CD19 hsCAR-T for Refractory/Relapsed CD19+ B-ALL Patients

NCT03902197 | Unknown Phase 2

• 1 other identifier: CD19hsCAR20190401
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

Brief Summary

This Phase II study is to evaluate the efficacy and safety of a CD19-targeting humanized selective CAR-T (CD19 hsCAR-T) in refractory/relapsed CD19+ B-ALL leukemia patients who have no available curative treatment options, have a limited prognosis with currently available treatments, and were previously treated with a B cell directed cell therapy.

Conditions

Acute Lymphoblastic Leukemia

Keywords

CD19 hsCAR-T; B-ALL; Humanized selective CAR

Outcome Measures

Primary Outcomes (1)

• Overall response rate (ORR) within 3 months

  Overall response rate (ORR) within 3 months after infusion of CD19 hsCAR-T

  3 months

Secondary Outcomes (4)

• Best overall response (BOR)

  3 months

• Duration of remission (DoR)

  1 year

• Event free survival within 1 year

  1 year

• Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability])

  6 months

Study Arms (1)

CD19 hsCAR-T

EXPERIMENTAL

This cohort will be administrated by T cells transduced with lentivirus vectors expressing CD19 hsCAR

Biological: CD19 hsCAR-T

Interventions

CD19 hsCAR-T BIOLOGICAL

CD19 hsCAR-T will be administered by I.V. infusion

CD19 hsCAR-T

Eligibility Criteria

• Age: 1 Year - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects with refractory/relapse B-cell ALL with no available curative treatment options (such as autologous or allogeneic SCT);
• Subjects previously treated with B cell-directed engineered cell therapy are eligible if they meet the following criteria:
• relapsed and/or MRD-positive after prior cell therapy;
• partial response to prior cell therapy;
• Clinical and laboratory data are available;
• Documented CD19 expression after previous B cell-directed therapies;
• Aged 1 to 75 years;
• KPS\>40；
• At least 2 weeks or 5 drug half-lives, whichever is shorter must have elapsed since any prior systemic therapy at the time the subject is planned for leukapheresis, except for systemic inhibitory/stimulatory immune checkpoint therapy;
• Women of childbearing potential must have a urine pregnancy test taken and proven negative prior to the treatment. All patients agree to use reliable methods of contraception during the trial period and throughout the last follow-up visit;
• Subjects with relapsed disease after prior allogeneic SCT (myeloablative or non-myeloablative) will be eligible if the patients do not present with active GVHD and are not undergoing immunosuppressive regimes;
• Patients with CNS3 (WCB ≥5/mL in CSF with presence of lymphoblasts) disease will be eligible if the CNS disease is responsive to therapy;
• Participation in the clinical trials should be voluntary with signed informed consent.

You may not qualify if:

• Patients with hypervolemia (white blood cell count\> 50 x 10\^9 / L) or rapidly progressive disease that in the estimation of the investigators and sponsors would compromise the patient's ability to complete the study;
• History of melanoma skin cancer or other primary tumors (eg, cervical cancer, bladder cancer, breast cancer) (except for those with 3 years or longer of cure);
• Patients with fungal, bacterial, viral, or other uncontrollable infections or infections requiring Level 4 isolation (UTI or inoculation assays may be performed if necessary);
• Patients with positive results for HIV, HBV, HCV tests;
• With CNS disorders such as cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or autoimmune disease with CNS involvement;
• History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, or other clinically significant cardiac diseases within 12 months of enrollment, or with cardiac atrial or cardiac ventricular lymphoma;
• Patients that are receiving anticoagulant therapy or have ever coagulation disorders;
• Any medical condition that in the judgment of the sponsors/investigators is likely to interfere with assessment of safety or efficacy of study;
• History of severe immediate hypersensitivity reaction to any of the agents used in this study;
• Female patients who are pregnant or breastfeeding;
• Feasibility assessment during screening demonstrates \<30% transduction of target lymphocytes, or insufficient expansion (\< 5-fold) in response to CD3/CD28 co-stimulation;
• Patients with any uncontrolled diseases that are unsuitable for enrollment;
• CNS3 disease that is progressive on therapy, or with CNS parenchymal lesions that might increase the risk of CNS toxicity;
• Any situation that is considered to potentially increase the risk of the subject or interfere with the outcome of the study;
• Patients who have been enrolled in other clinical studies.

Sponsors & Collaborators

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

Study Sites (2)

Beijing Children's Hospital Capital Meidcal University

Beijing, Beijing Municipality, China

RECRUITING

Beijing Children's Hospital, Capital Medical University

Beijing, Beijing Municipality, China

RECRUITING

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

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

  Beijing Children's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhiguo Chen, PhD

CONTACT

86-10-83198889; chenzhiguo@gmail.com

Yu Zhao, PhD

CONTACT

86-10-83198274; zhaoyu198387@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2019
• First Posted: April 3, 2019
• Study Start: April 22, 2019
• Primary Completion: December 31, 2021
• Study Completion: December 21, 2023
• Last Updated: April 8, 2019

Record last verified: 2019-03

Locations

CN (2)