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Trial Title:
Donor-Derived CD5 CAR T (CT125B) Cells for Relapsed or Refractory T- Cell Acute Lymphoblastic Leukemia/Lymphoma
NCT ID:
NCT05487495
Condition:
T-Cell Acute Lymphoblastic Leukemia/Lymphoma
Conditions: Official terms:
Lymphoma
Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Precursor T-Cell Lymphoblastic Leukemia-Lymphoma
Conditions: Keywords:
CAR-T
Leukemia
acute lymphoblastic leukemia/lymphoma
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Unknown status
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
CD5 CAR T (CT125B)
Description:
Subjects will be pretreated with chemotherapy prior to infusion of CAR T cells: After the
collection of PBMC and about 5 days before infusion, lymphodepletion (fludarabine at 30
mg/m^2/day and cyclophosphamide at 250 mg/m^2/day; for prior-SCT donor-derived CAR T-cell
infusion) or intensified lymphodepletion (fludarabine at 30 mg/m^2/day and
cyclophosphamide at 30 mg/kg/day; for new donor-derived CAR T-cell infusion) will be
administrated for 3 days.
Arm group label:
CD5 CAR T (CT125B)
Summary:
This is a FIH, single center, open label, non-randomized, single-arm, Phase I clinical
trial to evaluate the safety and tolerability of CD5 CAR T (CT125B) cells in subjects
with relapsed or refractory T-cell acute lymphoblastic leukemia/lymphoma. 9-18 subjects
will be enrolled. After the collection of PBMC and about 5 days before infusion,
lymphodepletion (fludarabine at 30 mg/m^2/day and cyclophosphamide at 250 mg/m^2/day; for
prior-SCT donor-derived CAR T-cell infusion) or intensified lymphodepletion (fludarabine
at 30 mg/m^2/day and cyclophosphamide at 30 mg/kg/day; for new donor-derived CAR T-cell
infusion) will be administrated for 3 days.
Then this study will be using BOIN1/2 approach from starting dose 1: 1×10^6 (±20%) to
dose 2: 2×10^6 (±20%). If the manufactured cells were not sufficient to meet the
preassigned standard dose criteria, patients are given infusion at a low dose of 5×10^5
(±20%) /kg.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
In order to be eligible to participate in this study, an individual must meet all of the
following criteria:
1. Candidates with relapsed or refractory CD5+ T cell acute lymphoblastic
leukemia/lymphoma, who have progressed after treatment with all standard therapies
or been intolerant of standard care, have limited prognosis with currently available
therapies and had no available curative treatment options (such as SCT or
chemotherapy)
2. Male or female, aged 1-70 years
3. No serious allergic constitution
4. Eastern Cooperative Oncology Group (ECOG) performance status (Oken et al., 1982)
score 0 to 2
5. Have life expectancy of at least 60 days based on investigator's judgement
6. CD5 positive on blasts in bone marrow or CSF by flow cytometry, or CD5 positive on
tumor tissues by immunohistochemistry; (CD5 positive criteria: Flow cytometry:
Positive: > 80% of tumor cells expressed CD5 and the mean fluorescence intensity
(MFI) of CD5 is the same as that in normal T cells; Dim: > 80% of tumor cells
expressed CD5, but the MFI of CD5 is lower than that in normal T cells as least as 1
log; Partial positive: 20-80% of tumor cells expressed CD5 and the MFI of CD5 is the
same as that in normal T cells. Tumor tissue immunohistochemistry: Positive > 30%
tumor cells expressed CD5)
7. Provide a signed informed consent before any screening procedure. Patients who
voluntarily participate in the study should have the ability to understand and sign
the informed consent form (ICF) and be willing to follow the visit schedule and
relevant study procedure, as specified in the protocol. Candidates aged 19-70 years
old need to be sufficiently conscious and able to sign the treatment consent form
and voluntary consent form. Candidates of 8-18 years old need to be sufficiently
conscious and able to sign the treatment consent form and voluntary consent form,
besides, their legal guardian or patient advocate also need to sign the treatment
consent form and voluntary consent form. Children candidates of 1-7 years old can be
recruited after the legal guardian or patient advocate need to sign the treatment
consent form and voluntary consent form.
8. Have suitable and available allogeneic hematopoietic stem cell transplantation
donor, and is willing to proceed to SCT if achieve CR.
Exclusion Criteria:
An individual who meets any of the following criteria will be excluded from participation
in this study:
1. Intracranial hypertension or disorder of consciousness
2. Symptomatic heart failure or severe arrhythmia
3. Symptoms of severe respiratory failure
4. Complicated with other types of malignant tumors
5. Diffuse intravascular coagulation
6. Serum creatinine and / or blood urea nitrogen ≥ 1.5 times of the normal value
7. Suffering from septicemia or other uncontrollable infections
8. Patients with uncontrollable diabetes
9. Severe mental disorders
10. Obvious and active intracranial lesions were detected by cranial magnetic resonance
imaging (MRI)
11. Have received organ transplantation (excluding bone marrow transplant)
12. Reproductive-aged female patients with positive blood HCG test
13. Screened to be positive of infection of hepatitis (including hepatitis B and C),
AIDS or syphilis
14. Post-CAR SCT is not feasible in patients
15. No donor is applicable for peripheral blood mononuclear cell (PBMC) collection or no
frozen donor's PBMC is available for manufacturing CAR T cells.
16. Patients unable to discontinue nucleoside antiviral drugs that have a similar
mechanism to ganciclovir
Gender:
All
Minimum age:
1 Year
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Beijing Gaobo Boren Hospital
Address:
City:
Beijing
Zip:
100070
Country:
China
Status:
Recruiting
Contact:
Last name:
Jing Pan, MD/PhD
Phone:
+8618911067969
Email:
panj@borenhospital.com
Start date:
July 27, 2022
Completion date:
July 27, 2024
Lead sponsor:
Agency:
Beijing Boren Hospital
Agency class:
Other
Source:
Beijing Boren Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05487495