NCT05827835 CD7 CAR-T Bridging to alloHSCT for R/R CD7+Malignant Hematologic Diseases
| NCT ID | NCT05827835 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Zhejiang University |
| Condition | Hematologic Diseases |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2023-04-30 |
| Primary Completion | 2026-04-25 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 30 participants in total. It began in 2023-04-30 with a primary completion date of 2026-04-25.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is a single-arm, open-label, single-center, phase I/II study. The primary objective is to evaluate the safety of CD7 CAR-T Bridging to allo-HSCT therapy for patients with CD7-positive relapsed or refractory Malignant Hematologic Diseases
Eligibility Criteria
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.
Contact & Investigator
He Huang, MD
PRINCIPAL INVESTIGATOR
First Affiliated Hospital of Zhejiang University
Frequently Asked Questions
Who can join the NCT05827835 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Hematologic Diseases. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05827835 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05827835 currently recruiting?
Yes, NCT05827835 is actively recruiting participants. Contact the research team at hehuangyu@126.com for enrollment information.
Where is the NCT05827835 trial being conducted?
This trial is being conducted at Hangzhou, China.
Who is sponsoring the NCT05827835 clinical trial?
NCT05827835 is sponsored by Zhejiang University. The principal investigator is He Huang, MD at First Affiliated Hospital of Zhejiang University. The trial plans to enroll 30 participants.