Research Development13(RD13)-02 Cell Injection in Patients With Relapsed or Refractory Cluster Of Differentiation 7(CD7)-Positive Hematological Malignancies

NCT05895994 | Completed Early Phase 1 DMC

• 1 other identifier: BHCT-RD13-02-07
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single-arm, open-label, single-center, phase I study. The primary objective is to evaluate the safety of CD7 Chimeric Antigen Receptor-T(CAR-T) therapy for patients with CD7-positive relapsed or refractory T-Acute Lymphoblastic Leukemia(ALL)/Lymphoblastic Lymphoma(LBL)/Acute Myelogenous Leukemia(AML), and to evaluate the pharmacokinetics of CD7 CAR-T in patients。

Conditions

Neoplasms; Neoplasms by Site; Hematologic Neoplasms; Hematologic Diseases

Outcome Measures

Primary Outcomes (3)

• Overall response rate (ORR)

  The proportion of patients with complete response (CR) /complete response with incomplete blood cell recovery (CRi)

  Evaluate at 4 weeks after CAR-T infusion

• Overall response rate (ORR)

  The proportion of patients with complete response (CR) /complete response with incomplete blood cell recovery (CRi)

  Evaluate at 8 weeks after CAR-T infusion

• Overall response rate (ORR)

  The proportion of patients with complete response (CR) /complete response with incomplete blood cell recovery (CRi)

  Evaluate at 12 weeks after CAR-T infusion

Secondary Outcomes (6)

• Objective response rate , ORR

  Up to 1 years after CAR-T infusion

• Overall response rate with Minimal Residual Disease (MRD)-negative, MRD-ORR

  Up to 1 years after CAR-T infusion

• Duration of remission (DOR)

  Up to 1 years after CAR-T infusion

• Event-free survival (EFS)

  Up to 1 years after CAR-T infusion

• The proportion of patients who receive hematopoietic stem cell transplantation

  Up to 1 years after CAR-T infusion

Study Arms (1)

RD13-02 cell infusion

EXPERIMENTAL

Drug: RD13-02 cell infusion

Interventions

RD13-02 cell infusion DRUG

CAR-T cells

RD13-02 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:

• Age 3-70
• Diagnosis of r/r T-ALL/LBL/AML.
• CD7 positive expression
• Bone marrow lymphoblasts ≥5% by morphologic evaluation at screening
• Creatinine clearance (as estimated by Cockcroft Gault) ≥ 60 mL/min, Serum alanine aminotransferase(ALT)/aspartate aminotransferase(AST) \< 3×upper limit of normal, Total bilirubin \< 1.5×upper limit of normal or ≤1.5mg/dl
• Left ventricular ejection fraction ≥ 50% .
• Baseline oxygen saturation ≥ 92% on room air.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
• The estimated survival time is more than 3 months.
• Subjects or their legal guardians volunteer to participate in the study and sign the informed consent.

You may not qualify if:

• Subjects with concomitant genetic syndromes associated with bone marrow failure states.
• Isolated extramedullary lesions
• Subjects with some cardiac conditions will be excluded.
• With uncontrolled active central nervous system leukemia (CNSL), cerebrospinal fluid grade Central Nervous System3(CNS3).
• History of traumatic brain injury, consciousness disturbance, epilepsy, cerebrovascular ischemia, and cerebrovascular hemorrhagic disease, which might compromise the ability of the subject to compliance with the obligations under the protocol.
• History of malignancy other than non-melanoma skin cancer or carcinoma.
• Primary immune deficiency.
• Presence of uncontrolled infections.
• Subjects with some anticancer therapy before CAR-T infusion will be excluded.
• Active uncontrolled acute infections.
• Known history of infection with human immunodeficiency virus (HIV); active or latent hepatitis B, hepatitis C and syphilis.
• Subjects who are receiving systemic steroid therapy prior to screening.
• Having received live/attenuated vaccine within 4 weeks prior to screening. 15.History of allergy to any component of the cell therapy product. 16.Pregnant or breastfeeding women 17.Any other issue which, in the opinion of the investigator, would make the subjects ineligible for the study.

Sponsors & Collaborators

• MEI HENG: lead
• Nanjing Bioheng Biotech Co., Ltd.: collaborator

Study Sites (1)

Union Hospital, Huazhong University of Science and Technology

Wuhan, Hubei, 430022, China

Location

MeSH Terms

Conditions

Neoplasms; Hematologic Neoplasms; Neoplasms by Site; Hematologic Diseases

Condition Hierarchy (Ancestors)

Hemic and Lymphatic Diseases

Study Design

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

Study Record Dates

• First Submitted: February 18, 2023
• First Posted: June 9, 2023
• Study Start: March 10, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: February 3, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)