Not Yet RecruitingPhase 1

Safety and Efficacy of DIT101 in Relapsed or Refractory Hematologic Malignancies

China15 participantsStarted 2026-04-15

Plain-language summary

This study is a single-arm, open-label clinical trial designed to evaluate the safety and tolerability of DIT101 in adults with relapsed or refractory hematologic malignancies and to explore its potential anti-tumor effects. DIT101 is an investigational in vivo CAR-T cell therapy administered by intravenous infusion. After administration, it is intended to generate CAR-T cells within the patient's body that can recognize and attack tumor cells. Unlike approved autologous CAR-T therapies, DIT101 does not require collection and ex vivo genetic modification of the participant's own cells. The study includes a screening period, DIT101 infusion treatment, a post-treatment intensive follow-up period of approximately 6 months, and a long-term follow-up period of up to 2 years, with visits every 3-6 months.

Who can participate

Age range18 Years – 70 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 considere…

What they're measuring

Safety#Incidence and severity of adverse events (AEs)

Timeframe: 2 years after completion of the DIT101 infusion or until death, whichever occurs first.

Safety#Incidence of Dose Limiting Toxicity (DLT)

Timeframe: 28 days after the first DIT101 infusion.

Trial details

NCT IDNCT07485504

SponsorTcelltech Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2028-10-15

Contact for this trial

Rui Feng, MD

+(86)13509312934 fengrui@tcelltech.com