CD19 CAR-T Consolidation Therapy for Acute Lymphoblastic Leukemia

Launched by THE FIRST AFFILIATED HOSPITAL OF SOOCHOW UNIVERSITY · Jun 11, 2019

Keywords

ClinConnect Summary

This clinical trial is exploring a new treatment approach for adults with a type of blood cancer called acute lymphoblastic leukemia (ALL) that is positive for a specific genetic marker known as the Philadelphia chromosome. The treatment combines a therapy called CD19 CAR-T with special T cells, known as feeding T cells (FTCs), to help improve the effectiveness of the CAR-T therapy. Participants in this study will first undergo a series of treatments to prepare their bodies, followed by receiving the CAR-T therapy along with FTCs to help boost the CAR-T cells' ability to fight the cancer. The trial aims to see how safe and effective this new combination therapy is over a period of up to two years.

To be eligible for this trial, participants must be adults aged 18 years or older with Philadelphia chromosome-positive acute B-ALL who have already had one round of CD19 CAR-T therapy and are currently taking medications called tyrosine kinase inhibitors (TKIs). They should not have serious health complications and should be able to perform daily activities with minimal assistance. Throughout the study, participants will be closely monitored for their response to the treatment and any side effects, helping researchers learn more about the best ways to use this innovative therapy in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 15-65 years of age at the time of signing informed consent
• • Diagnosed as de novo Philadelphia chromosome-positive CD19+ B-ALL
• • Karnofsky performance status ≥ 60 or Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
• • Unable to find a suitable donor or for other reasons to undergo allogeneic hematopoietic stem cell transplantation during the study
• • Ability and willingness to adhere to the study visit schedule and all protocol requirements
• • Voluntarily sign informed consent forms
• Exclusion Criteria:
• • Unable to tolerate any kind of TKIs (including the first- and second-generation tyrosine kinase inhibitors) for a long period.
• • Subjects who have positive mutation(s) of the ABL kinase domain and require the third-generation tyrosine kinase inhibitors for long-term therapies.
• • Inadequate hepatic function defined by aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) \> 3 × upper limit of normal (ULN) and direct bilirubin \> 1.5 × ULN
• • Inadequate renal function defined by serum creatinine \> 1.6 mg/dL
• • International ratio (INR) or partial thromboplastin time (PTT) \> 1.5 x ULN
• • Left ventricular ejection fraction \< 50%
• • Ongoing treatment with chronic immunosuppressants
• • Significant comorbid conditions or diseases which, in the judgment of the investigator, would place the subject at undue risk or interfere with the study; examples include, but are not limited to, cirrhotic liver disease, sepsis, recent significant traumatic injury, and other conditions
• • Known human immunodeficiency virus (HIV) positivity
• • Subjects with a history of stroke, unstable angina, myocardial infarction, or ventricular arrhythmia requiring medication or mechanical control
• • Subjects with second malignancies in addition to ALL
• • Pregnant or lactating women, or subjects refusing to take effective contraception measures
• • Other contraindications that are considered inappropriate to participate in this trial