RD13-01 for Patients With r/r CD7+ T/NK Cell Hematologic Malignancies
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: RD13-01 cell infusion
|
Drug: RD13-01 cell infusion
Universal CAR-T cells targeting CD7
|
Outcome Measures
Primary Outcome Measures
- Dose-limiting toxicity (DLT) [4 weeks after infusion]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Aged 3 to 70 years.
-
Diagnosis of r/r T-ALL/NK-ALL, T-LBL, or T-NHL (including PTCL-NOS, AITL, ALCL, Extranodal NK/T cell lymphoma).
-
ECOG: 0-2.
-
Life expectancy greater than 12 weeks.
-
Cardiac left ventricle ejection fraction ≥50%.
-
Informed consent explained to, understood by and signed by the patient/guardian. Patient/guardian is given a copy of informed consent.
Exclusion Criteria:
-
Pregnant or lactating.
-
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.
-
Patients with graft-versus-host disease (GVHD) or who need to use immunosuppressive drugs.
-
Participated in other clinical studies within 2 weeks prior to screening.
-
History of alcoholism, drug abuse or mental illness.
-
Any situations that the investigator believes may increase the risk of patients or interfere with the results of study.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | The First Affiliated Hospital,College of Medicine, Zhejiang University | Hangzhou | Zhejiang | China | 310003 |
Sponsors and Collaborators
- He Huang
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- BHCT-RD13-01-02