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Non-Hodgkin's LymphomaPhase 2NCT04586478

Phase II Clinical Trial of CNCT19 Cell Injection in the Treatment of Relapsed or Refractory Non-Hodgkin's Lymphoma

A Phase 2 study testing single dose of CNCT19 in people with Non-Hodgkin's Lymphoma, run by Juventas Cell Therapy Ltd. at 17 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

The study is a Phase II, single-arm, open-label, single-dose clinical trial, and its primary objective is to evaluate the efficacy and safety of CNCT19 Cell Injection in the treatment of relapsed or refractory NHL. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Non-Hodgkin's Lymphoma
What is being tested?
single dose of CNCT19
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
17 sitesChina
Study dates
26 Oct 2020to 30 Sep 2025
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients who are willing to sign the informed consent form;
  • Aged 18-75 years, male or female;
  • At screening, subjects complying with the following diagnostic and treatment requirements:
  • Complying with CD19-positive NHL according to the WHO classification 2017, which are provided specifically as follows:
  • Diffuse large B cell lymphoma (DLBCL), not otherwise specified (NOS);
  • Primary mediastinal large B cell lymphoma (PMBCL);
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  • Transformed follicular lymphoma
  • High grade B cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements, and high grade B cell lymphoma - not otherwise specified.
  • Previously received≥2nd-line adequate therapy or autologous hematopoietic stem cell transplantation (ASCT), including:
  • Received at least Rituximab or other CD20 targeted drugs containing (except CD20 negative tumors) chemotherapy and
  • Received at least one chemotherapy regimen containing anthracycline;
  • Definition of line: Stable disease (SD) after receiving a first-line adequate therapy or progressive disease (PD), and SD after a second-line therapy for at least 2 cycles or PD .
  • In relapsed or refractory status at screening:
  • Definition of relapse: Remission (including partial remission (PR) or complete remission (CR)) after treatment with at least the standard therapy regimen (it must contain Ribuximab), and then PD;
  • Definition of refractoriness:
  • Non-responsiveness to the last therapy: The best response by the last therapy is SD or PD; Relapse or progression after ASCT, including: Relapse (it must be proved by biopsy) or PD within 12 months after ASCT; if a rescue therapy is received, the patient is non-responsive (SD or PD) to the last therapy;
  • For transformed follicular lymphoma (TFL), patients must be treated adequately against FL, and after transformation, must have received at least once the therapy against TFL, and become relapsed or refractory after the last therapy.
  • Measurable imaging lesion at screening: Intranodal lesion must have a long diameter of more than 1.5 cm, and extranodal lesion must have a long diameter of more than 1.0 cm (per revised IWG Response Criteria 2014 in Lymphomas);
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
  • Adequate bone marrow reserve, defined as:
  • Absolute neutrophil count (ANC) > 1.0×109/L;
  • Absolute lymphocyte count (ALC) ≥ 0.3×109/L;
  • Platelet (PLT) ≥50×109/L;
  • Proper organ function, complying with the following criteria (except hepatic dysfunction due to tumor cell infiltration): Aspartate aminotransferase (AST) ≤ 3 Upper Limit of Normal (ULN); Alanine aminotransferase (ALT) ≤ 3 ULN; Total serum bilirubin ≤ 2 ULN, unless there exists concurrent Gilbert syndrome; patients with Gilbert syndrome, with total serum bilirubin ≤ 3 ULN and direct bilirubin ≤ 1.5 ULN, may be included; Renal function: serum creatinine ≤ 1.5 ULN or creatinine clearance ≥ 60 mL/min (Cockcroft-Gault formula); Minimum pulmonary reserve, defined as Grade ≤ 1 dyspnea, and blood oxygen saturation > 91% at non-oxygen inhalation status; International normalized ratio (INR) ≤ 1.5 ULN and activated partial thromboplastin time (aPTT) ≤ 1.5 ULN.
  • Vascular conditions for apheresis;
  • Women with child-bearing potential are negative in blood/urine pregnancy tests within 3 d prior to apheresis, and prior to infusion of CNCT19 cell injection infusion; any male or female patient with child-bearing potential must agree to adopt effective contraceptive measures throughout the study, and at least a year after administration of the investigational therapy. As judged by the investigator, a patient with child-bearing potential means that: He/she has normal sexual life and is biologically fertile to have children. Non-fertile female patients (i.e., complying one of the following criteria):Previously received hysterectomy, bilateral ovariectomy, or bilateral tubal ligation, or Medically confirmed ovarian failure, or Medically confirmed postmenopause (amenorrhea of at least 12 consecutive months).

Who cannot join

  • Patients with active central nervous system (CNS) lymphoma (a patient with CNS disease symptoms must receive lumbar puncture and MRI/CT to exclude CNS lymphoma).
  • Patients with existing central nervous system disease or with a history of central nervous system disease, e.g., epileptic seizure, cerebral ischemia/hemorrhage, paralysis, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, cerebellum disease, organic brain syndrome, mental disease, or any autoimmune disease involved with central nervous system.
  • Patients receiving any of the following drugs or therapies within the specified period prior to apheresis:
  • Alemtuzumab within 6 months prior to apheresis;
  • Cladribine within 3 months prior to apheresis;
  • Anti-CD20 monoclonal antibody within 7 d prior to apheresis;
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  • Venetoclax (BCL-2 inhibitor) within 4 d prior to apheresis;
  • Idelalisib (PI3Kδ kinase inhibitor) within 2 d prior to apheresis;
  • Lenalidomide within 1 d prior to apheresis;
  • Lymphocytotoxic chemotherapy within 2 weeks prior to apheresis - use in more than 3 half-lives prior to apheresis is eligible;
  • Non-lymphocytotoxic chemotherapy within 7 d prior to apheresis - use in more than 3 half-lives prior to apheresis is eligible;
  • Radiotherapy within 6 weeks prior to apheresis, including big bone marrow area (e.g., sternum or pelvis) - progressive disease at radiotherapy site, or PET positive lesion at other non-radiotherapy site is eligible; if there is existing PET positive lesion in other non-radiotherapy sites, then it is allowable to conduct radiotherapy at a single lesion within 2 weeks prior to apheresis.
  • Patients receiving chemotherapy within 2 weeks prior to CNCT19 Cell injection infusion, excluding the following conditions:
  • Pretreatment chemotherapy as specified by the protocol;
  • CNS lymphoma prophylaxis by intrathecal injection (it must be stopped within 1 week prior to infusion of CNCT19 Cell Injection).
  • Discontinuation of a systematic therapeutic hormone within 72 h prior to infusion of CNCT19 Cell Injection; however, use of the hormone in the physiological surrogate amount is eligible (e.g., Prednisone in a dose of <10 mg/d or equivalent).
  • Patients previously received CAR-T cell therapy.
  • Patients who have previously received allogeneic hematopoietic stem cell transplantation (allo-HSCT).
  • Patients with known active or uncontrolled synstemic autoimmune disease and under treatment.
  • Patients complying with any of hepatitis B surface antigen (HBsAg) and/or hepatitis B e antigen (HBeAg) positive, hepatitis B e antibody (HBe-Ab) and/or hepatitis B core antibody (HBc-Ab) positive and HBV-DNA copies being more than the lower limit of detection, hepatitis C antibody (HCV-Ab) positive, anti-treponemia pallidum antibody (TP-Ab) positive, EBV-DNA, and CMV-DNA copies being more than the lower limit of detection.
  • Patients who received a major surgery within 4 weeks prior to screening, and are not eligible for enrollment as judged by the investigator.
  • Patients with concurrent active malignancy; those with a history of malignancy, cured for≥2 years, are eligible.
  • Patients complying any of the following conditions: Left ventricular ejection fraction (LVEF) ≤45% (ECHO); New York Heart Association (NYHA) Grade III or IV congestive heart failure; Uncontrolled hypertension (systolic blood pressures≥140mmHg and/or diastolic blood pressures ≥90 mmHg), pulmonary hypertension, or unstable angina pectoris; Myocardial infarction or bridging or stent procedure within 12 months prior to administration of the drug; Clinically significant valvular heart disease; Other heart diseases unsuitable for enrollment, as judged by the investigator.
  • Patients with lymphoma involved with atrium or ventricle.
  • Patients with clinical emergency (e.g., intestinal infarction or vascular compression) requiring treatment, due to existing lymphoma body obstruction or compression at screening.
  • Patients with active hemorrhage at screening.
  • Patients with deep vein thrombosis within 6 months prior to screening, or a history of pulmonary embolism.
  • Patients who are known with a history of hypersensitivity reaction to any ingredient used for the drug product in the trial.
  • Patients vaccinated with a live vaccine within 6 weeks prior to screening.
  • Patients with active infection at screening.
  • Patients with a life expectancy of less than 3 months.
  • Patients participating in any other interventional clinical study or receiving treatment of an active investigational drug within 3 half-lives prior to CNCT19 Cell Injection infusion.

Trial locations and contacts

17 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Yan Zhou contact

+8615010390127

zhouyan@juventas.cn

17 sites in 1 country

China17 sites, 17 recruiting

  • Beijing Boren Hospital

    Beijing, Beijing Municipality

    Kai Hu, Dr.

    Recruiting

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality

    Yuqin Song, Dr.

    Recruiting

  • Peking University Third Hospital

    Beijing, Beijing Municipality

    Hongmei Jing, Dr.

    Recruiting

  • West China Hospital，Sichuan University

    Chengdu, Sichuan

    Ting Niu, Dr.

    Recruiting

  • The First Affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing Municipality

    Lin Liu, Dr.

    Recruiting

  • Xinqiao Hospital of TMMU

    Chongqing, Chongqing Municipality

    Li Gao, Dr.

    Recruiting

  • Guangdong Provincial Peoples' Hospital

    Guangzhou, Guangdong

    Wenyu Li, Dr.

    Recruiting

  • SunYat-Sen University Cancer Center

    Guangzhou, Guangdong

    Huiqing Huang, Dr.

    Recruiting

  • The First Affiliated Hospital, Zhejiang University school of Medicine

    Hangzhou, Zhejiang

    Jie Jin, Dr.

    Recruiting

  • Qilu Hospital of Shandong University

    Jinan, Shandong

    Chunyan Ji, Dr.

    Recruiting

  • Ruijin Hospital, Shanghai Jiaotong University School of Medicine

    Shanghai, Shanghai Municipality, 200025

    Weili Zhao, Dr.

    Recruiting

  • Tongji Hospital of Tongji University

    Shanghai, Shanghai Municipality

    Aibin Liang, Dr.

    Recruiting

  • Institute of Hematology & Blood Diseases Hospital

    Tianjin, Tianjin Municipality, 300020

    Dehui Zou, Dr.

    Recruiting

  • Tianjin Medical University Cancer Institute & Hospital

    Tianjin, Tianjin Municipality

    Lanfang Li, Dr.

    Recruiting

  • Tongji Hospital, Tongji Medical College of HUST

    Wuhan, Hubei

    Liang Huang, Dr.

    Recruiting

  • Henan Cancer Hospital

    Zhengzhou, Henan

    Keshu Zhou, Dr.

    Recruiting

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan

    Mingzhi Zhang, Dr.

    Recruiting

Other trials in China

About this study

The study is a Phase II, single-arm, open-label, single-dose clinical trial, and its primary objective is to evaluate the efficacy and safety of CNCT19 Cell Injection in the treatment of relapsed or refractory NHL.

Read the detailed description

The study is a Phase II, single-arm, open-label, single-dose clinical trial, and its primary objective is to evaluate the efficacy and safety of CNCT19 Cell Injection in the treatment of relapsed or refractory NHL. The study consists of screening period (8 weeks), treatment period (4 weeks), and follow-up period (2 years at most).

Being tested
single dose of CNCT19
Medical subject headings
Lymphoma, Non-Hodgkin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • single dose of CNCT19Biological

    Dose: 2.00 x 10^8 CNCT19 Cell Injection via intravenous infusion. Drug: Fludarabine Drug: Cyclophosphamide

Study groups in NCT04586478
Study groupRoleWhat they receive
Single dose of CNCT19ExperimentalA conditioning chemotherapy regimen of fludarabine and cyclophosphamide will be administered followed by investigational treatment, CNCT19.
Receives: Biological: single dose of CNCT19

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Remission Rate (ORR), which includes Complete Remission (CR) and Partial Remission (PR)

    Efficacy of CNCT19 as measured by ORR at the 3 months after CNCT19 Cell Injection infusion, which includes CR and PR.

    Measured: At 3 months after infusion

Secondary outcomes (9)

  1. CR rate at 3 months after CNCT19 infusion

    Efficacy of CNCT19 as measured by CR during the 3 months after CNCT19 Cell Injection infusion.

    Measured: 3 months

  2. ORR（CR+PR）/CR

    Measured: 28 days

  3. ORR（CR+PR）/CR

    Measured: 6 months

  4. Progression-free survival (PFS)

    PFS means duration from the CNCT19 Cell Injection infusion to progression of lymphoma, or death for any reason.

    Measured: 24 months

  5. Disease-free survival (DFS)

    DFS means duration from the beginning of complete remission to relapse of disease, or death (for any reason).

    Measured: 24 months

  6. Duration of Remission (DOR)

    DOR means the duration from reaching the response (e.g., CR or PR) criteria of the therapy to the first, clearly defined progressive disease, or death for disease under investigation.

    Measured: 24 months

  7. Best Overall Response (BOR)

    The best overall response after CNCT19 infusion.

    Measured: 24 months

  8. Overall Survival (OS)

    OS means duration from the CNCT19 Cell Injection infusion to death for any reason, or the last follow-up for survival.

    Measured: 24months

  9. Time to remission (TTR)

    TTR means duration from the CNCT19 Cell Injection infusion to the first response (irrespective of PR or CR, which comes first).

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Oct 2020
  2. Study start26 Oct 2020
  3. Primary completion30 Mar 2024
  4. Study completion30 Sep 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04586478
Sponsor's protocol ID
HY001205
Status last verified
Feb 2025
First submitted
8 Oct 2020
Last updated
7 Feb 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing single dose of CNCT19 in people with Non-Hodgkin's Lymphoma, run by Juventas Cell Therapy Ltd. at 17 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 26 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 7 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Yan Zhou (+8615010390127, zhouyan@juventas.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Remission Rate (ORR), which includes Complete Remission (CR) and Partial Remission (PR) (time frame: At 3 months after infusion). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04586478.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2025.

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