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B-cell Acute Lymphoblastic LeukemiaPhase 1/2CAR19T2NCT05613348

CD19 CAR T-cell Target Relapsed/Refractory Acute B Cell Leukemia/Lymphoma

A Phase 1/2 study testing CD19 CAR T-Cell(CAT19T2) in people with B-cell Acute Lymphoblastic Leukemia and B-Cell Lymphoma, Unspecified, run by Zhujiang Hospital at 2 sites in China.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

This study aims to evaluate the safety and efficacy of humanized Anti-CD19 Chimeric Antigen Receptor-T cell (CAR19T2 T cell) in children with refractory/relapsed B-cell acute lymphoblastic leukemia/lymphoma. Read more about this study

Who is it for?
Ages 1 year to 18 years
What is being tested?
CD19 CAR T-Cell(CAT19T2)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
2 sitesChina
Study dates
1 Dec 2022to 1 Dec 2028
Phase
Phase 1/2
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 1 year to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • ≥1 year old and ≤18 years.
  • Patients with relapsed and/or refractory CD19-positive B-cell acute leukemia/lymphoma.
  • Leukemia/lymphoma relapsed after allogeneic hematopoietic stem cell transplantation within four weeks, all immunosuppressive agents were stopped for at least four weeks, and no active graft-versus-host disease(GVHD) was detonated.
  • Lansky play (≤16 years old) scale ≥60% or Karnofsky (>16 years old) score ≥60% and Eastern Cooperative Oncology Group (ECOG) performance status ≤1. Patients who are unable to walk because of paralysis, but who are up in a wheelchair will be considered ambulatory to assess the performance score.
  • Adequate vascular access leukapheresis procedure. Absolute Lymphocyte count (ALC) greater than or equal to 100 cells/μL.
  • Adequate renal, hepatic, pulmonary, and cardiac function is defined as the following:
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  • Serum alanine aminotransferase/aspartate aminotransferase (ALT/AST) ≤ 5 upper limit of normal (ULN), Total bilirubin ≤2 x ULN.
  • A serum creatinine based on age/gender as follows: 1 to < 2 years: maximum serum creatinine 0.6 mg/dL (both male and female);2 to < 6 years: maximum serum creatinine 0.8 mg/dL (both male and female); 6 to < 10 years: maximum serum creatinine 1 mg/dL (both male and female); 10 to < 13 years: maximum serum creatinine 1.2 mg/dL (both male and female); 13 to < 16 years: maximum serum creatinine 1.5 mg/dL (male), 1.4 mg/dL (female); >=16 years: maximum serum creatinine 1.7 mg/dL (male), 1.4 mg/dL (female).
  • Baseline oxygen saturation > 92% on room air.
  • Echocardiogram or left ventricular ejection fraction (LVEF) greater than or equal to 45% confirmed by echocardiogram, no evidence of pericardial effusion (except trace or physiological), and no clinically significant arrhythmias.
  • Life expectancy of greater than or equal to 3 months.
  • Patients or legal guardians must sign an informed consent.

Who cannot join

  • Prior received any other CAR T cell and tumor vaccine treatment.
  • Patient with a previous history of active hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) infection.
  • Patient with uncontrolled systemic fungal, bacterial, viral, or other infection (including tuberculosis) despite appropriate antibiotics or other treatment.
  • Acute GVHD grade II-IV (Glucksberg criteria) or chronic GVHD requiring systemic treatment within 4 weeks before enrollment.
  • History or presence of any CNS disorder such as a seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, etc. (Except for CNS involvement of underlying hematological malignancy)
  • Severe psychological disorder or psychiatric illness.
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  • Combined with life-threatening severe organ failure.
  • Major non-medicinal surgery within four weeks.
  • Received other clinical trials within four weeks. 10. Women who are pregnant or breastfeeding.
  • 11. The following drugs patients must be stopped prior to leukapheresis:
  • Tyrosine Kinase Inhibitor (TKI) must be discontinued more than or equal to 3 days before collection.
  • Salvage chemotherapy must be stopped > 2 weeks and intrathecal chemotherapy in the 7 days prior to collection.
  • Systemic steroid therapy exceeding the equivalent of 0.5 mg/kg/day of methylprednisolone in the 7 days before collection.
  • Donor lymphocyte infusions (DLI) and Immunosuppressive therapies within 4 weeks before collection.
  • Received clofarabine or cladribine within 3 months prior to collection.
  • Receive blinatumomab within 4 weeks, inotuzumab ozogamicin, and rituximab within 4 months, and alemtuzumab within 6 months before collection.
  • 12. Tyrosine Kinase Inhibitor within 1 week and asparaginase within 4 weeks prior to CAR T-cell infusion.
  • 13. In the opinion of the PI, patients are present for any condition, not for enrollment.

Trial locations and contacts

2 sites in 1 country.

China2 sites

  • Guangdong Zhaotai Cell Bio-tech Co., LTD

    Guangzhou, Guangdong

  • Zhujiang Hospital of Southern Medical University

    Guanzhou, Guangdong

Other trials in China

About this study

Official title: Humanized CAR19T2 T Cell in Children With Refractory/Relapsed B-cell Leukemia/Lymphoma

This study aims to evaluate the safety and efficacy of humanized Anti-CD19 Chimeric Antigen Receptor-T cell (CAR19T2 T cell) in children with refractory/relapsed B-cell acute lymphoblastic leukemia/lymphoma.

Read the detailed description

CD19 CAR-T cells treating B-cell hematological malignancies have achieved unprecedented success. In this study, we investigated new third-generation autologous T cells (CAR19T2 T cells) genetically modified with humanized anti-CD19 construct incorporating CD28 and Toll-like receptor 2 (TLR2) costimulatory domains. CAR19T2 T cells will be modified before the infusion to those which could identify and kill the tumor cells (CD19+ cells). This study aims to evaluate the safety and efficacy of humanized Anti-CD19 Chimeric Antigen Receptor T cell (CAR19T2 T Cell) in children with refractory/relapsed B-cell acute lymphoblastic leukemia/lymphoma.

Being tested
CD19 CAR T-Cell(CAT19T2)
Keywords
CAR T-cell, CAR19T2 T cell, refractory/relapsed B-cell acute lymphoblastic leukemia, refractory/relapsed Lymphoma
Medical subject headings
Burkitt Lymphoma, Lymphoma, B-Cell, Lymphoma

What participants receive

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

  • CD19 CAR T-Cell(CAT19T2)Biological

    Drug: Fludarabine， Administered intravenously Drug: Cyclophosphamide， Administered intravenously

Study groups in NCT05613348
Study groupRoleWhat they receive
humanized CAR19T2 T cell to B-cell acute lymphoblastic leukemia/lymphomaExperimentalPatients received fludarabine and cyclophosphamide (Flu/Cy) for lymphodepletion (Cy at 300-500 mg/m2/dose for four days and Flu at 20-30 mg/m2/dose for two days) before CAR19T2 T cells administration. This CAR19T2 T cell will be infused over 30 minutes on days Day 0.
Receives: Biological: CD19 CAR T-Cell(CAT19T2)

What is being measured

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

  1. Overall response rate

    A total number of patients achieved a Complete response (CR) or CR with incomplete blood count recovery (CRi) on Day 28 and three months by an independent review committee(IRC) assessment, as evaluated by peripheral blood, bone marrow, central nervous system (CNS) symptoms, physical exam (PE), and cerebrospinal fluid(CSF).

    Measured: 3 months

  2. The maximum tolerated dose(MTD) of CAR19T2 T cells

    The maximum tolerated dose(MTD) of CD19-positive relapsed/ refractory acute leukemia/lymphoma treated with CAR19T2 T cells.

    Measured: 24 weeks

  3. Adverse Events (AEs)

    Type, frequency and severity of adverse events (AEs), serious adverse events (SAE), and laboratory abnormalities (overall and in clinical, histological and molecular subgroups).

    Measured: 3 years

Secondary outcomes (10)

  1. Minimal residual disease (MRD) negative response rate

    Patients achieving CR or CRi and a negative MRD bone marrow.

    Measured: Up to 12 months after infusion

  2. Event-free survival (EFS)

    Time from CAR19T2 T cell infusion to progressive disease (PD), disease relapse, start of a new anticancer therapy, or death from any cause, whichever occurs first.

    Measured: Up to 3 years after infusion

  3. Overall survival (OS)

    Time from CAR19T2 T cell infusion to time of death due to any cause.

    Measured: Up to 3 years after infusion

  4. CAR-T cell expansion level

    Copies numbers of CAR in peripheral blood (PB) and/or bone marrow (BM), CSF and lymph nodes, etc.

    Measured: 24 months

  5. The duration of CAR T cell persistence

    The duration of CAR T cell persistence in peripheral blood(PB) and/or bone marrow(BM), CSF and lymph nodes, etc.

    Measured: 24 months

  6. Rate of hematopoietic stem cell transplant (HSCT) after CAR19T2 T cell infusion

    Percentage of subjects who achieve a response after CAR19T2 T cell infusion and then proceed to HSCT.

    Measured: Up to 3 years after CAR19T2 T infusion

  7. Maximum concentration of CAR19T2 T cell and cytokines.

    Pharmacokinetics of CAR19T2 T cell in Maximum concentration.

    Measured: 12 months

  8. Time to peak concentration of CAR19T2 T cell and cytokines.

    Pharmacokinetics of CAR19T2 T cell in Time to peak concentration.

    Measured: 12 months

  9. Area under the curve of CAR19T2 T cell and cytokines.

    Pharmacokinetics of CAR19T2 T cell in Area under the curve.

    Measured: 12 months

  10. Incidence of hypogammaglobulinaemia

    Incidence and duration of hypogammaglobulinaemia.

    Measured: 12 months

Timeline

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

  1. First posted14 Nov 2022
  2. Study start1 Dec 2022 (estimated)
  3. Primary completion1 Dec 2025 (estimated)
  4. Study completion1 Dec 2028 (estimated)

Why it stopped: The company failed to provide corresponding CART services.

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
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05613348
Sponsor's protocol ID
2022-KY-094
Acronym
CAR19T2
Status last verified
Oct 2022
First submitted
13 Oct 2022
Last updated
18 Mar 2024
Results posted
No
Data monitoring committee
No
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 CD19 CAR T-Cell(CAT19T2) in people with B-cell Acute Lymphoblastic Leukemia and B-Cell Lymphoma, Unspecified, run by Zhujiang Hospital at 2 sites 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 12 inclusion and 18 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: withdrawn, as of the sponsor's last update on 18 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

The study was withdrawn before enrolling participants, so there are no results.

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?

Overall response rate (time frame: 3 months). The study lists 3 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 NCT05613348.

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 18 Mar 2024; AzTrials last refreshed its copy on 30 Oct 2026.

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