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CD7 CAR-T for Patients With r/r CD7+ T-ALL/T-LBL

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
He Huang
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. 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: Sujects with concomitant genetic syndromes associated with bone marrow failure states. Sujects with some cardiac conditions will be excluded. 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

  • The first affiliated hospital of medical college of zhejiang universityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

RD13-02 cell infusion

Arm Description

Outcomes

Primary Outcome Measures

Dose-limiting toxicity and Maximum Tolerated dose
The DLT is evaluated as the proportion of patients who experienced adverse events related to RD13-02 that meet the criteria for DLT events after the first infusion.

Secondary Outcome Measures

Overall response rate,ORR
The proportion of patients with CR (complete remission) /CRi (complete remission with incomplete blood count recovery); The proportion of patients with CR (complete response) /CRi (complete response with incomplete blood cell recovery) and PR (partial response).
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 patients who receive hematopoietic stem cell transplantation
Overall survival, OS
The time from CAR-T infusion to death due to any cause

Full Information

First Posted
December 25, 2022
Last Updated
February 6, 2023
Sponsor
He Huang
Collaborators
Nanjing Bioheng Biotech Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05716113
Brief Title
CD7 CAR-T for Patients With r/r CD7+ T-ALL/T-LBL
Official Title
A Study for Safety, Efficacy and Cellular Pharmacokinetics of CD7 CAR-T Cell for Patients With Relapsed or Refractory CD7 Positive T-cell Acute Lymphoblastic Leukemia/Lymphoblastic Lymphoma
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 15, 2023 (Anticipated)
Primary Completion Date
March 20, 2024 (Anticipated)
Study Completion Date
May 20, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
He Huang
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 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
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
22 (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
Dose-limiting toxicity and Maximum Tolerated dose
Description
The DLT is evaluated as the proportion of patients who experienced adverse events related to RD13-02 that meet the criteria for DLT events after the first infusion.
Time Frame
Up to 28 days after CAR-T cells infusion
Secondary Outcome Measure Information:
Title
Overall response rate,ORR
Description
The proportion of patients with CR (complete remission) /CRi (complete remission with incomplete blood count recovery); 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, 8, and 12 weeks after CAR-T infusion
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 patients who receive hematopoietic stem cell transplantation
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: Sujects with concomitant genetic syndromes associated with bone marrow failure states. Sujects with some cardiac conditions will be excluded. 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
He Huang, MD
Phone
+86-0571-87236476
Email
hehuangyu@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yongxian HU, MD
Phone
+86-0571-87236476
Email
huyongxian2000@aliyun.com
Facility Information:
Facility Name
The first affiliated hospital of medical college of zhejiang university
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310003
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yongxian HU, MD
Phone
+86-0571-87236476
Email
huyongxian2000@aliyun.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

CD7 CAR-T for Patients With r/r CD7+ T-ALL/T-LBL

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