T-Cell Non-Hodgkin LymphomaPhase 1/2NCT07022964
CD5 CAR T-Cell Therapy for r/r T-cell Lymphomas
A Phase 1/2 study testing CD5 CAR-T cells infusion in people with T-Cell Non-Hodgkin Lymphoma and T-cell Lymphoma (PTCL and CTCL), run by Beijing GoBroad Hospital at 3 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 to 70 years
- Conditions the study is for
- T-Cell Non-Hodgkin Lymphoma, T-cell Lymphoma (PTCL and CTCL)
- What is being tested?
- CD5 CAR-T cells infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 3 sitesChina
- Study dates
- 1 Jun 2025to 1 Jun 2028
- Phase
- Phase 1/2
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 14 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Inclusion Criteria (Patients who met all the inclusion criteria were eligible for enrolment):
- Relapsed or refractory 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., HSCT or chemotherapy);
- Male or female, age 14-70;
- Eastern Cooperative Oncology Group (ECOG) Physical Status Score 0-2;
- life expectancy is at least 60 days;
- Subjects should be capable of understanding and signing the informed consent 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 malignancy;
- 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 childbearing potential) with positive blood HCG test;
- Hepatitis (including hepatitis B and C) and positive screening for AIDS and syphilis.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China3 sites, 3 recruiting
- Recruiting
Beijing GoBroad Hospital
Beijing, 102200
Tengyu Wang, Ph.D, 86+18831006667, miaosc@gobroadhealthcare.com
- Recruiting
Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, 200025
Haiyang LU, Ph.D, 86+18221015770, lhy13062@rjh.com
- Recruiting
Shanghai Liquan Hospital
Shanghai, 200435
Su LI, Ph.D, 86+4000215005
About this study
Official title: A Multicenter, Open-Label, Non-Randomized, Single-Arm Phase I/II Clinical Study of Autologous and New Donor CD5CAR-T Cells for Relapsed or Refractory Mature T-Cell Lymphomas
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.
- Being tested
- CD5 CAR-T cells infusion
- Medical subject headings
- Lymphoma, T-Cell, Lymphoma, T-Cell, Cutaneous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CD5 CAR-T cells infusionDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| CD5 CAR-T therapy | Experimental | Enrolled patients were treated with anti-CD5 CAR-T cells, with or without allo-HSCT bridging. Receives: Drug: CD5 CAR-T cells infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-limiting toxicity (DLT)
Incidence and type of dose-limiting toxicity(DLT) within 21 days of CD5CAR-T infusion.
Measured: 21 days
Adverse events (AEs)
Total number, incidence and severity of adverse events (AEs) within 21 days of CD5 CAR-T infusion.
Measured: 21 days
Secondary outcomes (2)
Objective Response Rate (ORR)
The assessment of ORR by dose group at 21 and 90 Days after CD5 CAR T infusion.
Measured: 21, 90 days
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
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2025
- Study start1 Jun 2025
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for T-Cell Non-Hodgkin LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing GoBroad Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ruijin Hospital, Shanghai Liquan Hospital
- Responsible party
- Principal investigator, Jing Pan, Beijing GoBroad Hospital
- Investigators
- Tengyu Wang, Ph.D, Principal investigator, Beijing GoBroad Hospital, Beijing, Beijing 102200
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07022964
- Sponsor's protocol ID
- BJGBYY-IIT-LCYJ-2025-032
- Status last verified
- Sep 2026
- First submitted
- 8 Jun 2025
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided