ClinicalTrials.gg
RecruitingNCT07022964Updated Sep 11, 2026

CD5 CAR T-Cell Therapy for r/r T-cell Lymphomas

A Phase 1/2 interventional study of CD5 CAR-T cells infusion in T-Cell Non-Hodgkin Lymphoma and T-cell Lymphoma (PTCL and CTCL), sponsored by Beijing GoBroad Hospital. Recruiting at 3 sites in China. Open to participants aged 14 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-09-11.

Sponsored by Beijing GoBroad Hospital · Phase 1/2, Interventional, and Treatment

From the registry’s dates

  • Started Jun 2025; still recruiting 1 year 5 months later.
Phase
Phase 1/2
Study type
Interventional
Enrollment
36
Allocation
Not applicable
Ages
14 Years to 70 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 75 studies in Lymphoma, T-Cell with a site in China — 31 open to participants now, 34 under way, 4 of them phase 3. Lymphoma, T-Cell · China.

Planned enrollment
37th of 69
36 · median 38
Started
2025
with 9 others
Phase 1/2
12 of 75
6 open now
Primary completion
2026-11
later than 15 of 33 live
Registered
67th of 75
by date
Lead sponsor
2 of 75
Beijing GoBroad Hospital

Among the 75 studies in Lymphoma, T-Cell with a site in China, this one is the 37th largest by planned enrollment of the 69 interventional ones that give a count, is one of 10 that started in 2025, is one of 12 in phase 1/2, reaches primary completion later than 15 of the 33 other live ones, and was the 67th registered.

Lymphoma, T-Cell

310 studies on the registry are indexed under Lymphoma, T-Cell; 78 are open to participants now.

Browse Lymphoma, T-Cell studies →

Open to participants now

31 of the 75 studies in Lymphoma, T-Cell with a site in China are open now. Recruiting first, the newest first:

25 more — sign in →

All 31 open studies →

A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →

Who these studies take

Of the 68 Lymphoma, T-Cell studies recruiting now, 41 (60%) set no upper age limit and 21 (31%) stop at 75 or younger; 15 take children under 18; 2 take healthy volunteers.

This study: 14 Years to 70 Years · all sexes · no healthy volunteers.

The full table on the hub →

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02

Study summary

This is a multi-center, open-label, non-randomized, single-arm clinical trial. Refractory/relapse T-NHL patients are treated with autologous and allogeneic CD5 CAR T-cell therapy. The primary objective is to prospectively evaluate the safety of CD5 CAR T cell bridging to HSCT in the treatment of r/r T-NHL. The primary endpoint is the type and incidence of dose limiting toxicity (DLT) within 21 days after CD5 CAR-T cell infusion. A total of 36 subjects is estimated to be enrolled.

03

Conditions studied

  • T-Cell Non-Hodgkin Lymphoma
  • T-cell Lymphoma (PTCL and CTCL)
04

Who can participate

Ages eligible
14 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Inclusion Criteria (Patients who met all the inclusion criteria were eligible for enrolment):

  • CD7-positive T-cell lymphomas that were treated with with standard chemotherapy, with poor prognosis from currently available treatments at and no available treatment options (e.g., or chemotherapy);
  • Male or female, age 14-70;
  • (ECOG) Physical Status Score 0-2;
  • is at least 60 days;
  • Subjects should be capable of understanding and signing the form prior to any screening procedures. Subjects are willing to follow the study visit schedule and associated study procedures as specified in the protocol. Candidates between the ages of 19-70 years old will need to be sufficiently aware of and capable of signing the informed consent form; underage candidates between the ages of 14-18 years old will need to be sufficiently aware of the informed consent form and their legal guardian will also need to sign the informed consent form separately.

Exclusion Criteria (Patients who fulfil any of the following criteria may not be enrolled):

  • Patients with history of allogeneic HSCT but PBMNC is not available from prior- transplant donor for preparation of CAR T cells and peripheral blood tumour load >30%; patients without history of allogeneic HSCT and peripheral blood tumour load >30%;
  • Intracranial hypertension or cerebral impaired consciousness;
  • Symptomatic heart failure or severe arrhythmia;
  • Symptoms of severe respiratory failure;
  • With other types of ;
  • Diffuse intravascular coagulation;
  • Serum creatinine and/or urea nitrogen ≥ 1.5 times the normal value;
  • With sepsis or other uncontrollable infection;
  • Suffering from uncontrollable diabetes mellitus;
  • Severe mental disorders;
  • Have significant intracranial lesions on cranial MRI;
  • Organ transplantation (excluding haematopoietic stem cell transplantation) history;
  • Female patients (patients of ) with positive blood HCG test;
  • Hepatitis (including and C) and positive screening for AIDS and syphilis.
Terms in these criteria, in plain language(8)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Relapsed and refractory

Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.

Allogeneic and autologous transplant

Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
36 participants (estimated)

Study arms

  • Experimental
    CD5 CAR-T therapy

    Enrolled patients were treated with anti-CD5 CAR-T cells, with or without allo-HSCT bridging.

    Drug: CD5 CAR-T cells infusion

Interventions

  • DrugCD5 CAR-T cells infusion

    Approximately 3-5 days prior to CD5 CAR-T cell infusion, subjects are treated with FC regimen (fludarabine and cyclophosphamide) for lymphodepletion. CAR-T cell infusion are performed 48 h after completion of chemotherapy.

06

What researchers measure

Primary outcomes

  1. Dose-limiting toxicity (DLT)

    Incidence and type of dose-limiting toxicity(DLT) within 21 days of CD5CAR-T infusion.

    Time frame: 21 days

  2. Adverse events (AEs)

    Total number, incidence and severity of adverse events (AEs) within 21 days of CD5 CAR-T infusion.

    Time frame: 21 days

Secondary outcomes

  1. Objective Response Rate (ORR)

    The assessment of ORR by dose group at 21 and 90 Days after CD5 CAR T infusion.

    Time frame: 21, 90 days

  2. Duration of response (DOR)

    DOR is defined as the date when CR response criteria are first met to the date of relapse or death caused by T-NHL in the absence of documented relapse

    Time frame: up to 2 years

07

Study locations

3 of 3 sites recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jun 2025 (actual). Primary completion is estimated for Nov 2026, 17 months after the start.

Of 29 phase 1/2 interventional studies under Lymphoma, T-Cell, half reached primary completion within 62 months of starting (the median), counting those still running; a quarter within 49 and three quarters within 92. This study's planned 17 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 8, 2025
First posted
Jun 15, 2025
StartActual
Jun 1, 2025
Primary completionEst.
Nov 1, 2026
CompletionEst.
Jun 1, 2028
Last update
Sep 11, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 11, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07022964
Lead sponsor
Beijing GoBroad Hospital
Collaborators
Ruijin Hospital, Shanghai Liquan Hospital
Responsible party
Jing Pan (Director of Dept of Hemato-Oncology and Immunotherapy, Beijing GoBroad Hospital) — Principal investigator
First posted
Jun 15, 2025
Start date
Jun 1, 2025
Primary completion
Nov 1, 2026 (estimated)
Completion
Jun 1, 2028 (estimated)
Last update
Sep 11, 2026

Study contacts

Haiyang LU, Ph.D
Contact
lhy13062@rjh.com.cn
86+ 18221015770
Tengyu Wang, Ph.D
principal investigator · Beijing GoBroad Hospital, Beijing, Beijing 102200

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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