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Acute Lymphoblastic LeukemiaEarly Phase 1NCT04532268

A Study of Humanized CD19 CAR-T Cells Therapy for Patients With Relapsed and/or Refractory B-cell ALL and B-cell NHL

A Early Phase 1 study testing Humanized CD19 CAR-T cells in people with Acute Lymphoblastic Leukemia and Non-hodgkin Lymphoma,B Cell, run by Zhejiang University at 1 site in China.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

A Study of Humanized CD19 CAR-T Cells Therapy for Patients With Relapsed and/or Refractory B-cell Acute Lymphoblastic Leukemia and B-cell Non-Hodgkin's Lymphoma. Read more about this study

Who is it for?
Ages 3 to 75 years
What is being tested?
Humanized CD19 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
23 Aug 2020to 23 Aug 2026
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 3 to 75 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Male or female aged 3-70 years;
  • Histologically confirmed diagnosis of CD19+ B-ALL per the US National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines for Acute Lymphoblastic Leukemia (2016.v1);
  • Relapsed or refractory CD19+ B-ALL (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;
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  • 2 or more relapses;
  • The number of primordial cells (lymphoblast and prolymphocyte) in bone marrow is >5% (by morphology), and/or >1% (by flow cytometry);
  • Philadelphia-chromosome-negative (Ph-) patients; or Philadelphia-chromosome-positive (Ph+) patients who cannot tolerate TKI treatments or do not respond to 2 TKI treatments;
  • Male or female aged 18-75 years;
  • 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;
  • Common inclusion criteria for B-ALL and B-NHL:
  • 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

  • Subjects with any of the following exclusion criteria were not eligible for this trial:
  • 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;
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  • Concurrent therapy with systemic steroids within 2 weeks prior to screening, except for the patients recently or currently receiving inhaled steroids;
  • Previously treated with any CAR-T cell product or other genetically-modified 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.

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，College of Medicine, Zhejiang University

    Hangzhou, Zhejiang, 310003

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

    Recruiting

Other trials in China

About this study

Official title: Clinical Trial for the Safety and Efficacy of Humanized CD19 CAR-T Cells Therapy for Patients With Relapsed and/or Refractory B-cell Acute Lymphoblastic Leukemia and B-cell Non-Hodgkin's Lymphoma

A Study of Humanized CD19 CAR-T Cells Therapy for Patients With Relapsed and/or Refractory B-cell 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 CD19+ B-cell hematological malignancies, including acute lymphoblastic leukemia and B-cell non-Hodgkin's lymphoma. The selections of dose levels and the numberof subjects are based on clinical trials of similar foreign products. Two groups of patients will be enrolled, 36 in each group. Primary objective is to explore the safety, main consideration is dose-related safety.

Being tested
Humanized CD19 CAR-T cells
Keywords
Acute Lymphoblastic Leukemia, Non-Hodgkin's Lymphoma, CAR T-cell therapy
Medical subject headings
Precursor Cell Lymphoblastic Leukemia-Lymphoma, Lymphoma, Non-Hodgkin

What participants receive

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

  • Humanized CD19 CAR-T cellsDrug

    Also called Humanized CD19 CAR-T cells injection

    Each subject receive humanized CD19 CAR T-cells by intravenous infusion

Study groups in NCT04532268
Study groupRoleWhat they receive
Administration of Humanized CD19 CAR T-cellsExperimentalDose escalation follows the standard 3+3 dose escalation design. A total of 3 dose levels are set for subjects.
Receives: Drug: Humanized CD19 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 humanized CD19 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 humanized CD19 targeted CAR T-cells infusion

Secondary outcomes (9)

  1. B-cell acute lymphocytic leukemia(B-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. B-ALL, Overall survival (OS)

    From the first infusion of humanized CD19 CAR-T cells to death or the last visit

    Measured: Up to 2 years after humanized CD19 CAR-T cells infusion

  3. B-ALL, Event-free survival (EFS)

    From the first infusion of humanized CD19 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 humanized CD19 CAR-T cells infusion

  4. B cell non-hodgkin's lymphoma (B-NHL), Overall response rate (ORR)

    Assessment of ORR (ORR = CR + PR) per Lugano 2014 criteria

    Measured: At Week 4, 12, and Month 6, 12, 18, 24

  5. B-NHL, disease control rate (DCR)

    Assessment of DCR (DCR=CR+PR+SD) per Lugano 2014 criteria

    Measured: At Week 12 and Month 6, 12, 18, 24

  6. Quality of life

    Assessment of Quality of life using Research and Treatment of Cancer QOL Core Questionnaire 30 (EORTC QLQ-30) at Baseline, Month 1, 3, 6, 9 and 12

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

  7. IADL score

    Assessment of IADL score at Baseline, Month 1, 3, 6, 9 and 12

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

  8. ADL score

    Assessment of ADL score at Baseline, Month 1, 3, 6, 9 and 12

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

  9. HADS score

    Assessment of Hospital Anxiety and Depression Scale (HADS) score 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 posted31 Aug 2020
  2. Study start23 Aug 2020 (estimated)
  3. Primary completion23 Aug 2023 (estimated)
  4. Study completion23 Aug 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
NCT04532268
Sponsor's protocol ID
hCD19-001
Status last verified
Aug 2020
First submitted
20 Aug 2020
Last updated
31 Aug 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Zhou L, Fu W, Wu S, Xu K, Qiu L, Xu Y, Yan X, Zhang Q, Zhang M, Wang L, Hong R, Chang AH, Yu J, Fu S, Kong D, Li L, Wang Y, Li Z, Jiang H, Huang J, Liu Z, Su N, Wei G, Hu Y, Huang H. Derivation and validation of a novel score for early prediction of severe CRS after CAR-T therapy in haematological malignancy patients: A multi-centre study. Br J Haematol. 2023 Aug;202(3):517-524. doi: 10.1111/bjh.18873. Epub 2023 May 16.

    PubMed 37192741

  • Song F, Hu Y, Zhang Y, Zhang M, Yang T, Wu W, Huang S, Xu H, Chang AH, Huang H, Wei G. Safety and efficacy of autologous and allogeneic humanized CD19-targeted CAR-T cell therapy for patients with relapsed/refractory B-ALL. J Immunother Cancer. 2023 Feb;11(2):e005701. doi: 10.1136/jitc-2022-005701.

    PubMed 36808074

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Humanized CD19 CAR-T cells in people with Acute Lymphoblastic Leukemia and Non-hodgkin Lymphoma,B Cell, 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 23 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: status not confirmed, as of the sponsor's last update on 31 Aug 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?

Results are not available in the source record.

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 humanized CD19 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 NCT04532268, 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 31 Aug 2020.

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