Refractory Immune Effector Cell-related HemocytopeniaNCT06729320
A Randomized Controlled, Open, Single-center Clinical Study Evaluating the Efficacy and Safety of Umbilical Cord Blood Mononuclear Cells in Patients with Refractory Immune Effector Cell-related Hemocytopenia
A study testing Umbilical cord blood mononuclear cells and Conventional hematopoietic recovery therapy in people with Refractory Immune Effector Cell-related Hemocytopenia, run by Beijing GoBroad Hospital at 1 site in China.
Trial summary
The purpose of this study was to evaluate the safety and efficacy of umbilical cord blood mononuclear cell in the treatment of refractory immune effector cell-related hemocytopenia by observing the efficacy related factors and adverse reactions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Refractory Immune Effector Cell-related Hemocytopenia
- What is being tested?
- Umbilical cord blood mononuclear cells and Conventional hematopoietic recovery therapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2024to 1 Dec 2025
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years old (including boundary values), gender is not limited
- ECOG score 0-2 points
- Expected survival ≥6 months
- Patients who have received immune effector cell therapy (marketed CAR-T cell therapy or dual antibody therapy) (no target), have grade 3-4 hemocytopenia after treatment, and do not recover to grade 2 within 3 weeks after conventional treatment. Defined as follows:
- 1) The neutrophils again decreased to grade ≥3 within 1 week after G-CSF discontinuation, or 2) Unable to detach from red blood cell or platelet transfusion (infusion time less than one week requires re-infusion) (5) Understand the research protocol and sign the informed consent voluntarily
Who cannot join
- Patients who intend to undergo autologous hematopoietic stem cell transfusion or have undergone autologous hematopoietic stem cell transfusion
- Significant lack of compliance to complete the study plan (such as suffering from uncontrolled mental illness, etc.)
- Allergy or known allergy to any drug active ingredients, excipients, and blood products or preparations included in this study
- Pregnancy, breastfeeding, planning pregnancy, or unwillingness to use effective contraception as required by research
- There are other conditions that researchers believe are not suitable for inclusion
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
Beijing GoBroad Hospital
Beijing, Beijing Municipality, 102200
Kai Hu, +86 150 1039 0336, huk@gobroadhealthcare.com
About this study
The purpose of this study was to evaluate the safety and efficacy of umbilical cord blood mononuclear cell in the treatment of refractory immune effector cell-related hemocytopenia by observing the efficacy related factors and adverse reactions.
- Being tested
- Umbilical cord blood mononuclear cells, Conventional hematopoietic recovery therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Umbilical cord blood mononuclear cellsBiological
Intravenous infusion of UCB-MNCs (3×10^8/ time, once a week, four times in total)
Conventional hematopoietic recovery therapyCombination product
Including but not limited to G-CSF, TPO, TPO receptor agonists, transfusions of red blood cells, platelets, etc.
| Study group | Role | What they receive |
|---|---|---|
| Conventional hematopoietic recovery therapy | Active comparator | Conventional hematopoietic recovery therapy including but not limited to G-CSF, TPO, TPO receptor agonists, transfusions of red blood cells, platelets, etc. Receives: Combination Product: Conventional hematopoietic recovery therapy |
| Conventional hematopoietic recovery therapy+Umbilical cord blood mononuclear cells | Experimental | Umbilical cord blood mononuclear cells are obtained from umbilical cord blood by density gradient centrifugation Receives: Biological: Umbilical cord blood mononuclear cells; Combination Product: Conventional hematopoietic recovery therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The recovery time of neutrophils
On the first day after discontinuing G-CSF, the neutrophil count remained above 1.0 × 10^9/L for 7 consecutive days
Measured: 1 year
The recovery time of platelet
Starting from the second day of the most recent platelet transfusion, the first day of platelet count>50 × 10^9/L lasting for 7 days
Measured: 1 year
Safety of infusion
Acute allergies or infections related to umbilical cord blood mononuclear cell infusion, as well as shock and other infusion related reactions symptoms including but not limited to chills, fever, CRP, PCT, etc
Measured: 1 year
Secondary outcomes (3)
Recovery of hemoglobin levels after infusion
Hemoglobin content in blood routine examination
Measured: 1 year
Immune function reconstruction indicators at 1, 3, 6, and 12 months after transfusion
Including but not limited to CD3, CD4, CD8, CD19, etc. in lymphoid subgroups
Measured: 1, 3, 6, and 12 months
Overall survival rate
The proportion of participants who survived during the study period
Measured: 2 and 5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2024
- Study start1 Dec 2024 (estimated)
- Primary completion1 Jun 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractory Immune Effector Cell-related HemocytopeniaStudies of the same condition, open and under way.
- 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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing GoBroad Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kai Hu, Beijing GoBroad Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06729320
- Sponsor's protocol ID
- UCB-MNCs-2024
- Status last verified
- Dec 2024
- First submitted
- 8 Dec 2024
- Last updated
- 11 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 11 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled, Open, Single-center Clinical Study Evaluating the Efficacy and Safety of Umbilical Cord Blood Mononuclear Cells in Patients with Refractory Immune Effector Cell-related Hemocytopenia
- ClinicalTrials.gov ID
- NCT06729320
- Acronym / sponsor ID
- UCB-MNCs-2024
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Beijing GoBroad HospitalUniversity, hospital or other
- Study start
- 1 Dec 2024 (estimated)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 11 Dec 2024 (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 purpose of this study was to evaluate the safety and efficacy of umbilical cord blood mononuclear cell in the treatment of refractory immune effector cell-related hemocytopenia by observing the efficacy related factors and adverse reactions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional hematopoietic recovery therapy | Active comparator | Combination Product: Conventional hematopoietic recovery therapyConventional hematopoietic recovery therapy including but not limited to G-CSF, TPO, TPO receptor agonists, transfusions of red blood cells, platelets, etc. |
| Conventional hematopoietic recovery therapy+Umbilical cord blood mononuclear cells | Experimental | Biological: Umbilical cord blood mononuclear cells, Combination Product: Conventional hematopoietic recovery therapyUmbilical cord blood mononuclear cells are obtained from umbilical cord blood by density gradient centrifugation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥18 years old (including boundary values), gender is not limited
- ECOG score 0-2 points
- Expected survival ≥6 months
- Patients who have received immune effector cell therapy (marketed CAR-T cell therapy or dual antibody therapy) (no target), have grade 3-4 hemocytopenia after treatment, and do not recover to grade 2 within 3 weeks after conventional treatment. Defined as follows:
- 1) The neutrophils again decreased to grade ≥3 within 1 week after G-CSF discontinuation, or 2) Unable to detach from red blood cell or platelet transfusion (infusion time less than one week requires re-infusion) (5) Understand the research protocol and sign the informed consent voluntarily
Key exclusion criteria (5 listed)
- Patients who intend to undergo autologous hematopoietic stem cell transfusion or have undergone autologous hematopoietic stem cell transfusion
- Significant lack of compliance to complete the study plan (such as suffering from uncontrolled mental illness, etc.)
- Allergy or known allergy to any drug active ingredients, excipients, and blood products or preparations included in this study
- Pregnancy, breastfeeding, planning pregnancy, or unwillingness to use effective contraception as required by research
- There are other conditions that researchers believe are not suitable for inclusion
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 |
|---|---|---|
| Umbilical cord blood mononuclear cellsIntravenous infusion of UCB-MNCs (3×10^8/ time, once a week, four times in total) | Biological | Conventional hematopoietic recovery therapy+Umbilical cord blood mononuclear cells |
| Conventional hematopoietic recovery therapyIncluding but not limited to G-CSF, TPO, TPO receptor agonists, transfusions of red blood cells, platelets, etc. | Combination product | Conventional hematopoietic recovery therapy, Conventional hematopoietic recovery therapy+Umbilical cord blood mononuclear cells |
Primary outcome
The recovery time of neutrophils
Time frame: 1 year
On the first day after discontinuing G-CSF, the neutrophil count remained above 1.0 × 10^9/L for 7 consecutive days
The recovery time of platelet
Time frame: 1 year
Starting from the second day of the most recent platelet transfusion, the first day of platelet count>50 × 10^9/L lasting for 7 days
Safety of infusion
Time frame: 1 year
Acute allergies or infections related to umbilical cord blood mononuclear cell infusion, as well as shock and other infusion related reactions symptoms including but not limited to chills, fever, CRP, PCT, etc
3 secondary outcomes
Recovery of hemoglobin levels after infusion
Time frame: 1 year
Immune function reconstruction indicators at 1, 3, 6, and 12 months after transfusion
Time frame: 1, 3, 6, and 12 months
Overall survival rate
Time frame: 2 and 5 year
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 11 Dec 2024.
- Individual participant dataSharing planned: No
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 study testing Umbilical cord blood mononuclear cells and Conventional hematopoietic recovery therapy in people with Refractory Immune Effector Cell-related Hemocytopenia, run by Beijing GoBroad Hospital 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 5 inclusion and 5 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 11 Dec 2024. 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.
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 Kai Hu (+86 150 1039 0336, huk@gobroadhealthcare.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The recovery time of neutrophils (time frame: 1 year). The study lists 3 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 11 Dec 2024; AzTrials last refreshed its copy on 29 Oct 2026.