Safety and Efficacy of DIT101 in Relapsed or Refractory Hematologic Malignancies

NCT07485504 | Not Yet Recruiting Phase 1

• 1 other identifier: DIT101-IBL001
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Relapsed or Refractory Hematologic Malignancies

Outcome Measures

Primary Outcomes (2)

• Safety#Incidence and severity of adverse events (AEs)

  To evaluate the possible adverse events after DIT101 infusion, including the incidence, and severity of AEs

  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.

  28 days after the first DIT101 infusion.

Secondary Outcomes (6)

• Duration of Remission (DOR)

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

• Event-Free Survival (EFS)

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

• Leukemia-Free Survival (LFS)

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

• Proportion of Responding Subjects Receiving HSCT

  Up to 2 years following the completion of DIT101 infusion.

• Overall Survival (OS)

  Up to 2 years after DIT101 infusion or until death, whichever occurs first.

Other Outcomes (6)

• Time to Maximum Concentration (Tmax) of CAR-T Cells in Peripheral Blood

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

• Area Under the Concentration-Time Curve (AUC) of CAR-T Cells in Peripheral Blood

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

• Level of Interleukin-6 (IL-6) in Peripheral Blood

  Baseline, specified time points post-infusion, up to 2 years after completion of the DIT101 infusion.

Study Arms (1)

In Vivo CAR-T Therapy for Relapsed or Refractory Hematologic Malignancies

EXPERIMENTAL

Participants with relapsed or refractory hematologic malignancies will receive 1-2 intraveneous administrations of in Vivo CAR-T (DIT101).

Biological: In Vivo CAR-T Therapy

Interventions

In Vivo CAR-T Therapy BIOLOGICAL

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.

In Vivo CAR-T Therapy for Relapsed or Refractory Hematologic Malignancies

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Tcelltech Inc.: lead

Study Sites (1)

Hematology Hospital of Chinese Academy of Medical Sciences (Hematology Research Center of Chinese Academy of Medical Sciences)

Tianjin, China

Location

MeSH Terms

Conditions

Recurrence; Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Gangxiong Huang, MD

  Tcelltech Inc.

  STUDY CHAIR

Central Study Contacts

Rui Feng, MD

CONTACT

+(86)13509312934; fengrui@tcelltech.com

Xianzhen Chen, MM

CONTACT

+(86)18649725652; chenxianzhen@tcelltech.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2026
• First Posted: March 20, 2026
• Study Start: April 15, 2026
• Primary Completion (Estimated): October 15, 2028
• Study Completion (Estimated): October 15, 2028
• Last Updated: March 20, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)