CAR-T cell therapy targeting CD7 for certain T-cell cancers
The Safety and Clinical Efficacy of Human CD7 CAR-T Cell Therapy for Patients With Relapsed/Refractory CD7 Positive T Cell Hematological Maliganacies
This study is testing a new CAR-T cell therapy for patients with certain hard-to-treat T-cell cancers to see if it can help them when other treatments haven't worked.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 4 (estimated) |
| Ages | 14 Years to 70 Years |
| Sex | All |
| Sponsor | Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine Academic / other |
| Drugs / interventions | CAR-T, chemotherapy, Fludarabine, CAR T |
| Locations | 1 site (Shanghai) |
| Trial ID | NCT05290155 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety and efficacy of anti-CD7 CAR-T cell therapy in patients with relapsed or refractory CD7 positive T-cell malignancies, including various types of T lymphoblastic leukemia and lymphoma. It is a single-arm, open-label, dose escalation study that will administer three different doses of CAR-T cells based on the patient's body weight. The trial aims to determine how well this innovative treatment can work for patients who have not responded to previous therapies.
Who should consider this trial
Good fit: Ideal candidates are patients aged 14 to 70 with relapsed or refractory CD7 positive T-cell malignancies who have undergone multiple lines of prior therapy.
Not a fit: Patients who do not have CD7 positive T-cell malignancies or those with other types of cancer 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 malignancies.
How similar studies have performed: Other studies using CAR-T cell therapy have shown promising results in treating various hematological malignancies, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria 1. Fourteen to 70 Years Old, Male and female; 2. Expected survival \> 12 weeks; ECOG score 0-2; 3. Confirmed diagnosis of acute T cell leukemia and screened for CD7 positive,including following conditions:a. Patients who do not get a CR with ≥2 prior induction therapy b. Those who achieves CR, but have a early relapse(\<12months),or a late relapse (\>=12months) failing to acheive a CR after re-induction chemotherapy c. For any Patiens failed ASCT/allo-SCT 4. Relapsed and refractory patients with diagnosis of CD7 positive T cell lymphoma have had≥2 prior lines of therapy,who do not acheive at least a PR, or have a relapse including:a. Peripheral T cell lymphoma NOS, or b.Angioimmunoblastic T cell lymphoma,or c. Anaplastic large cell lymphoma c.Disease can be assessed(BM or CT scan) 5. Confirmed T lymphoblatic lymphoma：a. Patients who do not get a PR with ≥2 induction chemotherapy or a CR with ≥ 4 induction chemotherapy b. Relapsed patients failing to acheive a CR after 1 line salvage chemotherapy c. For any Patiens failed ASCT/allo-SCT d.Disease can be assessed(BM or CT scan) 6. The venous access required for collection can be established and mononuclear cell collection can be determined by the investigators; 7. Liver, kidney and cardiopulmonary functions meet the following requirements: a. Ccr≥60mL/min(Cockcroft Gault) b. Left ventricular ejection fraction \>50%; c.Baseline oxygen saturation\>92%; d. Total bilirubin ≤ 1.5×ULN; e. ALT and AST≤ 3×ULN; 8. Able to understand and sign the Informed Consent Exclusion Criteria: 1. Malignant tumors other than T cell malignancies within 5 years prior to screening, in addition to adequately treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, localized prostate cancer after radical resection, and ductal carcinoma in situ after radical resection; 2. Uncontrolled infection including bacteral or virus or fugal disease;patients with positive HBsAg or HBcAb and positive peripheral blood HBV DNA titer detection ;HCV antibody positive and peripheral blood HCV RNA positive; HIV antibody positive; syphilis positive; 3. Any instability of systemic disease, including but not limited to unstable angina, cerebrovascular accident, or transient cerebral ischemic (within 6 months prior to screening),myocardial infarction (within 6 months prior to screening), congestive heart failure (New York heart association (NYHA) classification ≥ III), need drug therapy of severe arrhythmia,liver, kidney, or metabolic disease; 4. Any uncontrolled disease may affect entry 5. Current or history of CNS involvement by malignancy.Known history or presence of clinically relevant central nervous system (CNS) pathology.Patients with a known history or prior diagnosis other immunologic or inflammatory disease affecting the CNS (such as epilepsy) 6. Patients who are receiving systemic steroid treatment and requiring long-term systemic steroid treatment during the treatment as determined by the investigator before screening (except inhalation or topical use); And subjects treated with systemic steroids (except inhalation or topical use) within 72h prior to cell transfusion; 7. Subjects treated with anti-PD1 or anti-PDL1 therapies within 3months before enrollment 8. Pregnant or lactating woman, and female subject who plans to have a pregnancy within 1 year after cell transfusion, or male subject whose partner plans to have a pr egnancy within 1 year after cell transfusion; 9. Active or uncontrollable infection requiring systemic therapy Received CAR-T treatment or other gene therapies before enrollment; 10. Kown be allergic to anti-TRBC1 CAR-T cells or drugs(Fludarabine or Cyclophophamide) 11. The investigators consider other conditions unsuitable for enrollment. 12. Patients who may not be able to sign the Informed Consent due to disease,or who do not understand or unwillingness or inability to comply with research requirements
Where this trial is running
Shanghai
- Xianmin General Song — Shanghai, China (Recruiting)
Study contacts
- Principal investigator: Xianmin G Song, M.D. — Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
- Study coordinator: Xianmin G Song, MD
- Email: shongxm@139.com
- Phone: 02163240090
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.