A Clinical Study of Anti-CD19 Chimeric Antigen Receptor T-Cell Injection (CNCT19) in the Treatment of Cluster of Differentiation 19 (CD19) Positive Relapsed or Refractory B Cell Malignancies

NCT04011293 | Unknown Early Phase 1

• 1 other identifier: HY001003
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single arm, open-label, single center study to determine the safety and efficacy of CNCT19 in adult patients with Relapsed or Refractory B cell Malignancies.

Conditions

Relapsed or Refractory Hematological Malignancies

Keywords

Relapsed; Refractory; Malignancy

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 (10)

• Response at Day 28±3 days

  1 month

• Percentage of patients who achieve complete remission (CR) or complete remission with incomplete blood count recovery (CRi) (partial remission，PR) at month 6 without SCT between CNCT19 infusion and Month 6 response assessment.

  6 months

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

  6 months

• Relapse-free survival

  24 months

• Progression-free survival

  24 months

Study Arms (1)

A

EXPERIMENTAL

Single dose of CNCT19

Biological: CNCT19

Interventions

CNCT19 BIOLOGICAL

0.5 to 4 x 10\^6 autologous CNCT19 transduced cells per kg body weight, with a maximum dose of 4 x 10\^8 autologous CNCT19 transduced cells via intravenous infusion.

A

Eligibility Criteria

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

You may qualify if:

• Informed consent is signed by a subject or his lineal relation.
• Age 18 or older.
• Relapsed or refractory B-cell lineage acute lymphoblastic leukemia (B-ALL)
• Relapsed or refractory
• Relapse within 12 months of first remission
• Without remission after 2 cycles of induction chemotherapy regimen.
• Without remission after more than 6 weeks of induction chemotherapy.
• nd or greater Bone Marrow (BM) relapse
• Any BM relapse after autologous/allogeneic stem cell transplantation (SCT)
• documentation of cluster of differentiation 19 (CD19) tumor expression demonstrated in bone marrow or peripheral blood within 3 months of study entry.
• Patients with Philadelphia chromosome positive (Ph+) ALL are eligible if they are intolerant to or have failed 1generation and/or 2 generation 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 or minimal residual disease (MRD) positive at screening
• Relapsed or refractory B-cell non-Hodgkin's lymphoma (NHL) with CD19-positive after two systemic lines of therapy
• Chemotherapy-refractory disease, defined as one of more of the following:
• No response to last line of therapy. i. Progressive disease (PD) as best response to most recent therapy regimen. ii. Stable disease (SD) as best response to most recent therapy with duration no longer than 6 month from last dose of therapy

You may not qualify if:

• Active central nervous system (CNS) involvement by malignancy.
• Patients with systemic vasculitis (such as Wegener granulomatosis, nodular polyarteritis, systemic lupus erythematosus) and active or uncontrolled autoimmune disease (such as autoimmune hemolytic anemia, etc.)
• Patients who are positive for any of HIV antibody, TP antibody, hepatitis B surface antigen (HBsAg) and hepatitis C virus (HCV) antibody.
• During the first four weeks of screening, the patient underwent major surgery which was assessed by the investigator as unsuitable for enrollment;
• The patient's heart fits any of the following conditions:
• 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(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.
• Has had treat with live vaccine within 6 weeks prior to screening；
• Patients with evidence of currently uncontrollable serious active infections (e.g., sepsis, bacteremia, fungemia, viremia, etc.).
• Life expectancy \< 12 weeks.
• Patients with other conditions making the patients unsuitable for receiving cell therapy as judged by the investigator.

Sponsors & Collaborators

• Shandong University: lead
• Juventas Cell Therapy Ltd.: collaborator

Study Sites (1)

Qilu Hospital of Shandong University

Jinan, Shandong, 250012, China

RECRUITING

MeSH Terms

Conditions

Recurrence; Hematologic Neoplasms; Neoplasms

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms by Site; Hematologic Diseases; Hemic and Lymphatic Diseases

Central Study Contacts

Chuanli Zhao, Dr.

CONTACT

‭+86 185 6008 7009‬; chuanlizhao@163.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 3, 2019
• First Posted: July 8, 2019
• Study Start: July 1, 2019
• Primary Completion: July 1, 2020
• Study Completion: April 1, 2022
• Last Updated: July 8, 2019

Record last verified: 2019-07

Locations

CN (1)