Mantle Cell LymphomaEarly Phase 1NCT05444322
A Study of RD14-01 in Patients With Relapsed or Refractory B Cell Non-Hodgkin Lymphoma
A Early Phase 1 study testing RD14-01 cell infusion in people with Mantle Cell Lymphoma and Diffuse Large B-cell Lymphoma, run by He Huang at 1 site in China.
Trial summary
This study is designed to explore the safety and tolerability of RD14-01 for patients with relapsed and/or refractory B-cell non-Hodgkin lymphoma. And to evaluate the efficacy and pharmacokinetics of RD14-01 in patients. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Mantle Cell Lymphoma, Diffuse Large B-cell Lymphoma, Follicular Lymphoma
- What is being tested?
- RD14-01 cell infusion
- 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
- 5 Jul 2022to 10 Jul 2025
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 to 75 years.
- Diagnosis of r/r MCL, DLBCL, or FL (Grade 1, 2 and 3a).
- ECOG: 0-1.
- Life expectancy greater than 3 months.
- 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 e-antigen (HBeAg) positive and peripheral blood hepatitis B virus (HBV) DNA titer detection is not within the normal range; hepatitis C virus (HCV) antibody positive; human immunodeficiency virus (HIV) antibody positive; syphilis antibody positive; cytomegalovirus (CMV) DNA positive; Epstein-Barr virus (EBV) DNA positive.
- Central nervous system (CNS) metastases.
- Participated in other clinical studies within 4 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
The First Affiliated Hospital, College of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310003
He Huang, PhD, 86-13605714822, hehuangyu@126.com
About this study
This study is designed to explore the safety and tolerability of RD14-01 for patients with relapsed and/or refractory B-cell non-Hodgkin lymphoma. And to evaluate the efficacy and pharmacokinetics of RD14-01 in patients.
- Being tested
- RD14-01 cell infusion
- Medical subject headings
- Lymphoma, Mantle-Cell, Lymphoma, Large B-Cell, Diffuse, Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RD14-01 cell infusionDrug
Autologous CAR T cells
| Study group | Role | What they receive |
|---|---|---|
| RD14-01 cell infusion | Experimental | Infused i.v. in a single dose Receives: Drug: RD14-01 cell infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-limiting toxicity
DLT
Measured: Up to 2 years
Maximum tolerable dose
MTD
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2022
- Study start5 Jul 2022
- Primary completion10 Jul 2024 (estimated)
- Study completion10 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mantle Cell LymphomaStudies 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
- He Huang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, He Huang, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05444322
- Sponsor's protocol ID
- BHCT-RD14-01
- Status last verified
- Jul 2022
- First submitted
- 29 Jun 2022
- Last updated
- 11 Jul 2022
- 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 11 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of RD14-01 in Patients With Relapsed or Refractory B Cell Non-Hodgkin Lymphoma
- ClinicalTrials.gov ID
- NCT05444322
- Acronym / sponsor ID
- BHCT-RD14-01
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- He HuangUniversity, hospital or other
- Study start
- 5 Jul 2022 (actual)
- Primary completion
- 10 Jul 2024 (estimated)
- Study completion
- 10 Jul 2025 (estimated)
- First posted
- 5 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 study is designed to explore the safety and tolerability of RD14-01 for patients with relapsed and/or refractory B-cell non-Hodgkin lymphoma. And to evaluate the efficacy and pharmacokinetics of RD14-01 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 |
|---|---|---|
| RD14-01 cell infusion | Experimental | Drug: RD14-01 cell infusionInfused i.v. in a single dose |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Aged 18 to 75 years.
- Diagnosis of r/r MCL, DLBCL, or FL (Grade 1, 2 and 3a).
- ECOG: 0-1.
- Life expectancy greater than 3 months.
- Cardiac left ventricle ejection fraction ≥50%.
Key exclusion criteria (6 listed)
- Pregnant or lactating.
- Hepatitis B surface antigen (HBsAg) or hepatitis B e-antigen (HBeAg) positive and peripheral blood hepatitis B virus (HBV) DNA titer detection is not within the normal range; hepatitis C virus (HCV) antibody positive; human immunodeficiency virus (HIV) antibody positive; syphilis antibody positive; cytomegalovirus (CMV) DNA positive; Epstein-Barr virus (EBV) DNA positive.
- Central nervous system (CNS) metastases.
- Participated in other clinical studies within 4 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 |
|---|---|---|
| RD14-01 cell infusionAutologous CAR T cells | Drug | RD14-01 cell infusion |
Primary outcome
Dose-limiting toxicity
Time frame: Up to 2 years
DLT
Maximum tolerable dose
Time frame: Up to 2 years
MTD
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2022.
- 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.
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 RD14-01 cell infusion in people with Mantle Cell Lymphoma and Diffuse Large B-cell Lymphoma, run by He Huang 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 11 Jul 2022. 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 He Huang, PhD (86-13605714822, hehuangyu@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 (time frame: Up to 2 years). 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 11 Jul 2022.