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

NCT04538599 | Completed Phase 1

• 1 other identifier: BHCT-RD13-01-02
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Hematologic Malignancies

Outcome Measures

Primary Outcomes (1)

• Dose-limiting toxicity (DLT)

  4 weeks after infusion

Study Arms (1)

RD13-01 cell infusion

EXPERIMENTAL

Drug: RD13-01 cell infusion

Interventions

RD13-01 cell infusion DRUG

Universal CAR-T cells targeting CD7

RD13-01 cell infusion

Eligibility Criteria

• Age: 3 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• He Huang: lead

Study Sites (1)

The First Affiliated Hospital，College of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310003, China

Location

Related Publications (2)

• Hu Y, Zhang M, Yang T, Mo Z, Wei G, Jing R, Zhao H, Chen R, Zu C, Gu T, Xiao P, Hong R, Feng J, Fu S, Kong D, Xu H, Cui J, Huang S, Liang B, Yuan X, Cui Q, Guo H, Yu Y, Feng Y, Jin C, Ren J, Chang AH, Wang D, Huang H. Sequential CD7 CAR T-Cell Therapy and Allogeneic HSCT without GVHD Prophylaxis. N Engl J Med. 2024 Apr 25;390(16):1467-1480. doi: 10.1056/NEJMoa2313812.

  PMID: 38657244 DERIVED

• Hu Y, Zhou Y, Zhang M, Zhao H, Wei G, Ge W, Cui Q, Mu Q, Chen G, Han L, Guo T, Cui J, Jiang X, Zheng X, Yu S, Li X, Zhang X, Chen M, Li X, Gao M, Wang K, Zu C, Zhang H, He X, Wang Y, Wang D, Ren J, Huang H. Genetically modified CD7-targeting allogeneic CAR-T cell therapy with enhanced efficacy for relapsed/refractory CD7-positive hematological malignancies: a phase I clinical study. Cell Res. 2022 Nov;32(11):995-1007. doi: 10.1038/s41422-022-00721-y. Epub 2022 Sep 23.

  PMID: 36151216 DERIVED

MeSH Terms

Conditions

Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: August 30, 2020
• First Posted: September 4, 2020
• Study Start: September 10, 2020
• Primary Completion: February 17, 2021
• Study Completion: November 30, 2021
• Last Updated: January 25, 2022

Record last verified: 2021-09

Locations

CN (1)