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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
Participants will receive 1 intravenous administration of DIT101, according to the study dosing regimen. A second dose at the same dose may be administered to eligible participants who show no response after initial treatment, upon sponsor approval.
Hematology Hospital of Chinese Academy of Medical Sciences (Hematology Research Center of Chinese Academy of Medical Sciences)
Tianjin, China
Safety#Incidence and severity of adverse events (AEs)
To evaluate the possible adverse events after DIT101 infusion, including the incidence, and severity of AEs
Time frame: 2 years after completion of the DIT101 infusion or until death, whichever occurs first.
Safety#Incidence of Dose Limiting Toxicity (DLT)
Incidence of dose limiting toxicities (DLTs) within 28 days after the first DIT101 infusion.
Time frame: 28 days after the first DIT101 infusion.
Duration of Remission (DOR)
Time from first achievement of Complete Response(CR), Complete Response with incomplete hematologic recovery(CRi) or Partial Response(PR) to disease relapse or death due to leukemia.
Time frame: 2 years after completion of the DIT101 infusion or until death, whichever occurs first.
Event-Free Survival (EFS)
Time from DIT101 infusion to earliest occurrence of any event: death after response, relapse, non-response, or treatment discontinuation due to leukemia- or treatment-related death, adverse events, or new anti-cancer therapy (excluding bridging hematopoietic stem cell transplantation (HSCT).
Time frame: 2 years after completion of the DIT101 infusion or until death, whichever occurs first.
Leukemia-Free Survival (LFS)
Time from first achievement of CR/CRi to disease relapse or death.
Time frame: 2 years after completion of the DIT101 infusion or until death, whichever occurs first.
Proportion of Responding Subjects Receiving HSCT
Percentage of subjects who achieve remission after DIT101 infusion and subsequently undergo hematopoietic stem cell transplantation.
Time frame: Up to 2 years following the completion of DIT101 infusion.
Overall Survival (OS)
Time from first DIT101 infusion to death from any cause.
Time frame: Up to 2 years after DIT101 infusion or until death, whichever occurs first.
Maximum Concentration (Cmax) of CAR-T Cells in Peripheral Blood
To evaluate the peak expansion level of CAR-T cells in peripheral blood following DIT101 infusion.
Time frame: up to 2 years after completion of the DIT101 infusion or until death, whichever occurs first.
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