CD5 CAR T-cell therapy for relapsed or refractory T-cell lymphoma

A Multicenter, Open-Label, Non-Randomized, Single-Arm Phase I/II Clinical Study of Autologous and New Donor CD7 CAR-T Cells for Relapsed or Refractory Mature T-Cell Lymphomas

This trial tries CD5 CAR T-cell therapy, using either the patient's own cells or donor cells, and may bridge to stem-cell transplant for people 14–70 with relapsed or refractory T-cell lymphoma.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 36 (estimated)
• Ages: 14 Years to 70 Years
• Sex: All
• Sponsor: Beijing GoBroad Hospital (Academic / other)
• Drugs / interventions: CAR T, chemotherapy, CAR-T
• Locations: 3 sites (Beijing and 2 other locations)
• Trial ID: NCT07022964 on ClinicalTrials.gov

What this trial studies

This multicenter, open-label, single-arm Phase 1/2 trial delivers autologous or allogeneic CD5-directed CAR T cells to patients with relapsed or refractory T-cell non-Hodgkin lymphomas. The primary objective is to test the safety of CD5 CAR T as a bridge to hematopoietic stem-cell transplantation, with the main endpoint being dose-limiting toxicities within 21 days after infusion. Up to 36 participants will be enrolled and monitored closely for cytokine release syndrome, neurotoxicity, infections, and other adverse events. Treatments and follow-up occur at three participating hospitals with scheduled visits to track safety and disease response.

Who should consider this trial

Good fit: Adolescents and adults (14–70 years) with relapsed or refractory T‑cell lymphoma who have exhausted standard treatments, have ECOG 0–2, and can provide informed consent are the intended candidates.

Not a fit: Patients with poor performance status (ECOG >2), active uncontrolled infections, very short life expectancy, or tumors that do not express the targeted antigen (CD5) are unlikely to benefit.

Why it matters

Potential benefit: If successful, this approach could induce remissions in patients who have exhausted standard options and enable curative stem-cell transplantation.

How similar studies have performed: CAR T-cell therapies transformed treatment for B-cell lymphomas, but CD5-directed CAR T for T-cell lymphomas is a newer strategy with only limited early-phase signs of activity so far.

Eligibility criteria

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.

Where this trial is running

Beijing and 2 other locations

• Beijing GoBroad Hospital — Beijing, China (Recruiting)
• Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine — Shanghai, China (Recruiting)
• Shanghai Liquan Hospital — Shanghai, China (Recruiting)

Study contacts

• Principal investigator: Tengyu Wang, Ph.D — Beijing GoBroad Hospital, Beijing, Beijing 102200
• Study coordinator: Haiyang LU, Ph.D

Conditions T-Cell Non-Hodgkin Lymphoma; T-cell Lymphoma