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Trial Title:
Autologous and Donor-derived CD7 CAR-T Therapy in Refractory or Relapsed T-cell Acute Lymphoblastic Leukemia/Lymphoma
NCT ID:
NCT06316427
Condition:
T-cell Acute Lymphoblastic Leukemia
Acute Lymphoblastic Leukemia, in Relapse
Refractory Acute Lymphoblastic Leukemia
Conditions: Official terms:
Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Precursor T-Cell Lymphoblastic Leukemia-Lymphoma
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Investigator Initiate Trial
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Autologous CD7 CAR T-cell
Description:
Peripheral blood mononuclear cells for the production of CD7 CAR T cells are collected
from patients.
Arm group label:
Arm-1
Intervention type:
Drug
Intervention name:
Prior-HSCT donor-derived CD7 CAR T-cell
Description:
Peripheral blood mononuclear cells for the production of CD7 CAR T cells are collected
from prior-HSCT donors.
Arm group label:
Arm-2
Intervention type:
Drug
Intervention name:
New donor-derived CD7 CAR T-cell
Description:
Peripheral blood mononuclear cells for the production of CD7 CAR T cells are collected
from new donors.
Arm group label:
Arm-3
Summary:
This is a single-center, open-label, non-randomized, phase I/II trial. Patients with
refractory or relapsed T-cell acute lymphoblastic leukemia/lymphoma (r/r T-ALL/T-LBL)
will receive autologous, prior-HSCT donor-derived or new donor-derived CD7 CAR T cells
according to their HSCT history, peripheral blood leukemia burden and at their
discretion. The primary objective is to learn about the safety of autologous, prior-HSCT
donor-derived and new donor-derived CD7 CAR T-cell therapy in patients with refractory or
relapsed T-cell acute lymphoblastic leukemia and lymphoma (r/r T-ALL/T-LBL) in phase I
and to learn about the efficacy of autologous, prior-HSCT donor-derived and new
donor-derived CD7 CAR T-cell therapy in patients with refractory or relapsed T-cell acute
lymphoblastic leukemia and lymphoma (r/r T-ALL/T-LBL) in phase II. The primary endpoint
is type and incidence of dose limiting toxicity (DLT) within 21 days after CD7 CAR T-cell
infusion in phase I and overall response rate (ORR), which includes CR, CRh, CRi, MLFS,
aplastic marrow for blood and bone marrow; central nervous system (CNS) remission; CR and
PR for lymphomatous extramedullary disease according to National Comprehensive Cancer
Network (NCCN) Guidelines Version 3.2023 of Acute Lymphoblastic Leukemia at 3 months (± 1
week) post CD7 CAR T-cell infusion in refractory or relapsed T-cell acute lymphoblastic
leukemia/lymphoma (r/r T-ALL/T-LBL) patients treated with CD7 CAR T cells in phase II. A
total number of 80 subjects will be enrolled.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
Only patients who meet all the following criteria can be included in the group:
1. CD7-positive refractory or relapsed T-cell acute lymphoblastic leukemia/lymphoma
(r/r T-ALL/T-LBL) with progression or intolerance after all standard treatments,
limited prognosis from currently available treatments and no available treatment
options (e.g. HSCT or chemotherapy).
2. Tumor cells in bone marrow or cerebrospinal fluid are positive for CD7 antigen by
flow cytometry or tumour tissue is positive for CD7 by immunohistochemistry (CD7
antigen positivity by flow cytometry: >80% of tumour cells expressing CD7 with a
mean fluorescence intensity [MFI] of CD7 similar to that of normal T cells are
considered to have fully positive expression; >80% of tumor cells expressing CD7 but
with an MFI of CD7 at least 1 log lower than that of normal T cells are considered
to have low expression [dim]; tumor cells with a CD7 expression rate between 20-80%
are considered to have partial expression; CD7 antigen positivity by pathological
immunohistochemistry: >30%);
3. Male or female, age 1-70 years;
4. No severe allergic constitution;
5. Eastern Cooperative Oncology Group (ECOG) performance status score (Oken et al.,
1982) of 0-2;
6. Life expectancy of at least 60 days as determined by the investigator;
7. Provide a signed informed consent form prior to any screening procedures; subjects
volunteering to participate in the study should be capable of understanding and
signing the informed consent form and be willing to follow the study visit schedule
and associated study procedures as specified in the protocol. Subjects aged 19-70
years old need to be sufficiently aware and capable of signing the informed consent
form; subjects aged 1-7 years can be recruited after legal guardians or patient
advocates sign the informed consent form; subjects aged 8-18 years need to be
sufficiently aware and able to sign the informed consent form, and their legal
guardians or patient advocates also need to sign the informed consent form.
Exclusion Criteria:
Patients with at least one of the following conditions are excluded:
1. Intracranial hypertension or unconscious;
2. Acute heart failure or severe arrhythmia;
3. Acute respiratory failure;
4. Other types of malignant tumors;
5. Diffuse intravascular coagulation;
6. Serum creatinine and/or blood urea nitrogen over 1.5 times the normal value;
7. Sepsis or other uncontrolled infection;
8. Uncontrolled diabetes mellitus;
9. Severe psychological disorder;
10. Obvious cranial lesions by cranial MRI;
11. Allergic constitution;
12. Organ recipients;
13. Pregnant or breastfeeding;
14. Active, uncontrolled infection, including hepatitis B virus (HBV), hepatitis C virus
(HCV), human immunodeficiency virus (HIV) or treponema pallidum (TP).
Gender:
All
Minimum age:
1 Year
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Beijing GoBroad Hospital
Address:
City:
Beijing
Zip:
102206
Country:
China
Status:
Recruiting
Start date:
March 22, 2024
Completion date:
March 30, 2028
Lead sponsor:
Agency:
Beijing GoBroad Hospital
Agency class:
Other
Source:
Beijing GoBroad Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06316427