Actively Recruiting
CAR-T-19 Injection in the Treatment of CD19-positive Relapsed/Refractory B-ALL
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
This is a phase II clinical study to evaluate the safety and efficacy of CAR-T-19 injection in the treatment of CD19-positive relapsed/refractory B-cell acute lymphoblastic leukemia.
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
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
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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