CD5 CAR-T Therapy for Refractory/Relapsed CD5+ T-cell Acute Lymphoblastic Leukemia

NCT05596266 | Unknown Phase 1

• 1 other identifier: 202001
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

T-cell Acute Lymphoblastic Leukemia

Keywords

CD5 CAR-T; T-ALL

Outcome Measures

Primary Outcomes (1)

• Safety: Incidence and severity of adverse events

  To evaluate the possible adverse events occurred within the first one month following CD5 CAR-T infusion, including the incidence and severity of symptoms such as cytokine release syndrome and neurotoxicity.

  First 1 month post CAR-T cells infusion

Secondary Outcomes (4)

• Efficacy: Remission Rate

  1 months post CAR-T cells infusion

• Best overall response (BOR)

  1 months

• Duration of remission (DoR)

  1 year

• Event free survival within 1 year

  1 year

Study Arms (1)

CD5 CAR-T

EXPERIMENTAL

This cohort will be administrated with T cells transduced with lentivirus vectors expressing CD5 CAR.

Biological: CD5 CAR-T

Interventions

CD5 CAR-T BIOLOGICAL

CD5 CAR-T will be administered by I.V. infusion.

CD5 CAR-T

Eligibility Criteria

• Age: 1 Year - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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;
• 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;
• Aged 1 to 18 years (including 18 years old);
• Eastern Cooperative Oncology Group (ECOG) score 0-2;
• Life expectancy greater than 12 weeks;
• Oxygen saturation of blood\>90%;
• Total bilirubin (TBil) ≤3 × upper limit normal, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 10 × upper limit of normal;
• Informed consent explained to, understood by and signed by patient/guardian.

You may not qualify if:

• Intracranial hypertension or brain consciousness disorder;
• Has an active GvHD;
• Has a history of severe pulmonary function damaging;
• With other tumors which is/are in advanced malignant stage and has/have systemic metastasis;
• Severe or persistent infection that cannot be effectively controlled；
• Presence of severe autoimmune diseases or immunodeficiency disease;
• Patients with active hepatitis B or hepatitis C (\[HBVDNA+\] or \[HCVRNA+\]);
• Patients with HIV infection or syphilis infection;
• Has a history of serious allergies to biological products (including antibiotics);
• Clinically significant viral infection or uncontrolled viral reactivation of EBV (Epstein-Barr virus), CMV (cytomegalovirus), ADV (adenovirus), BK-virus, or HHV (human herpesvirus)-6;
• 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;
• Received allogeneic hematopoietic stem cell transplantation within 6 months;
• Being pregnant and lactating or having pregnancy within 12 months;
• Any situations that the researchers believe will increase the risk for the subject or affect the results of the study.

Sponsors & Collaborators

• Xuanwu Hospital, Beijing: lead
• Baoding Children's Hospital: collaborator

Study Sites (1)

Xuanwu Hospital Capital Medical University

Beijing, Beijing Municipality, China

RECRUITING

MeSH Terms

Conditions

Precursor T-Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Zhiguo Chen, PhD

  Xuanwu Hospital, Beijing

  PRINCIPAL INVESTIGATOR

• Huyong Zheng, MD, PhD

  Baoding Children's Hospital; Beijing Children's Hospital, Capital Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhiguo Chen, PhD

CONTACT

86-10-83198889; chenzhiguo@gmail.com

Huyong Zheng, MD, PhD

CONTACT

010-59617621; zhenghuyong@bch.com.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2022
• First Posted: October 27, 2022
• Study Start: October 25, 2022
• Primary Completion: December 31, 2024
• Study Completion: October 25, 2025
• Last Updated: October 27, 2022

Record last verified: 2022-10

Locations

CN (1)