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T-cell Leukemia/LymphomaPhase 2NCT04689659

Multi-centers, Open-Label, Phase 2 Study to Evaluate the Efficacy and Safety of Donor-Derived CD7 CAR T Cells in Subjects With Relapsed or Refractory T-cell Leukemia/Lymphoma

A Phase 2 study testing chimeric antigen receptor T cell treatment in people with T-cell Leukemia/Lymphoma and Refractory T Lymphoblastic Leukemia/Lymphoma, run by Beijing Boren Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a multi-centers, single-arm, open label, Phase 2 clinical trial to evaluate the efficacy and safety of CD7 CAR T cells in subjects with relapsed or refractory T-cell leukemia/lymphoma. Seventy subjects will be enrolled. Read more about this study

Who is it for?
Ages 1 year to 70 years
What is being tested?
chimeric antigen receptor T cell treatment
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
55 participants
Where
1 siteChina
Study dates
1 Dec 2021to 3 Apr 2024
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 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 CD7+ T cell acute lymphoblastic leukemia/lymphoma, 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
  • CD7 positive in bone marrow or cerebrospinal fluid (CSF) by flow cytometry, or CD7 positive in tumor tissues by immunohistochemistry; (CD7 positive criteria: Flow cytometry: Positive: > 80% of tumor cells expressed CD7 and the mean fluorescence (MFI) of CD7 is the same as that in normal T cells; Dim: > 80% of tumor cells expressed CD7, but the MFI of CD7 is lower than that in normal T cells as least as 1log; Partial positive: 20-80% of tumor cells expressed CD7 and the MFI of CD7 is the same as that in normal T cells. tumor tissue immunohistochemistry: Positive > 30% tumor cells expressed CD7);
  • 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 1-7 can be recruited after the legal guardian or patient advocate has signed 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

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
Show all 14Show fewer
  • 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 human chorionic gonadotropin (HCG) test
  • Screened to be positive of infection of hepatitis (including hepatitis B and C), acquired immunodeficiency syndrome (AIDS) or syphilis

Trial locations and contacts

1 site in 1 country.

China1 site

  • Beijing Boren Hospital

    Beijing, Beijing Municipality, 100000

Other trials in China

About this study

This is a multi-centers, single-arm, open label, Phase 2 clinical trial to evaluate the efficacy and safety of CD7 CAR T cells in subjects with relapsed or refractory T-cell leukemia/lymphoma. Seventy subjects will be enrolled. CD7 CAR T cells will be given once intravenously at one dose (1×106, with an allowance of ± 20%) in patients received previous HSCT donor-derived CAR T cells. Patients who received fresh donor derived CD7 CAR T cells were given initial dose of 1×106, with an allowance of ± 20%. The dose levels may be adjusted during the study based on the specific number of cells on the day of fresh CAR T cells infusion, due to at this time all the patients have completed lymphodepleting, so we adopt the allowance of ±20% for each group of absolute infusion cells. And patients who were lower than the designed dose group were also given infusion, but they will be either assigned to the lower dose group or exclude from safety analysis of designed dose group.

Being tested
chimeric antigen receptor T cell treatment
Keywords
CAR-T
Medical subject headings
Leukemia, T-Cell, Lymphoma, Recurrence

What participants receive

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

  • chimeric antigen receptor T cell treatmentBiological

    CD7 CAR T cells will be given once intravenously at one dose (1×106, with an allowance of ± 20%) in patients received previous HSCT donor-derived CAR T cells. Patients who received fresh donor derived CD7 CAR T cells were given initial dose of 1×106, with an allowance of ± 20%. The dose levels may be adjusted during the study based on the specific number of cells on the day of fresh CAR T cells infusion, due to at this time all the patients have completed lymphodepleting, so we adopt the allowance of ±20% for each group of absolute infusion cells. And patients who were lower than the designed dose group were also given infusion, but they will be either assigned to the lower dose group or exclude from safety analysis of designed dose group.

Study groups in NCT04689659
Study groupRoleWhat they receive
chimeric antigen receptor T cell treatmentExperimentalNot described
Receives: Biological: chimeric antigen receptor T cell treatment

What is being measured

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

  1. Efficacy: Best overall response (BOR) rate

    Best overall response (BOR) rate to the CAR T treatment

    Measured: at 3 months

Timeline

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

  1. First posted30 Dec 2020
  2. Study start1 Dec 2021
  3. Primary completion3 Apr 2024
  4. Study completion3 Apr 2024

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
55 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04689659
Sponsor's protocol ID
BR-IIT-LCYJ-2020-005
Status last verified
May 2025
First submitted
28 Dec 2020
Last updated
18 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Pan J, Zhao L, Zhang Y, Seery S, Tan Y, Deng B, Shan L, Ling Z, Wu F, Wang Z, Wang Q, Yu X, Zheng Q, Xu X, Yuan Y, Tian Z, Zhang Y, Peng S, Chang AH, Feng X. Donor-derived CD7 CAR T cells for pediatric and adult relapsed/refractory T-ALL/LBL: a phase 2 trial. Blood. 2025 Dec 4;146(23):2745-2757. doi: 10.1182/blood.2025029299.

    PubMed 40712157

  • Velasquez MP. Allogeneic CD7-CAR T cells to bridge the gap? Transplant Cell Ther. 2023 Mar;29(3):139-140. doi: 10.1016/j.jtct.2023.02.006. No abstract available.

    PubMed 36858787

  • Pan J, Tan Y, Wang G, Deng B, Ling Z, Song W, Seery S, Zhang Y, Peng S, Xu J, Duan J, Wang Z, Yu X, Zheng Q, Xu X, Yuan Y, Yan F, Tian Z, Tang K, Zhang J, Chang AH, Feng X. Donor-Derived CD7 Chimeric Antigen Receptor T Cells for T-Cell Acute Lymphoblastic Leukemia: First-in-Human, Phase I Trial. J Clin Oncol. 2021 Oct 20;39(30):3340-3351. doi: 10.1200/JCO.21.00389. Epub 2021 Jul 29.

    PubMed 34324392

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing chimeric antigen receptor T cell treatment in people with T-cell Leukemia/Lymphoma and Refractory T Lymphoblastic Leukemia/Lymphoma, 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 8 inclusion and 14 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: finished, as of the sponsor's last update on 18 May 2025. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Efficacy: Best overall response (BOR) rate (time frame: at 3 months). 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 NCT04689659, which also lists 3 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 18 May 2025.

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