Adult B Acute Lymphoblastic LeukemiaEarly Phase 1NCT04626726
Adult B-ALL Treated by CART Cell Bridging Allogeneic Hematopoietic Stem Cell Transplantation
A Early Phase 1 study testing CD19 CAR-T, CD22 CAR-T and CD19+CD22 CAR-T in people with Adult B Acute Lymphoblastic Leukemia, run by Hebei Senlang Biotechnology Inc., Ltd. at 1 site in China.
Trial summary
This is an open, single-arm, phase I/phase II clinical study to evaluate efficacy and safety of chimeric antigen receptor T cell immunotherapy (CAR-T) in the treatment of Relapsed Refractory (R/R) adult acute lymphoblastic leukemia bridging allogeneic hematopoietic stem cell transplantation. Read more about this study
- Who is it for?
- Ages 14 to 65 years
- Conditions the study is for
- Adult B Acute Lymphoblastic Leukemia
- What is being tested?
- CD19 CAR-T, CD22 CAR-T and CD19+CD22 CAR-T
- 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
- 1 Apr 2020to 30 May 2023
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
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 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Be diagnosed a kind of Relapsed or Refractory Haematopoietic and Lymphoid Malignancies:
- ECOG score≤2;
- To be aged 1 to 65 years;
- More than a month lifetime from the consent signing date.
Who cannot join
- Serious cardiac insufficiency, left ventricular ejection fraction<50%;
- Has a history of severe pulmonary function damaging;
- Merging other progressing malignant tumor;
- Merging uncontrolled infection;
- Merging the metabolic diseases (except diabetes);
- Merging severe autoimmune diseases or immunodeficiency disease;
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- Patients with active hepatitis B or hepatitis C;
- Patients with HIV infection;
- Has a history of serious allergies on Biological products (including antibiotics);
- Has acute GvHD on allogeneic hematopoietic stem cell transplantation patients after stopping immunosuppressants a month;
- Pregnancy or lactation women;
- Any situation that would increase dangerousness of subjects or disturb the outcome of the clinical study according to the researcher's evaluation.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
No.2 Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050000
Jianqiang Li, PhD & MD, +86311-89928689, limmune@gmail.com
Jianmin Luo, PhD & MD, +86311-66002304
About this study
Official title: A Clinical Trial to Explore the Safety, Efficacy, and Remission Phase of CAR-T Cell in the Treatment of Adult Relapsed Refractory (R/R) Acute Lymphoblastic Leukemia Bridging Allogeneic Hematopoietic Stem Cell Transplantation
This is an open, single-arm, phase I/phase II clinical study to evaluate efficacy and safety of chimeric antigen receptor T cell immunotherapy (CAR-T) in the treatment of Relapsed Refractory (R/R) adult acute lymphoblastic leukemia bridging allogeneic hematopoietic stem cell transplantation.
Read the detailed description
This trial openly recruited 50 patients into the group and were given CAR-T treatment. Patients participating in clinical trials will be tested and evaluated in terms of treatment safety, efficacy, and response duration. As assessed by clinicians, adult B-ALL patients who meet the enrollment criteria, after adequate communication, the patient or family members voluntarily join the clinical study, and are willing to bridge allogeneic hematopoiesis within 3 months after enrollment using CAR-T therapy。
- Conditions
- Adult B Acute Lymphoblastic Leukemia
- Being tested
- CD19 CAR-T, CD22 CAR-T, CD19+CD22 CAR-T, Fludarabine, Cyclophosphamide
- Medical subject headings
- Burkitt Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CD19 CAR-TDrug
Also called Senl_19
CD19 CAR-T infusion for patients with CD19 positive tumor cells
CD22 CAR-TDrug
Also called Senl_22
CD22 CAR-T infusion for patients with CD22 positive tumor cells
CD19+CD22 CAR-TDrug
Also called Senl_19+22
CD19+CD22 CAR-T infusion for patients with CD19 positive and CD22 positive tumor cells
FludarabineDrug
Also called fiu
25mg/㎡ for D-4、D-3 and D-2
CyclophosphamideDrug
Also called ctx
500mg/㎡ for D-3 and D-2
| Study group | Role | What they receive |
|---|---|---|
| Volunteers | Experimental | The patient voluntarily signs the informed consent, and the patient meets the entry criteria to diagnose patients with acute B lymphocytic leukemia expressing specific target antigens Receives: Drug: CD19 CAR-T; Drug: CD22 CAR-T; Drug: CD19+CD22 CAR-T; Drug: Fludarabine; Drug: Cyclophosphamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Severe/Adverse Events as a Measure of Safety
Number of Participants with Severe/Adverse Events as a Measure of Safety
Measured: 28 days
Copies numbers of CAR in peripheral blood(PB) and/or bone marrow(BM)
Copies numbers of CAR in peripheral blood(PB) and/or bone marrow(BM)
Measured: 24 months
Secondary outcomes (2)
Objective response rate of complete remission and partial remission
Objective response rate of complete remission and partial remission
Measured: 24 months
Overall survival time
Overall survival time
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2020
- Study start1 Apr 2020
- Primary completion30 May 2023 (estimated)
- Study completion30 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adult B 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hebei Senlang Biotechnology Inc., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jianmin Luo, PhD&MD, Principal investigator, The Second Hospital of Hebei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04626726
- Sponsor's protocol ID
- CAR-T for adult B-ALL
- Status last verified
- Nov 2020
- First submitted
- 6 Nov 2020
- Last updated
- 13 Nov 2020
- 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 13 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Trial to Explore the Safety, Efficacy, and Remission Phase of CAR-T Cell in the Treatment of Adult Relapsed Refractory (R/R) Acute Lymphoblastic Leukemia Bridging Allogeneic Hematopoietic Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT04626726
- Acronym / sponsor ID
- CAR-T for adult B-ALL
- Conditions
- Adult B Acute Lymphoblastic Leukemia
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Hebei Senlang Biotechnology Inc., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 30 May 2023 (estimated)
- Study completion
- 30 May 2023 (estimated)
- First posted
- 13 Nov 2020 (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 an open, single-arm, phase I/phase II clinical study to evaluate efficacy and safety of chimeric antigen receptor T cell immunotherapy (CAR-T) in the treatment of Relapsed Refractory (R/R) adult acute lymphoblastic leukemia bridging allogeneic hematopoietic stem cell transplantation.
Detailed description
This trial openly recruited 50 patients into the group and were given CAR-T treatment. Patients participating in clinical trials will be tested and evaluated in terms of treatment safety, efficacy, and response duration. As assessed by clinicians, adult B-ALL patients who meet the enrollment criteria, after adequate communication, the patient or family members voluntarily join the clinical study, and are willing to bridge allogeneic hematopoiesis within 3 months after enrollment using CAR-T therapy。
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Volunteers | Experimental | Drug: CD19 CAR-T, Drug: CD22 CAR-T, Drug: CD19+CD22 CAR-T, Drug: Fludarabine, Drug: CyclophosphamideThe patient voluntarily signs the informed consent, and the patient meets the entry criteria to diagnose patients with acute B lymphocytic leukemia expressing specific target antigens |
Who may qualify
- Ages
- 14 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Be diagnosed a kind of Relapsed or Refractory Haematopoietic and Lymphoid Malignancies:
- ECOG score≤2;
- To be aged 1 to 65 years;
- More than a month lifetime from the consent signing date.
Key exclusion criteria (12 listed)
- Serious cardiac insufficiency, left ventricular ejection fraction<50%;
- Has a history of severe pulmonary function damaging;
- Merging other progressing malignant tumor;
- Merging uncontrolled infection;
- Merging the metabolic diseases (except diabetes);
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 |
|---|---|---|
| CD19 CAR-TAlso: Senl_19CD19 CAR-T infusion for patients with CD19 positive tumor cells | Drug | Volunteers |
| CD22 CAR-TAlso: Senl_22CD22 CAR-T infusion for patients with CD22 positive tumor cells | Drug | Volunteers |
| CD19+CD22 CAR-TAlso: Senl_19+22CD19+CD22 CAR-T infusion for patients with CD19 positive and CD22 positive tumor cells | Drug | Volunteers |
| FludarabineAlso: fiu25mg/㎡ for D-4、D-3 and D-2 | Drug | Volunteers |
| CyclophosphamideAlso: ctx500mg/㎡ for D-3 and D-2 | Drug | Volunteers |
Primary outcome
Number of Participants with Severe/Adverse Events as a Measure of Safety
Time frame: 28 days
Number of Participants with Severe/Adverse Events as a Measure of Safety
Copies numbers of CAR in peripheral blood(PB) and/or bone marrow(BM)
Time frame: 24 months
Copies numbers of CAR in peripheral blood(PB) and/or bone marrow(BM)
2 secondary outcomes
Objective response rate of complete remission and partial remission
Time frame: 24 months
Overall survival time
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2020.
- 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. This study is not recruiting at the moment.
Jianmin Luo, PhD&MD principal investigator
The Second Hospital of Hebei Medical University
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 CD19 CAR-T, CD22 CAR-T and CD19+CD22 CAR-T in people with Adult B Acute Lymphoblastic Leukemia, 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 4 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 13 Nov 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jianqiang Li, PhD&MD (+8631189928689, limmune@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Severe/Adverse Events as a Measure of Safety (time frame: 28 days). 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 Nov 2020.