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Trial Title:
CD5 CAR-T Therapy for Refractory/Relapsed CD5+ T-cell Acute Lymphoblastic Leukemia
NCT ID:
NCT05596266
Condition:
T-cell Acute Lymphoblastic Leukemia
Conditions: Official terms:
Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Precursor T-Cell Lymphoblastic Leukemia-Lymphoma
Conditions: Keywords:
CD5 CAR-T
T-ALL
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
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
Description:
CD5 CAR-T will be administered by I.V. infusion.
Arm group label:
CD5 CAR-T
Summary:
This is a phase I, interventional, single arm, open label, clinical study to evaluate the
safety and tolerability of CD5 CAR-T cells in refractory/relapsed CD5+ T-ALL patients who
have no available curative treatment options.
Detailed description:
T-acute lymphoblast leukemia (T-ALL) is a neoplastic lymphoid leukemia characterized by
the proliferation of immature precursor T cells. The combined chemotherapy has
significantly improved the prognosis of T-acute lymphoblast leukemia/lymphoma. However,
once the disease appears to be relapsed/refractory, there is limited treatment options,
and the overall prognosis is extremely poor. Therefore, exploring safe and effective
treatments is a critical unmet medical need. The patients will receive infusion of CAR
T-cells targeting CD5 to examine the safety and, possibly the efficacy of CD5 CAR T-Cells
in CD5+ relapsed or refractory acute leukemia.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Diagnosis of refractory or relapsed T-cell acute lymphoblastic leukemia (T-ALL)
according to the NCCN 2019.V2 Guideline. Refractory T-ALL is defined as a patient
who has failed to achieve complete remission after induction therapy. Relapsed T-ALL
is defined as the reappearance of blasts (5%) in either peripheral blood or bone
marrow. Patients whose tumor burden >5% blasts, or who have persistent positive
minimal residual disease (MRD), or have reappearance of extramedullary lesions are
also considered eligible;
2. CD5-positive tumor (≥70% CD5 positive blasts by flow cytometry or
immunohistochemistry (tissue) assessed by a CLIA certified Flow Cytometry/Pathology
laboratory). tumors burden >5%,or MRD+， or new extramedullary lesions reappeared;
3. Aged 1 to 18 years (including 18 years old);
4. Eastern Cooperative Oncology Group (ECOG) score 0-2;
5. Life expectancy greater than 12 weeks;
6. Oxygen saturation of blood>90%;
7. Total bilirubin (TBil) ≤3 × upper limit normal, aspartate aminotransferase (AST) and
alanine aminotransferase (ALT) ≤ 10 × upper limit of normal;
8. Informed consent explained to, understood by and signed by patient/guardian.
Exclusion Criteria:
1. Intracranial hypertension or brain consciousness disorder;
2. Has an active GvHD;
3. Has a history of severe pulmonary function damaging;
4. With other tumors which is/are in advanced malignant stage and has/have systemic
metastasis;
5. Severe or persistent infection that cannot be effectively controlled；
6. Presence of severe autoimmune diseases or immunodeficiency disease;
7. Patients with active hepatitis B or hepatitis C ([HBVDNA+] or [HCVRNA+]);
8. Patients with HIV infection or syphilis infection;
9. Has a history of serious allergies to biological products (including antibiotics);
10. Clinically significant viral infection or uncontrolled viral reactivation of EBV
(Epstein-Barr virus), CMV (cytomegalovirus), ADV (adenovirus), BK-virus, or HHV
(human herpesvirus)-6;
11. Presence of any symptomatic CNS disorder such as an uncontrolled seizure disorder,
cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune
disease with CNS involvement;
12. Received allogeneic hematopoietic stem cell transplantation within 6 months;
13. Being pregnant and lactating or having pregnancy within 12 months;
14. Any situations that the researchers believe will increase the risk for the subject
or affect the results of the study.
Gender:
All
Minimum age:
1 Year
Maximum age:
18 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Xuanwu Hospital Capital Medical University
Address:
City:
Beijing
Country:
China
Status:
Recruiting
Contact:
Last name:
Zhiguo Chen, PhD
Phone:
86-10-83198889
Email:
chenzhiguo@gmail.com
Contact backup:
Last name:
Huyong Zheng, MD, PhD
Phone:
010-59617621
Email:
zhenghuyong@bch.com.cn
Investigator:
Last name:
Zhiguo Chen, PhD
Email:
Principal Investigator
Investigator:
Last name:
Huyong Zheng, MD, PhD
Email:
Principal Investigator
Start date:
October 25, 2022
Completion date:
October 25, 2025
Lead sponsor:
Agency:
Xuanwu Hospital, Beijing
Agency class:
Other
Collaborator:
Agency:
Baoding Children's Hospital
Agency class:
Other
Source:
Xuanwu Hospital, Beijing
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05596266
