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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
In Vivo CAR-T Therapy
Biological/VaccineParticipants 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.
Treatment groups
15 Participants
are divided into 1 treatment groupGroup A: In Vivo CAR-T Therapy for Relapsed or Refractory Hematologic MalignanciesExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.2
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.Secondary outcomes
1
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.2
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.3
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.4
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.Other outcomes
1
Time to Maximum Concentration (Tmax) of CAR-T Cells in Peripheral Blood
To evaluate the time required to reach the maximum concentration 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.2
Area Under the Concentration-Time Curve (AUC) of CAR-T Cells in Peripheral Blood
To evaluate the total exposure 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.3
Level of Interleukin-6 (IL-6) in Peripheral Blood
To evaluate the concentration levels and changes from baseline of Interleukin-6 (IL-6) in peripheral blood at various time points following DIT101 infusion.
Time frame
Baseline, specified time points post-infusion, up to 2 years after completion of the DIT101 infusion.4
Level of Interleukin-10 (IL-10) in Peripheral Blood
To evaluate the concentration levels and changes from baseline of Interleukin-10 (IL-10) in peripheral blood at various time points following DIT101 infusion.
Time frame
Baseline, specified time points post-infusion, up to 2 years after completion of the DIT101 infusion.Sponsors and contacts
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Source ClinicalTrials.gov
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