Actively Recruiting
The Safety and Efficacy of RD06-03 CART Cell Injection in Patients With R/R Acute B-lymphoblastic Leukemia
Led by Anhui Provincial Hospital · Updated on 2025-01-23
9
Participants Needed
2
Research Sites
158 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is designed to explore the safety and efficacy for patients with relapsed and/or refractory B-cell lymphoblastic leukemia.
CONDITIONS
Official Title
The Safety and Efficacy of RD06-03 CART Cell Injection in Patients With R/R Acute B-lymphoblastic Leukemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 3 to 70 years, any gender or race
- Diagnosis of acute B-cell lymphoblastic leukemia confirmed by bone marrow exam
- Relapsed B-ALL: relapse within 12 months after first remission, or relapse after salvage chemotherapy, or relapse after stem cell transplantation
- Refractory B-ALL: failure to achieve complete remission after 2 cycles of induction chemotherapy or after salvage chemotherapy
- Ph+ALL patients eligible if relapsed or refractory after at least 2 tyrosine kinase inhibitor treatments or unable to tolerate or contraindicated for TKI treatment
- Bone marrow blasts at screening at least 5% with CD19 expression on tumor cells
- Organ function within specified limits including liver enzymes, creatinine, coagulation, heart function, and oxygen saturation
- Estimated survival longer than 3 months
- ECOG performance status of 0 to 2
- Fertile women agree to use effective contraception from 28 days before leukapheresis to 6 months after CAR-T infusion; fertile men agree to use barrier contraception and avoid semen donation during the trial
You will not qualify if you...
- Genetic syndromes causing bone marrow failure such as Fanconi anemia, Kostmann syndrome, or Shwachman syndrome
- Allergy to any component of the cellular product
- Active central nervous system leukemia at screening
- Purely extramedullary relapse
- Allogeneic stem cell transplant within 3 months prior or recent grade II-IV graft-versus-host disease
- Significant cardiovascular problems within 12 months including severe heart failure, myocardial infarction, unstable angina, or arrhythmias
- Uncontrolled active infections requiring IV therapy
- History of other primary cancers except certain treated non-melanoma skin cancers, cervical carcinoma in situ, localized prostate cancer, or ductal carcinoma in situ with disease-free survival over 2 years
- Autoimmune diseases requiring treatment or immunosuppressive therapy
- Received or planning to receive live attenuated vaccines within 4 weeks before or during the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Anhui Provincial Hospital
Hefei, Anhui, China, 230036
Actively Recruiting
2
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, China, 430000
Actively Recruiting
Research Team
X
Xiaoyu Zhu, phd
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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