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Trial Title:
CD5 Chimeric Antigen Receptor (CAR) T Cells in Subjects With Relapsed or Refractory T-Cell Acute Lymphoblastic Leukemia
NCT ID:
NCT06316856
Condition:
T-Cell Acute Lymphocytic 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
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Autologous CD5 CAR T-cells
Description:
Peripheral blood mononuclear cells for the production of CD5 CAR T-cells from patients.
Arm group label:
Autologous CD5 CAR T-cells
Intervention type:
Drug
Intervention name:
Previous stem-cell transplantation (SCT) donor-derived CD5 CAR T-cells
Description:
Peripheral blood mononuclear cells for the production of CD5 CAR T cells are collected
from previous SCT donors.
Arm group label:
Prior stem-cell transplantation (SCT) donor-derived CD5 CAR T-cells
Intervention type:
Drug
Intervention name:
Newly matched donor-derived CD5 CAR T-cells
Description:
Peripheral blood mononuclear cells for the production of CD5 CAR T cells are collected
from newly matched donors.
Arm group label:
Newly matched donor-derived CD5 CAR T-cells
Summary:
This is a single-center, open-label, non-randomized, phase 1/2 study of anti-CD5 CAR-T
cell therapy in patients with CD5+ relapsed or refractory T-cell malignancies. A bayesian
optimal interval (BOIN) 12 design will be used to explore the optimal biological dose
(OBD) from starting dose level 1: 1×10^6 (±20%) to dose level 2: 2×10^6 (±20%) in three
cohorts (autologous, previous-transplant-donor or newly matched donor-derived CD5 CAR T
cells). If the manufactured cells are not sufficient to meet the preassigned standard
dose criteria, patients will be given infusion at a low dose level of 5×10^5 (±20%) /kg.
The primary objective is to evaluate the safety and tolerability of CD5 CAR T cell
therapy in subjects, determine the OBD and recommend phase 2 dose (RP2D) in phase 1, and
evaluate the efficacy of CD5 CAR T cell therapy in phase 2. The primary endpoint is the
type and incidence of dose-limiting toxicity (DLT) within 28 days, and the incidence and
severity of adverse events (AEs) within 30 days after CD5 CAR T-cell infusion in phase 1,
the best overall response (BOR) at 3 months (± 1 week) after CD5 CAR T-cell infusion in
phase 2. A total number of 54 subjects will be enrolled.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
Only patients who meet all the following criteria can be included:
1. Candidates with relapse or refractory CD5+ T-cell malignancies, who have progressed
after treatment with all standard therapies or been intolerant of standard care,
have limited prognosis with currently available therapies and have no available
curative treatment options (such as stem-cell transplantation (SCT) or
chemotherapy);
2. For subjects who received autologous CD5 CAR T cells, the tumor burden in peripheral
blood is less than 20%, and suspending anti-neoplastic treatment for more than 2
weeks;
3. Aged 1-70 years;
4. No severe allergy;
5. Eastern Cooperative Oncology Group (ECOG) performance status 1 score 0 to 2;
6. Patients are expected to live for at least 60 days;
7. CD5+ on blasts in bone marrow (BM) or cerebrospinal fluid (CSF) and tumor tissues by
flow cytometry and immunohistochemistry, respectively. (Positive rate >80% by flow
cytometry with less than one log difference in mean fluorescence intensity from
normal T cells, or positive rate >30% positive by immunohistochemistry);
8. Provide a signed informed consent before any screening procedure. Subjects who
voluntarily participate in the study should have the ability to understand and sign
the informed consent form and be willing to follow the study visit schedule and
relevant study procedure, as specified in the protocol. Candidates aged 19-70 years
need to be sufficiently conscious and able to sign the treatment consent form and
voluntary consent form. Children candidates of 8-18 years old need to be
sufficiently conscious and able to sign the treatment consent form and voluntary
consent form and their legal guardian or patient advocate has also need to sign the
treatment consent form and voluntary consent form, respectively. Children candidates
of 1-7 can be recruited after the legal guardian or patient advocate has signed the
treatment consent form and voluntary consent form;
9. Have available allogeneic hematopoietic stem cell transplantation donor for the
subject who received newly matched donor-derived CD5 CAR T cells, and is willing to
perform SCT when CR is achieved.
Exclusion Criteria:
Patients with at least one of the following conditions are excluded:
1. Impaired consciousness or intracranial hypertension;
2. Symptomatic congestive heart failure or severe cardiac arrhythmia;
3. Manifestations of severe respiratory system failure;
4. Co-existence with other malignancies;
5. Disseminated intravascular coagulation;
6. Serum creatinine and/or blood urea nitrogen (BUN) ≥ 1.5-fold upper limit;
7. Sepsis or other uncontrollable infections;
8. Uncontrollable diabetes;
9. Serious mental illness;
10. Apparent and active intracranial lesions on cranial magnetic resonance imaging
(MRI);
11. Underwent organ transplantation, excepting SCT;
12. Pregnant females;
13. Positive test for infectious hepatitis, acquired immune deficiency syndrome (AIDS)
or syphilis;
14. Post-CAR SCT is not feasible in patients who plan to receive newly matched
donor-derived CD5 CAR T cells;
15. Inability to collect peripheral blood mononuclear cells (PBMC) or no frozen PBMC
available for CAR T cell manufacturing.
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:
June 18, 2024
Completion date:
June 30, 2026
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/NCT06316856
