OncoMatch/Clinical Trials/NCT05827835
CD7 CAR-T Bridging to alloHSCT for R/R CD7+Malignant Hematologic Diseases
Is NCT05827835 recruiting? Yes, currently enrolling (Jun 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
Treatments studied
Other
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.
Frequently asked questions
Is NCT05827835 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior autologous hematopoietic stem cell transplantation, anticancer chemotherapy or other drug treatment, other investigational drugs disqualifies patients from enrollment.
Does this trial require CD7?
Yes, CD7 overexpression is a required biomarker for enrollment.
Are patients with BCR alterations eligible?
No. BCR fusion is an exclusion criterion.
Are patients with ABL1 alterations eligible?
No. ABL1 fusion is an exclusion criterion.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
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