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Relapsed or Refractory Hematologic MalignanciesPhase 1NCT07485504

Safety and Efficacy of DIT101 in Relapsed or Refractory Hematologic Malignancies

A Phase 1 study testing In Vivo CAR-T Therapy in people with Relapsed or Refractory Hematologic Malignancies, run by Tcelltech Inc. at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
In Vivo CAR-T Therapy
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
1 siteChina
Study dates
15 Apr 2026to 15 Oct 2028
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
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  • 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 considered not of childbearing potential include those who are postmenopausal for ≥12 months or have undergone surgical sterilization (hysterectomy or bilateral oophorectomy).

Who cannot join

  • 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);
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  • 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;
  • HBsAg >10⁶ IU/mL;
  • HCV antibody positive;
  • EBV positive (EBER or copy number above normal).
  • Need for long-term systemic corticosteroid therapy during DIT-101 infusion (local or inhaled steroids allowed).
  • Active autoimmune disease requiring treatment, immunodeficiency, or use of immunosuppressive therapy.
  • Acute or moderate-to-severe chronic graft-versus-host disease (GvHD) within 4 weeks prior to screening.
  • Known severe allergy to any component of DIT-101.
  • Women of childbearing potential or men unable to use effective contraception during DIT-101 infusion and for 1 year post-infusion; plans for pregnancy within 1 year post-infusion in male or female subjects or their partners.
  • Any condition that, in the investigator's opinion, may increase risk or interfere with study outcomes.
  • Prior malignancy other than hematologic malignancy, except:
  • Malignancy treated with curative intent and disease-free ≥2 years;
  • Non-melanoma skin cancer adequately treated with no current evidence of disease.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Rui Feng, MD contact

+(86)13509312934

fengrui@tcelltech.com

Xianzhen Chen, MM contact

+(86)18649725652

chenxianzhen@tcelltech.com

China1 site

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

    Tianjin

Other trials in China

About this study

Official title: A Prospective, Single-Arm Study Evaluating the Safety and Efficacy of DIT101 in Subjects With Relapsed or Refractory Hematologic Malignancies

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.

Being tested
In Vivo CAR-T Therapy
Medical subject headings
Recurrence, Hematologic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • In Vivo CAR-T TherapyBiological

    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.

Study groups in NCT07485504
Study groupRoleWhat they receive
In Vivo CAR-T Therapy for Relapsed or Refractory Hematologic MalignanciesExperimentalParticipants with relapsed or refractory hematologic malignancies will receive 1-2 intraveneous administrations of in Vivo CAR-T (DIT101).
Receives: Biological: In Vivo CAR-T Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 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.

    Measured: 28 days after the first DIT101 infusion.

Secondary outcomes (6)

  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.

    Measured: 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).

    Measured: 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.

    Measured: 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.

    Measured: Up to 2 years following the completion of DIT101 infusion.

  5. Overall Survival (OS)

    Time from first DIT101 infusion to death from any cause.

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

  6. 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Mar 2026
  2. Study start15 Apr 2026 (estimated)
  3. Primary completion15 Oct 2028 (estimated)
  4. Study completion15 Oct 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
15 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07485504
Sponsor's protocol ID
DIT101-IBL001
Status last verified
Mar 2026
First submitted
2 Mar 2026
Last updated
20 Mar 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing In Vivo CAR-T Therapy in people with Relapsed or Refractory Hematologic Malignancies, run by Tcelltech Inc. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 20 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Rui Feng, MD (+(86)13509312934, fengrui@tcelltech.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety#Incidence and severity of adverse events (AEs) (time frame: 2 years after completion of the DIT101 infusion or until death, whichever occurs first.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07485504.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2026.

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