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CD5 CAR-T Therapy for Refractory/Relapsed CD5+ T-cell Acute Lymphoblastic Leukemia

Primary Purpose

T-cell Acute Lymphoblastic Leukemia

Status

Recruiting

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

CD5 CAR-T

About this trial

This is an interventional treatment trial for T-cell Acute Lymphoblastic Leukemia focused on measuring CD5 CAR-T, T-ALL

Eligibility Criteria

1 Year - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Diagnosis of refractory or relapsed T-cell acute lymphoblastic leukemia (T-ALL) according to the NCCN 2019.V2 Guideline. Refractory T-ALL is defined as a patient who has failed to achieve complete remission after induction therapy. Relapsed T-ALL is defined as the reappearance of blasts (5%) in either peripheral blood or bone marrow. Patients whose tumor burden >5% blasts, or who have persistent positive minimal residual disease (MRD), or have reappearance of extramedullary lesions are also considered eligible;
CD5-positive tumor (≥70% CD5 positive blasts by flow cytometry or immunohistochemistry (tissue) assessed by a CLIA certified Flow Cytometry/Pathology laboratory). tumors burden >5%,or MRD+， or new extramedullary lesions reappeared;
Aged 1 to 18 years (including 18 years old);
Eastern Cooperative Oncology Group (ECOG) score 0-2;
Life expectancy greater than 12 weeks;
Oxygen saturation of blood>90%;
Total bilirubin (TBil) ≤3 × upper limit normal, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 10 × upper limit of normal;
Informed consent explained to, understood by and signed by patient/guardian.

Exclusion Criteria:

Intracranial hypertension or brain consciousness disorder;
Has an active GvHD;
Has a history of severe pulmonary function damaging;
With other tumors which is/are in advanced malignant stage and has/have systemic metastasis;
Severe or persistent infection that cannot be effectively controlled；
Presence of severe autoimmune diseases or immunodeficiency disease;
Patients with active hepatitis B or hepatitis C ([HBVDNA+] or [HCVRNA+]);
Patients with HIV infection or syphilis infection;
Has a history of serious allergies to biological products (including antibiotics);
Clinically significant viral infection or uncontrolled viral reactivation of EBV (Epstein-Barr virus), CMV (cytomegalovirus), ADV (adenovirus), BK-virus, or HHV (human herpesvirus)-6;
Presence of any symptomatic CNS disorder such as an uncontrolled seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement;
Received allogeneic hematopoietic stem cell transplantation within 6 months;
Being pregnant and lactating or having pregnancy within 12 months;
Any situations that the researchers believe will increase the risk for the subject or affect the results of the study.

Sites / Locations

Xuanwu Hospital Capital Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CD5 CAR-T

Arm Description

This cohort will be administrated with T cells transduced with lentivirus vectors expressing CD5 CAR.

Outcomes

Primary Outcome Measures

Safety: Incidence and severity of adverse events

To evaluate the possible adverse events occurred within the first one month following CD5 CAR-T infusion, including the incidence and severity of symptoms such as cytokine release syndrome and neurotoxicity.

Secondary Outcome Measures

Efficacy: Remission Rate

Remission Rate including complete remission(CR)、CR with incomplete blood count recovery(CRi)、partial remission(PR), No remission(NR), overall remission (OR).

Best overall response (BOR)

Best overall response (BOR) of complete remission (CR) or CR with incomplete blood count recovery (CRi) within 1 months after CD5 CAR-T infusion.

Duration of remission (DoR)

Duration of remission (DoR) within 1 year following CD5 CAR-T infusion (DoR is defined as the duration from the date when the response criteria of CR or CRi is first met to the date of relapse or death due to ALL).

Event free survival within 1 year

Event free survival (EFS) within 1 year (EFS is defined as the time from start of the first infusion to the earliest of death from any cause or relapse).

Full Information

NCT ID

NCT05596266

First Posted

October 23, 2022

Last Updated

October 23, 2022

Sponsor

Xuanwu Hospital, Beijing

Collaborators

Baoding Children's Hospital

1. Study Identification

Unique Protocol Identification Number

NCT05596266

Brief Title

CD5 CAR-T Therapy for Refractory/Relapsed CD5+ T-cell Acute Lymphoblastic Leukemia

Official Title

A Phase I Study of CD5 CAR-T for Refractory/Relapsed CD5+ T-ALL Patients

Study Type

Interventional

2. Study Status

Record Verification Date

October 2022

Overall Recruitment Status

Recruiting

Study Start Date

October 25, 2022 (Anticipated)

Primary Completion Date

December 31, 2024 (Anticipated)

Study Completion Date

October 25, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Xuanwu Hospital, Beijing

Collaborators

Baoding Children's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

This is a phase I, interventional, single arm, open label, clinical study to evaluate the safety and tolerability of CD5 CAR-T cells in refractory/relapsed CD5+ T-ALL patients who have no available curative treatment options.

Detailed Description

T-acute lymphoblast leukemia (T-ALL) is a neoplastic lymphoid leukemia characterized by the proliferation of immature precursor T cells. The combined chemotherapy has significantly improved the prognosis of T-acute lymphoblast leukemia/lymphoma. However, once the disease appears to be relapsed/refractory, there is limited treatment options, and the overall prognosis is extremely poor. Therefore, exploring safe and effective treatments is a critical unmet medical need. The patients will receive infusion of CAR T-cells targeting CD5 to examine the safety and, possibly the efficacy of CD5 CAR T-Cells in CD5+ relapsed or refractory acute leukemia.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

T-cell Acute Lymphoblastic Leukemia

Keywords

CD5 CAR-T, T-ALL

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

CD5 CAR-T

Arm Type

Experimental

Arm Description

This cohort will be administrated with T cells transduced with lentivirus vectors expressing CD5 CAR.

Intervention Type

Biological

Intervention Name(s)

CD5 CAR-T

Intervention Description

CD5 CAR-T will be administered by I.V. infusion.

Primary Outcome Measure Information:

Title

Safety: Incidence and severity of adverse events

Description

Time Frame

First 1 month post CAR-T cells infusion

Secondary Outcome Measure Information:

Title

Efficacy: Remission Rate

Description

Remission Rate including complete remission(CR)、CR with incomplete blood count recovery(CRi)、partial remission(PR), No remission(NR), overall remission (OR).

Time Frame

1 months post CAR-T cells infusion

Title

Best overall response (BOR)

Description

Best overall response (BOR) of complete remission (CR) or CR with incomplete blood count recovery (CRi) within 1 months after CD5 CAR-T infusion.

Time Frame

1 months

Title

Duration of remission (DoR)

Description

Time Frame

1 year

Title

Event free survival within 1 year

Description

Event free survival (EFS) within 1 year (EFS is defined as the time from start of the first infusion to the earliest of death from any cause or relapse).

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

1 Year

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Diagnosis of refractory or relapsed T-cell acute lymphoblastic leukemia (T-ALL) according to the NCCN 2019.V2 Guideline. Refractory T-ALL is defined as a patient who has failed to achieve complete remission after induction therapy. Relapsed T-ALL is defined as the reappearance of blasts (5%) in either peripheral blood or bone marrow. Patients whose tumor burden >5% blasts, or who have persistent positive minimal residual disease (MRD), or have reappearance of extramedullary lesions are also considered eligible; CD5-positive tumor (≥70% CD5 positive blasts by flow cytometry or immunohistochemistry (tissue) assessed by a CLIA certified Flow Cytometry/Pathology laboratory). tumors burden >5%,or MRD+， or new extramedullary lesions reappeared; Aged 1 to 18 years (including 18 years old); Eastern Cooperative Oncology Group (ECOG) score 0-2; Life expectancy greater than 12 weeks; Oxygen saturation of blood>90%; Total bilirubin (TBil) ≤3 × upper limit normal, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 10 × upper limit of normal; Informed consent explained to, understood by and signed by patient/guardian. Exclusion Criteria: Intracranial hypertension or brain consciousness disorder; Has an active GvHD; Has a history of severe pulmonary function damaging; With other tumors which is/are in advanced malignant stage and has/have systemic metastasis; Severe or persistent infection that cannot be effectively controlled； Presence of severe autoimmune diseases or immunodeficiency disease; Patients with active hepatitis B or hepatitis C ([HBVDNA+] or [HCVRNA+]); Patients with HIV infection or syphilis infection; Has a history of serious allergies to biological products (including antibiotics); Clinically significant viral infection or uncontrolled viral reactivation of EBV (Epstein-Barr virus), CMV (cytomegalovirus), ADV (adenovirus), BK-virus, or HHV (human herpesvirus)-6; Presence of any symptomatic CNS disorder such as an uncontrolled seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement; Received allogeneic hematopoietic stem cell transplantation within 6 months; Being pregnant and lactating or having pregnancy within 12 months; Any situations that the researchers believe will increase the risk for the subject or affect the results of the study.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Zhiguo Chen, PhD

Phone

86-10-83198889

chenzhiguo@gmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

Huyong Zheng, MD, PhD

Phone

010-59617621

zhenghuyong@bch.com.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Zhiguo Chen, PhD

Organizational Affiliation

Xuanwu Hospital, Beijing

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Huyong Zheng, MD, PhD

Organizational Affiliation

Baoding Children's Hospital; Beijing Children's Hospital, Capital Medical University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Xuanwu Hospital Capital Medical University

City

Beijing

State/Province

Beijing

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Zhiguo Chen, PhD

Phone

86-10-83198889

chenzhiguo@gmail.com

First Name & Middle Initial & Last Name & Degree

Huyong Zheng, MD, PhD

Phone

010-59617621

zhenghuyong@bch.com.cn

First Name & Middle Initial & Last Name & Degree

Zhiguo Chen, PhD

First Name & Middle Initial & Last Name & Degree

Huyong Zheng, MD, PhD

12. IPD Sharing Statement

Learn more about this trial

CD5 CAR-T Therapy for Refractory/Relapsed CD5+ T-cell Acute Lymphoblastic Leukemia

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