Human CD19 Targeted T Cells Injection Therapy for Relapsed and Refractory CD19-positive Leukemia

NCT03798509 | Unknown Phase 1 DMC

• 1 other identifier: HRAIN01-ALL01
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the safety and tolerance of human CD19 targeted T Cells injection for the treatment of relapsed and refractory CD19-positive B-cell acute lymphoblastic leukemia. Patients will be given a conditioning chemotherapy regimen of fludarabine and cyclophosphamide followed by a single infusion of CD19 CAR+ T cells.

Conditions

CD19-positive; Acute Lymphoblastic Leukemia

Keywords

CD19; CAR-T; leukemia; Relapsed /Refractory; B-ALL

Outcome Measures

Primary Outcomes (1)

• DLT

  28 days post infusion

Secondary Outcomes (7)

• Duration of CAR-positive T cells in circulation

  2 years post infusion

• The concentration of CD19-positive B cells in peripheral blood.

  2 years post infusion

• Overall response rate (ORR) after administration

  90 days post infusion

• Duration of remission (DOR) after administration

  2 years post infusion

• Progress Free Survival (PFS) after administration

  2 years post infusion

Study Arms (1)

Human CD19 targeted T Cells Injection

EXPERIMENTAL

Drug: Human CD19 targeted T Cells Injection

Interventions

Human CD19 targeted T Cells Injection DRUG

Autologous genetically modified anti-CD19 CAR transduced T cells

Human CD19 targeted T Cells Injection

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• to 70 Years Old, Male and female;
• Expected survival \> 12 weeks;
• ECOG score 0-1;
• Bone marrow examination clearly diagnosed as CD19 positive B-cell acute lymphoblastic leukemia and who met one of the following conditions:
• Those who failed to achieve CR after at least 2 courses of standard chemotherapy or had early relapse after complete remission (\<12 months) or late relapse after complete remission (≥ 12 months) and failed to achieve CR after 1 course of standard chemotherapy;
• For Ph+ ALL: in addition to receiving at least 2 courses of standard chemotherapy, at least two TKIs should be treated with no complete remission or relapse after complete remission (Patients who cannot tolerate TKI therapy or have TKI treatment contraindications or have T315i mutation are excluded);
• Those who relapse after stem cell transplantation are not affected by previous treatments;
• The venous access required for collection can be established and mononuclear cell collection can be determined by the investigators;
• Liver, kidney and cardiopulmonary functions meet the following requirements:
• Creatinine is in the normal range;
• Left ventricular ejection fraction \>50%;
• Baseline oxygen saturation\>92%;
• Total bilirubin ≤ 2×ULN; ALT and AST ≤2.5 × ULN;
• Able to understand and sign the Informed Consent Document.

You may not qualify if:

• Graft-versus-host disease (GVHD), or need to use immunosuppressants;
• Malignant tumors other than acute lymphoblastic leukemia within 5 years prior to screening, in addition to adequately treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, localized prostate cancer after radical resection, and ductal carcinoma in situ after radical resection;
• Subjects with positive HBsAg or HBcAb and peripheral blood HBV DNA titer detection ≥ 1 × 102 copy number / L; HCV antibody positive and peripheral blood HCV RNA positive; HIV antibody positive; CMV DNA positive; syphilis positive;
• Any instability of systemic disease, including but not limited to unstable angina, cerebrovascular accident, or transient cerebral ischemic (within 6 months prior to screening), myocardial infarction (within 6 months prior to screening), congestive heart failure (New York heart association (NYHA) classification ≥ III), need drug therapy of severe arrhythmia, liver, kidney, or metabolic disease;
• Active or uncontrollable infection requiring systemic therapy within 14 days prior to enrollment;
• Pregnant or lactating woman, and female subject who plans to have a pregnancy within 1 year after cell transfusion, or male subject whose partner plans to have a pregnancy within 1 year after cell transfusion;
• Received CAR-T treatment or other gene therapies before enrollment;
• Patients with symptoms of central nervous system;
• Subjects who are receiving systemic steroid treatment and requiring long-term systemic steroid treatment during the treatment as determined by the investigator before screening (except inhalation or topical use); And subjects treated with systemic steroids (except inhalation or topical use) within 72h prior to cell transfusion;
• The investigators consider other conditions unsuitable for enrollment.

Sponsors & Collaborators

• Hrain Biotechnology Co., Ltd.: lead
• Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine: collaborator

Study Sites (1)

Shanghai General Hospital

Shanghai, Shanghai Municipality, 200080, China

RECRUITING

Related Publications (1)

• Wang H, Tsao ST, Gu M, Fu C, He F, Li X, Zhang M, Li N, Hu HM. A simple and effective method to purify and activate T cells for successful generation of chimeric antigen receptor T (CAR-T) cells from patients with high monocyte count. J Transl Med. 2022 Dec 19;20(1):608. doi: 10.1186/s12967-022-03833-6.

  PMID: 36536403 DERIVED

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Central Study Contacts

Hongliang Fang, doctor

CONTACT

021-58552006; fanghongliang@dashengbio.com

Study Design

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

Study Record Dates

• First Submitted: January 3, 2019
• First Posted: January 10, 2019
• Study Start: March 13, 2019
• Primary Completion: January 1, 2022
• Study Completion: January 1, 2024
• Last Updated: August 31, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)