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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: lhy13062@rjh.com.cn
• Phone: 86+ 18221015770

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Loncastuximab tesirine plus rituximab as bridging therapy before CAR-T for relapsed or refractory large B‑cell lymphoma

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.