Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

CNCT19 Following ASCT in Patients With Relapsed or Refractory B-cell Lymphoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04690192
Recruitment Status : Recruiting
First Posted : December 30, 2020
Last Update Posted : January 26, 2022
Sponsor:
Collaborator:
Juventas Cell Therapy Ltd.
Information provided by (Responsible Party):
Zou Dehui, Institute of Hematology & Blood Diseases Hospital

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The primary objective of this study is to explore the safety and efficacy of CNCT19 (a second-generation anti-CD19 CAR T-cell using 4-1BB as co-stimulatory domain provided by Juventas, Tianjin, China) infusion following ASCT in patients with relapsed or refractory B-cell lymphoma.

Condition or disease Intervention/treatment Phase
Large B-cell Lymphoma Biological: CNCT19 Drug: Gemcitabine Injection Drug: busulfan Drug: Melphalan Injection Phase 1 Phase 2

Detailed Description:
This is a single-center, non-randomized, open-label, prospective clinical trial to evaluate the safety and efficacy of CNCT19 infusion following high-dose chemotherapy and autologous stem-cell transplantation (HDT/ASCT) in patients with relapsed or refractory B-cell lymphoma. CNCT19 cells will be infused on day +3 (±1d) with a fixed dose of 2×10^6/kg. The study will assess the safety and efficacy of this combinational therapy, including the incidence and severity of cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS), hematological, and other non-hematological toxicities, and objective response rates and complete response rates and survivals of the subjects.
Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: CNCT19 Following Autologous Stem Cell Transplantation in Patients With Relapsed or Refractory Aggressive B-cell Lymphoma
Actual Study Start Date : January 1, 2021
Estimated Primary Completion Date : December 30, 2022
Estimated Study Completion Date : December 30, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: CNCT19 following ASCT
Participants will receive high-dose chemotherapy followed by stem-cell reinfusion, and a fixed dose of CNCT19 (2×10^6/kg) will be infused in a single-dose on day +2, +3 or +4.
 Biological: CNCT19
2×10^6/kg, infused in a single-dose on day +2, +3 or +4 following stem-cell infusion

Drug: Gemcitabine Injection
600mg/m2/h, infused for 3 hours with loading bolus of 75mg/m2, day -7, -3,

Drug: busulfan
105mg/m2, day -7 until -5,

Drug: Melphalan Injection
60mg/m2, day -3, -2


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Percentage of participants experiencing adverse events [ Time Frame: from the first day of high-dose chemotherapy until 2 years post CNCT19 infusion ]

Secondary Outcome Measures :
  1. Complete Response (CR) Rate [ Time Frame: 2 years post CNCT19 infusion ]
    Complete Response rate is defined as the incidence of a CR per the Lugano Classification (Cheson et al, 2014), as determined by study investigators.

  2. Objective Response Rate (ORR) [ Time Frame: 2 years post CNCT19 infusion ]
    ORR is defined as the incidence of either a CR or a partial response (PR) per the Lugano Classification as determined by study investigators.

  3. Progression-Free Survival (PFS) [ Time Frame: 2 years post CNCT19 infusion ]
    PFS is defined as the time from the CNCT19 infusion date to the date of disease progression or death from any cause.

  4. Duration of Response (DOR) [ Time Frame: 2 years post CNCT19 infusion ]
    DOR is defined only for participants who experience an objective response after CNCT19 infusion and is the time from the first objective response to disease progression or death from any cause.

  5. Disease-Free Survival (DFS) [ Time Frame: 2 years post CNCT19 infusion ]
    DFS is defined only for participants who achieve complete response after CNCT19 infusion and is the time from complete response to disease progression or death from any cause.

  6. Overall Survival (OS) [ Time Frame: 2 years post CNCT19 infusion ]
    OS is defined as the time from CNCT19 infusion to the date of death from any cause.


Other Outcome Measures:
  1. Levels of CNCT19 in blood [ Time Frame: 2 years post CNCT19 infusion ]
  2. Levels of cytokines in serum [ Time Frame: 1 month post CNCT19 infusion ]
  3. Levels of lymphocyte subsets in blood [ Time Frame: 1 year post CNCT19 infusion ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  1. Histologically confirmed large B-cell lymphoma including the following types

    • diffuse large B-cell lymphoma
    • high-grade B-cell lymphoma with or without MYC and BLC2 and/or BCL6 rearrangement
    • transformed lymphoma

  2. Relapsed or refractory diseases fulfilling one of the following criteria (individuals must have received anti-CD20 monoclonal antibody and anthracycline-containing chemotherapy regimen)

    • Primary refractory disease, defined as disease progression after first-line immunochemotherapy or disease progression within 6 weeks of the end of the last chemotherapy
    • Stable disease (SD) as best response after at least 4 cycles of first-line therapy
    • Partial response (PR) as best response after at least 6 cycles of first-line therapy (biopsy-proven residual disease is needed for individuals with Deauville score of 4)
    • PR as best response after at least 2 cycles of second-line therapy
    • Disease relapse ≤12 months after the completion of first-line immunochemotherapy
    • Relapsed or refractory disease after ≥2 lines of chemotherapy
  3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

  4. Adequate bone marrow function as evidenced by:

    • Absolute neutrophil count (ANC) ≥ 1000/uL
    • Platelet count≥ 75,000/uL

  5. Adequate renal and hepatic function defined as:

    • Serum alanine aminotransferase (ALT/AST) ≤ 3 upper limit of normal (ULN)
    • Total bilirubin ≤1.5 mg/dL, except in individuals with Gilbert's syndrome
    • Serum creatinine ≤2 ULN, or creatinine clearance (as estimated by Cockcroft Gault) ≥ 40 mL/min
  6. Cardiac ejection fraction ≥ 50%
  7. Baseline oxygen saturation > 92% on room air
  8. Life expectancy ≥3 months

Key Exclusion Criteria:

  1. Active Central Nervous System (CNS) involvement by lymphoma
  2. History of autologous or allogeneic stem cell transplantation
  3. Active HBV or HCV infection, defined as HBV-DNA or HCV-DNA levels above the normal upper limit, with or without abnormal liver function. Individuals with positive HBsAg or HBcAb should receive antiviral prophylaxis for at least 12 months after CNCT19 infusion.
  4. Presence of uncontrolled infection, cardio-cerebrovascular disease，coagulopathy, or connective tissue disease.
  5. History of seizure or other CNS disorder
  6. History of HIV infection
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04690192


Contacts
Layout table for location contacts
Contact: Wei Liu, Dr. 086-022-23909282 liuwei@ihcams.ac.cn

Locations
Layout table for location information
China, Tianjin
Institute of Hematology & Blood Diseases Hospital Recruiting
Tianjin, Tianjin, China, 300020
Contact: Wei Liu, Dr.    086-022-23909282    liuwei@ihcams.ac.cn   
Principal Investigator: Dehui Zou, Dr.         
Sponsors and Collaborators
Zou Dehui
Juventas Cell Therapy Ltd.
Investigators
Layout table for investigator information
Principal Investigator: Dehui Zou, Dr. Institute of Hematology & Blood Diseases Hospital, CAMS & PUMC
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Zou Dehui, Principal Investigator, Institute of Hematology & Blood Diseases Hospital
ClinicalTrials.gov Identifier: NCT04690192    
Other Study ID Numbers: IHBDH-IIT002
First Posted: December 30, 2020    Key Record Dates
Last Update Posted: January 26, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Zou Dehui, Institute of Hematology & Blood Diseases Hospital:
autologous stem-cell transplantation
anti-CD19 CAR T-cell
large B-cell lymphoma
Additional relevant MeSH terms:
Layout table for MeSH terms
Lymphoma
Lymphoma, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Gemcitabine
Melphalan
Busulfan
Antimetabolites, Antineoplastic
 Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Alkylating
Alkylating Agents
Myeloablative Agonists