CD7 CAR-T therapy followed by allogeneic stem cell transplant for relapsed/refractory CD7-positive blood cancers

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 single-arm, open-label, single-center phase I/II study gives adults with CD7-positive relapsed or refractory malignant hematologic diseases an infusion of CD7-directed CAR-T cells and, when appropriate, moves them on to allogeneic hematopoietic stem cell transplantation. The primary goal in phase I is to measure safety and tolerability of the CAR-T followed by transplant, while phase II will provide preliminary information on activity and feasibility of bridging to allo-HSCT. Patients will be closely monitored for adverse events, treatment response, and transplant-related outcomes at the First Affiliated Hospital of Zhejiang University in Hangzhou. As a single-center early-phase trial, it is intended to detect safety signals and inform larger studies rather than provide definitive efficacy proof.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Provision of signed and dated informed consent form (ICF)
* Male or female, older than 18 years (including 18 years)
* Anticipated survival time more than 12 weeks
* Eastern Cooperative Oncology Group (ECOG) performance status ≤2
* According to the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines for Acute Lymphocytic Leukemia and Acute Myeloid Leukemia (2016. v1), patients diagnosed as CD7+ALL and AML
* Consistent with r/r CD7+acute leukemia diagnosis, including any of the following conditions
* a. No CR after standard chemotherapy
* b. The first induction reaches CR, but CR ≤ 12 months
* c. Patients with r/r CD7+acute leukemia have not responded to the first or multiple remedial treatments
* d. Multiple recurrences
* Philadelphia chromosome negative (Ph -) subjects; Or cannot tolerate tyrosine kinase inhibitor (TKI) treatment; Or Philadelphia chromosome positive (Ph+) subjects who did not respond to both TKI treatments
* Normal lung function, oxygen saturation greater than 92% without oxygen inhalation
* The blood biochemical test results are consistent with the following results
* a. (AST) and (ALT) ≤ 2.5 × (ULN)
* b. Total bilirubin ≤ 1.5 × ULN
* c. 24-hour serum creatinine clearance ≥ 30 mL/min
* d. Lipase and amylase ≤ 2 × ULN
* Fertility capable men and women of childbearing age must agree to use effective contraception starting with the signing of an informed consent form until within 2 years after the use of the study drug. Women of reproductive age include pre menopausal women and women within 2 years after menopause. The blood pregnancy test for women of reproductive age must be negative at screening

Exclusion Criteria:

* Patients with the history of epilepsy or other CNS disease
* Pregnant or breastfeeding
* Active infection with no cure
* Patients with prolonged QT interval time or severe heart disease
* Have experienced hypersensitivity or intolerance to any drug used in this study
* Patients who received anticancer chemotherapy or other drug treatment within 2 weeks before screening
* Previous malignant tumors that require treatment or have evidence of recurrence within the previous 5 years of screening
* Clinically significant central nervous system lesions such as seizures, cerebral vascular ischemia/hemorrhage, dementia, cerebellar disease, psychosis, active central nervous system involvement, or cancerous meningitis
* In the past 2 years, terminal organ damage caused by autoimmune diseases (such as Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus) or the need for systematic application of immunosuppressive or other systemic disease control drugs
* Severe active viral, bacterial, or uncontrolled systemic fungal infections; Genetic bleeding/coagulation disorders, a history of non-traumatic bleeding or thromboembolism, and other diseases that may increase the risk of bleeding
* Patients who received autologous hematopoietic stem cell transplantation (ASCT) within 8 weeks before screening, or who plan to undergo ASCT during this study
* Participated in clinical trials of other drugs within 4 weeks or 5 drug half-lives (T1/2) before screening
* Any situation that the researchers believe may increase the risk of patients or interfere with the test results.

Where it's running

• The first affiliated hospital of medical college of zhejiang university
  Hangzhou, Zhejiang, China Recruiting

Study contacts

• Principal investigator: He Huang, MD — First Affiliated Hospital of Zhejiang University
• Study coordinator: He Huang, MD
• Email: hehuangyu@126.com
• Phone: +86-0571-87236476

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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.