Relapsed or Refractory Plasma Cell NeoplasmsEarly Phase 1NCT07519187
CAR 70-BCMA CAR-T Cells for the Treatment of Relapsed or Refractory Plasma Cell Neoplasms
A Early Phase 1 study testing CAR 70-BCMA CAR-T in people with Relapsed or Refractory Plasma Cell Neoplasms, run by The General Hospital of Western Theater Command at 1 site in China.
Trial summary
This is a single arm study to evaluate the safety and efficacy of CAR70-BCMA dual-target CAR-T cell therapy for relapsed and refractory plasma cell neoplasms. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Relapsed or Refractory Plasma Cell Neoplasms
- What is being tested?
- CAR 70-BCMA CAR-T
- 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
- 23 Apr 2026to 1 Apr 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 authorized representative has provided written informed consent and is willing and able to comply with scheduled visits, study treatment, laboratory tests, and other study procedures
- Diagnosis of relapsed or refractory plasma cell neoplasms, defined as follows:
- Clonal plasma cells positive for BCMA and/or CD70 expression as determined by flow cytometry or immunohistochemistry
- Patients with multiple myeloma, plasmacytoma, or plasma cell leukemia who have received at least three prior lines of therapy, including a proteasome inhibitor (PI), an immunomodulatory agent (IMiD), and an anti-CD38 monoclonal antibody, and whose best response was less than partial response (PR) or who experienced disease progression after achieving at least PR
- Patients with systemic light chain amyloidosis who have received at least two prior lines of therapy, including an anti-CD38 monoclonal antibody and either a proteasome inhibitor (PI) or an immunomodulatory agent (IMiD), and whose best response was less than partial response (PR) or who experienced disease progression after achieving at least PR
- Aged 18 to 75 years (inclusive), male or female
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- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Life expectancy greater than 3 months from the date of informed consent
- Hemoglobin (HGB) ≥ 60 g/L (transfusion permitted)
- Adequate hepatic, renal, cardiac, and pulmonary function meeting the following criteria:
- Creatinine ≤ 2 × upper limit of normal (ULN)
- Left ventricular ejection fraction (LVEF) ≥ 50%
- Oxygen saturation > 90%
- Total bilirubin ≤ 1.5 × ULN; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN
- The subject agrees to use contraceptive measures from the time of signing the informed consent form until 1 year after CAR-T cell infusion
Who cannot join
- Severe cardiac dysfunction with left ventricular ejection fraction (LVEF) < 50%
- History of severe pulmonary function impairment
- Concurrent progressive malignancy
- Concurrent severe infection that cannot be adequately controlled
- Concurrent severe autoimmune disease or congenital immunodeficiency
- Active hepatitis, defined as hepatitis B virus deoxyribonucleic acid (HBV-DNA) or hepatitis C virus ribonucleic acid (HCV-RNA) above the lower limit of detection
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- Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS), or syphilis infection
- History of severe allergic reaction to biological products (including antibiotics)
- Patients who have undergone allogeneic hematopoietic stem cell transplantation and still have acute graft-versus-host disease (GVHD) one month after discontinuation of immunosuppressive agents
- Presence of any other serious physical or mental illness, or laboratory abnormality that may increase the risk of study participation, interfere with the interpretation of study results, or render the patient unsuitable for study enrollment in the opinion of the investigator
- Female patients 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
General Hospital of Western Theater Command of PLA
Chengdu, Chengdu
About this study
Official title: Clinical Study on the Safety and Efficacy of CAR 70-BCMA Dual-Target CAR-T Therapy for Relapsed or Refractory Plasma Cell Neoplasms
This is a single arm study to evaluate the safety and efficacy of CAR70-BCMA dual-target CAR-T cell therapy for relapsed and refractory plasma cell neoplasms.
- Being tested
- CAR 70-BCMA CAR-T
- Keywords
- Relapsed and Refractory Plasma Cell Neoplasms., BCMA, CD70, CAR-T
- Medical subject headings
- Recurrence, Neoplasms, Plasma Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAR 70-BCMA CAR-TGenetic
Each subject will receive a single infusion of BCMA-CD70-CAR-T cells. A classic "3+3" dose escalation design will be employed.
| Study group | Role | What they receive |
|---|---|---|
| This is a single arm treatment of CAR 70-BCMA CAR-T cell | Experimental | CAR 70-BCMA CAR-T Therapy. Investigational product: CAR 70-BCMA CAR-T. Route of administration: Intravenous injection. Lymphodepleting chemotherapy regimen: A combination of fludarabine and cyclophosphamide will be administered prior to the infusion of CAR 70-BCMA CAR-T cells. Receives: Genetic: CAR 70-BCMA CAR-T |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the safety of CAR70-BCMA dual-target chimeric antigen receptor T-cell therapy in patients with relapsed or refractory plasma cell neoplasms expressing CD70 and/or BCMA based on the incidence of treatment-emergent adverse events (AEs).
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v5.0
Measured: Up to 3 years
To evaluate the safety of CAR70-BCMA CAR-T cells in the treatment of relapsed or refractory plasma cell neoplasms positive for CD70/BCMA based on the determination of the maximum tolerated dose (MTD).
Incidence of dose-limiting toxicity (DLT)
Measured: Up to 28 days after CAR-T treatment
Secondary outcomes (1)
To evaluate the efficacy of CAR70-BCMA CAR-T cells in the treatment of relapsed or refractory plasma cell neoplasms positive for CD70/BCMA based on the objective response rate (ORR).
Objective response rate (ORR) Description: For multiple myeloma (plasma cell neoplasms, plasma cell leukemia), the efficacy evaluation criteria refer to the Chinese Guidelines for the Diagnosis and Treatment of Multiple Myeloma (2024 Revision). ORR includes the proportion of stringent 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 CAR70-BCMA 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 posted9 Apr 2026
- Study start23 Apr 2026
- Primary completion1 Apr 2027 (estimated)
- Study completion1 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed or Refractory 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
- The General Hospital of Western Theater Command
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07519187
- Sponsor's protocol ID
- CAR 70-BCMA-YHWX
- Status last verified
- Jun 2026
- First submitted
- 2 Apr 2026
- Last updated
- 9 Jun 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 9 Jun 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 70-BCMA Dual-Target CAR-T Therapy for Relapsed or Refractory Plasma Cell Neoplasms
- ClinicalTrials.gov ID
- NCT07519187
- Acronym / sponsor ID
- CAR 70-BCMA-YHWX
- Keywords
- Relapsed and Refractory Plasma Cell Neoplasms., BCMA, CD70, CAR-T
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- The General Hospital of Western Theater CommandUniversity, hospital or other
- Study start
- 23 Apr 2026 (actual)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 Apr 2028 (estimated)
- First posted
- 9 Apr 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 CAR70-BCMA dual-target CAR-T cell therapy for relapsed and refractory 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 70-BCMA CAR-T cell | Experimental | Genetic: CAR 70-BCMA CAR-TCAR 70-BCMA CAR-T Therapy. Investigational product: CAR 70-BCMA CAR-T. Route of administration: Intravenous injection. Lymphodepleting chemotherapy regimen: A combination of fludarabine and cyclophosphamide will be administered prior to the infusion of CAR 70-BCMA 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 (15 listed)
- The subject or their legally authorized representative has provided written informed consent and is willing and able to comply with scheduled visits, study treatment, laboratory tests, and other study procedures
- Diagnosis of relapsed or refractory plasma cell neoplasms, defined as follows:
- Aged 18 to 75 years (inclusive), male or female
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Life expectancy greater than 3 months from the date of informed consent
Key exclusion criteria (11 listed)
- Severe cardiac dysfunction with left ventricular ejection fraction (LVEF) < 50%
- History of severe pulmonary function impairment
- Concurrent progressive malignancy
- Concurrent severe infection that cannot be adequately controlled
- Concurrent severe autoimmune disease or congenital immunodeficiency
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 70-BCMA CAR-TEach subject will receive a single infusion of BCMA-CD70-CAR-T cells. A classic "3+3" dose escalation design will be employed. | Genetic | This is a single arm treatment of CAR 70-BCMA CAR-T cell |
Primary outcome
To evaluate the safety of CAR70-BCMA dual-target chimeric antigen receptor T-cell therapy in patients with relapsed or refractory plasma cell neoplasms expressing CD70 and/or BCMA based on the incidence of treatment-emergent adverse events (AEs).
Time frame: Up to 3 years
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v5.0
To evaluate the safety of CAR70-BCMA CAR-T cells in the treatment of relapsed or refractory plasma cell neoplasms positive for CD70/BCMA based on the determination of the maximum tolerated dose (MTD).
Time frame: Up to 28 days after CAR-T treatment
Incidence of dose-limiting toxicity (DLT)
1 secondary outcome
To evaluate the efficacy of CAR70-BCMA CAR-T cells in the treatment of relapsed or refractory plasma cell neoplasms positive for CD70/BCMA based on the objective response rate (ORR).
Time frame: Within 3 months following infusion of CAR70-BCMA 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 9 Jun 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 70-BCMA CAR-T in people with Relapsed or Refractory Plasma Cell Neoplasms, run by The General Hospital of Western Theater Command 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 15 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 9 Jun 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 Hai Yi (13699418229, yihaimail@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the safety of CAR70-BCMA dual-target chimeric antigen receptor T-cell therapy in patients with relapsed or refractory plasma cell neoplasms expressing CD70 and/or BCMA based on the incidence of treatment-emergent adverse events (AEs). (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 9 Jun 2026.