ClinicalTrials.gg
RecruitingNCT07253259Updated Apr 14, 2026

A Clinical Study Evaluating the Safety and Efficacy of GT729 Universal Cell Injection in the Treatment of Refractory or Relapsed Chronic Graft-versus-host Disease (cGVHD)

An Early Phase 1 interventional study of GT729 Injection in cGVHD, sponsored by Grit Biotechnology. Recruiting at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-04-14.

Sponsored by Grit Biotechnology · Early Phase 1, Interventional, and Treatment

From the registry’s dates

  • Started Dec 2025; still recruiting 10 months later.

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Phase
Early Phase 1
Study type
Interventional
Enrollment
36
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
All
01

Study summary

The goal of this clinical study is to evaluate the safety and efficacy of GT729 universal cell injection in the treatment of refractory or relapsed chronic graft-versus-host disease (cGVHD).

02

Conditions studied

  • cGVHD
03

In context

Lead sponsor

Grit Biotechnology is the lead sponsor of 30 studies on the registry; 17 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Participants or their legal representatives voluntarily sign a written form, are willing and able to comply with the procedures of this study.
  • Aged 18 to 65 years old (inclusive) when signing the informed consent, regardless of gender.
  • Participants must meet the following criteria:

    1. The subjects are hematopoietic stem cell transplantation (alloHSCT) recipients with active chronic (active cGVHD) requiring systemic therapy.
    2. The subjects are patients with or relapsed active cGVHD after receiving at least two .
  • The laboratory test results during the screening period must meet the following criteria (except for indicators related to the study disease):

    1. ≥ 1.0×10⁹/L;
    2. ≥ 80g/L; count ≥ 30×10⁹/L;
    3. ≤ 3× (ULN); Aspartate transaminase ≤ 3×ULN; Total (TBIL) \< 2×ULN;
    4. rate ≥ 30 mL/min.
  • Women of childbearing age must:

At the time of screening, as confirmed by the investigator, the result of the serum β-human chorionic gonadotropin (β-hCG) pregnancy test is negative.

Exclusion criteria

Exclusion Criteria:

  • Evidence of recurrence of underlying malignant tumors or post-transplant lymphoproliferative disorder (PTLD) at the time of screening
  • Having a history of severe or allergies
  • Suffering from the following heart diseases:

    1. (NYHA) Class III or IV congestive heart failure;
    2. A myocardial infarction occurred or coronary artery bypass surgery was performed within 6 months before the screening period.
  • Participants with bleeding symptoms or a clear bleeding tendency within the 6 months prior to screening;
  • Participants with severe underlying medical conditions at the time of screening;
  • Participants who have undergone major surgery within 8 weeks prior to screening or are scheduled to undergo surgery during the study period;
  • History of organ transplantation;
  • According to the investigator's judgment, there are circumstances that would prevent the participant from completing the entire trial, confuse the trial results, or make participation in the trial not in the best interest of the participant.
Terms in these criteria, in plain language(16)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Allogeneic and autologous transplant

Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.

GVHD (graft-versus-host disease)

After a transplant from a donor, the donor’s immune cells attack the recipient’s body, often the skin, gut or liver.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Relapsed and refractory

Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.

Line of therapy

A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.

“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.

Absolute neutrophil count (ANC)

The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.

It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

Creatinine clearance (CrCl)

How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

05

Study design

Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
36 participants (estimated)

Study arms

  • Experimental
    GT729 Injection treatment group

    GT729 Injection

    Biological: GT729 Injection

Interventions

  • BiologicalGT729 Injection

    GT729 Injection

06

What researchers measure

Primary outcomes

  1. Proportion of participants experiencing dose limiting toxicity

    Proportion of participants experiencing dose limiting toxicity (DLT) within 28 days after cell infusion

    Time frame: 28 days

  2. Incidence of adverse events

    Incidence of adverse events per NCI-CTCAE version 5.0

    Time frame: From infusion to the end of the treatment at 24 months

Secondary outcomes

  1. Overall response rate (ORR)

    To evaluate the percentage of participants who have a confirmed partial response or complete response among total number of evaluable participants as assessed by the investigator

    Time frame: Up to 6 months post infusion

07

Study locations

1 of 1 sites recruiting
  • Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences
    Tianjin, Tianjin Municipality, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Dec 2025 (actual). Primary completion is estimated for Nov 2027, 23 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 19, 2025
First posted
Nov 28, 2025
StartActual
Dec 18, 2025
Primary completionEst.
Nov 30, 2027
CompletionEst.
Dec 31, 2028
Last update
Apr 14, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 14, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07253259
Lead sponsor
Grit Biotechnology
Responsible party
Sponsor
First posted
Nov 28, 2025
Start date
Dec 18, 2025
Primary completion
Nov 30, 2027 (estimated)
Completion
Dec 31, 2028 (estimated)
Last update
Apr 14, 2026

Study contacts

Erlie Jiang
Contact
Jiangerlie@ihcams.ac.cn
+8615122538106

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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