Prolonged Cytopenia Following CAR-T TherapyPhase 2ICAHT-001NCT07127289
Autologous Hematopoietic Stem Cell Infusion for Prolonged Cytopenia After CAR-T Cell Therapy
A Phase 2 study testing Autologous hematopoietic stem cell infusion in people with Prolonged Cytopenia Following CAR-T Therapy, run by Institute of Hematology & Blood Diseases Hospital, China at 1 site in China.
Trial summary
This is a prospective, single-arm, single-center clinical study designed to evaluate the safety of autologous hematopoietic stem cell infusion for the treatment of prolonged cytopenia following CAR-T cell therapy. Approximately 20 patients will be enrolled. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prolonged Cytopenia Following CAR-T Therapy
- What is being tested?
- Autologous hematopoietic stem cell infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- Aug 2025to Aug 2028
- Phase
- Phase 2
- 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
- Ability to understand and willingness to sign a written informed consent form (ICF).
- Age ≥ 18 years.
- Diagnosis of multiple myeloma according to the International Myeloma Working Group (IMWG) criteria.
- Prior treatment with CAR-T cell therapy and currently in remission or, in the opinion of the investigator, with refractory/progressive disease not requiring salvage therapy.
- Presence of grade 3-4 cytopenia (absolute neutrophil count < 1.0 × 10⁹/L, or platelet count < 50 × 10⁹/L, or hemoglobin < 80 g/L) either persisting or newly developed between day 30 and day 90 after CAR-T cell infusion; or deemed suitable for inclusion by the investigator based on clinical judgment.
- Availability of ≥ 1 × 10⁶/kg autologous hematopoietic stem cells in reserve.
Who cannot join
- Known intolerance, hypersensitivity, or contraindication to autologous hematopoietic stem cell infusion.
- Active hepatitis B or hepatitis C virus infection.
- Known HIV infection.
- Life expectancy <6 months.
- Woman who are pregnant or breastfeeding.
- Evidence of uncontrolled dysfunction of heart, lung, brain, and other important organs.
- Any other conditions that are not eligible for the trial in the judgement of the principal investigator.
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 and Blood Diseases Hospital Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality
Gang An, 86-022-23909171, angang@ihcams.ac.cn
About this study
Official title: A Prospective, Single-Arm, Single-Center Study of Autologous Hematopoietic Stem Cell Infusion for Prolonged Cytopenia After CAR-T Cell Therapy
This is a prospective, single-arm, single-center clinical study designed to evaluate the safety of autologous hematopoietic stem cell infusion for the treatment of prolonged cytopenia following CAR-T cell therapy. Approximately 20 patients will be enrolled.
- Being tested
- Autologous hematopoietic stem cell infusion
- Keywords
- Stem cell, CAR-T, prolonged cytopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous hematopoietic stem cell infusionBiological
Autologous hematopoietic stem cell infusion (0.5-3.0×10^6/kg)
| Study group | Role | What they receive |
|---|---|---|
| Autologous hematopoietic stem cell infusion | Experimental | Not described Receives: Biological: Autologous hematopoietic stem cell infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Neutrophil Counts After Autologous Stem Cell Infusion
Evaluate changes in neutrophil counts following autologous hematopoietic stem cell infusion.
Measured: up to 6 months after infusion
Changes in Platelet Counts After Autologous Stem Cell Infusion
Evaluate changes in platelet counts following autologous hematopoietic stem cell infusion.
Measured: up to 6 months after infusion
Changes in Hemoglobin Levels After Autologous Stem Cell Infusion
Evaluate changes in hemoglobin levels following autologous hematopoietic stem cell infusion.
Measured: up to 6 months after infusion
Incidence and Severity of Adverse Events Following Autologous Stem Cell Infusion
Assess safety by monitoring infusion-related adverse events, graded according to CTCAE v5.0.
Measured: up to 6 months after infusion
Secondary outcomes (1)
Incidence of Infections After Autologous Stem Cell Infusion
Evaluate the frequency and types of infections following stem cell infusion, including bacterial, viral, and fungal infections.
Measured: up to 6 months after infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2025
- Study startAug 2025 (estimated)
- Primary completionAug 2027 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prolonged Cytopenia Following CAR-T TherapyStudies of the same condition, open and under way.
- More trials run by Institute of Hematology & Blood Diseases Hospital, ChinaThe 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
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07127289
- Sponsor's protocol ID
- IIT2025001
- Acronym
- ICAHT-001
- Status last verified
- Jul 2025
- First submitted
- 30 Jul 2025
- Last updated
- 17 Aug 2025
- 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 17 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-Arm, Single-Center Study of Autologous Hematopoietic Stem Cell Infusion for Prolonged Cytopenia After CAR-T Cell Therapy
- ClinicalTrials.gov ID
- NCT07127289
- Acronym / sponsor ID
- ICAHT-001 / IIT2025001
- Keywords
- Stem cell, CAR-T, prolonged cytopenia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, ChinaUniversity, hospital or other
- Study start
- Aug 2025 (estimated)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 17 Aug 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.
This is a prospective, single-arm, single-center clinical study designed to evaluate the safety of autologous hematopoietic stem cell infusion for the treatment of prolonged cytopenia following CAR-T cell therapy. Approximately 20 patients will be enrolled.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Autologous hematopoietic stem cell infusion | Experimental | Biological: Autologous hematopoietic stem cell infusion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Ability to understand and willingness to sign a written informed consent form (ICF).
- Age ≥ 18 years.
- Diagnosis of multiple myeloma according to the International Myeloma Working Group (IMWG) criteria.
- Prior treatment with CAR-T cell therapy and currently in remission or, in the opinion of the investigator, with refractory/progressive disease not requiring salvage therapy.
- Presence of grade 3-4 cytopenia (absolute neutrophil count < 1.0 × 10⁹/L, or platelet count < 50 × 10⁹/L, or hemoglobin < 80 g/L) either persisting or newly developed between day 30 and day 90 after CAR-T cell infusion; or deemed suitable for inclusion by the investigator based on clinical judgment.
Key exclusion criteria (7 listed)
- Known intolerance, hypersensitivity, or contraindication to autologous hematopoietic stem cell infusion.
- Active hepatitis B or hepatitis C virus infection.
- Known HIV infection.
- Life expectancy <6 months.
- Woman who are pregnant or breastfeeding.
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 |
|---|---|---|
| Autologous hematopoietic stem cell infusionAutologous hematopoietic stem cell infusion (0.5-3.0×10^6/kg) | Biological | Autologous hematopoietic stem cell infusion |
Primary outcome
Changes in Neutrophil Counts After Autologous Stem Cell Infusion
Time frame: up to 6 months after infusion
Evaluate changes in neutrophil counts following autologous hematopoietic stem cell infusion.
Changes in Platelet Counts After Autologous Stem Cell Infusion
Time frame: up to 6 months after infusion
Evaluate changes in platelet counts following autologous hematopoietic stem cell infusion.
Changes in Hemoglobin Levels After Autologous Stem Cell Infusion
Time frame: up to 6 months after infusion
Evaluate changes in hemoglobin levels following autologous hematopoietic stem cell infusion.
Incidence and Severity of Adverse Events Following Autologous Stem Cell Infusion
Time frame: up to 6 months after infusion
Assess safety by monitoring infusion-related adverse events, graded according to CTCAE v5.0.
1 secondary outcome
Incidence of Infections After Autologous Stem Cell Infusion
Time frame: up to 6 months after 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 17 Aug 2025.
- 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 Phase 2 study testing Autologous hematopoietic stem cell infusion in people with Prolonged Cytopenia Following CAR-T Therapy, run by Institute of Hematology & Blood Diseases Hospital, China 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 6 inclusion and 7 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 17 Aug 2025. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Gang An, PhD&MD (86-022-23909171, angang@ihcams.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Neutrophil Counts After Autologous Stem Cell Infusion (time frame: up to 6 months after infusion). The study lists 4 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 17 Aug 2025.