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RD13-02 for Patients With r/r CD7+ T Cell Hematologic Malignancies

Primary Purpose

Hematologic Malignancies

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

About this trial

This is an interventional treatment trial for Hematologic Malignancies

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. 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. 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 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. Sujects 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. Subjects with acute graft-versus-host disease (GvHD) Having received live/attenuated vaccine within 4 weeks prior to screening. History of allergy to any component of the cell therapy product. Pregnant or breastfeeding women Any other issue which, in the opinion of the investigator, would make the sujects ineligible for the study.

Sites / Locations

  • Henan Cancer HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

RD13-02 cell infusion

Arm Description

drugs use generic name : RD13-02 CAR-T cell injection; dosage form : Cell injection; dosage : 2×10^8 CAR+ T cells; frequency : Once.

Outcomes

Primary Outcome Measures

Overall response rate, ORR
The proportion of patients with CR (complete response) /CRi (complete response with incomplete blood cell recovery) and PR (partial response).
Overall response rate, ORR
The proportion of patients with CR (complete response) /CRi (complete response with incomplete blood cell recovery) and PR (partial response).
Overall response rate, ORR
The proportion of patients with CR (complete response) /CRi (complete response with incomplete blood cell recovery) and PR (partial response).

Secondary Outcome Measures

Overall response rate with 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 HSCT
Overall survival, OS
The time from CAR-T infusion to death due to any cause

Full Information

First Posted
June 7, 2023
Last Updated
June 26, 2023
Sponsor
Henan Cancer Hospital
Collaborators
Nanjing Bioheng Biotech Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05923541
Brief Title
RD13-02 for Patients With r/r CD7+ T Cell Hematologic Malignancies
Official Title
Clinical Study on Efficacy, Safety and Cytopharmacokinetics of RD13-02 Cell Injection in the Treatment of Patients With Recurrent or Refractory CD7-positive Hematologic Malignancies
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 30, 2023 (Anticipated)
Primary Completion Date
June 7, 2025 (Anticipated)
Study Completion Date
June 7, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Henan Cancer Hospital
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

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 CAR-T therapy for patients with CD7-positive relapsed or refractory T-ALL/LBL, 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
Hematologic Malignancies

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
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
RD13-02 cell infusion
Arm Type
Experimental
Arm Description
drugs use generic name : RD13-02 CAR-T cell injection; dosage form : Cell injection; dosage : 2×10^8 CAR+ T cells; frequency : Once.
Intervention Type
Drug
Intervention Name(s)
RD13-02 cell infusion
Intervention Description
Universal CAR-T cells targeting CD7
Primary Outcome Measure Information:
Title
Overall response rate, ORR
Description
The proportion of patients with CR (complete response) /CRi (complete response with incomplete blood cell recovery) and PR (partial response).
Time Frame
Evaluate at 4 weeks after CAR-T infusion
Title
Overall response rate, ORR
Description
The proportion of patients with CR (complete response) /CRi (complete response with incomplete blood cell recovery) and PR (partial response).
Time Frame
Evaluate at 8 weeks after CAR-T infusion
Title
Overall response rate, ORR
Description
The proportion of patients with CR (complete response) /CRi (complete response with incomplete blood cell recovery) and PR (partial response).
Time Frame
Evaluate at 12 weeks after CAR-T infusion
Secondary Outcome Measure Information:
Title
Overall response rate with 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 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. 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. 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 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. Sujects 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. Subjects with acute graft-versus-host disease (GvHD) Having received live/attenuated vaccine within 4 weeks prior to screening. History of allergy to any component of the cell therapy product. Pregnant or breastfeeding women Any other issue which, in the opinion of the investigator, would make the sujects ineligible for the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shu Ke Zhou, Dr.
Phone
13674902391
Email
drzhouks77@163.com
Facility Information:
Facility Name
Henan Cancer Hospital
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450003
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shu Ke Zhou, Dr.
Phone
13674902391
Email
drzhouks77@163.com

12. IPD Sharing Statement

Learn more about this trial

RD13-02 for Patients With r/r CD7+ T Cell Hematologic Malignancies

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