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Acute T-lymphoblastic LeukemiaPhase 2NCT05745181

Clinical Study of Anti-CD1a CAR-T in the Treatment of R/R Acute T-lymphoblastic Leukemia/Lymphoblastic Lymphoma

A Phase 2 study testing CAR-T Cell Infusion in people with Acute T-lymphoblastic Leukemia and Acute T-lymphoblastic Lymphoma, run by The Affiliated Hospital of Xuzhou Medical 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 The sponsor has not verified this record for over two years, so it may be out of date.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

To evaluate the efficacy and safety of anti-CD1a CAR-T in the treatment of relapsed refractory acute T-lymphoblastic leukemia/lymphoblastic lymphoma. Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
CAR-T Cell Infusion
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteChina
Study dates
1 Feb 2023to 1 Jan 2026
Phase
Phase 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 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 1. Patients or their legal guardians voluntarily participate and sign the informed consent; 2. Male or female patients aged 18-70 years (including 18 and 70 years); 3. The patient was diagnosed with CD1a+ acute T lymphoblastic leukemia/lymphoblastic lymphoma by pathology or flow cytometry, and had no effective treatment options at present, such as chemotherapy or hematopoietic stem cell transplantation after recurrence; Alternatively, the patient voluntarily chooses to administer antiCD1a-CAR T cells as salvage therapy. Inclusion criteria
  • Patients or their legal guardians voluntarily participate and sign the informed consent;
  • Male or female patients aged 18-70 years (including 18 and 70 years);
  • The patient was diagnosed with CD1a+ acute T lymphoblastic leukemia/lymphoblastic lymphoma by pathology or flow cytometry, and had no effective treatment options at present, such as chemotherapy or hematopoietic stem cell transplantation after recurrence; Alternatively, the patient voluntarily chooses to administer antiCD1A-CAR T cells as salvage therapy.
  • The following two categories are included:
  • CD1a+T lymphoblastic lymphoma (T-LBL); (2) CD1a+ acute T-lymphoblastic leukemia (T-ALL). 5. Subject:
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  • There was no remission or residual lesions after treatment, and HSCT (auto/allo-HSCT) was not suitable;
  • Relapse occurred after CR, and HSCT (auto/allo-HSCT) was not suitable;
  • Patients with high risk factors;
  • Relapse or no remission after hematopoietic stem cell transplantation or cellular immunotherapy.
  • 6. Measurable or evaluable lesions; 7. The patient's main tissues and organs function well:
  • Liver function: ALT/AST < 3 times the upper limit of normal (ULN) and total bilirubin ≤34.2μmol/L;
  • Renal function: creatinine < 220 μmol/L;
  • Lung function: indoor oxygen saturation ≥95%;
  • Cardiac function: left ventricular ejection fraction (LVEF) ≥40%. 8. The patients had not received any anti-cancer treatment such as chemotherapy, radiotherapy, immunotherapy (such as immunosuppressive drugs) within the first 4 weeks of enrollment, and their previous treatment-related toxic reactions had recovered to ≤ grade 1 at the time of enrollment (except low toxicity such as hair loss); 9. The patient's peripheral shallow venous blood flow is smooth, which can meet the needs of intravenous infusion; 10. Patients with ECOG score ≤2 and expected survival time ≥3 months. 4. The following two categories are included:
  • CD1a+T lymphoblastic lymphoma (T-LBL); (2) CD1a+ acute T-lymphoblastic leukemia (T-ALL). 5. Subject:
  • There was no remission or residual lesions after treatment, and HSCT (auto/allo-HSCT) was not suitable;
  • Relapse occurred after CR, and HSCT (auto/allo-HSCT) was not suitable;
  • Patients with high risk factors;
  • Relapse or no remission after hematopoietic stem cell transplantation or cellular immunotherapy.
  • 6. Measurable or evaluable lesions; 7. The patient's main tissues and organs function well:
  • Liver function: ALT/AST < 3 times the upper limit of normal (ULN) and total bilirubin ≤34.2μmol/L;
  • Renal function: creatinine < 220 μmol/L;
  • Lung function: indoor oxygen saturation ≥95%;
  • Cardiac function: left ventricular ejection fraction (LVEF) ≥40%. 8. The patients had not received any anti-cancer treatment such as chemotherapy, radiotherapy, immunotherapy (such as immunosuppressive drugs) within the first 4 weeks of enrollment, and their previous treatment-related toxic reactions had recovered to ≤ grade 1 at the time of enrollment (except low toxicity such as hair loss); 9. The patient's peripheral shallow venous blood flow is smooth, which can meet the needs of intravenous infusion; 10. Patients with ECOG score ≤2 and expected survival time ≥3 months.

Who cannot join

  • Women who are pregnant (urine/blood pregnancy test positive) or breastfeeding;
  • Men or women who have planned to become pregnant within the last 1 year;
  • The patients were not guaranteed to take effective contraceptive measures (condoms or contraceptives, etc.) within 1 year after enrollment;
  • Patients had uncontrollable infectious diseases within 4 weeks prior to enrollment;
  • Active hepatitis B/C virus;
  • Hiv-infected patients;
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  • Suffering from a serious autoimmune disease or immunodeficiency disease;
  • The patient is allergic to antibodies, cytokines and other macromolecular biological drugs;
  • The patient had participated in other clinical trials within 6 weeks prior to enrollment;
  • Systemic use of hormones within 4 weeks prior to enrollment (except for inhaled hormones);
  • Suffers from mental illness;
  • The patient has substance abuse/addiction;
  • According to the researchers judgment, the patient had other conditions that were not suitable for inclusion.

Trial locations and contacts

1 site in 1 country.

Wei Sang, M.D., Ph.D. contact

13645207648

xyfylbl515@xzhmu.edu.cn

China1 site, 1 recruiting

  • The Affiliated Hospital of Xuzhou Medical University

    Xuzhou, Jiangsu, 221002

    Wei Sang, M.D., Ph.D., 13645207648, xyfylbl515@xzhmu.edu.cn

    Recruiting

Other trials in China

About this study

Official title: Clinical Study of Anti-CD1a CAR-T in the Treatment of Relapsed Refractory Acute T-lymphoblastic Leukemia/Lymphoblastic Lymphoma

To evaluate the efficacy and safety of anti-CD1a CAR-T in the treatment of relapsed refractory acute T-lymphoblastic leukemia/lymphoblastic lymphoma.

Read the detailed description

Acute T-lymphoblastic leukemia/lymphoblastic lymphoma (T-ALL/LBL) is a highly heterogeneous hematological malignancy usually associated with genetic alterations/mutations in transcription factors that are major regulators of hematopoietic stem/progenitor cell homeostasis and T cell development. 70% of patients develop mass with myeloid invasion and other leukemia symptoms.

CD1a, a transfer membrane glycoprotein, is a cell surface antigen present on cortical T-ALL cells. It is present in 40% of T-ALL cases. Specific expression of this antigen has also been observed in developing cortical thymus cells. It was also slightly expressed in langerhans cells, digital dendritic cells, B lymphocytes and gastrointestinal epithelial cells. CD1a4 was not expressed in CD34+ progenitor cells or T cells during ontogeny. This property of CD1a makes it a suitable target antigen whose targeting minimizes the possibility of non-tumor toxicity.

This study intends to treat r/r CD1a+T-ALL/LBL with CD1a CAR-T to observe its safety and efficacy.

Being tested
CAR-T Cell Infusion
Keywords
anti-CD1a CAR-T, relapsed refractory

What participants receive

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

  • CAR-T Cell InfusionBiological

    Peripheral blood mononuclear cells were isolated, amplified and cultured in vitro, pretreated with FC regimen, and Anti-CD1a CAR-T cells were transfused.

Study groups in NCT05745181
Study groupRoleWhat they receive
CAR-T Cell InfusionExperimentalPeripheral blood mononuclear cells were isolated, amplified and cultured in vitro, pretreated with FC regimen, and Anti-CD1a CAR-T cells were transfused.
Receives: Biological: CAR-T Cell Infusion

What is being measured

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

  1. Objective response rate

    CR+PR

    Measured: From 2 weeks to 1 year.

  2. Progression-free survival

    The time between treatment and observation of disease progression or death from any cause.

    Measured: From 2 weeks to 1 year.

  3. overall survival

    The time interval between patient infusion of CAR-T and death from any cause or the end of follow-up.

    Measured: From 2 weeks to 1 year.

  4. Event-free survival

    The time from the start of CAR-T infusion to the occurrence of any event.

    Measured: From 2 weeks to 1 year.

Secondary outcomes (3)

  1. Characterization of the level of CAR T cell expansion in subjects over time

    Characterization of the level of CAR T cell expansion in subjects over time.

    Measured: From 2 weeks to 1 year.

  2. Duration of CAR T cells in subjects

    Duration of CAR T cells in subjects

    Measured: From 2 weeks to 1 year.

  3. Characteristics of lymphocyte reduction in subjects

    Characteristics of lymphocyte reduction in subjects

    Measured: From 2 weeks to 1 year.

Timeline

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

  1. First posted27 Feb 2023
  2. Study start1 Feb 2023
  3. Primary completion1 Jan 2026 (estimated)
  4. Study completion1 Jan 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
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05745181
Sponsor's protocol ID
XYFY2022-KL479-01
Status last verified
Feb 2023
First submitted
14 Feb 2023
Last updated
27 Feb 2023
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 2 study testing CAR-T Cell Infusion in people with Acute T-lymphoblastic Leukemia and Acute T-lymphoblastic Lymphoma, run by The Affiliated Hospital of Xuzhou Medical 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 25 inclusion and 13 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 27 Feb 2023. 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?

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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Wei Sang, M.D., Ph.D. (13645207648, xyfylbl515@xzhmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective response rate (time frame: From 2 weeks to 1 year.). The study lists 4 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 NCT05745181.

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 27 Feb 2023.

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