ALL (Acute B-Lymphoblastic Leukemia)Early Phase 1NCT07470073
A Clinical Study Exploring the Safety, Efficacy and Cell Metabolic Kinetics of Universal Car-t Cell Injection in CD19 and / or CD20 Positive Relapsed / Refractory B-cell Acute Lymphoblastic Leukemia in Adolescents, Children and Adults
A Early Phase 1 study testing CT1190B cell injection in people with ALL (Acute B-Lymphoblastic Leukemia), run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.
Trial summary
This study is a single arm, open label, dose exploring clinical trial to evaluate the safety, efficacy, cellular metabolic dynamics, and pharmacodynamics of ct1190b cells in relapsed / refractory B-cell acute lymphoblastic leukemia. Read more about this study
- Who is it for?
- Ages 12 to 75 years
- Conditions the study is for
- ALL (Acute B-Lymphoblastic Leukemia)
- What is being tested?
- CT1190B cell injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2026to 31 Mar 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 12 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- voluntarily participate in clinical research; I fully understand and know this study and sign the informed consent form; ;
- aged 12-75 years (inclusive);
- relapsed / refractory B-ALL diagnosed by morphology, immunology or molecular science, and meeting one of the following conditions:
- The patients who did not achieve complete remission by the standardized induction chemotherapy, or early relapse (<12 months) after complete remission, or late relapse (≥ 12 months) after complete remission, and did not achieve complete remission by the standardized one course induction chemotherapy (except for the patients with late relapse who did not have a better treatment or did not tolerate other treatments according to the investigator's assessment), relapsed after 2 or more CR or CRI;
- For ph+all patients, in addition to receiving standard induction chemotherapy, they should also receive at least two kinds of TKI treatment without complete remission or relapse after complete remission (except those who cannot tolerate TKI treatment or have contraindications to TKI treatment, or those with T315I mutation do not need to receive TKI treatment);
- CD19 and / or CD20 positive in bone marrow or peripheral blood;
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- the proportion of bone marrow cell morphology or peripheral blood suggestive blasts ≥ 5%;
- estimated survival >12 weeks;
- study participants should meet the following inspection results (there should be no ongoing continuous supportive care):
- Endogenous creatinine clearance ≥ 30 ml/min (using Cockcroft Gault formula);
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 × ULN, total bilirubin ≤ 1.5 × ULN; In case of hepatobiliary invasion: AST and alt ≤ 5 × ULN, total bilirubin ≤ 3.0 × ULN;
- International normalized ratio (INR) and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN;
- Oxygen saturation in non oxygen inhalation state was > 91%;
- Left ventricular ejection fraction (LVEF) ≥ 50%.
- Male study participants who had active sex with women with reproductive potential were willing to use very effective and reliable methods of contraception within 1 year after receiving study treatment. All male study participants were absolutely forbidden to donate sperm within 1 year after receiving study treatment infusion during the study period.
Who cannot join
- pregnant or lactating women;
- there is HIV, syphilis infection, active hepatitis B virus infection (HBV-DNA is higher than the detection limit), or active hepatitis C virus infection (both HCV antibody and HCV-RNA are positive);
- there is currently any uncontrollable active infection, including but not limited to patients with active tuberculosis (judged by the investigator);
- there is active systemic autoimmune disease;
- patients with solitary extramedullary lesions;
- research participants with a history of neurological diseases, such as epilepsy, intracranial hemorrhage, severe brain injury, cerebellar disease, memory impairment, spinal cord compression or any disease involving the central nervous system, or suspected active central nervous system (CNS) metastasis;
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- patients with bone marrow failure status related genetic syndromes: such as Fanconi anemia, Kostmann syndrome, Shwachman syndrome or any other known bone marrow failure syndrome. Patients with Down syndrome were not excluded.
- for patients who relapsed after treatment with drugs targeting CD19 and / or CD20 before screening, the investigator judged that they could not benefit; 10. have received stem cell transplantation within 12 weeks before signing the informed consent; Received donor lymphocyte infusion (DLI) within 6 weeks;
- received the following treatments before cell infusion:
- Received anthracyclines, vinblastines, 6-mercaptopurine, 6-thioguanine, methotrexate, cytarabine, asparaginase, etc. within 7 days before infusion;
- Hydroxyurea and tyrosine kinase inhibitors were used within 3 days before infusion;
- Radiotherapy was used within 1 week before infusion (2 weeks interval for lung radiotherapy and 8 weeks interval for CNS radiotherapy);
- CNS prophylactic therapy (such as intrathecal injection of chemotherapeutic drugs) within 1 week before infusion;
- Give any T-cell lysis or antibody (such as alemtuzumab) within 8 weeks before infusion;
- Use monoclonal antibody, double antibody or ADC within 4 weeks before infusion;
- ;
- Received systemic glucocorticoids equivalent to >15 mg/ day prednisone within 3 days before infusion, except for glucocorticoids used locally;
- Polyethylene glycol asparaginase was used within 4 weeks before infusion;
- have been vaccinated with live attenuated vaccine, inactivated vaccine or RNA vaccine within 4 weeks before signing the informed consent;
- those who are allergic or intolerant to Qinglin drugs and tocilizumab, or allergic to components (dimethyl sulfoxide /dmso) in ct1190b cell infusion preparations; Or previous history of other serious allergies such as anaphylactic shock;
- patients with any of the following cardiac diseases before screening:
- New York Heart Association (NYHA) class III or IV heart failure;
- ;
- A history of clinically significant uncontrolled arrhythmias, such as ventricular arrhythmias;
- A history of severe non ischemic cardiomyopathy;
- Other heart diseases that the investigator believes may endanger the health of the patient due to participation in this clinical study;
- serious lung disease may endanger the patient's life after participating in the study as judged by the investigator;
- there are second primary malignant tumors that need treatment or have not been completely relieved in the past 2 years, except the following successfully treated tumors with low malignancy such as non metastatic basal cell carcinoma or squamous cell skin carcinoma, non metastatic prostate cancer, breast cancer or cervical cancer in situ, non muscle invasive bladder cancer or thyroid cancer;
- major surgery within 2 weeks before signing the informed consent, or major surgery planned during the study or within 4 weeks after giving the study treatment (excluding cataract and other local anesthesia surgery);
- after organ transplantation;
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
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430000
heng mei, M.D., Ph.D, 07596503286, hmei@hust.edu.cn
About this study
This study is a single arm, open label, dose exploring clinical trial to evaluate the safety, efficacy, cellular metabolic dynamics, and pharmacodynamics of ct1190b cells in relapsed / refractory B-cell acute lymphoblastic leukemia.
Read the detailed description
The study was divided into dose escalation phase and dose expansion phase. It is planned to enroll 18-36 study participants.
The participants were divided into two treatment groups. Group A was adult participants ≥ 18 years old who received ct1190b treatment. The dose escalation was tentatively determined at three dose levels: dl1:3.0 × 10^8, dl2:4.5 × 10^8, dl3:6.0 × 10^8 car-t cells. ， Group B consisted of 12-17-year-old adolescents and children. The dose escalation was tentatively defined as two dose levels. Dl1:3.0 × 10^6 /kg car-t cells, the maximum total number of infused cells was not more than 1.5 × 10^8 car-t cells, dl2:6.0 × 10^6 /kg car-t cells, the maximum total number of infused cells was not more than 3.0 × 10^8 car-t cells. The dose escalation of the two groups followed the "i3+3" design. It was planned to enroll 18-36 study participants. At the dose escalation stage, all patients of different subtypes were mixed into the group. Without distinguishing between groups, the dose escalation of group A was given priority. After obtaining certain data, the dose escalation of group B was performed (fig.it can receive other research data of the same indication of this product). If the starting dose of group A (3.0 × 10^8) meets the dose reduction standard according to the i3+3 principle (the i3+3 decision table indicates "d" or "Du", refer to the incremental decision table of the i3+3 principle for details), the investigator and the funder will jointly discuss and decide whether to enter the decreasing dose of 1.5 × 10^8. If the maximum dose currently set is not confirmed as the possible recommended dose (RD), the investigator and the funder can jointly decide whether to increase it to a higher dose to explore the possible recommended therapeutic dose. During the study, the dose group may be increased or decreased or the dose may be extended according to the safety, effectiveness and cellular metabolic dynamics data of the study participants.
- Conditions
- ALL (Acute B-Lymphoblastic Leukemia)
- Being tested
- CT1190B cell injection
- Keywords
- ALL (Acute B-Lymphoblastic Leukemia), CT1190B, CAR-T
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT1190B cell injectionBiological
Also called CT1190B
The active ingredient of the drug in this study is the chimeric antigen receptor targeting cd19/cd20 (car-cd19/cd20 for short) modified allogeneic T cells. In order to reduce the rejection of GVHD and host immune cells, TCR and B2M were knocked out, and the related modifications were also carried out to reduce the host NK cell immune rejection.
| Study group | Role | What they receive |
|---|---|---|
| CT1190B CAR-T cells Injection | Experimental | The study drug was ct1190b car T-cell injection, and the car-cd19/cd20 gene was site integrated into T-cells by using replicable lentivirus (RCL) and adeno-associated virus (AAV) gene editing technology. Receives: Biological: CT1190B cell injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number and severity of dose-limiting toxicity (DLT)events
DLT was collected to explore the maximum tolerated dose (MTD) and / or dose range of CT1190B
Measured: Within 28 days after cell infusion
Frequency, type and severity of AES
The frequency, type and severity of adverse events (AES) were collected. All adverse events will be evaluated according to the common terminology criteria for adverse events (CTCAE, version 5.0).
Measured: Within 12 months after cell infusion
Secondary outcomes (10)
Investigator assessed objective response rate (ORR)
Measured: The evaluation was performed within 12 months after cell infusion, such as 4 weeks, 8 weeks, 12 weeks, 4 months, 6 months, 9 months, 12 months after cell infusion
Investigator assessed complete response rate (CRR)
Measured: The evaluation was performed within 12 months after cell infusion, such as 4 weeks, 8 weeks, 12 weeks, 4 months, 6 months, 9 months, 12 months after cell infusion
Investigator assessed proportion of minimal residual disease negative (MRD)
Measured: The evaluation was performed within 12 months after cell infusion, such as 4 weeks, 8 weeks, 12 weeks, 4 months, 6 months, 9 months, 12 months after cell infusion
Investigator assessed duration of remission (DOR)
Measured: The evaluation was performed within 12 months after cell infusion, such as 4 weeks, 8 weeks, 12 weeks, 4 months, 6 months, 9 months, 12 months after cell infusion
Investigator assessed time to remission (TTR)
Measured: The evaluation was performed within 12 months after cell infusion, such as 4 weeks, 8 weeks, 12 weeks, 4 months, 6 months, 9 months, 12 months after cell infusion
Investigator assessed time to complete remission (TTCR)
Measured: The evaluation was performed within 12 months after cell infusion, such as 4 weeks, 8 weeks, 12 weeks, 4 months, 6 months, 9 months, 12 months after cell infusion
Investigator assessed • event free survival (EFS)
Measured: The evaluation was performed within 12 months after cell infusion, such as 4 weeks, 8 weeks, 12 weeks, 4 months, 6 months, 9 months, 12 months after cell infusion
Overall survival (OS)
Measured: The evaluation was performed within 12 months after cell infusion, such as 4 weeks, 8 weeks, 12 weeks, 4 months, 6 months, 9 months, 12 months after cell infusion
The level of CT1190B gene copy number
Cell metabolic dynamics analysis will be carried out according to different treatment groups. According to the actual blood collection time, individual ct1190b cell copy number time curves (linear and semi logarithmic) were drawn. According to the blood collection time, the average and median ct1190b cell copy number time curves (linear and semi logarithmic) were drawn.
Measured: Day 0 before cell infusion, Day 1, Day 3, Day 7, Day 10, Day 14, Day 18 (optional), Week 3, Week 4, Week 8, Month 4 and Month 6 after cell infusion
Duration of CT1190B gene copy number
Cell metabolic dynamics analysis will be carried out according to different treatment groups. According to the actual blood collection time, individual ct1190b cell copy number time curves (linear and semi logarithmic) were drawn. According to the blood collection time, the average and median ct1190b cell copy number time curves (linear and semi logarithmic) were drawn.
Measured: Day 0 before cell infusion, Day 1, Day 3, Day 7, Day 10, Day 14, Day 18 (optional), Week 3, Week 4, Week 8, Month 4 and Month 6 after cell infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2026
- Study start1 Apr 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ALL (Acute B-Lymphoblastic Leukemia)Studies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MEI HENG, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07470073
- Sponsor's protocol ID
- CT1190B-CG11013
- Status last verified
- Mar 2026
- First submitted
- 9 Mar 2026
- Last updated
- 13 Mar 2026
- Results posted
- No
- Data monitoring committee
- 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 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study Exploring the Safety, Efficacy and Cell Metabolic Kinetics of Universal Car-t Cell Injection in CD19 and / or CD20 Positive Relapsed / Refractory B-cell Acute Lymphoblastic Leukemia in Adolescents, Children and Adults
- ClinicalTrials.gov ID
- NCT07470073
- Acronym / sponsor ID
- CT1190B-CG11013
- Conditions
- ALL (Acute B-Lymphoblastic Leukemia)
- Keywords
- ALL (Acute B-Lymphoblastic Leukemia), CT1190B, CAR-T
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 13 Mar 2026 (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, dose exploring clinical trial to evaluate the safety, efficacy, cellular metabolic dynamics, and pharmacodynamics of ct1190b cells in relapsed / refractory B-cell acute lymphoblastic leukemia.
Detailed description
The study was divided into dose escalation phase and dose expansion phase. It is planned to enroll 18-36 study participants.
The participants were divided into two treatment groups. Group A was adult participants ≥ 18 years old who received ct1190b treatment. The dose escalation was tentatively determined at three dose levels: dl1:3.0 × 10^8, dl2:4.5 × 10^8, dl3:6.0 × 10^8 car-t cells. ， Group B consisted of 12-17-year-old adolescents and children. The dose escalation was tentatively defined as two dose levels. Dl1:3.0 × 10^6 /kg car-t cells, the maximum total number of infused cells was not more than 1.5 × 10^8 car-t cells, dl2:6.0 × 10^6 /kg car-t cells, the maximum total number of infused cells was not more than 3.0 × 10^8 car-t cells. The dose escalation of the two groups followed the "i3+3" design. It was planned to enroll 18-36 study participants. At the dose escalation stage, all patients of different subtypes were mixed into the group. Without distinguishing between groups, the dose escalation of group A was given priority. After obtaining certain data, the dose escalation of group B was performed (fig.it can receive other research data of the same indication of this product). If the starting dose of group A (3.0 × 10^8) meets the dose reduction standard according to the i3+3 principle (the i3+3 decision table indicates "d" or "Du", refer to the incremental decision table of the i3+3 principle for details), the investigator and the funder will jointly discuss and decide whether to enter the decreasing dose of 1.5 × 10^8. If the maximum dose currently set is not confirmed as the possible recommended dose (RD), the investigator and the funder can jointly decide whether to increase it to a higher dose to explore the possible recommended therapeutic dose. During the study, the dose group may be increased or decreased or the dose may be extended according to the safety, effectiveness and cellular metabolic dynamics data of the study participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CT1190B CAR-T cells Injection | Experimental | Biological: CT1190B cell injectionThe study drug was ct1190b car T-cell injection, and the car-cd19/cd20 gene was site integrated into T-cells by using replicable lentivirus (RCL) and adeno-associated virus (AAV) gene editing technology. |
Who may qualify
- Ages
- 12 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (15 listed)
- voluntarily participate in clinical research; I fully understand and know this study and sign the informed consent form; ;
- aged 12-75 years (inclusive);
- relapsed / refractory B-ALL diagnosed by morphology, immunology or molecular science, and meeting one of the following conditions:
- CD19 and / or CD20 positive in bone marrow or peripheral blood;
- the proportion of bone marrow cell morphology or peripheral blood suggestive blasts ≥ 5%;
Key exclusion criteria (30 listed)
- pregnant or lactating women;
- there is HIV, syphilis infection, active hepatitis B virus infection (HBV-DNA is higher than the detection limit), or active hepatitis C virus infection (both HCV antibody and HCV-RNA are positive);
- there is currently any uncontrollable active infection, including but not limited to patients with active tuberculosis (judged by the investigator);
- there is active systemic autoimmune disease;
- patients with solitary extramedullary lesions;
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 |
|---|---|---|
| CT1190B cell injectionAlso: CT1190BThe active ingredient of the drug in this study is the chimeric antigen receptor targeting cd19/cd20 (car-cd19/cd20 for short) modified allogeneic T cells. In order to reduce the rejection of GVHD and host immune cells, TCR and B2M were knocked out, and the related modifications were also carried out to reduce the host NK cell immune rejection. | Biological | CT1190B CAR-T cells Injection |
Primary outcome
The number and severity of dose-limiting toxicity (DLT)events
Time frame: Within 28 days after cell infusion
DLT was collected to explore the maximum tolerated dose (MTD) and / or dose range of CT1190B
Frequency, type and severity of AES
Time frame: Within 12 months after cell infusion
The frequency, type and severity of adverse events (AES) were collected. All adverse events will be evaluated according to the common terminology criteria for adverse events (CTCAE, version 5.0).
10 secondary outcomes
Investigator assessed objective response rate (ORR)
Time frame: The evaluation was performed within 12 months after cell infusion, such as 4 weeks, 8 weeks, 12 weeks, 4 months, 6 months, 9 months, 12 months after cell infusion
Investigator assessed complete response rate (CRR)
Time frame: The evaluation was performed within 12 months after cell infusion, such as 4 weeks, 8 weeks, 12 weeks, 4 months, 6 months, 9 months, 12 months after cell infusion
Investigator assessed proportion of minimal residual disease negative (MRD)
Time frame: The evaluation was performed within 12 months after cell infusion, such as 4 weeks, 8 weeks, 12 weeks, 4 months, 6 months, 9 months, 12 months after cell infusion
Investigator assessed duration of remission (DOR)
Time frame: The evaluation was performed within 12 months after cell infusion, such as 4 weeks, 8 weeks, 12 weeks, 4 months, 6 months, 9 months, 12 months after cell infusion
Investigator assessed time to remission (TTR)
Time frame: The evaluation was performed within 12 months after cell infusion, such as 4 weeks, 8 weeks, 12 weeks, 4 months, 6 months, 9 months, 12 months after cell infusion
Investigator assessed time to complete remission (TTCR)
Time frame: The evaluation was performed within 12 months after cell infusion, such as 4 weeks, 8 weeks, 12 weeks, 4 months, 6 months, 9 months, 12 months after cell infusion
Investigator assessed • event free survival (EFS)
Time frame: The evaluation was performed within 12 months after cell infusion, such as 4 weeks, 8 weeks, 12 weeks, 4 months, 6 months, 9 months, 12 months after cell infusion
Overall survival (OS)
Time frame: The evaluation was performed within 12 months after cell infusion, such as 4 weeks, 8 weeks, 12 weeks, 4 months, 6 months, 9 months, 12 months after cell infusion
The level of CT1190B gene copy number
Time frame: Day 0 before cell infusion, Day 1, Day 3, Day 7, Day 10, Day 14, Day 18 (optional), Week 3, Week 4, Week 8, Month 4 and Month 6 after cell infusion
Duration of CT1190B gene copy number
Time frame: Day 0 before cell infusion, Day 1, Day 3, Day 7, Day 10, Day 14, Day 18 (optional), Week 3, Week 4, Week 8, Month 4 and Month 6 after cell 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 13 Mar 2026.
- Individual participant dataSharing planned: No
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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 CT1190B cell injection in people with ALL (Acute B-Lymphoblastic Leukemia), run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology 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 15 inclusion and 30 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 13 Mar 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 Heng Mei, M.D., Ph.D (07596503286, hmei@hust.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number and severity of dose-limiting toxicity (DLT)events (time frame: Within 28 days after cell infusion). 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 13 Mar 2026.