cGVHDEarly Phase 1NCT07253259
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)
A Early Phase 1 study testing GT729 Injection in people with cGVHD, run by Grit Biotechnology at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- cGVHD
- What is being tested?
- GT729 Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteChina
- Study dates
- 18 Dec 2025to 31 Dec 2028
- Phase
- Early 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants or their legal representatives voluntarily sign a written informed consent 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:
- The subjects are allogeneic hematopoietic stem cell transplantation (alloHSCT) recipients with active chronic graft-versus-host disease (active cGVHD) requiring systemic immunosuppressive therapy.
- The subjects are patients with refractory or relapsed active cGVHD after receiving at least two lines of systemic treatment.
- The laboratory test results during the screening period must meet the following criteria (except for indicators related to the study disease):
Show all 12Show fewer
- Neutrophil count ≥ 1.0×10⁹/L;
- Hemoglobin ≥ 80g/L; Platelet count ≥ 30×10⁹/L;
- Alanine transaminase ≤ 3×upper limit of normal (ULN); Aspartate transaminase ≤ 3×ULN; Total bilirubin (TBIL) < 2×ULN;
- Creatinine clearance 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.
Who cannot join
- Evidence of recurrence of underlying malignant tumors or post-transplant lymphoproliferative disorder (PTLD) at the time of screening
- Having a history of severe hypersensitivity or allergies
- Suffering from the following heart diseases:
- New York Heart Association (NYHA) Class III or IV congestive heart failure;
- A myocardial infarction occurred or coronary artery bypass surgery was performed within 6 months before the screening period.
- Participants with clinically significant bleeding symptoms or a clear bleeding tendency within the 6 months prior to screening;
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality
Erlie Jiang, +8615122538106, Jiangerlie@ihcams.ac.cn
Erlie Jiang
About this study
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).
- Conditions
- cGVHD
- Being tested
- GT729 Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GT729 InjectionBiological
GT729 Injection
| Study group | Role | What they receive |
|---|---|---|
| GT729 Injection treatment group | Experimental | GT729 Injection Receives: Biological: GT729 Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants experiencing dose limiting toxicity
Proportion of participants experiencing dose limiting toxicity (DLT) within 28 days after cell infusion
Measured: 28 days
Incidence of adverse events
Incidence of adverse events per NCI-CTCAE version 5.0
Measured: 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
Measured: Up to 6 months post infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2025
- Study start18 Dec 2025
- Primary completion30 Nov 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for cGVHDStudies of the same condition, open and under way.
- More trials run by Grit BiotechnologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Grit Biotechnology
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07253259
- Sponsor's protocol ID
- GRIT-CD-CHN-729-001
- Status last verified
- Apr 2026
- First submitted
- 19 Nov 2025
- Last updated
- 14 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT07253259
- Acronym / sponsor ID
- GRIT-CD-CHN-729-001
- Conditions
- cGVHD
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Grit BiotechnologyIndustry (pharma, biotech, devices)
- Collaborators
- Institute of Hematology & Blood Diseases Hospital, China
- Study start
- 18 Dec 2025 (actual)
- Primary completion
- 30 Nov 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 28 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GT729 Injection treatment group | Experimental | Biological: GT729 InjectionGT729 Injection |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Participants or their legal representatives voluntarily sign a written informed consent 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:
- The laboratory test results during the screening period must meet the following criteria (except for indicators related to the study disease):
- Women of childbearing age must:
Key exclusion criteria (10 listed)
- Evidence of recurrence of underlying malignant tumors or post-transplant lymphoproliferative disorder (PTLD) at the time of screening
- Having a history of severe hypersensitivity or allergies
- Suffering from the following heart diseases:
- Participants with clinically significant 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GT729 InjectionGT729 Injection | Biological | GT729 Injection treatment group |
Primary outcome
Proportion of participants experiencing dose limiting toxicity
Time frame: 28 days
Proportion of participants experiencing dose limiting toxicity (DLT) within 28 days after cell infusion
Incidence of adverse events
Time frame: From infusion to the end of the treatment at 24 months
Incidence of adverse events per NCI-CTCAE version 5.0
1 secondary outcome
Overall response rate (ORR)
Time frame: Up to 6 months post infusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2026.
- Individual participant dataSharing planned: No
Related trials for cGVHD
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Not yet recruiting
Feasibility of a Robot-Guided Active Play Intervention for Children With Cerebral Palsy
Cerebral Palsy
Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
Chronic Pain Due to Cancer, Pain Catastrophizing
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing GT729 Injection in people with cGVHD, run by Grit Biotechnology 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 12 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 14 Apr 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 Erlie Jiang (+8615122538106, Jiangerlie@ihcams.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants experiencing dose limiting toxicity (time frame: 28 days). 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?
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 14 Apr 2026.