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Acute Myeloid LeukemiaEarly Phase 1NCT04662294

CD 70 CAR T for Patients With CD70 Positive Malignant Hematologic Diseases

A Early Phase 1 study testing CD70 CAR T-cells in people with Acute Myeloid Leukemia and Non-hodgkin's Lymphoma, run by Zhejiang University 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
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Trial summary

A Study of CD 70 CAR T for patients with CD70 positive malignant hematologic diseases Read more about this study

Who is it for?
Any age
What is being tested?
CD70 CAR T-cells
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
108 participants
Where
1 siteChina
Study dates
18 Nov 2021to 15 Jan 2027
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

  • Histologically confirmed diagnosis of CD70 AML per the US National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines for Acute Myeloid Leukemia (2016.v1);
  • Relapsed or refractory CD70+ 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;
  • Ineffectively after first or multiple remedial treatments;
  • 2 or more relapses;
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  • The number of primordial cells in bone marrow is > 5% (by morphology), and/or > 0.01% (by flowcytometry);
  • 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.
  • No gender and 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 CD70+ 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
  • Histologically confirmed diagnosis of CD70 multiple myeloma (MM)：
  • According to the diagnostic criteria of IMWG multiple myeloma, the diagnosis was recurrent / refractory multiple myeloma
  • Cases with recurrent positive minimal residual disease;
  • Extramedullary leision which is hard to be eradicated by chemotherapy or radiotherapy.
  • No gender and age limit;
  • Total bilirubin ≤ 51 umol/L, ALT and AST ≤ 3 times of upper limit of normal, 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.
  • Common inclusion criteria :
  • Total bilirubin ≤ 51 umol/L, ALT and AST ≤ 3 times of upper limit of normal, creatinine ≤ 176.8 umol/L;
  • Echocardiogram shows left ventricular ejection fraction (LVEF) ≥ 50%;
  • No active infection in the lungs, blood oxygen saturation in indoor air is ≥ 92%;
  • Estimated survival time ≥ 3 months;
  • ECOG performance status 0 to 2;
  • Patients or their legal guardians volunteer to participate in the study and sign the informed consent -

Who cannot join

  • History of craniocerebral trauma, conscious disturbance, epilepsy, cerebrovascular ischemia, and cerebrovascular hemorrhagic diseases;
  • Electrocardiogram shows prolonged QT interval, severe heart diseases such as severe arrhythmia in the past;
  • Pregnant (or lactating) women;
  • Patients with severe active infections (excluding simple urinary tract infection and bacterial pharyngitis);
  • Active infection of hepatitis B virus or hepatitis C virus;
  • Concurrent therapy with systemic steroids within 2 weeks prior to screening, except for the patients recently or currently receiving inhaled steroids;
Show all 11Show fewer
  • Previously treated with any CAR-T cell product or other geneticallymodified T cell therapies;
  • Creatinine >2.5mg/dl, or ALT / AST>3 times of normal amounts, or bilirubin>2.0 mg/dl;
  • Other uncontrolled diseases that were not suitable for this trial;
  • Patients with HIV infection;
  • Any situations that the investigator believes may increase the risk of patients 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

hehuangyu@126.com

Yongxian Hu, PhD contact

86-15957162012

huyongxian2000@aliyun.com

China1 site, 1 recruiting

  • The first affiliated hospital of medical college of zhejiang university

    Hangzhou, Zhejiang, 310003

    He Huang, MD, 86-13605714822, hehuangyu@126.com

    Recruiting

Other trials in China

About this study

Official title: Clinical Trial for the Safety and Efficacy of CD 70 CAR T for Patients With CD70 Positive Malignant Hematologic Diseases

A Study of CD 70 CAR T for patients with CD70 positive malignant hematologic diseases

Read the detailed description

This is a single arm, open-label, single-center study. This study is indicated for CD 70 CAR T for patients with CD70 positive malignant hematologic diseases. The selections of dose levels and the number of subjects are based on clinical trials of similar foreign products. 108 patients will be enrolled. Primary objective is to explore the safety,main consideration is dose-related safety.

Being tested
CD70 CAR T-cells
Keywords
CAR T-cell therapy, CD70, Acute Myeloid Leukemia, Non-Hodgkin's lymphoma, Multiple Myeloma
Medical subject headings
Leukemia, Myeloid, Acute, Lymphoma, Non-Hodgkin, Multiple Myeloma

What participants receive

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

  • CD70 CAR T-cellsBiological

    Also called CD70 CAR-T cells injection

    Each subject receive CD70 CAR T-cells by intravenous infusion

Study groups in NCT04662294
Study groupRoleWhat they receive
T-ALLExperimentalNot described
Receives: Biological: CD70 CAR T-cells
T-NHLExperimentalNot described
Receives: Biological: CD70 CAR T-cells
AMLExperimentalNot described
Receives: Biological: CD70 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 CD70 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 CD70 targeted CAR T-cells infusion

Secondary outcomes (13)

  1. Acute Myeloid Leukemia (AML), Overall response rate (ORR)

    Assessment of ORR (ORR = CR + CRi) at Month 1, 3, 6, 12, 18 and 24

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

  2. AML, Overall survival (OS)

    From the first infusion of CD70 CAR-T cells to death or the last visit

    Measured: Up to 2 years after CD70 CAR-T cells infusion

  3. AML, Event-free survival (EFS)

    From the first infusion of CD70 CAR-T cells to the occurrence of any event, including death, relapse or gene relapse, disease progression (any one occurs first), and the last visit

    Measured: Up to 2 years after CD70 CAR-T cells infusion

  4. Non-Hodgkin's lymphoma (NHL), Overall response rate (ORR)

    Assessment of ORR (ORR = CR + CRi) at Month 1, 3, 6, 12, 18 and 24

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

  5. NHL, Overall survival (OS)

    From the first infusion of CD70 CAR-T cells to death or the last visit

    Measured: Up to 2 years after CD70 CAR-T cells infusion

  6. NHL, Event-free survival (EFS)

    From the first infusion of CD70 CAR-T cells to the occurrence of any event, including death, relapse or gene relapse,

    Measured: Up to 2 years after CD70 CAR-T cells infusion

  7. Multiple myeloma (MM), Overall response rate (ORR)

    Assessment of ORR (ORR = CR + CRi) at Month 1, 3, 6, 12, 18 and 24

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

  8. MM, Overall survival (OS)

    From the first infusion of CD70 CAR-T cells to death or the last visit

    Measured: Up to 2 years after CD70 CAR-T cells infusion

  9. MM, Event-free survival (EFS)

    From the first infusion of CD70 CAR-T cells to the occurrence of any event, including death, relapse or gene relapse

    Measured: Up to 2 years after CD70 CAR-T cells infusion

  10. Quality of life

    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

  11. 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

  12. 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

  13. 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 posted10 Dec 2020
  2. Study start18 Nov 2021 (estimated)
  3. Primary completion15 Jan 2024 (estimated)
  4. Study completion15 Jan 2027 (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
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
108 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04662294
Sponsor's protocol ID
CD70-001
Status last verified
Dec 2020
First submitted
22 Oct 2020
Last updated
4 Nov 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Dewulf J, Flieswasser T, Delahaye T, Vangestel C, Miranda A, de Haard H, Jacobs J, Smits E, Van den Wyngaert T, Elvas F. Site-specific 68Ga-labeled nanobody for PET imaging of CD70 expression in preclinical tumor models. EJNMMI Radiopharm Chem. 2023 Apr 24;8(1):8. doi: 10.1186/s41181-023-00194-3.

    PubMed 37093350

  • Golubovskaya V. CAR-T Cells Targeting Immune Checkpoint Pathway Players. Front Biosci (Landmark Ed). 2022 Apr 2;27(4):121. doi: 10.31083/j.fbl2704121.

    PubMed 35468680

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing CD70 CAR T-cells in people with Acute Myeloid Leukemia and 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 38 inclusion and 11 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 4 Nov 2021. 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, hehuangyu@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 CD70 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 NCT04662294, which also lists 2 linked publications.

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 4 Nov 2021; AzTrials last refreshed its copy on 6 Nov 2026.

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