Hematological MalignanciesPhase 2NCT05454241
CD7 CAR-T for Patients With r/r CD7+ Hematologic Malignancies
A Phase 2 study testing Anti-CD7 CAR-T in people with Hematological Malignancies, run by Institute of Hematology & Blood Diseases Hospital, China at 1 site in China.
Trial summary
This is a open-label, phase 2 study to evaluate the efficacy, safety and PK of CD7 chimeric antigen receptors treatment for patients with refractory/relapsed CD7 positive hematological malignancies. Read more about this study
- Who is it for?
- Ages 3 to 70 years
- Conditions the study is for
- Hematological Malignancies
- What is being tested?
- Anti-CD7 CAR-T
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteChina
- Study dates
- 7 Sep 2022to 31 Aug 2024
- Phase
- Phase 2
- 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 3 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosed CD7 positive relapsed/refractory hematological malignancies.
- Echocardiography shows left ventricular ejection fraction (LVEF) ≥ 50%;
- There is no active pulmonary infection, and the oxygen saturation during air inhalation is more than 92%;
- The estimated survival time is more than 3 months;
- Eastern cooperative oncology group (ECOG) performance status of 0 to 2
- The patients or their legal guardians voluntarily participated in the trial and signed the informed consent.
Who cannot join
- Patients with history of epilepsy or other central nervous system diseases;
- Patients with prolonged QT or severe heart disease;
- Pregnant or lactating women
- Patients with uncontrolled active infection.
- Positive for any of the following etiological tests: HIV, HBV, HCV
- Any other conditions that researcher think it is inappropriate for the subject to anticipate the trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy, Safety and PK of CD7 CAR-T in Patients With Relapsed or Refractory CD7+ Hematological Malignancies
This is a open-label, phase 2 study to evaluate the efficacy, safety and PK of CD7 chimeric antigen receptors treatment for patients with refractory/relapsed CD7 positive hematological malignancies.
- Conditions
- Hematological Malignancies
- Being tested
- Anti-CD7 CAR-T
- Keywords
- T-ALL/LBL, AML
- Medical subject headings
- Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti-CD7 CAR-TDrug
Universal CAR-T cells targeting CD7
| Study group | Role | What they receive |
|---|---|---|
| anti-CD7 UCAR-T cells | Experimental | Not described Receives: Drug: Anti-CD7 CAR-T |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate(ORR)
Number of patients who achieved response after treatment of CD7 CAR-T cell.
Measured: 1 Year
Secondary outcomes (2)
Duration of overall response (DOR)
Duration of overall response will be assessed from the CAR-T cell infusion to progression, death or last follow-up.
Measured: 1 Year
Overall survival(OS)
OS will be assessed from the CAR-T cell infusion to death or last follow-up.
Measured: 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2022
- Study start7 Sep 2022
- Primary completion31 Aug 2024
- Study completion31 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematological MalignanciesStudies 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
- 14 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ying Wang, Dr., Principal investigator, Hematology Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05454241
- Sponsor's protocol ID
- IIT2022020
- Status last verified
- Jun 2023
- First submitted
- 4 Jul 2022
- Last updated
- 13 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: When the research is completed, it will be shared in the form of a paper publication
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy, Safety and PK of CD7 CAR-T in Patients With Relapsed or Refractory CD7+ Hematological Malignancies
- ClinicalTrials.gov ID
- NCT05454241
- Acronym / sponsor ID
- IIT2022020
- Conditions
- Hematological Malignancies
- Keywords
- T-ALL/LBL, AML
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, ChinaUniversity, hospital or other
- Study start
- 7 Sep 2022 (actual)
- Primary completion
- 31 Aug 2024 (actual)
- Study completion
- 31 Aug 2024 (actual)
- First posted
- 12 Jul 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.
This is a open-label, phase 2 study to evaluate the efficacy, safety and PK of CD7 chimeric antigen receptors treatment for patients with refractory/relapsed CD7 positive hematological malignancies.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| anti-CD7 UCAR-T cells | Experimental | Drug: Anti-CD7 CAR-T |
Who may qualify
- Ages
- 3 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosed CD7 positive relapsed/refractory hematological malignancies.
- Echocardiography shows left ventricular ejection fraction (LVEF) ≥ 50%;
- There is no active pulmonary infection, and the oxygen saturation during air inhalation is more than 92%;
- The estimated survival time is more than 3 months;
- Eastern cooperative oncology group (ECOG) performance status of 0 to 2
Key exclusion criteria (6 listed)
- Patients with history of epilepsy or other central nervous system diseases;
- Patients with prolonged QT or severe heart disease;
- Pregnant or lactating women
- Patients with uncontrolled active infection.
- Positive for any of the following etiological tests: HIV, HBV, HCV
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 |
|---|---|---|
| Anti-CD7 CAR-TUniversal CAR-T cells targeting CD7 | Drug | anti-CD7 UCAR-T cells |
Primary outcome
Overall Response Rate(ORR)
Time frame: 1 Year
Number of patients who achieved response after treatment of CD7 CAR-T cell.
2 secondary outcomes
Duration of overall response (DOR)
Time frame: 1 Year
Overall survival(OS)
Time frame: 1 Year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2025.
- Individual participant dataSharing planned: No. When the research is completed, it will be shared in the form of a paper publication
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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.
Ying Wang, Dr. principal investigator
Hematology Hospital, Chinese Academy of Medical Sciences
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 Anti-CD7 CAR-T in people with Hematological Malignancies, 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 6 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: finished, as of the sponsor's last update on 13 Mar 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Response Rate(ORR) (time frame: 1 Year). 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 2025.