Status:
TERMINATED
CD19-CD22 Chimeric Antigen Receptor T (CAR-T) Cell for Treatment of B Cell Acute Lymphoblastic Leukemia (B-ALL)
Lead Sponsor:
Institute of Hematology & Blood Diseases Hospital, China
Collaborating Sponsors:
Juventas Cell Therapy Ltd.
Conditions:
Relapsed or Refractory B Cell Acute Lymphoblastic Leukemia
Eligibility:
All Genders
3+ years
Phase:
EARLY_PHASE1
Brief Summary
This is a single arm, open-label, single center study to determine the safety and efficacy of CD19-CD22 CAR-T cells in patients with CD19+CD22+ Leukemia.
Detailed Description
This is a single arm, open-label, single center study to determine the safety and efficacy of CD19-CD22 CAR-T cells in patients with relapsed or refractory B-ALL. The study will have the following seq...
Eligibility Criteria
Inclusion
- Informed consent is signed by a subject or his lineal relation.
- Age 3 and older.
- Documentation of cluster of differentiation 19 (CD19) and or cluster of differentiation 19 (CD22) expression on leukemic blasts in the BM, peripheral blood within 3 months of screening.;
- Relapsed or refractory B-cell ALL
- Relapse within 12 months of first remission
- Without remission after 2 cycles of induction chemotherapy regimen.
- Without remission or relapse after salvage treatments.
- Any BM relapse after autologous stem cell transplantation (ASCT).
- Without remission or relapse after any prior CD19 targeted therapy;
- Patients with Philadelphia chromosome positive (Ph+) ALL are eligible if they are intolerant to or have failed 2 lines of tyrosine kinase inhibitor therapy (TKI); no TKI salvage treatments if the patient has a BCR-ABL1 kinase domain gatekeeper mutation Thr315Ile (T315I) mutation.
- Bone marrow with ≥ 5% lymphoblasts by morphologic assessment at screening；
- Eastern cooperative oncology group (ECOG) performance status of 0 to 2.
- Adequate organ function defined as:
- Aspartate aminotransferase (AST) ≤3 upper limit of normal (ULN);
- Serum alanine aminotransferase (ALT) ≤3 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.
- Absolute lymphocyte count ≥0.3 x 10⁹/L.
- Women of child-bearing potential and all male participants must use highly effective methods of contraception for a period of 1 year after the CD19-CD22 CAR-T cells infusion.
Exclusion
- Active central nervous system leukemia
- Patients with evidence of currently uncontrollable serious active infections (e.g., sepsis, bacteremia, fungemia, viremia, etc.).
- Patients who are positive for any of HIV antibody, TP antibody, hepatitis B surface antigen (HBsAg) and hepatitis C virus (HCV) antibody.
- Major surgery within ≤ 4 weeks before enrollment.
- Prior malignancy, except carcinoma in situ of the skin or cervix treated with curative intent.
- Impaired cardiac function:
- Left Ventricular Ejection Fraction (LVEF) ≤45%;
- III/IV congestive heart failure (NYHA);
- Severe arrhythmia (except for Atrial fibrillation, Paroxysmal supraventricular tachycardia);
- Corrected QT interval (QTc) ≥450ms (male) or QTc≥470ms (female)（QTc using Bazett's formula (QTcB)=QT/RR\^0.5）;
- Myocardial infarction or Coronary Artery Bypass Graft Surgery, heart stent surgery.
- Other heart diseases that have been judged by the investigator to be unsuitable for receiving cell therapy.
- Patients with a history of epilepsy or other active central nervous system diseases.
- Life expectancy \< 12 weeks.
- Allergy to macromolecule biopharmaceuticals such as antibodies or cytokines.
- Subjects who are receiving systemic steroid treatment and who have been determined by the researchers to require long-term treatment with systemic steroids during treatment, and subjects treated with systemic steroids must be excluded \< 72 hours prior to CNCT19 infusion (except inhalation or local use).
- Patients with other conditions making the patients unsuitable for receiving cell therapy as judged by the investigator.
Key Trial Info
Start Date :
September 30 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2020
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT04034446
Start Date
September 30 2019
End Date
December 1 2020
Last Update
June 3 2025
Active Locations (1)
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1
Institute of Hematology & Blood Diseases Hospital
Tianjin, China, 300020