RD13-01 for Patients With r/r CD7+ T/NK Cell Hematologic Malignancies

H

He Huang

Status and phase

Completed
Phase 1

Conditions

Hematologic Malignancies

Treatments

Drug: RD13-01 cell infusion

Study type

Interventional

Funder types

Other

Identifiers

NCT04538599
BHCT-RD13-01-02

Details and patient eligibility

About

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.

Enrollment

12 patients

Sex

All

Ages

3 to 70 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

12 participants in 1 patient group

RD13-01 cell infusion
Experimental group
Treatment:
Drug: RD13-01 cell infusion

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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