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

T Acute Lymphoblastic Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04620655
• Other study ID #: BHCT-RD13-01-03
• Status: Recruiting
• Phase: N/A
• Start date: November 15, 2020
• Est. completion date: November 15, 2022

Study information

• Verified date: November 2020
• Source: Hebei Yanda Ludaopei Hospital
• Contact: Xian Zhang
• Phone: +86-13641041596
• Email: zhxian2[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: November 15, 2022
• Est. primary completion date: November 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Precursor Cell Lymphoblastic Leukemia-Lymphoma
• Precursor T-Cell Lymphoblastic Leukemia-Lymphoma
• T Acute Lymphoblastic Leukemia
• T-lymphoblastic Lymphoma

Intervention

Drug:
• RD13-01 cell infusion
Universal CAR-T cells targeting CD7

Locations

Country	Name	City	State
China	Hebei Yanda Ludaopei Hospital	Langfang	Hebei

Sponsors (1)

Lead Sponsor	Collaborator
Min Xiang

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dose-limiting toxicity (DLT)		4 weeks after infusion