ImmunotherapyEarly Phase 1NCT05652530
Clinical Study of the Safety and Efficacy of BCMA CAR-NK
A Early Phase 1 study testing Chimeric Antigen Receptor NK Cell Injection Targeting BCMA (BCMA CAR-NK) in people with Immunotherapy and Multiple Myeloma, run by Shenzhen Pregene Biopharma Co., Ltd. at 1 site in China.
Trial summary
The goal of this clinical trial is to study of the Safety and Efficacy of Chimeric Antigen Receptor NK Cell Injection Targeting BCMA (BCMA CAR-NK) in Patients with Relapsed/Refractory Multiple Myeloma Primary Endpoints: To evaluate the safety and tolerability of patients with relapsed/refractory multiple myeloma… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Immunotherapy, Multiple Myeloma
- What is being tested?
- Chimeric Antigen Receptor NK Cell Injection Targeting BCMA (BCMA CAR-NK)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteChina
- Study dates
- 13 Nov 2022to 30 Nov 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or above, no gender preference.
- Patients who have received at least 3 prior lines of treatment for multiple myeloma and have failed at least proteasome inhibitor and immunomodulator therapy; Each line has at least 1 complete treatment cycle unless the best remission status for that treatment is documented as progressive disease (PD) (as per the IMWG efficacy evaluation criteria published in 2016, Appendix 4); PD must be documented during or within 12 months after receiving the last treatment.
- Presence of measurable lesions at screening, which are defined as any of the following situations:
- Serum M protein≥1 g/dL (≥10 g/L) Urinary M protein≥200 mg/24 hours Serum free light chain (FLC): abnormal serum FLC ratio (<0.26 or >1.65) and involved FLC≥10 mg/dL (100 mg/L)
- ECOG score (Appendix 1): 0~1.
- Expected survival≥3 months.
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- The following test values within 7 days prior to lymphocyte clearance meet the following criteria:
- Hematology Absolute lymphocyte count:≥0.5×109/L[Granulocyte colony-stimulating factor (G-CSF) is allowed, but subjects should not have received this supportive therapy within 7 days prior to laboratory test during the screening period] Absolute neutrophil count:≥1.0×10^9 /L[Granulocyte colony-stimulating factor (G-CSF) is allowed, but subjects should not have received this supportive therapy within 7 days prior to laboratory test during the screening period].
- Platelets:Subjects platelet count ≥50 x 10^9/L (subjects must not receive transfusion support within 7 days prior to laboratory test during the screening period) Hemoglobin:≥8.0 g/dL (recombinant human erythropoietin is allowed) [subjects have not received a red blood cell (RBC) transfusion within 7 days prior to laboratory test during the screening period].
- Liver Total bilirubin (serum) :Total bilirubin (serum) ≤1.5 × ULN AST and ALT:≤3× ULN
- Peripheral venous pathway meets the requirements of intravenous drip.
- Subjects agree to use reliable methods for contraception from the time of signing the informed consent till 1 year after the transfusion.
- Voluntary participation in the clinical trial and signing of the informed consent form.
Who cannot join
- Subjects who have had a severe anaphylactic reaction.
- Subjects who received the following anti-MM therapy within a specific time prior to lymphocyte clearance.
- Small molecule targeted therapy within 2 weeks or 5 half-lives (whichever is longer).
- Large-molecule drug within 4 weeks or 2 half-lives (whichever is longer). Cytotoxic drugs, modern Chinese medicine preparations with antitumor effects within 2 weeks.
- Immunomodulators therapy within 1 week.
- Subjects who have received a live or attenuated vaccine within 4 weeks prior to lymphocyte clearance.
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- Subjects who have received the following therapy within 7 days prior to lymphocyte clearance, or that requires long-term treatment during the study period according to the investigators:
- Systemic steroid therapy (except for inhaled one or topical use). Immunosuppressive therapy. Treatment of graft-versus-host response.
- Subjects presenting with incomplete recovery or stabilization to grade 1 (NCI-CTCAE v5.0) of toxicity (including peripheral neuropathy) caused by prior treatments.
- Cardiac disease: episode of myocardial infarction≤6 months prior to lymphocyte clearance; episode of unstable angina, severe arrhythmia as judged by the investigators, or coronary artery bypass graft≤3 months prior to lymphocyte clearance.
- Women who are pregnant or breastfeeding.
- Subjects who, in the opinion of the investigators, have any clinical or laboratory test abnormalities or other reasons that make them ineligible to participate in this clinical study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Henan Cancer Hospital
Zhengzhou, Henan, 450000
Baijun Fan, 13526607830, fdation@126.com
About this study
Official title: Clinical Study of the Safety and Efficacy of Chimeric Antigen Receptor NK Cell Injection Targeting BCMA (BCMA CAR-NK) in Patients With Relapsed/Refractory Multiple Myeloma
The goal of this clinical trial is to study of the Safety and Efficacy of Chimeric Antigen Receptor NK Cell Injection Targeting BCMA (BCMA CAR-NK) in Patients with Relapsed/Refractory Multiple Myeloma
Primary Endpoints:
Read more
To evaluate the safety and tolerability of patients with relapsed/refractory multiple myeloma (RR/MM) after BCMA CAR-NK infusion.
To determine the maximum tolerated dose (MTD) and/or subsequent recommended dose (RD) of BCMA CAR-NK in patients with RR/MM.
Secondary Endpoints:
To preliminarily evaluate the effectiveness of BCMA CAR-NK in patients with RR/MM.
To preliminarily evaluate the pharmacokinetic parameters of BCMA CAR-NK cells in patients with RR/MM.
To preliminarily evaluate BCMA CAR-NK cell survival in subjects blood in relation to efficacy, adverse events and relevant biomarker levels.
To preliminarily evaluate the relationship between donors and subjects KIR-Ligand mismatch and safety \& efficacy.
To preliminarily evaluate the impact of the degree of HLA genotype matching between donors and subjects on the survival of BCMA CAR-NK cells in the subjects blood.
Subjects are enrolled and treated with lymphocyte clearance chemotherapy (including pre-clearance evaluation), pre-infusion evaluation and BCMA CAR-NK cells infusion and enter the follow-up period after the end of the DLT observation period.
- Conditions
- Immunotherapy, Multiple Myeloma
- Being tested
- Chimeric Antigen Receptor NK Cell Injection Targeting BCMA (BCMA CAR-NK)
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chimeric Antigen Receptor NK Cell Injection Targeting BCMA (BCMA CAR-NK)Drug
Also called Lymphocyte clearance
This product is allogeneic NK cells which are cryopreserved after in vitro CAR genetic modification and scale-up manufacturing. Subjects are enrolled and treated with lymphocyte clearance chemotherapy (including pre-clearance evaluation), pre-infusion evaluation and BCMA CAR-NK cells infusion.
| Study group | Role | What they receive |
|---|---|---|
| BCMA CAR-NK | Experimental | Not described Receives: Drug: Chimeric Antigen Receptor NK Cell Injection Targeting BCMA (BCMA CAR-NK) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Toxicity Assessment per Adverse Event reporting classified according to CTCAE V5.0
per Adverse Event reporting classified according to CTCAE V5.0
Measured: Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2022
- Study start13 Nov 2022
- Primary completion30 Sep 2023 (estimated)
- Study completion30 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ImmunotherapyStudies 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
- 19 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenzhen Pregene Biopharma Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05652530
- Sponsor's protocol ID
- PRG2101
- Status last verified
- Dec 2022
- First submitted
- 28 Nov 2022
- Last updated
- 15 Dec 2022
- 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 15 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of the Safety and Efficacy of Chimeric Antigen Receptor NK Cell Injection Targeting BCMA (BCMA CAR-NK) in Patients With Relapsed/Refractory Multiple Myeloma
- ClinicalTrials.gov ID
- NCT05652530
- Acronym / sponsor ID
- PRG2101
- Conditions
- Immunotherapy, Multiple Myeloma
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 19 participants (estimated)
- Lead sponsor
- Shenzhen Pregene Biopharma Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 13 Nov 2022 (actual)
- Primary completion
- 30 Sep 2023 (estimated)
- Study completion
- 30 Nov 2023 (estimated)
- First posted
- 15 Dec 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.
The goal of this clinical trial is to study of the Safety and Efficacy of Chimeric Antigen Receptor NK Cell Injection Targeting BCMA (BCMA CAR-NK) in Patients with Relapsed/Refractory Multiple Myeloma
Primary Endpoints:
To evaluate the safety and tolerability of patients with relapsed/refractory multiple myeloma (RR/MM) after BCMA CAR-NK infusion.
To determine the maximum tolerated dose (MTD) and/or subsequent recommended dose (RD) of BCMA CAR-NK in patients with RR/MM.
Secondary Endpoints:
To preliminarily evaluate the effectiveness of BCMA CAR-NK in patients with RR/MM.
To preliminarily evaluate the pharmacokinetic parameters of BCMA CAR-NK cells in patients with RR/MM.
To preliminarily evaluate BCMA CAR-NK cell survival in subjects blood in relation to efficacy, adverse events and relevant biomarker levels.
To preliminarily evaluate the relationship between donors and subjects KIR-Ligand mismatch and safety \& efficacy.
To preliminarily evaluate the impact of the degree of HLA genotype matching between donors and subjects on the survival of BCMA CAR-NK cells in the subjects blood.
Subjects are enrolled and treated with lymphocyte clearance chemotherapy (including pre-clearance evaluation), pre-infusion evaluation and BCMA CAR-NK cells infusion and enter the follow-up period after the end of the DLT observation period.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BCMA CAR-NK | Experimental | Drug: Chimeric Antigen Receptor NK Cell Injection Targeting BCMA (BCMA CAR-NK) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Age 18 years or above, no gender preference.
- Patients who have received at least 3 prior lines of treatment for multiple myeloma and have failed at least proteasome inhibitor and immunomodulator therapy; Each line has at least 1 complete treatment cycle unless the best remission status for that treatment is documented as progressive disease (PD) (as per the IMWG efficacy evaluation criteria published in 2016, Appendix 4); PD must be documented during or within 12 months after receiving the last treatment.
- Presence of measurable lesions at screening, which are defined as any of the following situations:
- Serum M protein≥1 g/dL (≥10 g/L) Urinary M protein≥200 mg/24 hours Serum free light chain (FLC): abnormal serum FLC ratio (<0.26 or >1.65) and involved FLC≥10 mg/dL (100 mg/L)
- ECOG score (Appendix 1): 0~1.
Key exclusion criteria (12 listed)
- Subjects who have had a severe anaphylactic reaction.
- Subjects who received the following anti-MM therapy within a specific time prior to lymphocyte clearance.
- Small molecule targeted therapy within 2 weeks or 5 half-lives (whichever is longer).
- Large-molecule drug within 4 weeks or 2 half-lives (whichever is longer). Cytotoxic drugs, modern Chinese medicine preparations with antitumor effects within 2 weeks.
- Immunomodulators therapy within 1 week.
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 |
|---|---|---|
| Chimeric Antigen Receptor NK Cell Injection Targeting BCMA (BCMA CAR-NK)Also: Lymphocyte clearanceThis product is allogeneic NK cells which are cryopreserved after in vitro CAR genetic modification and scale-up manufacturing. Subjects are enrolled and treated with lymphocyte clearance chemotherapy (including pre-clearance evaluation), pre-infusion evaluation and BCMA CAR-NK cells infusion. | Drug | BCMA CAR-NK |
Primary outcome
Safety and Toxicity Assessment per Adverse Event reporting classified according to CTCAE V5.0
Time frame: Day 28
per Adverse Event reporting classified according to CTCAE V5.0
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 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 Chimeric Antigen Receptor NK Cell Injection Targeting BCMA (BCMA CAR-NK) in people with Immunotherapy and Multiple Myeloma, run by Shenzhen Pregene Biopharma Co., Ltd. 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 13 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: status not confirmed, as of the sponsor's last update on 15 Dec 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Toxicity Assessment per Adverse Event reporting classified according to CTCAE V5.0 (time frame: Day 28). 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 15 Dec 2022.