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B-cell Non Hodgkin LymphomaPhase 1/2NCT05338931

Safety, Tolerability, and Efficacy of AT101 in Patients With Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma

A Phase 1/2 study testing AT101(Anti-CD19 Chimeric Antigen Receptor T cell) in people with B-cell Non Hodgkin Lymphoma, run by AbClon at 1 site in South Korea.

Recruiting

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

Sites and contacts
Official record
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Trial summary

Determine MTD based on the safety and tolerability of AT101 and the RP2D for patients with recurrent or non-reactive B-cell NHL. Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
B-cell Non Hodgkin Lymphoma
What is being tested?
AT101(Anti-CD19 Chimeric Antigen Receptor T cell)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
82 participants
Where
1 siteSouth Korea
Study dates
15 Mar 2022to 15 Sep 2030
Phase
Phase 1/2
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 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • B cell non-Hodgkin lymphoma based on WHO classification 2017
  • incompatible with existing standard therapies or have had disease progression, and whose standard therapies do not currently have available standard therapies due to reasons such as intolerance/inadequacies or rejection
  • The Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
  • adequate hematological, kidney, liver, lung, heart and bone marrow function without blood transfusion within two weeks prior to screening
  • Those with a minimum life expectancy of 12 weeks or more
  • In women with childbearing, clinical response tests (serum- or ure-hCG) were negatively identified during this trial
  • Those who have agreed in writing to participate voluntarily in this trial

Who cannot join

  • Those who have previously had a history of treating homologic autologous hemoblastitis (allogeneic HSCT)
  • At101/adcidmilisers, anticancer chemotherapy/adcidms for lymphodeletion or those who are hypersensitive to tocilizumab
  • Those who cannot take autologous blood
  • Those who have received chemotherapy or radiotherapy, excluding lymphodeletion, within two weeks prior to IP administration
  • Persons who have not been recovered (CTCAE grade ≤1 or baseline) due to previous treatment
  • Those who have identified a condition that, at the test's discretion, may affect safety and validation during the trial period.
Show all 16Show fewer
  • Those who have identified the following forces at the time of screening:
  • Those who have been clinically aware of heart disease within 6 months prior to screening
  • Those identified as thromboembolic disease, pulmonary embolism or bleeding bleeding diatheses within 6 months prior to screening
  • Those who have identified a history of malignant tumors other than B-cell non-Hodgkin's lymphoma within five years prior to screening
  • Those who have undergone major surgery within 4 weeks prior to screening
  • Those who have undergone non-critical surgery within two weeks prior to screening
  • Childbearing women or men who do not have the will to use effective contraception for a longer period of time, either 12 months after clinical trial period and AT101 administration or when AT101 in the body is not identified
  • Those who have been administered or applied to other IP/ID within 4 weeks of screening
  • Those who are addicted to alcohol and/or medication
  • Those who are unfit or unable to participate in this trial when judged by PI

Trial locations and contacts

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

Young ha Lee contact

82-2-2109-1283

yhlee@abclon.com

South Korea1 site, 1 recruiting

  • Asan Medical Center

    Seoul

    Deok-hyun Yoon

    Recruiting

Other trials in South Korea

About this study

Official title: An Open-label, Single-arm, Multi-center, Phase I/II Study to Evaluate the Safety, Tolerability, and Efficacy of AT101 (Anti-CD19 Chimeric Antigen Receptor T Cell) in Patients With Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma

Determine MTD based on the safety and tolerability of AT101 and the RP2D for patients with recurrent or non-reactive B-cell NHL.

Read the detailed description

Determine the maximum tolerant dose (MTD) based on the safety and tolerability of AT101 and the recommended dose 2 dose (RP2D) in phase 2 trials for patients with recurrent or non-reactive B cell non-Hodgkin lymphoma (B-cell NHL).

Being tested
AT101(Anti-CD19 Chimeric Antigen Receptor T cell)
Keywords
Anti-CD19 Chimeric Antigen Receptor T cell
Medical subject headings
Lymphoma, B-Cell

What participants receive

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

  • AT101(Anti-CD19 Chimeric Antigen Receptor T cell)Drug

    Also called AT101

    Anti-CD19 Chimeric Antigen Receptor T cell

Study groups in NCT05338931
Study groupRoleWhat they receive
AT101(Anti-CD19 Chimeric Antigen Receptor T cell)ExperimentalAnti-CD19 Chimeric Antigen Receptor T cell
Receives: Drug: AT101(Anti-CD19 Chimeric Antigen Receptor T cell)

What is being measured

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

  1. Determine the maximum tolerant dose (MTD) and Recommended Phase 2 Dose (RP2D)

    Phase I: Tolerability of AT101 and the recommended dose 2 dose (RP2D) in phase 2 trials

    Measured: 28 days

  2. Overall response rate (ORR) by Independent assessment

    Phase II: Proportion of subjects whose best overall response in tumor evaluation was evaluated as a complete response or a partial response

    Measured: 5 years

Secondary outcomes (11)

  1. Overall response rate (ORR) by Investigator assessment

    Proportion of subjects whose best overall response in tumor evaluation

    Measured: 5 years

  2. Duration of overall response (DOR)

    Time from first response (CR or PR) to the date of initial objectively documented progression

    Measured: 5 years

  3. Overall survival(OS)

    Time from randomization to death

    Measured: 5 years

  4. Progression free survival (PFS)

    Time from randomization to disease progression or death

    Measured: 5 years

  5. Time to response (TTR)

    Time from randomization to CR or PR

    Measured: 5 years

  6. Event free survival (EFS)

    Time from randomization to progression, subsequent chemotherapy or death

    Measured: 5 years

  7. Incidence of adverse Event

    Measured: 5 years

  8. Peak concentration (Cmax) of AT101

    Measured: 5 years

  9. Area under the concentration versus time curve (AUC) of AT101

    Measured: 5 years

  10. AT101 transgene expression

    Measured: 5 years

  11. Replication-competent lentivirus (RCL) as Assessed by quantitative polymerase

    Measured: 5 years

Timeline

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

  1. First posted21 Apr 2022
  2. Study start15 Mar 2022
  3. Primary completion15 Mar 2030 (estimated)
  4. Study completion15 Sep 2030 (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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
82 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05338931
Sponsor's protocol ID
AbClon
Status last verified
Apr 2022
First submitted
1 Apr 2022
Last updated
26 May 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Zhang Y, Patel RP, Kim KH, Cho H, Jo JC, Jeong SH, Oh SY, Choi YS, Kim SH, Lee JH, Angelos M, Guruprasad P, Cohen I, Ugwuanyi O, Lee YG, Pajarillo R, Cho JH, Carturan A, Paruzzo L, Ghilardi G, Wang M, Kim S, Kim SM, Lee HJ, Park JH, Cui L, Lee TB, Hwang IS, Lee YH, Lee YJ, Porazzi P, Liu D, Lee Y, Kim JH, Lee JS, Yoon DH, Chung J, Ruella M. Safety and efficacy of a novel anti-CD19 chimeric antigen receptor T cell product targeting a membrane-proximal domain of CD19 with fast on- and off-rates against non-Hodgkin lymphoma: a first-in-human study. Mol Cancer. 2023 Dec 9;22(1):200. doi: 10.1186/s12943-023-01886-9.

    PubMed 38066564

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing AT101(Anti-CD19 Chimeric Antigen Receptor T cell) in people with B-cell Non Hodgkin Lymphoma, run by AbClon at 1 site in South Korea.

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 7 inclusion and 16 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 26 May 2022. 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 South Korea. 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?

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 Young ha Lee (82-2-2109-1283, yhlee@abclon.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Determine the maximum tolerant dose (MTD) and Recommended Phase 2 Dose (RP2D) (time frame: 28 days). The study lists 2 primary outcomes in all. 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 NCT05338931, 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 26 May 2022.

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