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Refractory B-Cell LymphomaEarly Phase 1NCT03690310

Study of Anti-CD19 CAR NK Cells in Relapsed and Refractory B Cell Lymphoma

A Early Phase 1 study testing Anti-CD19 CAR NK Cells in people with Refractory B-Cell Lymphoma, run by Allife Medical Science and Technology Co., Ltd..

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This is a single-centre, single-arm and open-label study to investigate the safety and efficacy of anti CD19 CAR NK cells in patients with relapsed refractory B cell lymphoma. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Refractory B-Cell Lymphoma
What is being tested?
Anti-CD19 CAR NK Cells
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
9 participants
Where
No sites listed yet
Study dates
Mar 2019to Nov 2021
Phase
Early Phase 1
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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • CD19 (+) B cell lymphoma confirmed by pathological immunohistochemistry or flow cytometry
  • Previously accepted ≥ first-line regimen chemotherapy
  • Unconditional acceptance of hematopoietic stem cell transplantation or recurrence after hematopoietic stem cell transplantation
  • Over 18 years old and under 70 years old
  • The expected survival period is more than 3 months.
  • ECOG≤2
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  • Important organ function is satisfied: cardiac ultrasound indicates cardiac ejection fraction ≥50%, no abnormal electrocardiogram; blood oxygen saturation ≥90%; creatinine clearance ≥40 mL/min; ALT and AST≤3 times normal range, Total bilirubin ≤ 2.0 mg / dL;
  • Blood routine: Hgb≥80 g/L, ANC≥1×109/L, PLT≥50×109/L;
  • The pregnancy test for women of childbearing age must be negative; both men and women must agree to use effective contraception during the treatment period and for the following 1 year.
  • Measurable target lesion

Who cannot join

  • Patients with extramedullary relapse
  • Burkitt's lymphoma/leukemia
  • Previously received gene product treatment, anti-CD19/anti-CD3 treatment, or any anti-CD19 treatment;
  • Liver and kidney function:
  • Total bilirubin > 2 x ULN (Gilbert Syndrome > 3 x ULN)
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) > 3 × ULN
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  • Serum creatinine clearance >60 mL/min
  • Serological examination:
  • Absolute neutrophil count (ANC) <0.75x109/L
  • Platelet count (PLT) <50x109/L
  • Active hepatitis B (HBV-DNA > 1000 copies / mL), hepatitis C, or uncontrolled infection
  • GVHD ≥ 2 or anti-GVHD treatment
  • IM19 CAR NK cells received allogeneic cell therapy within 6 weeks before infusion, such as donor lymphocyte infusion;
  • Subject received the most recent treatment (release, chemotherapy, or other) less than 4 weeks
  • Active CNS disease (tumor cells in CSF, but < 5 WBCs/mL can be included);
  • Intracranial hypertension or unconsciousness; respiratory failure; diffuse vascular internal coagulation
  • Creatinine > 1.5 times normal upper limit or ALT / AST > 3 times normal upper limit or bilirubin > 2 times normal upper limit
  • New York Heart Association (NYHA) graded above or above
  • Uncontrollable diabetes
  • Suffering from other uncontrolled diseases, the researchers believe that it is not suitable for joining
  • Any situation that the investigator believes may increase the risk of the subject or interfere with the test results

About this study

Official title: An Observational Clinical Study on the Safety and Efficacy of Anti-CD19 CAR NK Cells in Relapsed and Refractory B Cell Lymphoma

This is a single-centre, single-arm and open-label study to investigate the safety and efficacy of anti CD19 CAR NK cells in patients with relapsed refractory B cell lymphoma.

Being tested
Anti-CD19 CAR NK Cells
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.

  • Anti-CD19 CAR NK CellsBiological

    Anti-CD19 CAR NK Cells injection

Study groups in NCT03690310
Study groupRoleWhat they receive
Anti-CD19 CAR NK CellsExperimentalTotal dose of 50-600 thousand /kg Anti-CD19 CAR NK cells will be administered at day0
Receives: Biological: Anti-CD19 CAR NK Cells

What is being measured

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

  1. Occurrence of treatment related adverse events as assessed by CTCAE v4.0

    Defined as >= Grade 3 signs/symptoms, laboratory toxicities, and clinical events) that are possibly, likely, or definitely related to study treatment.

    Measured: Day 3-Year 2 after injection

Timeline

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

  1. First posted1 Oct 2018
  2. Study startMar 2019 (estimated)
  3. Primary completionNov 2020 (estimated)
  4. Study completionNov 2021 (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
Early Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
9 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03690310
Sponsor's protocol ID
CD19 CAR NK-BJZL-01
Status last verified
Sep 2018
First submitted
27 Sep 2018
Last updated
31 Jan 2019
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Anti-CD19 CAR NK Cells in people with Refractory B-Cell Lymphoma, run by Allife Medical Science and Technology Co., Ltd..

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 10 inclusion and 21 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: status not confirmed, as of the sponsor's last update on 31 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

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?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

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

Are results available for this study?

Results are not available in the source record.

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?

Occurrence of treatment related adverse events as assessed by CTCAE v4.0 (time frame: Day 3-Year 2 after injection). 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 NCT03690310.

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 31 Jan 2019; AzTrials last refreshed its copy on 7 Nov 2026.

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