UnknownNot Applicable

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

China24 participantsStarted 2020-11-15

Plain-language 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.

Who can participate

Age range3 Years – 70 Years

SexALL

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Inclusion criteria

✓. Aged 3 to 70 years.
✓. Diagnosis of r/r T-ALL/T-LBL.
✓. 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.

What they're measuring

Dose-limiting toxicity (DLT)

Timeframe: 4 weeks after infusion

Trial details

NCT IDNCT04620655

SponsorMin Xiang

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-11-15

Contact for this trial

Xian Zhang

+86-13641041596 zhxian2@126.com

View on ClinicalTrials.gov More T Acute Lymphoblastic Leukemia trials