CD19-CD22 Chimeric Antigen Receptor T (CAR-T) Cell for Treatment of B Cell Acute Lymphoblastic Leukemia (B-ALL)

NCT04034446 | Terminated Early Phase 1

• 1 other identifier: QT2019005
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single arm, open-label, single center study to determine the safety and efficacy of CD19-CD22 CAR-T cells in patients with CD19+CD22+ Leukemia.

Conditions

Relapsed or Refractory B Cell Acute Lymphoblastic Leukemia

Keywords

Relapsed; Refractory; B-ALL

Outcome Measures

Primary Outcomes (2)

• Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

  24 months

• Overall remission rate (ORR)

  3 months

Secondary Outcomes (6)

• Response at Day 28 days

  1 month

• Percentage of patients who achieve complete remission (CR) or complete remission with incomplete blood count recovery (CRi) at month 6 without SCT between CD19-CD22 CAR-T cells infusion and Month 6 response assessment.

  6 months

• Percentage of patients who achieve CR or CRi with minimal residual disease (MRD) negative bone marrow

  6 months

• Relapse-free survival (RFS)

  24 months

• Duration of remission (DOR)

  24 months

Study Arms (1)

A

EXPERIMENTAL

Single dose of CD19-CD22 CAR-T cells

Biological: CD19-CD22 CAR-T cells

Interventions

CD19-CD22 CAR-T cells BIOLOGICAL

0.5 to 3.0 x 106 autologous CD19-CD22 CAR-T cells per kg body weight, with a maximum dose of 4 x 108 autologous CD19-CD22 CAR-T cells via intravenous infusion.

A

Eligibility Criteria

• Age: 3 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Informed consent is signed by a subject or his lineal relation.
• Age 3 and older.
• Documentation of cluster of differentiation 19 (CD19) and or cluster of differentiation 19 (CD22) expression on leukemic blasts in the BM, peripheral blood within 3 months of screening.;
• Relapsed or refractory B-cell ALL
• Relapse within 12 months of first remission
• Without remission after 2 cycles of induction chemotherapy regimen.
• Without remission or relapse after salvage treatments.
• Any BM relapse after autologous stem cell transplantation (ASCT).
• Without remission or relapse after any prior CD19 targeted therapy;
• Patients with Philadelphia chromosome positive (Ph+) ALL are eligible if they are intolerant to or have failed 2 lines of tyrosine kinase inhibitor therapy (TKI); no TKI salvage treatments if the patient has a BCR-ABL1 kinase domain gatekeeper mutation Thr315Ile (T315I) mutation.
• Bone marrow with ≥ 5% lymphoblasts by morphologic assessment at screening；
• Eastern cooperative oncology group (ECOG) performance status of 0 to 2.
• Adequate organ function defined as:
• Aspartate aminotransferase (AST) ≤3 upper limit of normal (ULN);
• Serum alanine aminotransferase (ALT) ≤3 ULN;

You may not qualify if:

• Active central nervous system leukemia
• Patients with evidence of currently uncontrollable serious active infections (e.g., sepsis, bacteremia, fungemia, viremia, etc.).
• Patients who are positive for any of HIV antibody, TP antibody, hepatitis B surface antigen (HBsAg) and hepatitis C virus (HCV) antibody.
• Major surgery within ≤ 4 weeks before enrollment.
• Prior malignancy, except carcinoma in situ of the skin or cervix treated with curative intent.
• Impaired cardiac function:
• Left Ventricular Ejection Fraction (LVEF) ≤45%;
• III/IV congestive heart failure (NYHA);
• Severe arrhythmia (except for Atrial fibrillation, Paroxysmal supraventricular tachycardia);
• Corrected QT interval (QTc) ≥450ms (male) or QTc≥470ms (female)（QTc using Bazett's formula (QTcB)=QT/RR\^0.5）;
• Myocardial infarction or Coronary Artery Bypass Graft Surgery, heart stent surgery.
• Other heart diseases that have been judged by the investigator to be unsuitable for receiving cell therapy.
• Patients with a history of epilepsy or other active central nervous system diseases.
• Life expectancy \< 12 weeks.
• Allergy to macromolecule biopharmaceuticals such as antibodies or cytokines.

Sponsors & Collaborators

• Institute of Hematology & Blood Diseases Hospital, China: lead
• Juventas Cell Therapy Ltd.: collaborator

Study Sites (1)

Institute of Hematology & Blood Diseases Hospital

Tianjin, 300020, China

Location

MeSH Terms

Conditions

Recurrence; Burkitt Lymphoma

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Epstein-Barr Virus Infections; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Tumor Virus Infections; Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Design

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

Study Record Dates

• First Submitted: July 24, 2019
• First Posted: July 26, 2019
• Study Start: September 30, 2019
• Primary Completion: July 21, 2020
• Study Completion: December 1, 2020
• Last Updated: June 3, 2025

Record last verified: 2020-05

Locations

CN (1)