T Acute Lymphoblastic LeukemiaNCT04620655
RD13-01 for Patients With r/r CD7+ T-ALL/T-LBL
A study testing RD13-01 cell infusion in people with T Acute Lymphoblastic Leukemia and T-lymphoblastic Lymphoma, run by Min Xiang at 1 site in China.
Trial summary
This study is designed to explore the safety of RD13-01 for patients with CD7+ relapsed and/or refractory T cell acute lymphoblastic leukemia or lymphoblastic lymphoma. And to evaluate the efficacy and pharmacokinetics of RD13-01 in patients. Read more about this study
- Who is it for?
- Ages 3 to 70 years
- Conditions the study is for
- T Acute Lymphoblastic Leukemia, T-lymphoblastic Lymphoma
- What is being tested?
- RD13-01 cell infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 15 Nov 2020to 15 Nov 2022
- Phase
- Interventional
- 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
- Aged 3 to 70 years.
- Diagnosis of r/r T-ALL/T-LBL.
- ECOG: 0-2.
- Life expectancy greater than 12 weeks.
- Cardiac left ventricle ejection fraction ≥50%.
- Informed consent explained to, understood by and signed by the patient/ guardian. Patient/guardian is given a copy of informed consent.
Who cannot join
- Pregnant or lactating.
- Hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) positive and peripheral blood hepatitis B virus (HBV) DNA titer detection is not within the normal range; hepatitis C virus (HCV) antibody positive and peripheral blood hepatitis C Viral (HCV) RNA positive; human immunodeficiency virus (HIV) antibody positive; cytomegalovirus (CMV) DNA positive; syphilis positive.
- Patients with graft-versus-host disease (GVHD) or who need to use immunosuppressive drugs.
- Participated in other clinical studies within 2 weeks prior to screening.
- History of alcoholism, drug abuse or mental illness.
- Any situations that the investigator believes may increase the risk of patients or interfere with the results of study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Hebei Yanda Ludaopei Hospital
Langfang, Hebei, 065200
Xian Zhang, +86-13641041596, zhxian2@126.com
About this study
This study is designed to explore the safety of RD13-01 for patients with CD7+ relapsed and/or refractory T cell acute lymphoblastic leukemia or lymphoblastic lymphoma. And to evaluate the efficacy and pharmacokinetics of RD13-01 in patients.
- Being tested
- RD13-01 cell infusion
- Medical subject headings
- Precursor T-Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RD13-01 cell infusionDrug
Universal CAR-T cells targeting CD7
| Study group | Role | What they receive |
|---|---|---|
| RD13-01 cell infusion | Experimental | Not described Receives: Drug: RD13-01 cell infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-limiting toxicity (DLT)
Measured: 4 weeks after infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2020
- Study start15 Nov 2020 (estimated)
- Primary completion15 Nov 2021 (estimated)
- Study completion15 Nov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for T 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
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Min Xiang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Min Xiang, Hebei Yanda Ludaopei Hospital
- Investigators
- Xian Zhang, Principal investigator, Hebei Yanda Ludaopei Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04620655
- Sponsor's protocol ID
- BHCT-RD13-01-03
- Status last verified
- Nov 2020
- First submitted
- 3 Nov 2020
- Last updated
- 9 Nov 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RD13-01 for Patients With r/r CD7+ T-ALL/T-LBL
- ClinicalTrials.gov ID
- NCT04620655
- Acronym / sponsor ID
- BHCT-RD13-01-03
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Min XiangUniversity, hospital or other
- Study start
- 15 Nov 2020 (estimated)
- Primary completion
- 15 Nov 2021 (estimated)
- Study completion
- 15 Nov 2022 (estimated)
- First posted
- 9 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 study is designed to explore the safety of RD13-01 for patients with CD7+ relapsed and/or refractory T cell acute lymphoblastic leukemia or lymphoblastic lymphoma. And to evaluate the efficacy and pharmacokinetics of RD13-01 in patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RD13-01 cell infusion | Experimental | Drug: RD13-01 cell infusion |
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)
- Aged 3 to 70 years.
- Diagnosis of r/r T-ALL/T-LBL.
- ECOG: 0-2.
- Life expectancy greater than 12 weeks.
- Cardiac left ventricle ejection fraction ≥50%.
Key exclusion criteria (6 listed)
- Pregnant or lactating.
- Hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) positive and peripheral blood hepatitis B virus (HBV) DNA titer detection is not within the normal range; hepatitis C virus (HCV) antibody positive and peripheral blood hepatitis C Viral (HCV) RNA positive; human immunodeficiency virus (HIV) antibody positive; cytomegalovirus (CMV) DNA positive; syphilis positive.
- Patients with graft-versus-host disease (GVHD) or who need to use immunosuppressive drugs.
- Participated in other clinical studies within 2 weeks prior to screening.
- History of alcoholism, drug abuse or mental illness.
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 |
|---|---|---|
| RD13-01 cell infusionUniversal CAR-T cells targeting CD7 | Drug | RD13-01 cell infusion |
Primary outcome
Dose-limiting toxicity (DLT)
Time frame: 4 weeks after infusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2020.
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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.
Xian Zhang principal investigator
Hebei Yanda Ludaopei 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 RD13-01 cell infusion in people with T Acute Lymphoblastic Leukemia and T-lymphoblastic Lymphoma, run by Min Xiang 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: status not confirmed, as of the sponsor's last update on 9 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.
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 Xian Zhang (+86-13641041596, zhxian2@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose-limiting toxicity (DLT) (time frame: 4 weeks after infusion). 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 9 Nov 2020.