A Clinical Trial of CNCT19 Cells in the Treatment of CD19 Positive Relapsed or Refractory Acute Lymphoblastic Leukemia

  • STATUS
    Recruiting
  • days left to enroll
    47
  • participants needed
    18
  • sponsor
    Juventas Cell Therapy Ltd.
Updated on 17 February 2021

Summary

This is a single arm, open-label, non-randomized, dose-escalation, phase I study to determine the safety and efficacy of CNCT19 in adult patients with relapsed or refractory acute lymphoblastic leukemia.

Description

This is a single arm, open-label, non-randomized, dose-escalation, phase I study to determine the safety and efficacy of CNCT19 in adult patients with relapsed or refractory acute lymphoblastic leukemia. The study will have the following sequential phases: Screening, Pre-Treatment (Cell Product Preparation & Lymphodepleting Chemotherapy), Treatment and Follow-up, and Survival Follow-up. The total duration of the study is 2 years from CNCT19 cell infusion.

Details
Condition Relapsed or Refractory Acute Lymphoblastic Leukemia
Treatment single dose of CNCT19
Clinical Study IdentifierNCT04230473
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 ALL
Relapse within 12 months of first remission
Without remission after more than 6 weeks of induction chemotherapy or without remission after 2 cycles of induction chemotherapy regimen
2nd or greater Bone Marrow (BM) relapse OR
First relapse after chemotherapy, without remission after at least 1 rescue treatment
Any BM relapse after autologous 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 1 generation and/or 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
Have appropriate vascular conditions for apheresis
Non-hematological toxic reactions (excluding diseases related) caused by previous treatment were restored to 1 level before screening (excluding 2 level of neurotoxicity caused by hair loss and chemotherapy drugs)
Women of childbearing age have a negative blood / urine pregnancy test within 7 days before 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 six months after the CNCT19 infusion

Exclusion Criteria

Active 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
Pegylated-asparaginase must be stopped > 4 weeks prior to CNCT19 infusion
CNS prophylaxis treatment must be stopped > 1 week 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 had treatment with any prior CAR-T therapy
\. Patients who have previously received allogeneic hematopoietic stem cell
transplantation (allo-HSCT)
\. Patients with systemic vasculitis (such as Wegener granulomatosis, nodular
polyarteritis, systemic lupus erythematosus) and active or uncontrolled
autoimmune disease (such as autoimmune hemolytic anemia, etc.)
\. Patients who are positive for any of HBsAg, HBeAg, HBeAb, HBcAb, HCV-Ab
TP-Ab
\. Active malignancy. Patients with Prior malignancy that has been cured for
years are excluded
\. a. Left Ventricular Ejection Fraction (LVEF) 45%; b. III/IV congestive
heart failure (NYHA); c. Severe arrhythmia ; QTc450ms (male)or QTc470ms
(female)(QTcB=QT/RR1/2); d.Uncontrolled hypertension (systolic blood pressure
mmHg and / or diastolic blood pressure 90 mmHg) or pulmonary hypertension
or unstable angina; e. 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
\. Clinically significant pleural effusion
\. Patients with a history of epilepsy, cerebrovascular ischemia
hemorrhage, cerebellar disease or other active central nervous system
diseases
\. History of deep vein thrombosis or pulmonary embolism within 6 months of
screening
\. Known history of hypersensitivity to ingredients used in the drug
\. Has had treat with live vaccine within 6 weeks prior to screening
\. Patients with evidence of currently uncontrollable serious active
infections (e.g., sepsis, bacteremia, fungemia, viremia, etc.)
\. Life expectancy < 3 months
\. Patient in other interventional clinical studies within 3 months before
screening, who have received active drug therapy, or who intend to participate
in another clinical trial or receive anti-tumor therapy outside the protocol
during the entire study
\. Patients with other conditions making the patients unsuitable for
receiving cell therapy as judged by the investigator
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