Hematologic Malignancies
Conditions
Brief summary
This study is designed to explore the safety of RD13-01 for patients with CD7+ relapsed and/or refractory T/NK-cell hematologic malignancies. And to evaluate the efficacy and pharmacokinetics of RD13-01 in patients.
Interventions
Universal CAR-T cells targeting CD7
Sponsors
He Huang
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
3 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Aged 3 to 70 years. 2. Diagnosis of r/r T-ALL/NK-ALL, T-LBL, or T-NHL (including PTCL-NOS, AITL, ALCL, Extranodal NK/T cell lymphoma). 3. ECOG: 0-2. 4. Life expectancy greater than 12 weeks. 5. Cardiac left ventricle ejection fraction ≥50%. 6. Informed consent explained to, understood by and signed by the patient/guardian. Patient/guardian is given a copy of informed consent.
Exclusion criteria
1. Pregnant or lactating. 2. Hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) positive and peripheral blood hepatitis B virus (HBV) DNA titer detection is not within the normal range; hepatitis C virus (HCV) antibody positive and peripheral blood hepatitis C Viral (HCV) RNA positive; human immunodeficiency virus (HIV) antibody positive; cytomegalovirus (CMV) DNA positive; syphilis positive. 3. Patients with graft-versus-host disease (GVHD) or who need to use immunosuppressive drugs. 4. Participated in other clinical studies within 2 weeks prior to screening. 5. History of alcoholism, drug abuse or mental illness. 6. Any situations that the investigator believes may increase the risk of patients or interfere with the results of study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dose-limiting toxicity (DLT) | 4 weeks after infusion |
Countries
China
Outcome results
None listed