Diffuse Large B-cell Lymphoma, Follicular Lymphoma, Mantle Cell Lymphoma
Conditions
Brief summary
This study is designed to explore the safety and tolerability of RD14-01 for patients with relapsed and/or refractory B-cell non-Hodgkin lymphoma. And to evaluate the efficacy and pharmacokinetics of RD14-01 in patients.
Interventions
DRUGRD14-01 cell infusion
Autologous CAR T cells
Sponsors
He Huang
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Aged 18 to 75 years. 2. Diagnosis of r/r MCL, DLBCL, or FL (Grade 1, 2 and 3a). 3. ECOG: 0-1. 4. Life expectancy greater than 3 months. 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 e-antigen (HBeAg) positive and peripheral blood hepatitis B virus (HBV) DNA titer detection is not within the normal range; hepatitis C virus (HCV) antibody positive; human immunodeficiency virus (HIV) antibody positive; syphilis antibody positive; cytomegalovirus (CMV) DNA positive; Epstein-Barr virus (EBV) DNA positive. 3. Central nervous system (CNS) metastases. 4. Participated in other clinical studies within 4 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 | Description |
|---|---|---|
| Dose-limiting toxicity | Up to 2 years | DLT |
| Maximum tolerable dose | Up to 2 years | MTD |
Countries
China
Contacts
Primary ContactHe Huang, PhD
Outcome results
None listed