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Refractory or Relapsed B-cell Non-Hodgkin LymphomaPhase 1/2NCT05842707

Study of Cord Blood-derived CAR NK Cells Targeting CD19/CD70 in Refractory/Relapsed B-cell Non-Hodgkin Lymphoma

A Phase 1/2 study testing dualCAR-NK19/70 cell in people with Refractory or Relapsed B-cell Non-Hodgkin Lymphoma, run by Aibin Liang，MD，Ph.D. at 1 site 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

To find the highest tolerable dose of dualCAR-NK19/70 (a type of cell therapy) that can be given to patients who have B-cell lymphoma that is relapsed or refractory. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
dualCAR-NK19/70 cell
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
1 siteChina
Study dates
18 Jan 2023to 18 Jan 2029
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 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Voluntarily participate in the study and sign the informed consent;
  • Age 18-75, male and female;
  • Histologically confirmed diffuse large B-cell lymphoma (DLBCL), transformed follicular lymphoma (tFL), primary mediastinal B-cell lymphoma (PMBCL), mantle cell lymphoma (MCL), and other Indolent B-cell NHL transforming types:
  • （A） Relapsed or Refractory DLBCL and tFL after 2 lines Immunotherapy or chemotherapy ; （B） Definition of Refractory large B cell lymphoma (SCHOLAR - 1 Research Standard) : disease progression after more than 4 courses of standard Immunotherapy or chemotherapy; Or the time of disease stabilization ≤ 6 months; Or disease progression or recurrence within 12 months after autologous hematopoietic stem cell transplantation (auto-HSCT); （C） Relapsed or Refractory MCL must be 1 line with immune chemotherapy; BTK inhibitors are resistant or intolerant as 2-line therapy; （D） Relapsed or Refractory disease after chemotherapy including rituximab and anthracycline.
  • There was at least one measurable lesion with the longest diameter ≥ 1.5cm;
  • Estimated life expectancy of more than 12 weeks other than primary disease;
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  • Previously confirmed diagnosis as CD19+ or CD70+ B-NHL.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 3.
  • Adequate reserve of organ function:
  • （A） Serum alanine aminotransferase (ALT) / aspartate aminotransferase (AST) ≤2.5 times the Upper Limit of Normal (ULN) for age; （B） A creatinine clearance (as estimated either by a direct urine collection or Cockcroft-Gault Equation) > 60mL/min; （C） Total bilirubin and alkaline phosphatase ≤1.5 times the Upper Limit of Normal (ULN) for age; （D） glomerular filtration rate > 50 ml/min （E） Cardiac ejection fraction (EF) ≥ 45% as determined by an echocardiogram (ECHO) or Multigated Radionuclide Angiography (MUGA); （F） Baseline oxygen saturation >92% on room air （G） Absolute neutrophil count > 1000/μL, Platelet count > 45,000/μL ,Hemoglobin > 80g/L;
  • Once previous autologous hematopoietic stem cell transplantation (auto-HSCT) is allowed;
  • For systemic therapy(Such as systemic chemotherapy, systemic radiotherapy and immunotherapy), at least 3 weeks，for Targeted drug therapy alone，at least 2 weeks，must have elapsed at the time of cell infusion;
  • Either having failed or Relapsed after CAR-T therapy at 3 months of assessment;
  • Subjects of child-bearing or child-fathering potential must be willing to practice birth control from the time of enrollment on this study until the follow-up period of the study. Women of childbearing potential must have a negative serum or urine pregnancy test.
  • The viral load of severe coronavirus disease 2019 (COVID-19) is undetectable per quantitative PCR and/or nucleic acid testing for two tests.

Who cannot join

  • Allergic to any of the components of cell products;
  • Previous or concurrent of other type of maligant tumors;
  • Acute GvHD or generalized chronic GvHD with grade II-IV (Glucksberg standard) after previous autologous hematopoietic stem cell transplantation (auto-HSCT); Or receiving of anti-GVHD therapy;
  • Known history of systemic gene therapy within the prior 3 months;
  • Active systemic fungal, viral, or bacterial infection (except for simple urinary tract infections and bacterial pharyngitis), however, Preventive treatment is permitted;
  • Known history of infection with hepatitis B (HBsAg positive, but HBV-DNA<1000 is not excluded) or hepatitis C virus (including virus carriers), syphilis and other acquired and congenital immunodeficiency diseases, including but not limited to HIV infection;
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  • Class III or IV heart failure as defined by the New York Heart Association;
  • Persisting toxicities (>grade 1, except for clinically non-significant toxicities such as alopecia, fatigue, and anorexia) due to prior trerapy;
  • Known history of active seizures or presence of seizure activities or other central nervous system disease;
  • Have evidence of central nervous system lymphoma(CNS lymphoma) on CT or MRI;
  • Breast-feeding woman;
  • Any circumstances that possibly increase the risk of subjects or interfere with study results, which judged by investigator.

Trial locations and contacts

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

aibin Liang contact

18601670600

lab7182@tongji.edu.cn

Ping Li contact

13564181131

lilyforever76@126.com

China1 site, 1 recruiting

  • Shanghai Tongji Hospital, Tongji University School of Medicine

    Shanghai, Shanghai Municipality, 200065

    Aibin Liang, MD, Ph.D, 0086-021-66111019, lab7182@tongji.edu.cn

    Recruiting

Other trials in China

About this study

To find the highest tolerable dose of dualCAR-NK19/70 (a type of cell therapy) that can be given to patients who have B-cell lymphoma that is relapsed or refractory.

Read the detailed description

Primary Objectives:

--The primary objective is to determine the safety and identify the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) of dualCAR-NK19/70 in patients with r/r B-cell lymphomas.

Hypothesis: DualCAR-NK19/70 will be safe, well-tolerated, and effective in patients with r/r B-cell lymphomas.

Secondary Objectives:

--The secondary objective is to determine the efficacy in adults with r/r LBCL and FL grade 3B treated at the MTD or RP2D of dualCAR-NK19/70. Although the clinical benefit of dualCAR-NK19/70 has not yet been established, the intent of offering this treatment is to provide a possible therapeutic benefit, and thus the patient will be carefully monitored for tumor response and symptom relief in addition to safety and tolerability. Secondary endpoints include overall response rate (ORR; including CR + PR) and CR rate as defined by the Lugano Classification response criteria for malignant lymphoma, DOR, PFS, and OS.

Exploratory Objectives:

--The exploratory objectives are to assess the cellular kinetics and pharmacodynamic effects of dualCAR-NK19/70 and to evaluate biomarkers associated with response, resistance, and toxicity after administration of dualCAR-NK19/70 in blood and tumor samples.

Being tested
dualCAR-NK19/70 cell
Keywords
B-cell Non-Hodgkin Lymphoma, CAR NK Cells Targeting CD19/CD70, Cord Blood-derived
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.

  • dualCAR-NK19/70 cellDrug

    Also called CAR-NK cell

    Given by IV (vein)

Study groups in NCT05842707
Study groupRoleWhat they receive
Part 1 (dose escalation) and Part 2 (dose expansion)ExperimentalPart 1 (dose escalation) the dose of dualCAR-NK19/70 participants receive will depend on when you join this study. Up to 3 dose levels of dualCAR-NK19/70 will be tested. About 3-6 participants will be enrolled at each dose level. The first group of participants will receive the lowest dose level of dualCAR-NK19/70. Each new group will receive a higher dose of dualCAR-NK19/70 than the group before it, if no intolerable side effects were seen. This will continue until the highest tolerable dose of dualCAR-NK19/70 is found. Part 2 (dose expansion) Participants will receive dualCAR-NK19/70 at the recommended dose that was found in Part 1.
Receives: Drug: dualCAR-NK19/70 cell

What is being measured

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

  1. incidence of dose limiting toxicity(DLTs)

    To evaluate the safety,tolerabitility,and determine the recommended dosage of cord blood-derived CAR NK cells targeting CD19/CD70

    Measured: up to 28 days

Secondary outcomes (5)

  1. Objective Response Rate（ORR）

    To determine the anti-tumor effectivity of CB dualCAR-NK19/70

    Measured: 6 months

  2. Complete Remission Rate(CRR)

    To determine the anti-tumor effectivity of CB dualCAR-NK19/70

    Measured: 3 months

  3. Overall survival(OS)

    To determine the anti-tumor effectivity of CB dualCAR-NK19/70

    Measured: Up to 3 years

  4. Duration of Response(DOR)

    To determine the anti-tumor effectivity of CB dualCAR-NK19/70

    Measured: Up to 3 years

  5. progression-free survival(PFS)

    To determine the anti-tumor effectivity of CB dualCAR-NK19/70

    Measured: Up to 3 years

Timeline

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

  1. First posted6 May 2023
  2. Study start18 Jan 2023
  3. Primary completion18 Jan 2028 (estimated)
  4. Study completion18 Jan 2029 (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
48 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05842707
Sponsor's protocol ID
2023-008
Status last verified
Apr 2023
First submitted
25 Mar 2023
Last updated
6 May 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing dualCAR-NK19/70 cell in people with Refractory or Relapsed B-cell Non-Hodgkin Lymphoma, run by Aibin Liang，MD，Ph.D. 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 15 inclusion and 12 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 6 May 2023. 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?

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 aibin Liang (18601670600, lab7182@tongji.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

incidence of dose limiting toxicity(DLTs) (time frame: up to 28 days). 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 NCT05842707.

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 6 May 2023.

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