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

NCT ID: NCT05596266

Last Updated: 2022-10-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-25
• Study Completion Date: 2025-10-25

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.

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.

Conditions

T-cell Acute Lymphoblastic Leukemia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CD5 CAR-T

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

Group Type: EXPERIMENTAL

CD5 CAR-T

Intervention Type: BIOLOGICAL

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

Interventions

CD5 CAR-T

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

Intervention Type: BIOLOGICAL

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.

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Baoding Children's Hospital

OTHER

Sponsor Role: collaborator

Xuanwu Hospital, Beijing

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Zhiguo Chen, PhD

Role: PRINCIPAL_INVESTIGATOR

Xuanwu Hospital, Beijing

Huyong Zheng, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Xuanwu Hospital Capital Medical University

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Zhiguo Chen, PhD

Role: CONTACT

chenzhiguo@gmail.com

86-10-83198889

Huyong Zheng, MD, PhD

Role: CONTACT

zhenghuyong@bch.com.cn

010-59617621

Facility Contacts

Zhiguo Chen, PhD

Role: primary

chenzhiguo@gmail.com

86-10-83198889

Huyong Zheng, MD, PhD

Role: backup

zhenghuyong@bch.com.cn

010-59617621

Other Identifiers

202001

Identifier Type: -

Identifier Source: org_study_id