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Relapsed and/or Refractory Acute Lymphoblastic LeukemiaEarly Phase 1NCT04609241

CD79b CAR-T Cell Therapy for Patients With Relapsed and/or Refractory Acute Lymphoblastic Leukemia and B-cell Non-Hodgkin's Lymphoma

A Early Phase 1 study testing CD79b CAR-T Cells in people with Relapsed and/or Refractory Acute Lymphoblastic Leukemia and Relapsed and/or Refractory B-cell Non-Hodgkin's Lymphoma, run by Zhejiang University at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

A study of CD79b CAR-T Cell Therapy for Patients With Relapsed and/or Refractory Acute Lymphoblastic Leukemia and B-cell Non-Hodgkin's Lymphoma Read more about this study

Who is it for?
Any age
What is being tested?
CD79b CAR-T Cells
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
72 participants
Where
1 siteChina
Study dates
15 Nov 2020to 15 Nov 2026
Phase
Early Phase 1
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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Only For B-ALL
  • No gender or age limit
  • Histologically confirmed diagnosis of CD69b+ B-ALL per the US National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines for Acute Myeloid Leukemia (2016.v1);
  • Relapsed or refractory CD123+ AML (meeting one of the following conditions):
  • CR not achieved after standardized chemotherapy;
  • CR achieved following the first induction, but CR duration is less than 12 months;
Show all 26Show fewer
  • Ineffectively after first or multiple remedial treatments;
  • 2 or more relapses;
  • The number of primordial cells in bone marrow is > 5% (by morphology), and/or > 0.01% (by flowcytometry);
  • Philadelphia chromosome negative(Ph-) subjects; Ph+ subjects who cannot tolerate tyrosine kinase inhibitor (TKI) treatment or who do not respond to two kinds of TKI treatment;
  • Only For B-NHL
  • No gender or age limit;
  • Histologically confirmed diagnosis of DLBCL (NOS), FL, DLBCL transformed from CLL/SLL, PMBCL, and HGBCL per the WHO Classification Criteria for Lymphoma (2016);
  • Relapsed or refractory B-NHL (meeting one of the following conditions):
  • <!-- -->
  • No response or relapse after second-line or above chemotherapy regimens;
  • Primary drug resistance;
  • Relapse after auto-HSCT;
  • At least one assessable tumor lesion per Lugano 2014 criteria
  • For both B-ALL and B-NHL
  • Total bilirubin ≤ 51 umol/L, ALT and AST ≤ 3 times of upper limit ofnormal, creatinine ≤ 176.8 umol/L;
  • Echocardiogram shows left ventricular ejection fraction (LVEF) ≥50%;
  • No active infection in the lungs, blood oxygen saturation in indoorair is ≥ 92%;
  • Estimated survival time ≥ 3 months;
  • ECOG performance status 0 to 2;
  • Patients or their legal guardians volunteer to participate in the studyand sign the informed consent.

Who cannot join

  • 1. History of craniocerebral trauma, conscious disturbance,epilepsy,cerebrovascular ischemia, and cerebrovascular, hemorrhagicdiseases; 2. Electrocardiogram shows prolonged QT interval, severe heart diseasessuch as severe arrhythmia in the past; 3. Pregnant (or lactating) women; 4. Patients with severe active infections (excluding simple urinarytractinfectionand bacterial pharyngitis); 5. Active infection of hepatitis B virus or hepatitis C virus; 6. Previously treated with any CAR-T cell product or other genetically modified T cell therapies; 7. Insufficient amplification capacity in response to CD3 / CD28 co-stimulus signal (<5 times) 8. Creatinine>2.5mg/dl, or ALT / AST > 3 times of normal amounts, or bilirubin>2.0 mg/dl; 9. Other uncontrolled diseases that were not suitable for this trial; 10. Patients with HIV infection; 11. Any situations that the investigator believes may increase the risk ofpatients or interfere with the results of study.

Trial locations and contacts

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

He Huang, PhD contact

86-13605714822

huangheyu@126.com

Yongxian Hu, PhD contact

86-15957162012

huyongxian2000@aliyun.com

China1 site

  • The First Affiliated Hospital, College of Medicine, Zhejiang University

    Hangzhou, Zhejiang

    He Huang, PhD

Other trials in China

About this study

Official title: Clinical Trial for the Safety and Efficacy of Murine CD79b CAR-T Therapy for Patients With Relapsed and/or Refractory B-cell Acute Lymphoblastic Leukemia and B-cell Non-Hodgkin's Lymphoma

A study of CD79b CAR-T Cell Therapy for Patients With Relapsed and/or Refractory Acute Lymphoblastic Leukemia and B-cell Non-Hodgkin's Lymphoma

Read the detailed description

This is a single arm, open-label, single-center study. This study is indicated for relapsed or refractory Relapsed and/or Refractory Acute Lymphoblastic Leukemia and B-cell Non-Hodgkin's Lymphoma. The selections of dose levels and the number of subjects are based on clinical trials of similar foreign products. 72 patients will be enrolled. Primary objective is to explore the safety, main consideration is dose-related safety.

Being tested
CD79b CAR-T Cells

What participants receive

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

  • CD79b CAR-T CellsDrug

    Each subject receive CD79b CAR-Tcells by intravenous infusion

Study groups in NCT04609241
Study groupRoleWhat they receive
Administration of CD79b CAR-T CellExperimentalNot described
Receives: Drug: CD79b CAR-T Cells

What is being measured

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

  1. Dose-limiting toxicity (DLT)

    Adverse events assessed according to NCI-CTCAE v5.0 criteria

    Measured: Baseline up to 28 days after CD79b targeted CAR T-cells infusion

  2. Incidence of treatment-emergent adverse events (TEAEs)

    Incidence of treatment-emergent adverse events [Safety and Tolerability]

    Measured: Up to 2 years after CD79b targeted CAR T-cells infusion

Secondary outcomes (10)

  1. Acute Lymphoblastic Leukemia (ALL), Overall response rate (ORR)

    Assessment of ORR (ORR = CR + CRi) at Month 6, 12, 18 and 24

    Measured: At Month 1, 3, 6, 12, 18 and 24

  2. ALL, Overall survival（OS）

    From the first infusion of CD79b CAR-T cells to death or the last visit

    Measured: Up to 2 years after CD79b CAR-T cells infusion

  3. ALL, Event-free survival (EFS)

    From the first infusion of CD79b CAR-T cells to the occurrence of any event, including death, relapse or generelapse, disease progression (any one occurs first), and the last visit

    Measured: Up to 2 years after CD79b CAR-T cells infusion

  4. B-cell Non-Hodgkin's Lymphoma（B-NHL）, Overall response rate (ORR)

    Assessment of ORR (ORR = CR + CRi) at Month 6, 12, 18 and 24

    Measured: At Month 1, 3, 6, 12, 18 and 24

  5. B-NHL, Overall survival（OS）

    From the first infusion of CD79b CAR-T cells to death or the last visit

    Measured: Up to 2 years after CD79b CAR-T cells infusion

  6. B-NHL, Event-free survival (EFS)

    From the first infusion of CD79b CAR-T cells to the occurrence of any event, including death, relapse or generelapse, disease progression (any one occurs first), and the last visit

    Measured: Up to 2 years after CD79b CAR-T cells infusion

  7. Quality of life(EORTC QLQ-C30) Core 30 (EORTC QLQ-C30)

    Assessment using European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) scale [For item1-28: max score: 112, min score: 28, higher scores mean a better outcome; for item 28-29: max score: 14, min score: 2, higher scores mean a worse outcome] to measure Quality of life at Baseline, Month 1, 3, 6, 9 and 12

    Measured: At Baseline, Month 1, 3, 6, 9 and 12

  8. Activities of Daily Living (ADL) score

    Assessment using Activities of Daily Living (ADL) scale (Barthel Index) [max score: 100, min score: 0, higher scores mean a better outcome] at Baseline, Month 1, 3, 6, 9 and 12

    Measured: At Baseline, Month 1, 3, 6, 9 and 12

  9. Instrumental Activities of Daily Living (IADL) score

    Assessment of Instrumental Activities of Daily Living (IADL) scale [max score: 56, min score: 14, higher scores mean a worse outcome] at Baseline, Month 1, 3, 6, 9 and 12

    Measured: At Baseline, Month 1, 3, 6, 9 and 12

  10. Hospital Anxiety and Depression Scale (HADS) score

    Assessment using Hospital Anxiety and Depression Scale (HADS) [max score: 42, min score: 0, higher scores mean a worse outcome] at Baseline, Month 1, 3, 6, 9 and 12

    Measured: At Baseline, Month 1, 3, 6, 9 and 12

Timeline

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

  1. First posted30 Oct 2020
  2. Study start15 Nov 2020 (estimated)
  3. Primary completion15 Nov 2023 (estimated)
  4. Study completion15 Nov 2026 (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
72 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04609241
Sponsor's protocol ID
CD79b-001
Status last verified
Oct 2020
First submitted
23 Oct 2020
Last updated
30 Oct 2020
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 Early Phase 1 study testing CD79b CAR-T Cells in people with Relapsed and/or Refractory Acute Lymphoblastic Leukemia and Relapsed and/or Refractory B-cell Non-Hodgkin's Lymphoma, run by Zhejiang University 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 26 inclusion and 1 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: opening soon, as of the sponsor's last update on 30 Oct 2020. 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 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?

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 He Huang, PhD (86-13605714822, huangheyu@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose-limiting toxicity (DLT) (time frame: Baseline up to 28 days after CD79b targeted CAR T-cells infusion). 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 NCT04609241.

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 30 Oct 2020.

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