High-risk Plasma Cell NeoplasmsEarly Phase 1NCT07416682
CAR BCMA-70 CAR-T Cells for the Treatment of High-risk Plasma Cell Neoplasms
A Early Phase 1 study testing CAR BCMA-CD70-T cells and fludarabine and cyclophosphamide in people with High-risk Plasma Cell Neoplasms, run by Affiliated Hospital to Academy of Military Medical Sciences at 1 site in China.
Trial summary
This is a single arm study to evaluate the safety and efficacy of CAR BCMA-CD70 CAR-T cell therapy for high-risk plasma cell neoplasms. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- High-risk Plasma Cell Neoplasms
- What is being tested?
- CAR BCMA-CD70-T cells and fludarabine and cyclophosphamide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 14 Apr 2026to 30 Jan 2028
- Phase
- Early 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The subject or their legally acceptable representative has provided written informed consent and is willing and able to comply with all scheduled study visits, study treatment administration, laboratory tests, and other required trial procedures.
- Clinically diagnosed with high-risk plasma cell neoplasm, meeting any one of the following molecular/cytogenetic or clinical criteria:
- Deletion of the short arm of chromosome 17 (del(17p)) with clonal proportion ≥ 20%, and/or TP53 gene mutation;
- IgH translocation (t(4;14), t(14;16), or t(14;20)) combined with 1q amplification (1q+) and/or deletion of the short arm of chromosome 1 (del(1p32));
- Chromosome 1 abnormalities: monoallelic del(1p32) plus 1q+, or biallelic del(1p32);
- β₂-microglobulin ≥ 5.5 mg/L with normal serum creatinine (< 1.2 mg/dL).
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- Age 18 to 75 years (inclusive), male or female.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2.
- Life expectancy > 3 months from the date of signed informed consent.
- Hemoglobin (HGB) ≥ 60 g/L (transfusion permitted).
- Adequate hepatic, renal, and cardiopulmonary function as defined by:
- Serum creatinine ≤ 2 × ULN;
- Left ventricular ejection fraction (LVEF%) ≥ 50%;
- Blood oxygen saturation > 90%;
- Total bilirubin ≤ 1.5 × ULN; ALT and AST ≤ 2.5 × ULN.
- Subject agrees to use highly effective contraception from the date of informed consent until 1 year after CAR-T cell infusion.
Who cannot join
- Severe cardiac insufficiency with left ventricular ejection fraction (LVEF%) < 50%.
- History of severe chronic lung disease associated with impaired pulmonary function.
- Concurrent active or progressive malignant tumors other than the target plasma cell neoplasm.
- Concurrent severe infection that cannot be effectively controlled with standard therapy.
- Concurrent severe autoimmune disease or congenital immunodeficiency disorders.
- Active viral hepatitis, defined as hepatitis B virus DNA (HBV-DNA) or hepatitis C virus RNA (HCV-RNA) levels above the lower limit of detection (LLOD).
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- Human immunodeficiency virus (HIV) infection, known acquired immunodeficiency syndrome (AIDS), or syphilis infection.
- History of severe allergic reactions to biological products, including antibiotics.
- Recipients of allogeneic hematopoietic stem cell transplantation (allo-HSCT) with persistent acute graft-versus-host disease (aGVHD) that does not resolve within 1 month after discontinuing immunosuppressive therapy.
- Presence of other severe physical or psychiatric illnesses, or significant laboratory abnormalities, that may increase the risks of study participation, interfere with study outcomes, or render the subject otherwise unsuitable for enrollment as determined by the investigator.
- Female subjects of childbearing potential who are pregnant or breastfeeding.
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
the Fifth Medical Center of Chinese People's Liberation Army General Hospital
Beijing, Beijing Municipality
About this study
Official title: Clinical Study on the Safety and Efficacy of CAR BCMA-CD70 Dual-target CAR-T Therapy for High-risk Plasma Cell Neoplasms
This is a single arm study to evaluate the safety and efficacy of CAR BCMA-CD70 CAR-T cell therapy for high-risk plasma cell neoplasms.
- Conditions
- High-risk Plasma Cell Neoplasms
- Being tested
- CAR BCMA-CD70-T cells, fludarabine and cyclophosphamide
- Keywords
- High-risk Plasma Cell Neoplasms, BCMA, CD70, CAR-T
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAR BCMA-CD70-T cellsGenetic
Each subject will be infused with single dose of BCMA-CD70-CAR-T cells. A classic "3+3" dose escalation will be employed. The low dose is 1×10^6 /kg, the medium dose is 2×10^6 /kg, and the high dose is 3×10^6 /kg.
fludarabine and cyclophosphamideDrug
Description: Drug: Fludarabine Fludarabine will be given at a dose of 30 mg/m2/day intravenously (IV) for 3 days prior to the infusion of BCMA-CD70-CAR-T cells. Drug: Cyclophosphamide Cyclophosphamide will be given at a dose of 300 mg/m2/day intravenously (IV) for 3 days prior to the infusion of BCMA-CD70-CAR-T cells.
| Study group | Role | What they receive |
|---|---|---|
| This is a single arm treatment of CAR BCMA-CD70 CAR-T cell | Experimental | Experimental: CAR BCMA-CD70 T cells Therapy. Investigational product: CAR BCMA-CD70 T cells. Route of administration: Intravenous injection. Lymphodepleting chemotherapy regimen: A combination of fludarabine and cyclophosphamide will be administered prior to the infusion of BCMA-CD70-CAR-T cells. Receives: Genetic: CAR BCMA-CD70-T cells; Drug: fludarabine and cyclophosphamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
According to the incidence of treatment-related adverse events (AEs) to evaluate the safetyof CAR BCMA-CD70 CAR-T cells in the treatment of CD70/BCMA positive high-risk plasma cell neoplasms.
Incidence of treatment-related adverse events (AEs) Description: Number and severity of adverse events graded according to CTCAE v5.0, including cytokine release syndrome (CRS) graded by ASTCT criteria and immune effector cell-associated neurotoxicity syndrome (ICANS) graded by ASBMT criteria
Measured: up to 3 years
According to the determine the Maximal Tolerable Dose(MTD) to evaluate the safety of CAR BCMA-CD70 CAR-T cells in the treatment of CD70/BCMA positive high-risk plasma cell neoplasms.
Measured: MTD will be determined based on DLTs observed during the first 28 days of study treatment
Secondary outcomes (1)
According to the objective response rate (ORR) to evaluate the efficacy of CAR BCMA-CD70 CAR-T cells in the treatment of CD70/BCMA positive high-risk plasma cell neoplasms.
Overall response rate (ORR) Description: Multiple myeloma (plasma cell neoplasms, plasma cell leukemia) refers to the efficacy evaluation criteria in the Chinese Guidelines for the Diagnosis and Treatment of Multiple Myeloma (revised in 2024),ORR includes strictly defined proportions of complete response (sCR), complete response (CR), very good partial response (VGPR), partial response (PR), and minimal response (MR).
Measured: Within 3 months following infusion of CAR BCMA-CD70 CAR-T cells
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2026
- Study start14 Apr 2026
- Primary completion30 Jan 2027 (estimated)
- Study completion30 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High-risk Plasma Cell 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Affiliated Hospital to Academy of Military Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07416682
- Sponsor's protocol ID
- CAR BCMA-70-XYBYXB
- Status last verified
- Jul 2026
- First submitted
- 11 Feb 2026
- Last updated
- 13 Jul 2026
- 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 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on the Safety and Efficacy of CAR BCMA-CD70 Dual-target CAR-T Therapy for High-risk Plasma Cell Neoplasms
- ClinicalTrials.gov ID
- NCT07416682
- Acronym / sponsor ID
- CAR BCMA-70-XYBYXB
- Conditions
- High-risk Plasma Cell Neoplasms
- Keywords
- High-risk Plasma Cell Neoplasms, BCMA, CD70, CAR-T
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Affiliated Hospital to Academy of Military Medical SciencesUniversity, hospital or other
- Study start
- 14 Apr 2026 (actual)
- Primary completion
- 30 Jan 2027 (estimated)
- Study completion
- 30 Jan 2028 (estimated)
- First posted
- 18 Feb 2026 (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 study to evaluate the safety and efficacy of CAR BCMA-CD70 CAR-T cell therapy for high-risk plasma cell neoplasms.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| This is a single arm treatment of CAR BCMA-CD70 CAR-T cell | Experimental | Genetic: CAR BCMA-CD70-T cells, Drug: fludarabine and cyclophosphamideExperimental: CAR BCMA-CD70 T cells Therapy. Investigational product: CAR BCMA-CD70 T cells. Route of administration: Intravenous injection. Lymphodepleting chemotherapy regimen: A combination of fludarabine and cyclophosphamide will be administered prior to the infusion of BCMA-CD70-CAR-T cells. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- The subject or their legally acceptable representative has provided written informed consent and is willing and able to comply with all scheduled study visits, study treatment administration, laboratory tests, and other required trial procedures.
- Clinically diagnosed with high-risk plasma cell neoplasm, meeting any one of the following molecular/cytogenetic or clinical criteria:
- Age 18 to 75 years (inclusive), male or female.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2.
- Life expectancy > 3 months from the date of signed informed consent.
Key exclusion criteria (11 listed)
- Severe cardiac insufficiency with left ventricular ejection fraction (LVEF%) < 50%.
- History of severe chronic lung disease associated with impaired pulmonary function.
- Concurrent active or progressive malignant tumors other than the target plasma cell neoplasm.
- Concurrent severe infection that cannot be effectively controlled with standard therapy.
- Concurrent severe autoimmune disease or congenital immunodeficiency disorders.
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 |
|---|---|---|
| CAR BCMA-CD70-T cellsEach subject will be infused with single dose of BCMA-CD70-CAR-T cells. A classic "3+3" dose escalation will be employed. The low dose is 1×10^6 /kg, the medium dose is 2×10^6 /kg, and the high dose is 3×10^6 /kg. | Genetic | This is a single arm treatment of CAR BCMA-CD70 CAR-T cell |
| fludarabine and cyclophosphamideDescription: Drug: Fludarabine Fludarabine will be given at a dose of 30 mg/m2/day intravenously (IV) for 3 days prior to the infusion of BCMA-CD70-CAR-T cells. Drug: Cyclophosphamide Cyclophosphamide will be given at a dose of 300 mg/m2/day intravenously (IV) for 3 days prior to the infusion of BCMA-CD70-CAR-T cells. | Drug | This is a single arm treatment of CAR BCMA-CD70 CAR-T cell |
Primary outcome
According to the incidence of treatment-related adverse events (AEs) to evaluate the safetyof CAR BCMA-CD70 CAR-T cells in the treatment of CD70/BCMA positive high-risk plasma cell neoplasms.
Time frame: up to 3 years
Incidence of treatment-related adverse events (AEs) Description: Number and severity of adverse events graded according to CTCAE v5.0, including cytokine release syndrome (CRS) graded by ASTCT criteria and immune effector cell-associated neurotoxicity syndrome (ICANS) graded by ASBMT criteria
According to the determine the Maximal Tolerable Dose(MTD) to evaluate the safety of CAR BCMA-CD70 CAR-T cells in the treatment of CD70/BCMA positive high-risk plasma cell neoplasms.
Time frame: MTD will be determined based on DLTs observed during the first 28 days of study treatment
1 secondary outcome
According to the objective response rate (ORR) to evaluate the efficacy of CAR BCMA-CD70 CAR-T cells in the treatment of CD70/BCMA positive high-risk plasma cell neoplasms.
Time frame: Within 3 months following infusion of CAR BCMA-CD70 CAR-T cells
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 Jul 2026.
- 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 Early Phase 1 study testing CAR BCMA-CD70-T cells and fludarabine and cyclophosphamide in people with High-risk Plasma Cell Neoplasms, run by Affiliated Hospital to Academy of Military Medical Sciences 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 16 inclusion and 11 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 Jul 2026. 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?
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 Yamei Wu (+86 01066947164, rippleya@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
According to the incidence of treatment-related adverse events (AEs) to evaluate the safetyof CAR BCMA-CD70 CAR-T cells in the treatment of CD70/BCMA positive high-risk plasma cell neoplasms. (time frame: up to 3 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 13 Jul 2026.