Acute Lymphoblastic LeukemiaNCT05618041
The Safety and Efficay Investigation of CAR-T Cell Therapy for Patients With Hematological Malignancies
A study testing CAR-T Autologous T cell injection in people with Acute Lymphoblastic Leukemia and Lymphoma, run by Hebei Senlang Biotechnology Inc., Ltd. at 1 site in China.
Trial summary
To evaluate the tolerability and safety of CAR-T technology in patients with relapsed or refractory hematolymphoid malignancies. Read more about this study
- Who is it for?
- Ages 14 to 75 years
- Conditions the study is for
- Acute Lymphoblastic Leukemia, Lymphoma, Multiple Myeloma
- What is being tested?
- CAR-T Autologous T cell injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 7 Sep 2022to 6 Dec 2027
- 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 14 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Sign the informed consent and be willing and able to comply with the visit, treatment protocol, laboratory examination, and other requirements of the study as specified in the study procedure sheet;
- Diagnosed as recurrent or refractory lymphoma, leukemia or myeloma;
- Tumor cells express targets for CAR-T cell therapy (results: flow cytometry or Immunohistochemical test confirmation);
- Age 14-75 (including threshold), gender unlimited;
- Eastern Cooperative Oncology Group (ECOG) score ≤2;
- HGB ≥ 70g/L (blood transfusion allowed);
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- Liver and kidney functions, heart and lung functions meet the following requirements:
- Creatinine ≤ 1.5 × ULN;
- Left ventricular ejection fraction ≥ 50%;
- Blood oxygen saturation>90%;
- Total bilirubin ≤ 1.5 × ULN； ALT and AST ≤ 2.5 × ULN;
- For T cell tumor patients, if tumor cells are detected in peripheral blood during screening, flow cytometry should be used to detect that the tumor cell surface immunophenotype is CD4 and CD8 double negative. If the immunophenotype of peripheral blood tumor cells is not double negative for CD4 and CD8, the condition that the proportion of peripheral blood tumor cells is ≤ 1% shall be met;
- Subjects with pregnancy plans must agree to use contraception before entering the study and after the study lasts for six months; If the subject is pregnant or suspected of being pregnant, the investigator shall be informed immediately;
- The subject or guardian understands and signs the informed consent form;
- Expected survival longer than 3 months.
Who cannot join
- Severe cardiac insufficiency;
- Have a history of severe lung impairment;
- Complicated with other advanced malignant tumors;
- Complicated with severe or persistent infection that cannot be effectively controlled;
- Complicated with severe autoimmune diseases or congenital immune deficiency;
- Active hepatitis (HBV DNA or HCV RNA positive);
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- Human immunodeficiency virus (HIV) infection or syphilis infection;
- Have a history of severe allergy to biological products (including antibiotics);
- If there is a history of hematopoietic stem cell transplantation, it should be no more than 6 months before the patient receives allogeneic hematopoietic stem cell transplantation;
- Subjects who received CAR-T therapy or other gene modified cell therapy before screening;
- Conditions that the investigator believes may increase the risk to the subject or interfere with the outcome of the study.
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
Shanxi Bethune Hospital
Taiyuan, Shanxi
Weiwei Tian, MD, 008613485304136
About this study
To evaluate the tolerability and safety of CAR-T technology in patients with relapsed or refractory hematolymphoid malignancies.
Read the detailed description
Main research purposes:
To evaluate the tolerability and safety of CAR-T technology in patients with relapsed or refractory hematolymphoid malignancies.
Secondary research purposes:
Objective Evaluation of Cytodynamic Characteristics of CAR-T in Different Types of Hematological Malignancies
- Conditions
- Acute Lymphoblastic Leukemia, Lymphoma, Multiple Myeloma
- Being tested
- CAR-T Autologous T cell injection
- Keywords
- CD19,CD20,BCMA, B-ALL/MM/NHL
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma, Lymphoma, Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAR-T Autologous T cell injectionBiological
Also called CD19 CAR-T, CD20 CAR-T, BCMA CAR-T
Biological: CAR-T; Drug: Cyclophosphamide,Fludarabine；Procedure: Leukapheresis
| Study group | Role | What they receive |
|---|---|---|
| CAR-T Autologous T cell injection | Experimental | Patients will be treated with CAR-T cells Receives: Biological: CAR-T Autologous T cell injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety: Incidence and severity of adverse events
To evaluate the possible adverse events occurred within first one month after CAR-T infusion, including the incidence and severity of symptoms such as cytokine release syndrome and neurotoxicity
Measured: First 1 month post CAR-T cells infusion
Efficacy: Remission Rate
Complete remission (CR) Complete remission with incomplete recovery of blood cells (CRI), positive minimal residual tumor (MRD+) or negative tumor (MRD -) CR/CRI, disease recurrence or progression (PD) were evaluated, and the overall remission rate was ORR=CR+CRI; For drenching Complete remission (CR), partial remission (PR), disease stability (SD) Disease recurrence or progression (PD) was evaluated, and the overall remission rate was ORR=CR+PR; For multiple myeloma Complete remission (CR), partial remission (VGPR, PR), disease stability (SD), disease recurrence or progression (PD) were adopted, Overall remission rate ORR=CR+VGPR+PR;
Measured: 3 months post CAR-T cells infusion
Secondary outcomes (3)
progression-free survival (PFS)
progression-free survival (PFS) time
Measured: 24 months post CAR-T cells infusion
CAR-T proliferation
the copy number of Senl CAR- T cells in the genomes of PBMC by qPCR method
Measured: 3 months post CAR-T cells infusion
Cytokine release
Cytokine( IL-6,IL-10,IFN-γ,TNF-α ) concentration (pg/mL) by flow cytometry method
Measured: 1 month post CAR-T cells infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2022
- Study start7 Sep 2022
- Primary completion6 Sep 2027 (estimated)
- Study completion6 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Lymphoblastic LeukemiaStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- Single Group Assignment
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hebei Senlang Biotechnology Inc., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hebei Taihe Chunyu Biotechnology Co., Ltd
- Responsible party
- Sponsor
- Investigators
- Weiwei w Tian, MD, Study director, Shanxi Bethune Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05618041
- Sponsor's protocol ID
- 20221019
- Status last verified
- Jun 2025
- First submitted
- 8 Nov 2022
- Last updated
- 24 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
He S, Peng J, Yang X, Meng F, Huang L, Huang L, Tian W, Gao Z, Zhao J, Wang Z, Wei J. Peripheral Blood Smears Distinguish Infective Fever after CAR-T Therapy. Front Biosci (Landmark Ed). 2023 Nov 24;28(11):299. doi: 10.31083/j.fbl2811299.
PubMed 38062808
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety and Efficay Investigation of CAR-T Cell Therapy for Patients With Hematological Malignancies
- ClinicalTrials.gov ID
- NCT05618041
- Acronym / sponsor ID
- 20221019
- Conditions
- Acute Lymphoblastic Leukemia, Lymphoma, Multiple Myeloma
- Keywords
- CD19,CD20,BCMA, B-ALL/MM/NHL
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Hebei Senlang Biotechnology Inc., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Hebei Taihe Chunyu Biotechnology Co., Ltd
- Study start
- 7 Sep 2022 (actual)
- Primary completion
- 6 Sep 2027 (estimated)
- Study completion
- 6 Dec 2027 (estimated)
- First posted
- 16 Nov 2022 (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.
To evaluate the tolerability and safety of CAR-T technology in patients with relapsed or refractory hematolymphoid malignancies.
Detailed description
Main research purposes:
To evaluate the tolerability and safety of CAR-T technology in patients with relapsed or refractory hematolymphoid malignancies.
Secondary research purposes:
Objective Evaluation of Cytodynamic Characteristics of CAR-T in Different Types of Hematological Malignancies
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single Group Assignment
| Arm | Type | Receives |
|---|---|---|
| CAR-T Autologous T cell injection | Experimental | Biological: CAR-T Autologous T cell injectionPatients will be treated with CAR-T cells |
Who may qualify
- Ages
- 14 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (15 listed)
- Sign the informed consent and be willing and able to comply with the visit, treatment protocol, laboratory examination, and other requirements of the study as specified in the study procedure sheet;
- Diagnosed as recurrent or refractory lymphoma, leukemia or myeloma;
- Tumor cells express targets for CAR-T cell therapy (results: flow cytometry or Immunohistochemical test confirmation);
- Age 14-75 (including threshold), gender unlimited;
- Eastern Cooperative Oncology Group (ECOG) score ≤2;
Key exclusion criteria (11 listed)
- Severe cardiac insufficiency;
- Have a history of severe lung impairment;
- Complicated with other advanced malignant tumors;
- Complicated with severe or persistent infection that cannot be effectively controlled;
- Complicated with severe autoimmune diseases or congenital immune deficiency;
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 |
|---|---|---|
| CAR-T Autologous T cell injectionAlso: CD19 CAR-T, CD20 CAR-T, BCMA CAR-TBiological: CAR-T; Drug: Cyclophosphamide,Fludarabine；Procedure: Leukapheresis | Biological | CAR-T Autologous T cell injection |
Primary outcome
Safety: Incidence and severity of adverse events
Time frame: First 1 month post CAR-T cells infusion
To evaluate the possible adverse events occurred within first one month after CAR-T infusion, including the incidence and severity of symptoms such as cytokine release syndrome and neurotoxicity
Efficacy: Remission Rate
Time frame: 3 months post CAR-T cells infusion
Complete remission (CR) Complete remission with incomplete recovery of blood cells (CRI), positive minimal residual tumor (MRD+) or negative tumor (MRD -) CR/CRI, disease recurrence or progression (PD) were evaluated, and the overall remission rate was ORR=CR+CRI; For drenching Complete remission (CR), partial remission (PR), disease stability (SD) Disease recurrence or progression (PD) was evaluated, and the overall remission rate was ORR=CR+PR; For multiple myeloma Complete remission (CR), partial remission (VGPR, PR), disease stability (SD), disease recurrence or progression (PD) were adopted, Overall remission rate ORR=CR+VGPR+PR;
3 secondary outcomes
progression-free survival (PFS)
Time frame: 24 months post CAR-T cells infusion
CAR-T proliferation
Time frame: 3 months post CAR-T cells infusion
Cytokine release
Time frame: 1 month post CAR-T cells 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 24 Jun 2025.
- Derived from this study: PubMed 38062808He S, Peng J, Yang X, Meng F, Huang L, Huang L, Tian W, Gao Z, Zhao J, Wang Z, Wei J. Peripheral Blood Smears Distinguish Infective Fever after CAR-T Therapy. Front Biosci (Landmark Ed). 2023 Nov 24;28(11):299. doi: 10.31083/j.fbl2811299.
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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.
Weiwei w Tian, MD study director
Shanxi Bethune Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CAR-T Autologous T cell injection in people with Acute Lymphoblastic Leukemia and Lymphoma, run by Hebei Senlang Biotechnology Inc., Ltd. 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 11 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 24 Jun 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.
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 Weiwei w Tian, MD (008613485304136, tianweiwei@yeah.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety: Incidence and severity of adverse events (time frame: First 1 month post CAR-T cells 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?
On the ClinicalTrials.gov record for NCT05618041, which also lists 1 linked publication.
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 24 Jun 2025; AzTrials last refreshed its copy on 8 Nov 2026.