Safety and Efficacy of DIT101 in Relapsed or Refractory Hematologic Malignancies
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-70
SponsorTcelltech Inc.
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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).
Systemic chemotherapy within 1 week;
Trial design
Treatments tested in this trial
- In Vivo CAR-T Therapy
Treatment groups
15 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov