CD7 CAR T-Cell Therapy for T-Cell Lymphomas

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 study is testing a new CAR T-cell therapy for people with T-cell lymphomas that haven't responded to regular treatments to see if it is safe and effective.

Quick facts

• Phase: PHASE1; PHASE2
• Study type: Interventional
• Enrollment: 36 (estimated)
• Ages: 14 Years to 70 Years
• Sex: All
• Sponsor: Beijing GoBroad Hospital (other)
• Drugs / interventions: CAR T, chemotherapy, CAR-T
• Locations: 4 sites (Beijing, Beijing Municipality and 3 other locations)
• Trial ID: NCT06925464 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and efficacy of CD7 CAR T-cell therapy in patients with relapsed or refractory T-cell lymphomas. It is a multi-center, open-label, non-randomized, single-arm trial that aims to treat patients who have not responded to standard chemotherapy. The primary focus is on assessing the type and incidence of dose limiting toxicity within 21 days following the infusion of CD7 CAR T-cells. A total of 36 subjects are expected to be enrolled in this trial.

Who should consider this trial

Good fit: Ideal candidates are patients aged 14-70 with relapsed or refractory CD7-positive T-cell lymphomas who have exhausted standard treatment options.

Not a fit: Patients with CD7-negative T-cell lymphomas or those who are not eligible for the specified age range may not benefit from this study.

Why it matters

Potential benefit: If successful, this therapy could provide a new treatment option for patients with difficult-to-treat T-cell lymphomas.

How similar studies have performed: While CAR T-cell therapies have shown promise in other types of lymphomas, this specific approach targeting CD7 is relatively novel and has not been extensively tested in prior studies.

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, Beijing Municipality and 3 other locations

• Beijing GoBroad Hospital — Beijing, Beijing Municipality, China (RECRUITING)
• 湛江中心人民医院 — Zhanjiang, Guangdong, China (RECRUITING)
• Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine — Shanghai, Shanghai Municipality, China (RECRUITING)
• Shanghai Liquan Hospital — Shanghai, Shanghai Municipality, China (RECRUITING)

Study contacts

• Study coordinator: Haiyang LU, Ph.D

Conditions: T-Cell Non-Hodgkin Lymphoma, T-cell Lymphoma