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

Primary Purpose

Neoplasms, Hematologic Neoplasms, Neoplasms by Site

Status
Recruiting
Phase
Early Phase 1
Locations
China
Study Type
Interventional
Intervention
RD13-02 cell infusion
Sponsored by
MEI HENG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neoplasms

Eligibility Criteria

3 Years - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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. 14.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.

Sites / Locations

  • Union Hospital, Huazhong University of Science and TechnologyRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

RD13-02 cell infusion

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Objective response rate , ORR
The proportion of patients with CR (complete response) /CRi (complete response with incomplete blood cell recovery) and partial response (PR).
Overall response rate with Minimal Residual Disease (MRD)-negative, MRD-ORR
Proportion of patients achieving CR/CRi who is MRD-negative in bone marrow
Duration of remission (DOR)
The time from CR/CRi and PR to disease relapsed or death due to disease progression after CAR-T infusion
Event-free survival (EFS)
The time from first achieving CR/CRi to relapse or death
The proportion of patients who receive hematopoietic stem cell transplantation
The proportion of subjects who achieved remission after infusion who received Hematopoietic Stem Cell Transplantation (HSCT)
Overall survival (OS)
The time from CAR-T infusion to death due to any cause

Full Information

First Posted
February 18, 2023
Last Updated
June 8, 2023
Sponsor
MEI HENG
Collaborators
Nanjing Bioheng Biotech Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05895994
Brief Title
Research Development13(RD13)-02 Cell Injection in Patients With Relapsed or Refractory Cluster Of Differentiation 7(CD7)-Positive Hematological Malignancies
Official Title
A Study on the Efficacy, Safety and Cellular Pharmacokinetics of RD13-02 Cell Injection in Patients With Relapsed or Refractory CD7-positive Hematological Malignancies
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 10, 2023 (Actual)
Primary Completion Date
February 20, 2025 (Anticipated)
Study Completion Date
February 20, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
MEI HENG
Collaborators
Nanjing Bioheng Biotech Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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。

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neoplasms, Hematologic Neoplasms, Neoplasms by Site, Hematologic Diseases

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
RD13-02 cell infusion
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
RD13-02 cell infusion
Intervention Description
CAR-T cells
Primary Outcome Measure Information:
Title
Overall response rate (ORR)
Description
The proportion of patients with complete response (CR) /complete response with incomplete blood cell recovery (CRi)
Time Frame
Evaluate at 4 weeks after CAR-T infusion
Title
Overall response rate (ORR)
Description
The proportion of patients with complete response (CR) /complete response with incomplete blood cell recovery (CRi)
Time Frame
Evaluate at 8 weeks after CAR-T infusion
Title
Overall response rate (ORR)
Description
The proportion of patients with complete response (CR) /complete response with incomplete blood cell recovery (CRi)
Time Frame
Evaluate at 12 weeks after CAR-T infusion
Secondary Outcome Measure Information:
Title
Objective response rate , ORR
Description
The proportion of patients with CR (complete response) /CRi (complete response with incomplete blood cell recovery) and partial response (PR).
Time Frame
Up to 1 years after CAR-T infusion
Title
Overall response rate with Minimal Residual Disease (MRD)-negative, MRD-ORR
Description
Proportion of patients achieving CR/CRi who is MRD-negative in bone marrow
Time Frame
Up to 1 years after CAR-T infusion
Title
Duration of remission (DOR)
Description
The time from CR/CRi and PR to disease relapsed or death due to disease progression after CAR-T infusion
Time Frame
Up to 1 years after CAR-T infusion
Title
Event-free survival (EFS)
Description
The time from first achieving CR/CRi to relapse or death
Time Frame
Up to 1 years after CAR-T infusion
Title
The proportion of patients who receive hematopoietic stem cell transplantation
Description
The proportion of subjects who achieved remission after infusion who received Hematopoietic Stem Cell Transplantation (HSCT)
Time Frame
Up to 1 years after CAR-T infusion
Title
Overall survival (OS)
Description
The time from CAR-T infusion to death due to any cause
Time Frame
Up to 1 years after CAR-T infusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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. 14.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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Heng Mei, Dr.
Phone
13886160811
Email
hmei@hust.edu.cn
Facility Information:
Facility Name
Union Hospital, Huazhong University of Science and Technology
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430022
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Heng Mei, M.D., Ph.D
Email
hmei@hust.edu.cn
First Name & Middle Initial & Last Name & Degree
Yinqiang Zhang
Phone
15007101371
Email
zyq_107@126.com
First Name & Middle Initial & Last Name & Degree
Heng Mei, M.D., Ph.D

12. IPD Sharing Statement

Plan to Share IPD
No

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

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