia, or clinically significant conduction abnormalities that can be seen on ECG, including QTc interval 480ms (QTcB=QT/RR1/2); d. Hypertension that has not been controlled after standard treatment (systolic 140 mmHg and/or diastolic blood pressure 90 mmHg); e. Unstable angina; f. Myocardial infarction or Coronary Artery Bypass Graft Surgery, heart stent surgery < 6 months prior to CNCT19 infusion; f. Clinically significant valvular disease; g. Other heart diseases that have been judged by the investigator to be unsuitable for receiving cell therapy. 13. Clinically significant pleural effusion. 14. Patients with a history of epilepsy, cerebrovascular ischemia / hemorrhage, cerebellar disease or other active central nervous system diseases. 15. History of deep vein thrombosis or pulmonary embolism within 6 months of screening. 16. Known history of hypersensitivity to ingredients used in the drug. 17. Has had treat with live vaccine within 6 weeks prior to screening. 18. Patients with active infections in screening. 19. Life expectancy < 3 months. 20. Patient in other interventional clinical studies, who received live investigational product, including: Unlisted new drugs within 3 months before CNCT19 injection, marketed drug within 5 half-lives before CNCT19 injection, or who intend to participate in another clinical trial or receive anti-tumor therapy outside the protocol during the entire study. 21. Patients with other conditions making the patients unsuitable for receiving cell therapy as judged by the investigator
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