Immune Effector Cell Associated HematotoxicityEarly Phase 1MSC-ICAHTNCT07212335
Safety and Efficacy of Umbilical Cord Blood-Derived Mesenchymal Stem Cells in the Treatment of Long-Term Cytopenia After CAR-T Therapy
A Early Phase 1 study testing Mesenchymal Stem Cell Infusion in people with Immune Effector Cell Associated Hematotoxicity, run by Institute of Hematology & Blood Diseases Hospital, China at 1 site in China.
Trial summary
This study is a single arm, open label, exploratory clinical study aimed at evaluating the efficacy, and safety of allogeneic umbilical cord blood-derived mesenchymal stem cells in the treatment of long-term cytopenia after CAR-T therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Immune Effector Cell Associated Hematotoxicity
- What is being tested?
- Mesenchymal Stem Cell Infusion
- 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
- 1 Oct 2025to 30 Sep 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must meet all the following criteria to be enrolled in this study:
- 1.Voluntarily participate in the study and sign the informed consent form;
- 2.Aged ≥ 18 years, regardless of gender;
- 3.Patients with acute lymphoblastic leukemia (ALL), lymphoma, or myeloma who still have severe cytopenia (meeting any of the following conditions: absolute neutrophil count ≤ 1×10⁹/L; platelet count ≤ 30×10⁹/L; hemoglobin ≤ 70 g/dL) 3 weeks after CAR-T cell infusion;
- 4.ECOG performance status score ≤ 2;
- 5.Estimated survival time ≥ 6 months;
- 6.For female patients of childbearing potential, a negative pregnancy test result is required. Female patients of childbearing potential and male patients must use highly effective contraceptive measures during the study period and for 4 months/6 months after the discontinuation of treatment, respectively.
Who cannot join
- Patients with any of the following conditions are prohibited from enrolling in this study:
- 1.Having received other anti-tumor treatments (including but not limited to chemotherapy, radiotherapy, targeted therapy, immunotherapy, or hematopoietic stem cell transplantation) that may affect the hematopoietic system or blood cell count within 1 month before the screening period after CAR-T cell infusion;
- 2.Significant bone marrow infiltration by tumor cells during the screening period (for ALL: bone marrow morphological examination showing leukemia cell proportion > 5%; for multiple myeloma (MM) and lymphoma: bone marrow flow cytometry showing positive minimal residual disease (MRD), or bone marrow pathological immunohistochemistry showing lymphoma/clonal plasma cell infiltration);
- 3.Presence of any of the following conditions within 1 week before the first dose administration: infection with hemodynamic instability (requiring vasoactive drug support); deep fungal infection confirmed by imaging or microbiology (e.g., invasive aspergillosis, bloodstream infection, etc.); Pneumocystis jirovecii pneumonia, active tuberculosis, viremia (cytomegalovirus, parvovirus B19, etc.), and viral pneumonia (cytomegalovirus, COVID-19 virus, influenza virus, adenovirus, parainfluenza virus, etc.); as well as other severe infections that may affect hematopoiesis as judged by the investigator;
- 4.Serum creatinine or blood urea nitrogen ≥ 1.5 times the upper limit of normal (ULN);
- 5.Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 3 times ULN; total bilirubin ≥ 1.5 times ULN;
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- 6.Other severe and/or uncontrolled diseases, or conditions that may affect study participation as judged by the investigator, including but not limited to: severe cardiac rhythm or conduction abnormalities (e.g., ventricular arrhythmias requiring clinical intervention, second-degree to third-degree atrioventricular block, etc.), corrected QT interval using Fridericia's formula (QTcF) > 480 ms on electrocardiogram; New York Heart Association (NYHA) heart function classification of Grade Ⅲ-Ⅳ; uncontrolled diabetes mellitus (glycated hemoglobin [HbA1c] > 9%); refractory hypertension; chronic obstructive pulmonary disease (forced expiratory volume in 1 second [FEV1] < 50% of predicted value), etc.;
- 7.History of arteriovenous thrombosis or atherosclerosis;
- 8.Positive for anti-human immunodeficiency virus (HIV) antibody or anti-Treponema pallidum specific antibody; positive for hepatitis B surface antigen (HBsAg); or positive for hepatitis B core antibody with hepatitis B virus deoxyribonucleic acid (HBV-DNA) > ULN; or hepatitis C virus ribonucleic acid (HCV-RNA) > ULN;
- 9.A history of or current malignant solid tumor (except cured non-invasive basal cell or squamous cell carcinoma of the skin and/or other cured carcinoma in situ; except other malignant tumors that have achieved clinical cure for > 5 years with no recurrence within 5 years);
- 10.Within 6 months after allogeneic hematopoietic stem cell transplantation, or donor cell chimerism rate ≤ 95%, or presence of active acute graft-versus-host disease (aGVHD) of Grade Ⅱ or higher, or moderate to severe chronic graft-versus-host disease (cGVHD);
- 11.Having received a live vaccine within 4 weeks before the first dose administration, or planning to receive any live vaccine during the study period;
- 12.Pregnant or lactating female patients;
- 13.Patients with mental disorders;
- 14.Participation in any other study drug trial (including vaccine trials) or exposure to other study drugs within 4 weeks or 5 half-lives (whichever is longer) before the first dose administration;
- 15.Patients who refuse to sign the informed consent form;
- 16.Other conditions deemed unsuitable for study inclusion by the 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
Chinese Academy of Medical Sciences Hospital of Hematology (Chinese Academy of Medical Sciences Institute of Hematology)
Tianjin, 300020
Zhenzhen Wang, 22-23608095, wangzhenzhen@ihcams.ac.cn
About this study
Official title: Single-Arm, Exploratory Clinical Study to Evaluate the Safety and Efficacy of Umbilical Cord Blood-Derived Mesenchymal Stem Cells in the Treatment of Long-Term Cytopenia After CAR-T Therapy
This study is a single arm, open label, exploratory clinical study aimed at evaluating the efficacy, and safety of allogeneic umbilical cord blood-derived mesenchymal stem cells in the treatment of long-term cytopenia after CAR-T therapy.
Read the detailed description
This is a single-center, open-label, dose-escalation exploratory trial, whose primary objective is to evaluate the safety and preliminary efficacy of human umbilical cord-derived mesenchymal stem cell injection in patients with acute lymphoblastic leukemia, lymphoma, and multiple myeloma who still suffer from severe cytopenia 3 weeks after CAR-T infusion, so as to provide dose evidence and efficacy reference for subsequent studies.
Targeting the severe cytopenia complication with a high incidence rate (27%-95%) after CAR-T therapy and limited efficacy of conventional treatments, this trial adopts a "3+3" dose-escalation design. All three groups use a unified single dose of 2×10⁶ cells/kg body weight, differing only in infusion frequency (Group A: once; Group B: twice; Group C: four times), with 3 patients initially enrolled in each group. The dose-limiting toxicity (DLT) observation period is 28 days; if 2 or more DLTs occur, dose escalation will be terminated. The total sample size ranges from 15 to 24 cases, with a 24-week follow-up (weekly for the first 8 weeks and monthly from week 9 to week 24).
Cell Preparation: Dispensed according to the actual body weight of each subject at a standard dose of 2×10⁶ cells/kg body weight, in compliance with GMP requirements. The cell viability is ≥85%, and the preparation can only be released after passing pathogenic microorganism, purity and tumorigenicity screenings.
Infusion Procedure: Administer 5mg dexamethasone 30 minutes before infusion to prevent allergies. Thaw and mix the preparation at room temperature before infusion, with an initial rate of 20 drops/min for the first 15 minutes; if no discomfort occurs, adjust the rate to 40-60 drops/min (completing the infusion within 30-60 minutes). Monitor vital signs every 15 minutes during infusion and keep the patient under observation for 2 hours after infusion.
Safety: Graded according to NCI CTCAE 5.0. Acute reactions are monitored for 24 hours, delayed reactions are specifically examined at weeks 4, 8, 12 and 24, and serious adverse events (SAEs) must be reported within 24 hours.
Efficacy: Complete response (CR) and partial response (PR) require "dual-test compliance + 7 days without blood product transfusion" (with an interval of ≥48 hours). The response rate and duration are calculated at weeks 4 and 8 as key time points.
Immunological Detection: Collect samples at baseline and at weeks 1, 4 and 8 after infusion to detect inflammatory markers, immune cells and cytokines.
- Being tested
- Mesenchymal Stem Cell Infusion
- Keywords
- ICAHT, hematotoxicity, CAR-T, cytopenia
- Medical subject headings
- Cytopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mesenchymal Stem Cell InfusionBiological
Mesenchymal stem cells: intravenous infusion, 2×10⁶ cells/kg body weight/week (once weekly), with 1 to 4 administrations based on different dosage groups.
| Study group | Role | What they receive |
|---|---|---|
| MSC | Experimental | Mesenchymal stem cells: intravenous infusion, 2×10⁶ cells/kg body weight/week (once weekly), with 1 to 4 administrations based on different dosage groups. Receives: Biological: Mesenchymal Stem Cell Infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v5.0
Measured: From recruitment to 24 weeks after the last treatment.
Secondary outcomes (5)
Complete Response (CR) rate
Complete Response (CR) Criteria (no red blood cell/platelet transfusion for at least 7 days and meeting the standard in two consecutive tests):
Hemoglobin (Hb) ≥ 100 g/L (for adults) or ≥ the lower limit of age-adjusted normal value; Absolute Neutrophil Count (ANC) ≥ 1.5×10⁹/L; Platelet Count (PLT) ≥ 100×10⁹/L.
Measured: At Week 4 and Week 8 after the completion of MSC infusion
Partial Response (PR) rate
Partial Response (PR) Criteria: Meeting any of the following conditions (no red blood cell/platelet transfusion for at least 7 days and meeting the standard in two consecutive tests):
Neutrophils: Absolute value increased by ≥ 0.5×10⁹/L compared with the baseline; Platelets: Absolute value increased by ≥ 10×10⁹/L compared with the baseline; Hemoglobin: Absolute value increased by ≥ 15 g/L compared with the baseline.
Measured: At Week 4 and Week 8 after the completion of MSC infusion
Overall Response (OR) rate
OR=PR+CR
Measured: At Week 4 and Week 8 after the completion of MSC infusion
Response time
The median time from the first MSC infusion to the first achievement of CR/PR for various blood cell types.
Measured: From the first MSC infusion to 8th week after the last MSC infusion
Duration of Relief（DOR）
Measured: from the date of achiving CR/PR to the earliest occurrence of hematopoietic indices falling below the CR/PR criteria or the end of the preset 24-week follow-up period after the first MSC infusion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2025
- Study start1 Oct 2025
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immune Effector Cell Associated HematotoxicityStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- The study is divided into two phases: dose escalation phase and dose expansion phase.The dose escalation phase adopted a "3+3" design, with MTD (Maximum Tolerated Dose) determined by DLT (Dose-Limiting Toxicity) incidence. There are three groups: A, B, and C, with 3 subjects in each group. Group A: intravenous infusion of 2 × 10⁶ cells/kg body weight once; Group B: intravenous infusion of 2 × 10⁶ cells/kg body weight, once a week for 2 times; Group C: intravenous infusion of 2.0 × 10⁶ cells/kg body weight, once a week for 4 times. No DLT in three subjects means proceeding to the next higher dose group.One DLT in three subjects requires enrolling three more subjects.No DLT in these additions allows advancing to the higher dose group.The trial terminates when two or more DLTs occur in three or six subjects, with the current dose defined as MTD. In the dose expansion phase, investigators will select one specific dose test group (either A, B, or C) and expand the sample size by 6 subjects.
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07212335
- Sponsor's protocol ID
- IIT2025028
- Acronym
- MSC-ICAHT
- Status last verified
- Oct 2026
- First submitted
- 30 Sep 2025
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Researchers qualified can request the dataset, including de-identified individual subject data. Data may be requested from PI from 12 months to 36 months after study completion.
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-Arm, Exploratory Clinical Study to Evaluate the Safety and Efficacy of Umbilical Cord Blood-Derived Mesenchymal Stem Cells in the Treatment of Long-Term Cytopenia After CAR-T Therapy
- ClinicalTrials.gov ID
- NCT07212335
- Acronym / sponsor ID
- MSC-ICAHT / IIT2025028
- Keywords
- ICAHT, hematotoxicity, CAR-T, cytopenia
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, ChinaUniversity, hospital or other
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Sep 2028 (estimated)
- First posted
- 8 Oct 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 study is a single arm, open label, exploratory clinical study aimed at evaluating the efficacy, and safety of allogeneic umbilical cord blood-derived mesenchymal stem cells in the treatment of long-term cytopenia after CAR-T therapy.
Detailed description
This is a single-center, open-label, dose-escalation exploratory trial, whose primary objective is to evaluate the safety and preliminary efficacy of human umbilical cord-derived mesenchymal stem cell injection in patients with acute lymphoblastic leukemia, lymphoma, and multiple myeloma who still suffer from severe cytopenia 3 weeks after CAR-T infusion, so as to provide dose evidence and efficacy reference for subsequent studies.
Targeting the severe cytopenia complication with a high incidence rate (27%-95%) after CAR-T therapy and limited efficacy of conventional treatments, this trial adopts a "3+3" dose-escalation design. All three groups use a unified single dose of 2×10⁶ cells/kg body weight, differing only in infusion frequency (Group A: once; Group B: twice; Group C: four times), with 3 patients initially enrolled in each group. The dose-limiting toxicity (DLT) observation period is 28 days; if 2 or more DLTs occur, dose escalation will be terminated. The total sample size ranges from 15 to 24 cases, with a 24-week follow-up (weekly for the first 8 weeks and monthly from week 9 to week 24).
Cell Preparation: Dispensed according to the actual body weight of each subject at a standard dose of 2×10⁶ cells/kg body weight, in compliance with GMP requirements. The cell viability is ≥85%, and the preparation can only be released after passing pathogenic microorganism, purity and tumorigenicity screenings.
Infusion Procedure: Administer 5mg dexamethasone 30 minutes before infusion to prevent allergies. Thaw and mix the preparation at room temperature before infusion, with an initial rate of 20 drops/min for the first 15 minutes; if no discomfort occurs, adjust the rate to 40-60 drops/min (completing the infusion within 30-60 minutes). Monitor vital signs every 15 minutes during infusion and keep the patient under observation for 2 hours after infusion.
Safety: Graded according to NCI CTCAE 5.0. Acute reactions are monitored for 24 hours, delayed reactions are specifically examined at weeks 4, 8, 12 and 24, and serious adverse events (SAEs) must be reported within 24 hours.
Efficacy: Complete response (CR) and partial response (PR) require "dual-test compliance + 7 days without blood product transfusion" (with an interval of ≥48 hours). The response rate and duration are calculated at weeks 4 and 8 as key time points.
Immunological Detection: Collect samples at baseline and at weeks 1, 4 and 8 after infusion to detect inflammatory markers, immune cells and cytokines.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The study is divided into two phases: dose escalation phase and dose expansion phase.The dose escalation phase adopted a "3+3" design, with MTD (Maximum Tolerated Dose) determined by DLT (Dose-Limiting Toxicity) incidence. There are three groups: A, B, and C, with 3 subjects in each group. Group A: intravenous infusion of 2 × 10⁶ cells/kg body weight once; Group B: intravenous infusion of 2 × 10⁶ cells/kg body weight, once a week for 2 times; Group C: intravenous infusion of 2.0 × 10⁶ cells/kg body weight, once a week for 4 times. No DLT in three subjects means proceeding to the next higher dose group.One DLT in three subjects requires enrolling three more subjects.No DLT in these additions allows advancing to the higher dose group.The trial terminates when two or more DLTs occur in three or six subjects, with the current dose defined as MTD. In the dose expansion phase, investigators will select one specific dose test group (either A, B, or C) and expand the sample size by 6 subjects.
| Arm | Type | Receives |
|---|---|---|
| MSC | Experimental | Biological: Mesenchymal Stem Cell InfusionMesenchymal stem cells: intravenous infusion, 2×10⁶ cells/kg body weight/week (once weekly), with 1 to 4 administrations based on different dosage groups. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 1.Voluntarily participate in the study and sign the informed consent form;
- 2.Aged ≥ 18 years, regardless of gender;
- 3.Patients with acute lymphoblastic leukemia (ALL), lymphoma, or myeloma who still have severe cytopenia (meeting any of the following conditions: absolute neutrophil count ≤ 1×10⁹/L; platelet count ≤ 30×10⁹/L; hemoglobin ≤ 70 g/dL) 3 weeks after CAR-T cell infusion;
- 4.ECOG performance status score ≤ 2;
- 5.Estimated survival time ≥ 6 months;
Key exclusion criteria (17 listed)
- Patients with any of the following conditions are prohibited from enrolling in this study:
- 1.Having received other anti-tumor treatments (including but not limited to chemotherapy, radiotherapy, targeted therapy, immunotherapy, or hematopoietic stem cell transplantation) that may affect the hematopoietic system or blood cell count within 1 month before the screening period after CAR-T cell infusion;
- 2.Significant bone marrow infiltration by tumor cells during the screening period (for ALL: bone marrow morphological examination showing leukemia cell proportion > 5%; for multiple myeloma (MM) and lymphoma: bone marrow flow cytometry showing positive minimal residual disease (MRD), or bone marrow pathological immunohistochemistry showing lymphoma/clonal plasma cell infiltration);
- 3.Presence of any of the following conditions within 1 week before the first dose administration: infection with hemodynamic instability (requiring vasoactive drug support); deep fungal infection confirmed by imaging or microbiology (e.g., invasive aspergillosis, bloodstream infection, etc.); Pneumocystis jirovecii pneumonia, active tuberculosis, viremia (cytomegalovirus, parvovirus B19, etc.), and viral pneumonia (cytomegalovirus, COVID-19 virus, influenza virus, adenovirus, parainfluenza virus, etc.); as well as other severe infections that may affect hematopoiesis as judged by the investigator;
- 4.Serum creatinine or blood urea nitrogen ≥ 1.5 times the upper limit of normal (ULN);
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 |
|---|---|---|
| Mesenchymal Stem Cell InfusionMesenchymal stem cells: intravenous infusion, 2×10⁶ cells/kg body weight/week (once weekly), with 1 to 4 administrations based on different dosage groups. | Biological | MSC |
Primary outcome
Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v5.0
Time frame: From recruitment to 24 weeks after the last treatment.
5 secondary outcomes
Complete Response (CR) rate
Time frame: At Week 4 and Week 8 after the completion of MSC infusion
Partial Response (PR) rate
Time frame: At Week 4 and Week 8 after the completion of MSC infusion
Overall Response (OR) rate
Time frame: At Week 4 and Week 8 after the completion of MSC infusion
Response time
Time frame: From the first MSC infusion to 8th week after the last MSC infusion
Duration of Relief（DOR）
Time frame: from the date of achiving CR/PR to the earliest occurrence of hematopoietic indices falling below the CR/PR criteria or the end of the preset 24-week follow-up period after the first MSC 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 26 Oct 2026.
- Individual participant dataSharing planned: Yes. Researchers qualified can request the dataset, including de-identified individual subject data. Data may be requested from PI from 12 months to 36 months after study completion.
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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 Mesenchymal Stem Cell Infusion in people with Immune Effector Cell Associated Hematotoxicity, 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 7 inclusion and 17 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 26 Oct 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 Zhenzhen Wang (22-23608095, wangzhenzhen@ihcams.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v5.0 (time frame: From recruitment to 24 weeks after the last treatment.). 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 26 Oct 2026.