Overview

RD13-01 for Patients With r/r CD7+ T-ALL/T-LBL

Status:
Recruiting
Trial end date:
2022-11-15
Target enrollment:
0
Participant gender:
All
Summary
This study is designed to explore the safety of RD13-01 for patients with CD7+ relapsed and/or refractory T cell acute lymphoblastic leukemia or lymphoblastic lymphoma. And to evaluate the efficacy and pharmacokinetics of RD13-01 in patients.
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Min Xiang
Criteria
Inclusion Criteria:

1. Aged 3 to 70 years.

2. Diagnosis of r/r T-ALL/T-LBL.

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.