NK T-Cell LymphomaPhase 1NCT06732492
RD13-02 Cell Injection in Patients with Relapsed or Refractory CD7-Positive Natural Killer/T Cell Malignancies
A Phase 1 study testing RD13-02 cell infusion in people with NK T-Cell Lymphoma and CART Therapy, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.
Trial summary
This is a single-arm, open-label, single-center, phase I study. The primary objective is to evaluate the safety of CD7 Chimeric Antigen Receptor-T(CAR-T) therapy for patients with CD7-positive relapsed or refractory natural killer/T cell lymphoma, and to evaluate the pharmacokinetics of CD7 CAR-T in patients。 Read more about this study
- Who is it for?
- Ages 3 to 70 years
- Conditions the study is for
- NK T-Cell Lymphoma, CART Therapy, CD7-positive Relapsed/Refractory Lymphoid Hematologic Malignancies
- What is being tested?
- RD13-02 cell infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 31 Oct 2024to 31 Dec 2027
- Phase
- Phase 1
- 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 3 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age 3-70
- Diagnosis of r/r NK/T lymphoma.
- CD7 positive expression
- Bone marrow lymphoblasts ≥5% by morphologic evaluation at screening
- Creatinine clearance (as estimated by Cockcroft Gault) ≥ 60 mL/min, Serum alanine aminotransferase(ALT)/aspartate aminotransferase(AST) < 3×upper limit of normal, Total bilirubin < 1.5×upper limit of normal or ≤1.5mg/dl
- Left ventricular ejection fraction ≥ 50% .
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- Baseline oxygen saturation ≥ 92% on room air.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
- The estimated survival time is more than 3 months.
- Subjects or their legal guardians volunteer to participate in the study and sign the informed consent.
Who cannot join
- Subjects with concomitant genetic syndromes associated with bone marrow failure states.
- Isolated extramedullary lesions
- Subjects with some cardiac conditions will be excluded.
- With uncontrolled active central nervous system leukemia (CNSL), cerebrospinal fluid grade Central Nervous System3(CNS3).
- History of traumatic brain injury, consciousness disturbance, epilepsy, cerebrovascular ischemia, and cerebrovascular hemorrhagic disease, which might compromise the ability of the subject to compliance with the obligations under the protocol.
- History of malignancy other than non-melanoma skin cancer or carcinoma.
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- Primary immune deficiency.
- Presence of uncontrolled infections.
- Subjects with some anticancer therapy before CAR-T infusion will be excluded.
- Active uncontrolled acute infections.
- Known history of infection with human immunodeficiency virus (HIV); active or latent hepatitis B, hepatitis C and syphilis.
- Subjects who are receiving systemic steroid therapy prior to screening.
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
Union Hospital
Wuhan, Hubei, 430022
Heng Mei, 027-8572600, hmei@hust.edu.cn
Yinqiang Zhang, 15007101371, zhang_yq@hust.edu.cn
About this study
This is a single-arm, open-label, single-center, phase I study. The primary objective is to evaluate the safety of CD7 Chimeric Antigen Receptor-T(CAR-T) therapy for patients with CD7-positive relapsed or refractory natural killer/T cell lymphoma, and to evaluate the pharmacokinetics of CD7 CAR-T in patients。
- Conditions
- NK T-Cell Lymphoma, CART Therapy, CD7-positive Relapsed/Refractory Lymphoid Hematologic Malignancies
- Being tested
- RD13-02 cell infusion
- Medical subject headings
- Lymphoma, Extranodal NK-T-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RD13-02 cell infusionDrug
Also called universal CD7 CAR-T cells
CAR-T cells
| Study group | Role | What they receive |
|---|---|---|
| RD13-02 cell infusion | Experimental | RD13-02 cells targeting CD7 were injected intravenously Receives: Drug: RD13-02 cell infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response rate (ORR)
The proportion of patients with complete response (CR) /complete response with incomplete blood cell recovery (CRi)
Measured: Evaluate at 4 weeks after CAR-T infusion
Secondary outcomes (3)
Duration of remission (DOR)
The time from CR/CRi and PR to disease relapsed or death due to disease progression after CAR-T infusion
Measured: Up to 1 years after CAR-T infusion
Event-free survival (EFS)
The time from first achieving CR/CRi to relapse or death
Measured: Up to 1 years after CAR-T infusion
Overall survival (OS)
The time from CAR-T infusion to death due to any cause
Measured: Up to 1 years after CAR-T infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2024
- Study start31 Oct 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NK T-Cell LymphomaStudies of the same condition, open and under way.
- More trials run by Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyThe 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Nanjing Bioheng Biotech Co., Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06732492
- Sponsor's protocol ID
- WHUH-RD13-02-01
- Status last verified
- Oct 2024
- First submitted
- 10 Dec 2024
- Last updated
- 13 Dec 2024
- Results posted
- No
- Data monitoring committee
- 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 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RD13-02 Cell Injection in Patients with Relapsed or Refractory CD7-Positive Natural Killer/T Cell Malignancies
- ClinicalTrials.gov ID
- NCT06732492
- Acronym / sponsor ID
- WHUH-RD13-02-01
- Conditions
- NK T-Cell Lymphoma, CART Therapy, CD7-positive Relapsed/Refractory Lymphoid Hematologic Malignancies
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyUniversity, hospital or other
- Collaborators
- Nanjing Bioheng Biotech Co., Ltd.
- Study start
- 31 Oct 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 13 Dec 2024 (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 single-arm, open-label, single-center, phase I study. The primary objective is to evaluate the safety of CD7 Chimeric Antigen Receptor-T(CAR-T) therapy for patients with CD7-positive relapsed or refractory natural killer/T cell lymphoma, and to evaluate the pharmacokinetics of CD7 CAR-T in patients。
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RD13-02 cell infusion | Experimental | Drug: RD13-02 cell infusionRD13-02 cells targeting CD7 were injected intravenously |
Who may qualify
- Ages
- 3 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- Age 3-70
- Diagnosis of r/r NK/T lymphoma.
- CD7 positive expression
- Bone marrow lymphoblasts ≥5% by morphologic evaluation at screening
- Creatinine clearance (as estimated by Cockcroft Gault) ≥ 60 mL/min, Serum alanine aminotransferase(ALT)/aspartate aminotransferase(AST) < 3×upper limit of normal, Total bilirubin < 1.5×upper limit of normal or ≤1.5mg/dl
Key exclusion criteria (12 listed)
- Subjects with concomitant genetic syndromes associated with bone marrow failure states.
- Isolated extramedullary lesions
- Subjects with some cardiac conditions will be excluded.
- With uncontrolled active central nervous system leukemia (CNSL), cerebrospinal fluid grade Central Nervous System3(CNS3).
- History of traumatic brain injury, consciousness disturbance, epilepsy, cerebrovascular ischemia, and cerebrovascular hemorrhagic disease, which might compromise the ability of the subject to compliance with the obligations under the protocol.
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 |
|---|---|---|
| RD13-02 cell infusionAlso: universal CD7 CAR-T cellsCAR-T cells | Drug | RD13-02 cell infusion |
Primary outcome
Overall response rate (ORR)
Time frame: Evaluate at 4 weeks after CAR-T infusion
The proportion of patients with complete response (CR) /complete response with incomplete blood cell recovery (CRi)
3 secondary outcomes
Duration of remission (DOR)
Time frame: Up to 1 years after CAR-T infusion
Event-free survival (EFS)
Time frame: Up to 1 years after CAR-T infusion
Overall survival (OS)
Time frame: Up to 1 years after CAR-T 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 13 Dec 2024.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing RD13-02 cell infusion in people with NK T-Cell Lymphoma and CART Therapy, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology 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 10 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: looking for participants now, as of the sponsor's last update on 13 Dec 2024. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Heng Mei, Ph.D&M.D (027-8572600, hmei@hust.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall response rate (ORR) (time frame: Evaluate at 4 weeks after CAR-T 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 13 Dec 2024.