Revolutionary CAR-T shot? new therapy builds cancer fighters inside you
NCT ID NCT07485504
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early study tests a new treatment called DIT101 for people with blood cancers that have come back or stopped responding to other treatments. DIT101 is given as an IV infusion and works by creating cancer-fighting cells inside the body, avoiding the need to remove and modify cells in a lab. The study will enroll 15 adults to check safety and see if the therapy can shrink tumors.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 15 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Apr 2026
An estimate. Start dates often move.
- Expected to finish
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Oct 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 70 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Hematology Hospital of Chinese Academy of Medical Sciences (Hematology Research Center of Chinese Academy of Medical Sciences)
Tianjin, China
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Other studies related to the condition(s) this trial covers.