NeoplasmsEarly Phase 1NCT05907603
Research Development（RD）13-02 Chimeric Antigen Receptor(CAR) -T Cell Injection for Patients With r/r Cluster Of Differentiation 7（CD7）+ T-Acute Lymphoblastic Leukemia(ALL)/T-Lymphoblastic Lymphoma(LBL) /Acute Myelogenous Leukemia(AML)
A Early Phase 1 study testing RD13-02 cell infusion in people with Neoplasms and Hematologic Neoplasms, run by Kai Lin Xu，MD 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 CAR-T therapy for patients with CD7-positive relapsed or refractory T-ALL/LBL/AML, 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
- Neoplasms, Hematologic Neoplasms, Hematologic Diseases
- 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
- 8 participants
- Where
- 1 siteChina
- Study dates
- 8 Mar 2023to 31 Aug 2024
- 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 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 T-ALL/LBL/AML.
- 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
- For AML patients, there are acute promyelocytic leukemia (APL) and Abelson Murine Leukemia Viral Oncogene Homolog(BCR-ABL) positive leukemia (chronic myeloid leukemia with acute(CML)-BC).
- Subjects with concomitant genetic syndromes associated with bone marrow failure states.
- Subjects with some cardiac conditions will be excluded.
- 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.
- Primary immune deficiency.
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- 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.
- Subjects with acute graft-versus-host disease (GvHD)
- Having received live/attenuated vaccine within 4 weeks prior to screening.
- History of allergy to any component of the cell therapy product.
- Pregnant or breastfeeding women
- Any other issue which, in the opinion of the investigator, would make the subjects ineligible for the study.
Trial locations and contacts
1 site in 1 country.
China1 site
Affiliated hospital of Xuzhou medical college
Xuzhou, Jiangsu, 221000
About this study
Official title: Clinical Study on Efficacy, Safety and Pharmacokinetics of CAR T Cell Injection in Patients With Recurrent or Refractory Cluster Of Differentiation 7(CD7)-Positive Hematologic Malignancies
This is a single-arm, open-label, single-center, phase I study. The primary objective is to evaluate the safety of CD7 CAR-T therapy for patients with CD7-positive relapsed or refractory T-ALL/LBL/AML, and to evaluate the pharmacokinetics of CD7 CAR-T in patients.
- Conditions
- Neoplasms, Hematologic Neoplasms, Hematologic Diseases
- Being tested
- RD13-02 cell infusion
- Medical subject headings
- Neoplasms, Hematologic Neoplasms, Hematologic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RD13-02 cell infusionDrug
CAR-T cells
| Study group | Role | What they receive |
|---|---|---|
| Research Development 13(RD13)-02 cell infusion | Experimental | drugs use generic name : RD13-02 CAR-T cell injection ; dosage form : Cell injection ; dosage : 2×10^8 CAR+ T cells ; frequency : Once. 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
Overall response rate, ORR
The proportion of patients with CR (complete response) /CRi (complete response with incomplete blood cell recovery) .
Measured: Evaluate at 8 weeks after CAR-T infusion
Overall response rate, ORR
The proportion of patients with CR (complete response) /CRi (complete response with incomplete blood cell recovery) .
Measured: Evaluate at 12 weeks after CAR-T infusion
Secondary outcomes (6)
Objective response rate , ORR
The proportion of patients with CR (complete response) /CRi (complete response with incomplete blood cell recovery) and partial response (PR).
Measured: Up to 1 years after CAR-T infusion
Overall response rate with Minimal Residual Disease (MRD)-negative, MRD-ORR
Proportion of patients achieving CR/CRi who is MRD-negative in bone marrow
Measured: Up to 1 years after CAR-T infusion
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
The proportion of patients who receive hematopoietic stem cell transplantation
The proportion of subjects who achieved remission after infusion who received Hematopoietic Stem Cell Transplantation (HSCT)
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 posted18 Jun 2023
- Study start8 Mar 2023
- 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 NeoplasmsStudies 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
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kai Lin Xu，MD
- Sponsor type
- University, hospital or other
- Collaborators
- Nanjing Bioheng Biotech Co., Ltd.
- Responsible party
- Sponsor-investigator, Kai Lin Xu，MD, Xuzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05907603
- Sponsor's protocol ID
- BHCT-RD13-02-06
- Status last verified
- Nov 2024
- First submitted
- 7 Jun 2023
- Last updated
- 21 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 21 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on Efficacy, Safety and Pharmacokinetics of CAR T Cell Injection in Patients With Recurrent or Refractory Cluster Of Differentiation 7(CD7)-Positive Hematologic Malignancies
- ClinicalTrials.gov ID
- NCT05907603
- Acronym / sponsor ID
- BHCT-RD13-02-06
- Conditions
- Neoplasms, Hematologic Neoplasms, Hematologic Diseases
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Kai Lin Xu，MDUniversity, hospital or other
- Collaborators
- Nanjing Bioheng Biotech Co., Ltd.
- Study start
- 8 Mar 2023 (actual)
- Primary completion
- 31 Aug 2024 (actual)
- Study completion
- 31 Aug 2024 (actual)
- First posted
- 18 Jun 2023 (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 CAR-T therapy for patients with CD7-positive relapsed or refractory T-ALL/LBL/AML, and to evaluate the pharmacokinetics of CD7 CAR-T 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 |
|---|---|---|
| Research Development 13(RD13)-02 cell infusion | Experimental | Drug: RD13-02 cell infusiondrugs use generic name : RD13-02 CAR-T cell injection ; dosage form : Cell injection ; dosage : 2×10^8 CAR+ T cells ; frequency : Once. |
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 T-ALL/LBL/AML.
- 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 (16 listed)
- For AML patients, there are acute promyelocytic leukemia (APL) and Abelson Murine Leukemia Viral Oncogene Homolog(BCR-ABL) positive leukemia (chronic myeloid leukemia with acute(CML)-BC).
- Subjects with concomitant genetic syndromes associated with bone marrow failure states.
- Subjects with some cardiac conditions will be excluded.
- 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.
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 infusionCAR-T cells | Drug | Research Development 13(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) .
Overall response rate, ORR
Time frame: Evaluate at 8 weeks after CAR-T infusion
The proportion of patients with CR (complete response) /CRi (complete response with incomplete blood cell recovery) .
Overall response rate, ORR
Time frame: Evaluate at 12 weeks after CAR-T infusion
The proportion of patients with CR (complete response) /CRi (complete response with incomplete blood cell recovery) .
6 secondary outcomes
Objective response rate , ORR
Time frame: Up to 1 years after CAR-T infusion
Overall response rate with Minimal Residual Disease (MRD)-negative, MRD-ORR
Time frame: Up to 1 years after CAR-T infusion
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
The proportion of patients who receive hematopoietic stem cell transplantation
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
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 21 Nov 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 RD13-02 cell infusion in people with Neoplasms and Hematologic Neoplasms, run by Kai Lin Xu，MD 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 16 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 21 Nov 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?
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?
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: Evaluate at 4 weeks after CAR-T infusion). The study lists 3 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 21 Nov 2024.