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T-Cell Acute Lymphoblastic LeukemiaPhase 1NCT05032599

Donor-Derived CD5 CAR T Cells in Subjects with Relapsed or Refractory T-Cell Acute Lymphoblastic Leukemia

A Phase 1 study testing CD5 CART in people with T-Cell Acute Lymphoblastic Leukemia, run by Beijing Boren Hospital at 1 site in China.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This is a FIH, single center, open label, non-randomized, single-arm, Phase I clinical trial to evaluate the safety and tolerability of CD5 CAR T cells in subjects with relapsed or refractory T-cell acute lymphoblastic leukemia. At least 18 subjects will be enrolled. Read more about this study

Who is it for?
Ages 1 year to 70 years
Conditions the study is for
T-Cell Acute Lymphoblastic Leukemia
What is being tested?
CD5 CART
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
19 participants
Where
1 siteChina
Study dates
14 Sep 2021to 1 Sep 2024
Phase
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 1 year to 70 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • In order to be eligible to participate in this study, an individual must meet all of the following criteria:
  • Candidates with relapse or refractory CD5+ T cell acute lymphoblastic leukemia, who have progressed on after treatment with all standard therapies or intolerant of standard care, have limited prognosis with currently available therapies and had no available curative treatment options (such as SCT or chemotherapy)
  • Male or female, aged 1-70 years
  • No serious allergic constitution
  • Eastern Cooperative Oncology Group (ECOG) performance status (Oken et al., 1982) score 0 to 2
  • Have life expectancy of at least 60 days based on investigator's judgement
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  • CD5 positive in bone marrow or cerebrospinal fluid (CSF) by flow cytometry, or CD5 positive in tumor tissues by immunohistochemistry; (CD5 positive criteria: Flow cytometry: Positive: > 80% of tumor cells expressed CD5 and the MFI of CD5 is the same as that in normal T cells; Dim: > 80% of tumor cells expressed CD5, but the MFI of CD5 is lower than that in normal T cells as least as 1log; Partial positive: 20-80% of tumor cells expressed CD5 and the MFI of CD5 is the same as that in normal T cells. tumor tissue immunohistochemistry: Positive > 30% tumor cells expressed CD5);
  • Provide a signed informed consent before any screening procedure; subjects who voluntarily participate in the study should have the ability to understand and sign the informed consent form and be willing to follow the study visit schedule and relevant study procedure, as specified in the protocol. Candidates aged 19-70 years need to be sufficiently conscious and able to sign the treatment consent form and voluntary consent form; Children candidates of 8-18 years old need to be sufficiently conscious and able to sign the treatment consent form and voluntary consent form and their legal guardian or patient advocate has also need to sign the treatment consent form and voluntary consent form, respectively.Children candidates of 1-7 can be recruited after the legal guardian or patient advocate has signed the treatment consent form and voluntary consent form.
  • Have suitable and available allogeneic hematopoietic stem cell transplantation donor, and is willing to proceed to SCT if achieve CR.

Who cannot join

  • An individual who meets any of the following criteria will be excluded from participation in this study:
  • Intracranial hypertension or disorder of consciousness
  • Symptomatic heart failure or severe arrhythmia
  • Symptoms of severe respiratory failure
  • Complicated with other types of malignant tumors
  • Diffuse intravascular coagulation
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  • Serum creatinine and / or blood urea nitrogen ≥ 1.5 times of the normal value
  • Suffering from septicemia or other uncontrollable infections
  • Patients with uncontrollable diabetes
  • Severe mental disorders
  • Obvious and active intracranial lesions were detected by cranial magnetic resonance imaging (MRI)
  • Have received organ transplantation (excluding bone marrow transplant)
  • Reproductive-aged female patients with positive blood HCG test
  • Screened to be positive of infection of hepatitis (including hepatitis B and C), AIDS or syphilis
  • Post-CAR SCT is not feasible in patients who plan to receive new-donor derived CD5 CAR T cells
  • No donor is applicable for peripheral blood mononuclear cell (PBMC) collection or no frozen donor's PBMC is available for manufacturing CAR T cells.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Beijing Boren Hospital

    Beijing, Beijing Municipality, 100070

Other trials in China

About this study

Official title: First-in-Human (FIH), Open-Label, Non-Randomized, Single-Arm Phase 1 Study to Evaluate the Safety and Tolerability of Donor-Derived CD5 CAR T Cells in Subjects with Relapsed or Refractory T-Cell Acute Lymphoblastic Leukemia

This is a FIH, single center, open label, non-randomized, single-arm, Phase I clinical trial to evaluate the safety and tolerability of CD5 CAR T cells in subjects with relapsed or refractory T-cell acute lymphoblastic leukemia. At least 18 subjects will be enrolled. After the collection of PBMC and about 5 days before infusion, lymphodepletion (fludarabine at 30 mg/m^2/day and cyclophosphamide at 250 mg/m^2/day; for prior-SCT donor-derived CAR T-cell infusion) or intensified lymphodepletion (fludarabine at 30 mg/m^2/day and cyclophosphamide at 30 mg/kg/day; for new donor-derived CAR T-cell infusion) will be administrated for 3 days.

Then this study will be using BOIN1/2 approach from starting dose 1: 1×10^6 (±20%) to dose 2: 2×10^6 (±20%). If the manufactured cells were not sufficient to meet the preassigned standard dose criteria, patients are given infusion at a low dose of 5×10^5 (±20%) /kg.

Being tested
CD5 CART
Keywords
CAR-T, leukemia, acute lymphoblastic leukemia
Medical subject headings
Precursor T-Cell Lymphoblastic Leukemia-Lymphoma, Leukemia, Precursor Cell Lymphoblastic Leukemia-Lymphoma

What participants receive

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

  • CD5 CARTBiological

    Subjects will be pretreated with chemotherapy prior to infusion of CAR T cells: After the collection of PBMC and about 5 days before infusion, lymphodepletion (fludarabine at 30 mg/m^2/day and cyclophosphamide at 250 mg/m^2/day; for prior-SCT donor-derived CAR T-cell infusion) or intensified lymphodepletion (fludarabine at 30 mg/m^2/day and cyclophosphamide at 30 mg/kg/day; for new donor-derived CAR T-cell infusion) will be administrated for 3 days.

Study groups in NCT05032599
Study groupRoleWhat they receive
CD5 CARTExperimentalAll patients who receive CD5 CART cell infusion
Receives: Biological: CD5 CART

What is being measured

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

  1. Incidence and type of dose-limiting toxicity (DLT)

    Measured: 21 days post intravenous injection

  2. Incidence and severity of adverse events (AE)

    Measured: 30 days post intravenous injection

Secondary outcomes (4)

  1. Objective response rate (ORR)

    Objective response rate (ORR) according to NCCN, Complete response（CR),CR with incomplete blood count recovery(CRi) .

    Measured: 30 days post infusion

  2. Quantification of CAR T cells

    Quantification of CAR T cells by flow cytometry and/or quantitative PCR in peripheral blood and cerebral spinal fluid (CSF).

    Measured: 2 years post infusion

  3. Severe adverse events (SAE)

    The incidence of any severe adverse event (SAE) and the severity of SAE from day 30 to 2 years.

    Measured: 2 years post infusion

  4. Best overall response (BOR)

    Best overall response (BOR) rate at 3 months.

    Measured: 3 months post infusion

Timeline

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

  1. First posted2 Sep 2021
  2. Study start14 Sep 2021
  3. Primary completion1 Sep 2023
  4. Study completion1 Sep 2024

Why it stopped: ethic commitee decision

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
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
19 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05032599
Sponsor's protocol ID
BRYY-IIT-LCYJ-2021-015
Status last verified
Feb 2023
First submitted
31 Aug 2021
Last updated
14 Nov 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Pan J, Tan Y, Shan L, Seery S, Deng B, Ling Z, Xu J, Duan J, Wang Z, Wang K, Yu X, Zheng Q, Xu X, Hu G, Tan T, Yuan Y, Tian Z, Yan F, Han Y, Zhang J, Feng X. Allogeneic CD5-specific CAR-T therapy for relapsed/refractory T-ALL: a phase 1 trial. Nat Med. 2025 Jan;31(1):126-136. doi: 10.1038/s41591-024-03282-2. Epub 2024 Oct 1.

    PubMed 39354195

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing CD5 CART in people with T-Cell Acute Lymphoblastic Leukemia, run by Beijing Boren Hospital 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 9 inclusion and 16 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: stopped early, as of the sponsor's last update on 14 Nov 2024. 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 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.

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 stopped early (reason given: ethic commitee decision). Results are not available in the source record.

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?

Incidence and type of dose-limiting toxicity (DLT) (time frame: 21 days post intravenous injection). 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 NCT05032599, which also lists 1 linked publication.

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 14 Nov 2024; AzTrials last refreshed its copy on 6 Nov 2026.

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