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Large B-cell LymphomaPhase 1/2NCT04690192

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

A Phase 1/2 study testing CNCT19, Gemcitabine Injection and busulfan in people with Large B-cell Lymphoma, run by Institute of Hematology & Blood Diseases Hospital, China at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Large B-cell Lymphoma
What is being tested?
CNCT19, Gemcitabine Injection and busulfan
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteChina
Study dates
1 Jan 2021to 30 Dec 2024
Phase
Phase 1/2
Are there results?
None posted in the registry

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 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
  • 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
Show all 22Show fewer
  • 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
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Adequate bone marrow function as evidenced by:
  • Absolute neutrophil count (ANC) ≥ 1000/uL
  • Platelet count≥ 75,000/uL
  • 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
  • Cardiac ejection fraction ≥ 50%
  • Baseline oxygen saturation > 92% on room air
  • Life expectancy ≥3 months

Who cannot join

  • Active Central Nervous System (CNS) involvement by lymphoma
  • History of autologous or allogeneic stem cell transplantation
  • 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.
  • Presence of uncontrolled infection, cardio-cerebrovascular disease，coagulopathy, or connective tissue disease.
  • History of seizure or other CNS disorder
  • History of HIV infection

Trial locations and contacts

1 site in 1 country.

China1 site

  • Institute of Hematology & Blood Diseases Hospital

    Tianjin, Tianjin Municipality, 300020

Other trials in China

About this study

Official title: CNCT19 Following Autologous Stem Cell Transplantation in Patients With Relapsed or Refractory Aggressive B-cell Lymphoma

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.

Read the 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.

Being tested
CNCT19, Gemcitabine Injection, busulfan, Melphalan Injection
Keywords
autologous stem-cell transplantation, anti-CD19 CAR T-cell, large B-cell lymphoma

What participants receive

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

  • CNCT19Biological

    2×10^6/kg, infused in a single-dose on day +2, +3 or +4 following stem-cell infusion

  • Gemcitabine InjectionDrug

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

  • busulfanDrug

    105mg/m2, day -7 until -5,

  • Melphalan InjectionDrug

    60mg/m2, day -3, -2

Study groups in NCT04690192
Study groupRoleWhat they receive
CNCT19 following ASCTExperimentalParticipants 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.
Receives: Biological: CNCT19; Drug: Gemcitabine Injection; Drug: busulfan; Drug: Melphalan Injection

What is being measured

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

  1. Percentage of participants experiencing adverse events

    Measured: from the first day of high-dose chemotherapy until 2 years post CNCT19 infusion

Secondary outcomes (6)

  1. Complete Response (CR) Rate

    Complete Response rate is defined as the incidence of a CR per the Lugano Classification (Cheson et al, 2014), as determined by study investigators.

    Measured: 2 years post CNCT19 infusion

  2. Objective Response Rate (ORR)

    ORR is defined as the incidence of either a CR or a partial response (PR) per the Lugano Classification as determined by study investigators.

    Measured: 2 years post CNCT19 infusion

  3. Progression-Free Survival (PFS)

    PFS is defined as the time from the CNCT19 infusion date to the date of disease progression or death from any cause.

    Measured: 2 years post CNCT19 infusion

  4. Duration of Response (DOR)

    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.

    Measured: 2 years post CNCT19 infusion

  5. Disease-Free Survival (DFS)

    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.

    Measured: 2 years post CNCT19 infusion

  6. Overall Survival (OS)

    OS is defined as the time from CNCT19 infusion to the date of death from any cause.

    Measured: 2 years post CNCT19 infusion

Timeline

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

  1. First posted30 Dec 2020
  2. Study start1 Jan 2021
  3. Primary completion30 Dec 2023
  4. Study completion30 Dec 2024

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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04690192
Sponsor's protocol ID
IIT2020013
Status last verified
May 2025
First submitted
26 Dec 2020
Last updated
13 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: IPD that underlie results in a publication

Publications

  • Liu W, Liu W, Zou H, Chen L, Huang W, Lv R, Xu Y, Liu H, Shi Y, Wang K, Wang Y, Xiong W, Deng S, Yi S, Sui W, Peng G, Ma Y, Wang H, Lv L, Wang J, Wei J, Qiu L, Zheng W, Zou D. Combinational therapy of CAR T-cell and HDT/ASCT demonstrates impressive clinical efficacy and improved CAR T-cell behavior in relapsed/refractory large B-cell lymphoma. J Immunother Cancer. 2024 Apr 16;12(4):e008857. doi: 10.1136/jitc-2024-008857.

    PubMed 38631712

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing CNCT19, Gemcitabine Injection and busulfan in people with Large B-cell Lymphoma, run by Institute of Hematology & Blood Diseases Hospital, China at 1 site 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 22 inclusion and 6 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: finished, as of the sponsor's last update on 13 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of participants experiencing adverse events (time frame: from the first day of high-dose chemotherapy until 2 years post CNCT19 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 NCT04690192, which also lists 1 linked publication.

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 13 May 2025.

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