Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-26 @ 3:16 PM
NCT ID:
NCT07485504
Eligibility Criteria:
Inclusion Criteria:
* Adults aged 18 to \<70 years, any gender.
* Voluntarily provide written informed consent and willing to comply with all study procedures.
* Diagnosed with relapsed or refractory B-cell acute lymphoblastic leukemia/lymphoma (B-ALL/LBL), or other relapsed/refractory hematologic malignancies as judged by the investigator and confirmed by the collaborating institution.
* Tumor cells confirmed positive for the target antigen by immunophenotyping.
* Bone marrow blast ≥5% at screening and/or presence of extramedullary disease.
* For B-ALL/LBL patients, meets criteria for relapsed/refractory disease, including:
* Primary refractory after ≥2 cycles of standard chemotherapy or not achieving CR after multiple salvage regimens;
* Relapse within 12 months after CR or ≥12 months relapse after CR not achieving CR after subsequent standard therapy;
* Relapse after hematopoietic stem cell transplantation;
* Relapse after prior CAR-T therapy targeting the same antigen.
* ECOG performance status 0-2.
* Expected survival \>3 months.
* Adequate organ function, including:
* Renal: creatinine clearance \>45 mL/min;
* Hepatic: total bilirubin ≤3×ULN, ALT/AST ≤5×ULN;
* Coagulation: PT, APTT, or INR ≤1.5×ULN;
* Cardiac: LVEF ≥50% within 1 month;
* Pulmonary: SpO₂ ≥92% at rest on room air;
* Hematologic and immune function considered sufficient to tolerate study treatment.
* Women of childbearing potential must have a negative pregnancy test; women considered not of childbearing potential include those who are postmenopausal for ≥12 months or have undergone surgical sterilization (hysterectomy or bilateral oophorectomy).
Exclusion Criteria:
* Pregnant or breastfeeding women.
* Known hereditary bone marrow failure syndromes (e.g., Fanconi anemia, Kostmann syndrome, Shwachman syndrome, or other known marrow failure syndromes).
* Uncontrolled active central nervous system leukemia (CNSL; CNS2 or CNS3).
* Prior anti-cancer therapy before screening, including:
* Systemic chemotherapy within 1 week;
* Systemic immunotherapy/targeted therapy (monoclonal antibodies, bispecific antibodies, ADCs, etc.) with last dose \<5 half-lives or \<4 weeks (whichever is shorter);
* Donor lymphocyte infusion within 6 weeks;
* CAR-T therapy or hematopoietic stem cell transplantation within 3 months;
* Radiotherapy within 4 weeks (unless bone marrow reserve \>5% and investigator judges it does not affect eligibility);
* Persistent clinically significant toxicity from prior therapy not recovered to ≤CTCAE Grade 1 (except alopecia).
* Uncontrolled severe active infection.
* History of significant cardiac disease, including: severe heart failure (NYHA class III-IV), myocardial infarction or PCI/stent within 12 months, unstable angina, QTc \>480 ms, or other clinically significant arrhythmia per investigator judgment.
* History of CNS injury, seizure, stroke, or brain hemorrhage requiring treatment within 6 months.
* Active viral infections:
* HIV antibody positive, syphilis serology positive;
* HBsAg \>10⁶ IU/mL;
* HCV antibody positive;
* EBV positive (EBER or copy number above normal).
* Need for long-term systemic corticosteroid therapy during DIT-101 infusion (local or inhaled steroids allowed).
* Active autoimmune disease requiring treatment, immunodeficiency, or use of immunosuppressive therapy.
* Acute or moderate-to-severe chronic graft-versus-host disease (GvHD) within 4 weeks prior to screening.
* Known severe allergy to any component of DIT-101.
* Women of childbearing potential or men unable to use effective contraception during DIT-101 infusion and for 1 year post-infusion; plans for pregnancy within 1 year post-infusion in male or female subjects or their partners.
* Any condition that, in the investigator's opinion, may increase risk or interfere with study outcomes.
* Prior malignancy other than hematologic malignancy, except:
* Malignancy treated with curative intent and disease-free ≥2 years;
* Non-melanoma skin cancer adequately treated with no current evidence of disease.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT07485504
Study Brief:
Protocol Section:
NCT07485504