CD7 CAR-T therapy for patients with relapsed or refractory T-cell malignancies

Autologous and Donor-derived CD7 CAR T-cell Therapy in Refractory or Relapsed T-cell Malignancies: a Multi-center, Open-label, Phase Ⅰ/Ⅱ Clinical Trial

This study is testing a new type of CAR-T therapy for people with T-cell leukemia that hasn't responded to other treatments to see if it can help them feel better.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 1 Year to 70 Years
• Sex: All
• Sponsor: Beijing GoBroad Hospital (Academic / other)
• Drugs / interventions: chemotherapy, CAR T
• Locations: 4 sites (Beijing, Beijing Municipality and 3 other locations)
• Trial ID: NCT06316427 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and efficacy of autologous and donor-derived CD7 CAR T-cell therapy in patients suffering from refractory or relapsed T-cell malignancies, specifically T-cell acute lymphoblastic leukemia. The study is multi-center and open-label, involving patients who have not responded to standard treatments. Participants will receive CD7 CAR T cells based on their hematopoietic stem cell transplant history and leukemia burden. The primary objectives include assessing dose limiting toxicity and overall response rates to the treatment.

Who should consider this trial

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

Not a fit: Patients with CD7-negative malignancies or those who have not progressed after standard treatments may not benefit from this study.

Why it matters

Potential benefit: If successful, this therapy could provide a new treatment option for patients with limited prognosis due to refractory or relapsed T-cell malignancies.

How similar studies have performed: While CAR T-cell therapies have shown promise in other hematological malignancies, this specific approach targeting CD7 in T-cell malignancies is relatively novel.

Eligibility criteria

Inclusion Criteria:

Only patients who meet all the following criteria can be included in the group:

1. CD7-positive refractory or relapsed T-cell malignancies with progression or intolerance after all standard treatments, limited prognosis from currently available treatments and no available treatment options (e.g. HSCT or chemotherapy).
2. Tumor cells in bone marrow or cerebrospinal fluid are positive for CD7 antigen by flow cytometry or tumour tissue is positive for CD7 by immunohistochemistry (CD7 antigen positivity by flow cytometry: \>80% of tumour cells expressing CD7 with a mean fluorescence intensity \[MFI\] of CD7 similar to that of normal T cells are considered to have fully positive expression; \>80% of tumor cells expressing CD7 but with an MFI of CD7 at least 1 log lower than that of normal T cells are considered to have low expression \[dim\]; tumor cells with a CD7 expression rate between 20-80% are considered to have partial expression; CD7 antigen positivity by pathological immunohistochemistry: \>30%);
3. Male or female, age 1-70 years;
4. No severe allergic constitution;
5. Eastern Cooperative Oncology Group (ECOG) performance status score (Oken et al., 1982) of 0-2;
6. Life expectancy of at least 60 days as determined by the investigator;
7. Provide a signed informed consent form prior to any screening procedures; subjects volunteering to participate in the study should be capable of understanding and signing the informed consent form and be willing to follow the study visit schedule and associated study procedures as specified in the protocol. Subjects aged 19-70 years old need to be sufficiently aware and capable of signing the informed consent form; subjects aged 1-7 years can be recruited after legal guardians or patient advocates sign the informed consent form; subjects aged 8-18 years need to be sufficiently aware and able to sign the informed consent form, and their legal guardians or patient advocates also need to sign the informed consent form.

Exclusion Criteria:

Patients with at least one of the following conditions are excluded:

1. Intracranial hypertension or unconscious;
2. Acute heart failure or severe arrhythmia;
3. Acute respiratory failure;
4. Other types of malignant tumors;
5. Diffuse intravascular coagulation;
6. Serum creatinine and/or blood urea nitrogen over 1.5 times the normal value;
7. Sepsis or other uncontrolled infection;
8. Uncontrolled diabetes mellitus;
9. Severe psychological disorder;
10. Obvious cranial lesions by cranial MRI;
11. Allergic constitution;
12. Organ recipients;
13. Pregnant or breastfeeding;
14. Active, uncontrolled infection, including hepatitis B virus (HBV), hepatitis C virus (HCV), human immunodeficiency virus (HIV) or treponema pallidum (TP).

Where this trial is running

Beijing, Beijing Municipality and 3 other locations

• Beijing GoBroad Hospital — Beijing, Beijing Municipality, China (Recruiting)
• Zhaxin Hospital of Integrated Traditional Chinese and Western Medicine — Shanghai, Shanghai Municipality, China (Recruiting)
• Shanghai Liquan Hospital — Shanghai, Shanghai Municipality, China (Recruiting)
• The General Hospital of Western Theater Command PLA — Chengdu, Sichuan, China (Not_yet_recruiting)

Study contacts

• Study coordinator: zhuojun ling

Conditions T-cell Acute Lymphoblastic Leukemia; Acute Lymphoblastic Leukemia, in Relapse; Refractory Acute Lymphoblastic Leukemia; T-cell Malignancies