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Clinical Study of SenL-T7 CAR T Cells in the Treatment of Relapsed and Refractory CD7+ T-cell Lymphoblastic Leukemia or T-cell Lymphoblastic Lymphoma

Primary Purpose

SenL-T7 CAR T Cells for CD7+ T-cell Lymphoblastic Leukemia or T-cell Lymphoblastic Lymphoma

Status

Active

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Senl-T7

About this trial

This is an interventional treatment trial for SenL-T7 CAR T Cells for CD7+ T-cell Lymphoblastic Leukemia or T-cell Lymphoblastic Lymphoma

Eligibility Criteria

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

Inclusion Criteria:

Diagnosis of relapsed/refractory T-cell lymphoblastic leukemia or T-cell lymphoblastic lymphoma: Induction therapy failed to achieve a complete remission of minor residual negative; Recurrence: after complete remission, any tumor load in the peripheral blood or bone marrow was 5%, or slightly residual positive, or new extramedullary lesions occurred；
CD7 expression in tumor cells was detected by flow cytometry；
Life expectancy greater than 12 weeks；
KPS or Lansky score≥60;
HGB≥70g/L (can be transfused);
2-70 years old;
oxygen saturation of blood#90%#;
Total bilirubin (TBil)≤3 × upper limit normal, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 5×upper limit of normal;
Informed consent explained to, understood by and signed by patient/ guardian.

Exclusion Criteria:

Any of the following cardiac criteria: Atrial fibrillation/flutter; Myocardial infarction within the last 12 months; Prolonged QT syndrome or secondary prolonged QT, per investigator discretion. Cardiac echocardiography with LVSF (left ventricular shortening fraction)<30% or LVEF(left ventricular ejection fraction)<50%; or clinically significant pericardial effusion. Cardiac dysfunction NYHA(New York Heart Association) III or IV (Confirmation of absence of these conditions on echocardiogram within 12 months of treatment);
Has an active GvHD;
Has a history of severe pulmonary function damaging;
With other tumors which is/are in advanced malignant and has/have systemic metastasis;
Severe or persistent infection that cannot be effectively controlled;
Merging 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 on Biological products (including antibiotics);
Clinically significant viral infection or uncontrolled viral reactivation of EBV(Epstein-Barr virus), CMV(cytomegalovirus), ADV(adenovirus), BKvirus, or HHV(human herpesvirus)-6.
Presence of symptomatic disorders of the central nervous system, which include but not limited to uncontrolled epilepsy, cerebrovascular ischemia/hemorrhage, dementia, and cerebellar disease, etc.;
Have received transplant treatment for less than 6 months in prior to enrollment;
Being pregnant and lactating or having pregnancy within 12 months;
Any situations that the researchers believe will increase the risks for the subject or affect the results of the study.

Sites / Locations

Hebei yanda Ludaopei Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CD7 CAR-T

Arm Description

Outcomes

Primary Outcome Measures

Safety: Incidence and severity of adverse events

To evaluate the possible adverse events occurred within first one month after CD7 CAR-T infusion, including the incidence and severity of symptoms such as cytokine release syndrome and neurotoxicity

Remission Rate

To obsere the efficacy of CAR-T cells after infusion, complete remission (CR), complete remission with incomplete recovery of blood cells (CRi), minimal tumor residual positive(MRD+) or negative (MRD-) CR/CRi, disease recurrence or progression (PD) will be used for evaluation.

Secondary Outcome Measures

duration of response (DOR)

CAR-T proliferation

the copy number of CD7 CAR- T cells in the genomes of PBMC by qPCR method

progression-free survival (PFS)

progression-free survival (PFS) time

Cytokine release

Cytokine( IL-6,IL-10,IFN-γ,TNF-α ) concentration (pg/mL) by flow cytometry

CAR-T proliferation

percentage of CD7 CAR- T cells measured by flow cytometry method

Full Information

NCT ID

NCT04916860

First Posted

June 1, 2021

Last Updated

March 30, 2023

Sponsor

Hebei Senlang Biotechnology Inc., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT04916860

Brief Title

Clinical Study of SenL-T7 CAR T Cells in the Treatment of Relapsed and Refractory CD7+ T-cell Lymphoblastic Leukemia or T-cell Lymphoblastic Lymphoma

Official Title

Clinical Study of SenL-T7 CAR T Cells in the Treatment of Relapsed and Refractory CD7+ T-cell Lymphoblastic Leukemia or T-cell Lymphoblastic Lymphoma

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

January 27, 2021 (Actual)

Primary Completion Date

January 31, 2023 (Actual)

Study Completion Date

March 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hebei Senlang Biotechnology Inc., Ltd.

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 an open, single-arm, clinical study to evaluate efficacy and safety of anti CD7 CAR-T cell in the treatment of relapsed and refractory CD7+ T-cell lymphoblastic leukemia or T-cell lymphoblastic lymphoma

Detailed Description

This study is an open, prospective, dose-increasing clinical study with patients with relapsed or refractory CD7+ T-cell lymphoblastic leukemia or T-cell lymphoblastic lymphoma as subjects. In order to evaluate the safety and efficacy of SENL-T7 in patients with CD7+ T-cell lymphoblastic leukemia or T-cell lymphoblastic lymphoma, the PK/PD indicators of SENL-T7 are also collected. In this study, no dose grouping is set, and 0.5-2E6 /kg× actual body weight dose is selected for reinfusion according to patients' disease diagnosis and tumor load. The Main research objectives: To evaluate the safety and efficacy of SENL-T7 in patients with relapsed or refractory CD7+ T-cell lymphoblastic leukemia or T-cell lymphoblastic lymphoma. The Secondary research objectives: To investigate the cellular dynamics of SENL-T7 CAR T cells in patients with relapsed or refractory CD7+ T-cell lymphoblastic leukemia or T-cell lymphoblastic lymphoma.

6. Conditions and Keywords

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

SenL-T7 CAR T Cells for CD7+ T-cell Lymphoblastic Leukemia or T-cell Lymphoblastic Lymphoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

CD7 CAR-T

Arm Type

Experimental

Intervention Type

Biological

Intervention Name(s)

Senl-T7

Intervention Description

Patients will be treated with CD7 CAR-T cells

Primary Outcome Measure Information:

Title

Safety: Incidence and severity of adverse events

Description

To evaluate the possible adverse events occurred within first one month after CD7 CAR-T infusion, including the incidence and severity of symptoms such as cytokine release syndrome and neurotoxicity

Time Frame

First 1 month post CAR-T cells infusion

Title

Remission Rate

Description

Time Frame

3 months post CAR-T cells infusion

Secondary Outcome Measure Information:

Title

duration of response (DOR)

Description

duration of response (DOR)

Time Frame

24 months post CAR-T cells infusion

Title

CAR-T proliferation

Description

the copy number of CD7 CAR- T cells in the genomes of PBMC by qPCR method

Time Frame

3 months post CAR-T cells infusion

Title

progression-free survival (PFS)

Description

progression-free survival (PFS) time

Time Frame

24 months post CAR-T cells infusion

Title

Cytokine release

Description

Cytokine( IL-6,IL-10,IFN-γ,TNF-α ) concentration (pg/mL) by flow cytometry

Time Frame

First 1 month post CAR-T cells infusion

Title

CAR-T proliferation

Description

percentage of CD7 CAR- T cells measured by flow cytometry method

Time Frame

3 months post CAR-T cells infusion

10. Eligibility

Sex

All

Minimum Age & Unit of Time

2 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Diagnosis of relapsed/refractory T-cell lymphoblastic leukemia or T-cell lymphoblastic lymphoma: Induction therapy failed to achieve a complete remission of minor residual negative; Recurrence: after complete remission, any tumor load in the peripheral blood or bone marrow was 5%, or slightly residual positive, or new extramedullary lesions occurred； CD7 expression in tumor cells was detected by flow cytometry； Life expectancy greater than 12 weeks； KPS or Lansky score≥60; HGB≥70g/L (can be transfused); 2-70 years old; oxygen saturation of blood#90%#; Total bilirubin (TBil)≤3 × upper limit normal, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 5×upper limit of normal; Informed consent explained to, understood by and signed by patient/ guardian. Exclusion Criteria: Any of the following cardiac criteria: Atrial fibrillation/flutter; Myocardial infarction within the last 12 months; Prolonged QT syndrome or secondary prolonged QT, per investigator discretion. Cardiac echocardiography with LVSF (left ventricular shortening fraction)<30% or LVEF(left ventricular ejection fraction)<50%; or clinically significant pericardial effusion. Cardiac dysfunction NYHA(New York Heart Association) III or IV (Confirmation of absence of these conditions on echocardiogram within 12 months of treatment); Has an active GvHD; Has a history of severe pulmonary function damaging; With other tumors which is/are in advanced malignant and has/have systemic metastasis; Severe or persistent infection that cannot be effectively controlled; Merging 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 on Biological products (including antibiotics); Clinically significant viral infection or uncontrolled viral reactivation of EBV(Epstein-Barr virus), CMV(cytomegalovirus), ADV(adenovirus), BKvirus, or HHV(human herpesvirus)-6. Presence of symptomatic disorders of the central nervous system, which include but not limited to uncontrolled epilepsy, cerebrovascular ischemia/hemorrhage, dementia, and cerebellar disease, etc.; Have received transplant treatment for less than 6 months in prior to enrollment; Being pregnant and lactating or having pregnancy within 12 months; Any situations that the researchers believe will increase the risks for the subject or affect the results of the study.

Facility Information:

Facility Name

Hebei yanda Ludaopei Hospital

City

Beijing

State/Province

Hebei

Country

China

12. IPD Sharing Statement

Learn more about this trial

Clinical Study of SenL-T7 CAR T Cells in the Treatment of Relapsed and Refractory CD7+ T-cell Lymphoblastic Leukemia or T-cell Lymphoblastic Lymphoma

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