OncoMatch/Clinical Trials/NCT05827835
CD7 CAR-T Bridging to alloHSCT for R/R CD7+Malignant Hematologic Diseases
Is NCT05827835 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies CD7 CAR-T cells for hematologic diseases.
Treatment: CD7 CAR-T cells — 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
Check if I qualifyExtracted eligibility criteria
Biomarker criteria
Required: CD7 overexpression
patients diagnosed as CD7+ALL and AML
Excluded: BCR fusion
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
Excluded: ABL1 fusion
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
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: chemotherapy
No CR after standard chemotherapy; The first induction reaches CR, but CR ≤ 12 months; have not responded to the first or multiple remedial treatments; Multiple recurrences
Cannot have received: autologous hematopoietic stem cell transplantation
Exception: within 8 weeks before screening or planned during study
Patients who received autologous hematopoietic stem cell transplantation (ASCT) within 8 weeks before screening, or who plan to undergo ASCT during this study
Cannot have received: anticancer chemotherapy or other drug treatment
Exception: within 2 weeks before screening
Patients who received anticancer chemotherapy or other drug treatment within 2 weeks before screening
Cannot have received: other investigational drugs
Exception: within 4 weeks or 5 drug half-lives (T1/2) before screening
Participated in clinical trials of other drugs within 4 weeks or 5 drug half-lives (T1/2) before screening
Lab requirements
Kidney function
24-hour serum creatinine clearance ≥ 30 ml/min
Liver function
ast and alt ≤ 2.5 × uln; total bilirubin ≤ 1.5 × uln
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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