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CD7 CAR-T Bridging to alloHSCT for R/R CD7+Malignant Hematologic Diseases

Primary Purpose

Hematologic Diseases, Neoplasms

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
CD7 CAR-T cells injection
Allogeneic hematopoietic stem cell transplantation
Sponsored by
Zhejiang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hematologic Diseases focused on measuring allo-HSCT, CD7 CAR-T

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Provision of signed and dated informed consent form (ICF) Male or female, 18-75 years old Anticipated survival time more than 12 weeks Eastern Cooperative Oncology Group (ECOG) performance status ≤2 According to the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines for Acute Lymphocytic Leukemia and Acute Myeloid Leukemia (2016. v1), patients diagnosed as CD7+ALL and AML Consistent with r/r CD7+acute leukemia diagnosis, including any of the following conditions a. No CR after standard chemotherapy b. The first induction reaches CR, but CR ≤ 12 months c. Patients with r/r CD7+acute leukemia have not responded to the first or multiple remedial treatments d. Multiple recurrences Philadelphia chromosome negative (Ph -) subjects; Or cannot tolerate tyrosine kinase inhibitor (TKI) treatment; Or Philadelphia chromosome positive (Ph+) subjects who did not respond to both TKI treatments Normal lung function, oxygen saturation greater than 92% without oxygen inhalation The blood biochemical test results are consistent with the following results a. (AST) and (ALT) ≤ 2.5 × (ULN) b. Total bilirubin ≤ 1.5 × ULN c. 24-hour serum creatinine clearance ≥ 30 mL/min d. Lipase and amylase ≤ 2 × ULN Fertility capable men and women of childbearing age must agree to use effective contraception starting with the signing of an informed consent form until within 2 years after the use of the study drug. Women of reproductive age include pre menopausal women and women within 2 years after menopause. The blood pregnancy test for women of reproductive age must be negative at screening Exclusion Criteria: Patients with the history of epilepsy or other CNS disease Pregnant or breastfeeding Active infection with no cure Patients with prolonged QT interval time or severe heart disease Have experienced hypersensitivity or intolerance to any drug used in this study Patients who received anticancer chemotherapy or other drug treatment within 2 weeks before screening Previous malignant tumors that require treatment or have evidence of recurrence within the previous 5 years of screening Clinically significant central nervous system lesions such as seizures, cerebral vascular ischemia/hemorrhage, dementia, cerebellar disease, psychosis, active central nervous system involvement, or cancerous meningitis In the past 2 years, terminal organ damage caused by autoimmune diseases (such as Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus) or the need for systematic application of immunosuppressive or other systemic disease control drugs Severe active viral, bacterial, or uncontrolled systemic fungal infections; Genetic bleeding/coagulation disorders, a history of non-traumatic bleeding or thromboembolism, and other diseases that may increase the risk of bleeding Patients who received autologous hematopoietic stem cell transplantation (ASCT) within 8 weeks before screening, or who plan to undergo ASCT during this study Participated in clinical trials of other drugs within 4 weeks or 5 drug half-lives (T1/2) before screening Any situation that the researchers believe may increase the risk of patients or interfere with the test results.

Sites / Locations

  • The first affiliated hospital of medical college of zhejiang universityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment Group

Arm Description

R/R CD7+Malignant Hematologic Diseases

Outcomes

Primary Outcome Measures

Incidence and level of AE and SAE
Adverse events assessed according to NCI-CTCAE v5.0 criteria

Secondary Outcome Measures

CAR-T cell expression
CAR-T cell expression in vivo
CAR-T related cytokine expression
CAR-T related cytokine expression
Survival Rate (SR)
Survival Rate (SR)
Time-To-Progression(TTP)
Time from the beginning of treatment to the progression of the disease
Progression-free survival (PFS)
Assessment of PFS at Month 6,12,18and 24
Duration of remission,DOR
The time from CR/CRi and PR to disease relapsed or death due to disease progression after CAR-T infusion
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).
Clinical Benefit Rate(CBR)
ORR+MR
Disease Control Rate (DCR)
CBR+SD
Overall survival, OS
The time from CAR-T infusion to death due to any cause
Minimal Residual Disease
MRD in CR and sCR patients
Bone marrow transplantation STR
Monitoring the status of allogeneic hematopoietic stem cell transplantation using STR-PCR

Full Information

First Posted
March 30, 2023
Last Updated
April 11, 2023
Sponsor
Zhejiang University
Collaborators
Yake Biotechnology Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05827835
Brief Title
CD7 CAR-T Bridging to alloHSCT for R/R CD7+Malignant Hematologic Diseases
Official Title
A Study to Evaluate the Efficacy and Safety of CD7CAR-T Bridging to Allogeneic Hematopoietic Stem Cell Transplantation in Patients With Refractory or Relapsed CD7 Positive Malignant Hematologic Diseases
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 30, 2023 (Anticipated)
Primary Completion Date
April 25, 2025 (Anticipated)
Study Completion Date
April 25, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zhejiang University
Collaborators
Yake Biotechnology Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
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 Bridging to allo-HSCT therapy for patients with CD7-positive relapsed or refractory Malignant Hematologic Diseases

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hematologic Diseases, Neoplasms
Keywords
allo-HSCT, CD7 CAR-T

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment Group
Arm Type
Experimental
Arm Description
R/R CD7+Malignant Hematologic Diseases
Intervention Type
Drug
Intervention Name(s)
CD7 CAR-T cells injection
Intervention Description
CD7 CAR T cells treat patients with refractory or relapsed CD7 positive Malignant Hematologic Diseases
Intervention Type
Other
Intervention Name(s)
Allogeneic hematopoietic stem cell transplantation
Intervention Description
In this study, Allogeneic hematopoietic stem cell transplantation is used as a bridge therapy to CD7 CAR T cells infusion to treat patients with refractory or relapsed CD7 positive Malignant Hematologic Diseases
Primary Outcome Measure Information:
Title
Incidence and level of AE and SAE
Description
Adverse events assessed according to NCI-CTCAE v5.0 criteria
Time Frame
Baseline up to 28 days after CD7 CAR T-cells infusion
Secondary Outcome Measure Information:
Title
CAR-T cell expression
Description
CAR-T cell expression in vivo
Time Frame
Evaluate at 1, 2, 3, 4, 8,12,16, 20 and 24 weeks after CAR-T infusion
Title
CAR-T related cytokine expression
Description
CAR-T related cytokine expression
Time Frame
Evaluate at 1, 2, 3 and 4 weeks after CAR-T infusion
Title
Survival Rate (SR)
Description
Survival Rate (SR)
Time Frame
Evaluate at 6, 9, and 12 months
Title
Time-To-Progression(TTP)
Description
Time from the beginning of treatment to the progression of the disease
Time Frame
Month 2,3,4,6,12,18and 24
Title
Progression-free survival (PFS)
Description
Assessment of PFS at Month 6,12,18and 24
Time Frame
Month 6,12,18and 24
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 Treatment
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
Clinical Benefit Rate(CBR)
Description
ORR+MR
Time Frame
Up to 24 weeks after Treatment
Title
Disease Control Rate (DCR)
Description
CBR+SD
Time Frame
Up to 12 weeks after Treatment
Title
Overall survival, OS
Description
The time from CAR-T infusion to death due to any cause
Time Frame
Up to 1 years after Treatment
Title
Minimal Residual Disease
Description
MRD in CR and sCR patients
Time Frame
Up to 2 years after Treatment
Title
Bone marrow transplantation STR
Description
Monitoring the status of allogeneic hematopoietic stem cell transplantation using STR-PCR
Time Frame
Evaluate at 4, 8,12,16 and 20 weeks after allogeneic hematopoietic stem cell transplantation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Provision of signed and dated informed consent form (ICF) Male or female, 18-75 years old Anticipated survival time more than 12 weeks Eastern Cooperative Oncology Group (ECOG) performance status ≤2 According to the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines for Acute Lymphocytic Leukemia and Acute Myeloid Leukemia (2016. v1), patients diagnosed as CD7+ALL and AML Consistent with r/r CD7+acute leukemia diagnosis, including any of the following conditions a. No CR after standard chemotherapy b. The first induction reaches CR, but CR ≤ 12 months c. Patients with r/r CD7+acute leukemia have not responded to the first or multiple remedial treatments d. Multiple recurrences Philadelphia chromosome negative (Ph -) subjects; Or cannot tolerate tyrosine kinase inhibitor (TKI) treatment; Or Philadelphia chromosome positive (Ph+) subjects who did not respond to both TKI treatments Normal lung function, oxygen saturation greater than 92% without oxygen inhalation The blood biochemical test results are consistent with the following results a. (AST) and (ALT) ≤ 2.5 × (ULN) b. Total bilirubin ≤ 1.5 × ULN c. 24-hour serum creatinine clearance ≥ 30 mL/min d. Lipase and amylase ≤ 2 × ULN Fertility capable men and women of childbearing age must agree to use effective contraception starting with the signing of an informed consent form until within 2 years after the use of the study drug. Women of reproductive age include pre menopausal women and women within 2 years after menopause. The blood pregnancy test for women of reproductive age must be negative at screening Exclusion Criteria: Patients with the history of epilepsy or other CNS disease Pregnant or breastfeeding Active infection with no cure Patients with prolonged QT interval time or severe heart disease Have experienced hypersensitivity or intolerance to any drug used in this study Patients who received anticancer chemotherapy or other drug treatment within 2 weeks before screening Previous malignant tumors that require treatment or have evidence of recurrence within the previous 5 years of screening Clinically significant central nervous system lesions such as seizures, cerebral vascular ischemia/hemorrhage, dementia, cerebellar disease, psychosis, active central nervous system involvement, or cancerous meningitis In the past 2 years, terminal organ damage caused by autoimmune diseases (such as Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus) or the need for systematic application of immunosuppressive or other systemic disease control drugs Severe active viral, bacterial, or uncontrolled systemic fungal infections; Genetic bleeding/coagulation disorders, a history of non-traumatic bleeding or thromboembolism, and other diseases that may increase the risk of bleeding Patients who received autologous hematopoietic stem cell transplantation (ASCT) within 8 weeks before screening, or who plan to undergo ASCT during this study Participated in clinical trials of other drugs within 4 weeks or 5 drug half-lives (T1/2) before screening Any situation that the researchers believe may increase the risk of patients or interfere with the test results.
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
He Huang, MD
Organizational Affiliation
First Affiliated Hospital of Zhejiang University
Official's Role
Principal Investigator
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
He Huang, MD
Phone
86-13605714822
Email
hehuangyu@126.com
First Name & Middle Initial & Last Name & Degree
Yongxian Hu, MD
Phone
+8615957162012
Email
huyongxian2000@aliyun.com

12. IPD Sharing Statement

Learn more about this trial

CD7 CAR-T Bridging to alloHSCT for R/R CD7+Malignant Hematologic Diseases

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