Description:
Phase I was a single arm, open label, dose increasing study to explore the safety, tolerance
and Cytodynamic characteristics of the drug, and to preliminarily observe the efficacy of the
study drug in relapsed / refractory CD7 Positive hematolymph system malignant tumor patients,
so as to explore the clinical applicable dose of phase II. Since the activity and toxicity of
cellular drugs (long-term survival drugs) do not have obvious dose dependence, and the
increase of their dose may be accompanied by the increase of toxicity, rather than necessary
for therapeutic effect, it is not necessarily suitable to recommend the effective dose
according to the maximum tolerable dose (MTD). Therefore, this study will be based on the
safety data, as well as the preliminary efficacy, efficacy and drug The end point of
pharmacokinetics (ORR, the content of CD7 Positive Cells, the expansion and duration of car-t
cells) were comprehensively considered to determine the recommended dose for phase II
clinical trial.Main research purposes Objective to evaluate the safety and tolerability of T
cell injection targeting CD7 autologous chimeric antigen receptor in the treatment of
relapsed / refractory CD7 Positive hematological and lymphoid malignancies.
Title
- Brief Title: CD7-CART in the Treatment of r / r CD7 Positive Hemolymph System Malignancies on Increasing Dose and Open Label Study
- Official Title: Early Clinical Study on Increasing Dose and Open Label of T Cell Injection Targeting CD7 Autologous Chimeric Antigen Receptor in the Treatment of Relapsed / Refractory CD7 Positive Hemolymph System Malignancies
Clinical Trial IDs
- ORG STUDY ID:
PG-CART-07-001
- NCT ID:
NCT04480788
Conditions
- T Lymphoblastic Leukemia/Lymphoma
- Extramedullary NK-T-cell Lymphoma, Nasal Type
- Peripheral T-cell Lymphoma, Nonspecific
- Angioimmunoblastic T-cell Lymphoma
- Enteropathy-Associated T-Cell Lymphoma
- Anaplastic Large Cell Lymphoma, ALK-negative
- T-cell Lymphoblastic Leukemia
Interventions
Drug | Synonyms | Arms |
---|
T cell injection targeting CD7 chimeric antigen receptor | | T cell injection targeting CD7 chimeric antigen receptor |
Purpose
Phase I was a single arm, open label, dose increasing study to explore the safety, tolerance
and Cytodynamic characteristics of the drug, and to preliminarily observe the efficacy of the
study drug in relapsed / refractory CD7 Positive hematolymph system malignant tumor patients,
so as to explore the clinical applicable dose of phase II. Since the activity and toxicity of
cellular drugs (long-term survival drugs) do not have obvious dose dependence, and the
increase of their dose may be accompanied by the increase of toxicity, rather than necessary
for therapeutic effect, it is not necessarily suitable to recommend the effective dose
according to the maximum tolerable dose (MTD). Therefore, this study will be based on the
safety data, as well as the preliminary efficacy, efficacy and drug The end point of
pharmacokinetics (ORR, the content of CD7 Positive Cells, the expansion and duration of car-t
cells) were comprehensively considered to determine the recommended dose for phase II
clinical trial.Main research purposes Objective to evaluate the safety and tolerability of T
cell injection targeting CD7 autologous chimeric antigen receptor in the treatment of
relapsed / refractory CD7 Positive hematological and lymphoid malignancies.
Trial Arms
Name | Type | Description | Interventions |
---|
T cell injection targeting CD7 chimeric antigen receptor | Experimental | | - T cell injection targeting CD7 chimeric antigen receptor
|
Eligibility Criteria
Inclusion Criteria:
- The age ranged from 7 to 70 years (including the cut-off value), regardless of gender
- The expected survival time was more than 6 weeks
- ECOG score 0-1
- Malignant lymphoma (including but not limited to acute T-lymphoblastic leukemia /
lymphoma; extramedullary NK / T-cell lymphoma, nasal type; peripheral T-cell lymphoma,
nonspecific; vascular immunoblastic T-cell lymphoma; intestinal disease associated
T-cell lymphomas; anaplastic large cell lymphoma (ALK -); T-cell lymphoblastic
leukemia)
- When screening, hematological malignancies with CD7 Positive confirmed by bone marrow
examination or tumor pathology with positive rate of CD7 ≥ 30%, meeting one of the
following conditions:
1. At least two chemotherapy regimens failed or did not achieve complete remission
or relapse;
2. Patients who relapsed after stem cell transplantation were not affected by other
treatment methods;
- For peripheral blood involved acute T-lymphoblastic leukemia / lymphoma and NK /
T-cell lymphoma, patients with TCR rearrangement were detected by ngs
- The liver and kidney function, heart and lung function meet the following
requirements:
1. Creatinine ≤ 1.5 ULN;
2. LVEF ≥ 45%;
3. Blood oxygen saturation > 91%;
4. The total bilirubin ≤ 2 × ULN; ALT and AST ≤ 2.5 × ULN; the abnormal ALT and AST
caused by diseases (such as liver infiltration or bile duct obstruction) can be
relaxed to ≤ 5 × ULN;
- Understand the experiment and have signed the informed consent
Exclusion Criteria:
- Those who need immunosuppressant;
- For intestinal disease-related T-cell lymphoma, patients with intestinal ulcer or
hematochezia were examined by colonoscopy;
- In addition to cervical carcinoma in situ, basal cell or squamous cell skin cancer,
local prostate cancer after radical operation, and breast ductal carcinoma in situ
after radical operation;
- The patients with positive HBsAg or HBcAb and HBV DNA titer in peripheral blood were
not within the normal reference value; those with positive anti HCV antibody and
positive HCV RNA in peripheral blood; those with HIV antibody positive and
cytomegalovirus DNA positive Syphilis was positive;
- Severe heart disease: including but not limited to unstable angina pectoris,
myocardial infarction (within 6 months before screening), congestive heart failure
(NYHA classification ≥ III), severe arrhythmia;
- Unstable systemic diseases judged by researchers: including but not limited to severe
liver, kidney or metabolic diseases requiring drug treatment;
- Within 7 days before screening, there were active or uncontrollable infections
requiring systemic treatment (except for mild genitourinary system infection and upper
respiratory tract infection);
- Pregnant or lactating women, female subjects planning pregnancy within 1 year after
cell reinfusion or male subjects whose partners plan to conceive within 1 year after
cell reinfusion;
- Patients who had received car-t therapy or other gene modified cell therapy before
screening;
- Subjects who were receiving systemic steroid therapy or were receiving systemic
steroid therapy for 7 days were excluded;
- Participated in other clinical studies within 3 months before screening;
- There was evidence of central nervous system invasion during screening;
- According to the judgment of the researchers, it does not conform to the condition of
cell preparation;
- Other researchers think it is not suitable to be included in the study.
Maximum Eligible Age: | 70 Years |
Minimum Eligible Age: | 7 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Dose-limiting toxicity (DLT) |
Time Frame: | Up to 2 years |
Safety Issue: | |
Description: | |
Secondary Outcome Measures
Measure: | Safety results |
Time Frame: | Up to 2 years |
Safety Issue: | |
Description: | Number of adverse events |
Measure: | PK |
Time Frame: | Up to 2 years |
Safety Issue: | |
Description: | The maximum concentration (Cmax) |
Measure: | PK |
Time Frame: | Up to 2 years |
Safety Issue: | |
Description: | the time to reach the maximum concentration (Tmax) |
Measure: | PK |
Time Frame: | Up to 2 years |
Safety Issue: | |
Description: | The area under the curve (auc0-28d ) at 28d respectively after administration |
Measure: | PD |
Time Frame: | Up to 2 years |
Safety Issue: | |
Description: | Absolute value of CD7 Positive Cells in peripheral blood at each time point |
Measure: | PD |
Time Frame: | Up to 2 years |
Safety Issue: | |
Description: | The proportion of CD7 Positive Cells in peripheral blood at each time point |
Measure: | ORR |
Time Frame: | Up to 2 years |
Safety Issue: | |
Description: | The total response rate was 3 months and 6 months |
Measure: | overall survival (OS) |
Time Frame: | Up to 2 years |
Safety Issue: | |
Description: | Time from initiation of CD7 car-t cell therapy to death (for any reason) |
Measure: | Search Results Featured snippet from the web Duration of response (DOR) |
Time Frame: | Up to 2 years |
Safety Issue: | |
Description: | The time from the first assessment of Cr or PR to the first assessment of recurrence or progression of the disease or death from any cause |
Measure: | Progression-free survival (PFS) |
Time Frame: | Up to 2 years |
Safety Issue: | |
Description: | The time from the beginning of treatment with CD7 car-t cells to the first progression of disease or death from any cause |
Measure: | Immunogenicity |
Time Frame: | Up to 2 years |
Safety Issue: | |
Description: | The positive rate of human anti car antibody at each time point |
Details
Phase: | Phase 1 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | PersonGen BioTherapeutics (Suzhou) Co., Ltd. |
Last Updated
January 6, 2021