Actively Recruiting
Phase II Study of CAR-T-19 Injection for CD19-positive Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia in Patients 25 Years and Younger
Led by Beijing Yongtai Ruike Biotechnology Company Ltd · Updated on 2025-01-13
100
Participants Needed
1
Research Sites
173 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of CAR-T-19 cell injection to treat patients up to 25 years old with CD19-positive relapsed or refractory B-cell acute lymphoblastic leukemia (B-ALL). This phase II, multi-center, single-arm, open-label study focuses on patients whose disease has returned or not responded to previous treatments, including those with specific genetic factors and prior therapies. The study aims to measure the objective response rate at 3 months after treatment. Participants will first undergo leukapheresis to collect their own lymphocytes. Then, they receive lymphodepleting chemotherapy with cyclophosphamide and fludarabine for three consecutive days. Following chemotherapy, patients will be infused with genetically modified CAR-T-19 cells targeting the CD19 protein at a dose targeting 2.5 million cells per kilogram of body weight, within a specified dose range. This treatment is designed to help the immune system target and attack leukemia cells. During the study, participants will be closely monitored through bone marrow exams, blood tests, and assessments of organ function and performance status. Researchers will track the presence of tumor cells expressing CD19, safety parameters, and treatment response. Women of childbearing potential and their partners must use effective contraception during and for two years after treatment. The total duration of study participation depends on treatment and follow-up schedules, including safety assessments and monitoring for side effects.
CONDITIONS
Official Title
CAR-T-19 Injection in the Treatment of CD19-positive Relapsed/Refractory B-ALL
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntary participation with signed informed consent and ability to complete all trial procedures
- Age 25 years or younger at screening, any gender
- Confirmed diagnosis of B-ALL with relapsed or refractory status as defined by specific relapse timelines or treatment responses
- For Ph+ALL, relapsed or refractory after at least two Tyrosine kinase inhibitor treatments or specific exceptions
- Presence of CD19 expression on tumor cells in bone marrow or peripheral blood
- Bone marrow blasts 5% or greater at screening
- Adequate organ function including liver enzymes, bilirubin, oxygen saturation, heart function, and kidney function
- Karnofsky performance status 70 or higher for age 16 years and older, or Lansky performance status 50 or higher for under 16 years
- Life expectancy of at least 12 weeks
- Adequate venous access for apheresis with no contraindications
- Negative pregnancy test for women of childbearing potential before screening and prior to infusion, with agreement to use effective contraception during study and for 2 years after
- For prior allogeneic stem cell transplant patients, specific donor eligibility and health criteria must be met
You will not qualify if you...
- Isolated relapse outside the bone marrow
- Genetic syndromes except Down Syndrome
- Diagnosis of Burkitt's lymphoma or leukemia
- Active central nervous system disease or active CNS leukemia with neurological symptoms
- History or presence of other malignant tumors except certain treated cancers
- Uncontrolled or intravenous treatment-requiring infections
- Hematopoietic stem cell transplant within 3 months or active graft-versus-host disease grade 2 to 4
- Recent anti-tumor therapies within defined washout periods before apheresis
- Systemic glucocorticoid use within 1 week before apheresis except physiological doses
- Use of long-acting or short-acting G-CSF within specified days before apheresis
- Positive tests for hepatitis B, hepatitis C, HIV, EB virus, or cytomegalovirus beyond normal limits
- Previous CAR-T therapy targeting any antigen
- Allergies to albumin or aminoglycoside antibiotics
- Live vaccine within 6 weeks before screening
- Organ transplantation other than hematopoietic stem cell transplantation
- Participation in other interventional clinical trials or anti-tumor therapies within 3 months before screening
- Any other conditions deemed inappropriate by the investigator to participate
AI-Screening
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Trial Site Locations
Total: 1 location
1
Hematology Hospital of the Chinese Academy of Medical Sciences
Tianjin, China
Actively Recruiting
Research Team
X
Xiaofan Zhu
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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